230 results on '"Clifton O. Bingham"'
Search Results
2. Pain Sensitization as a Potential Mediator of the Relationship Between Sleep Disturbance and Subsequent Pain in Rheumatoid Arthritis
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Jing Song, Lutfiyya N. Muhammad, Tuhina Neogi, Dorothy D. Dunlop, Alyssa Wohlfahrt, Marcy B. Bolster, Clifton O. Bingham, Daniel J. Clauw, Wendy Marder, and Yvonne C. Lee
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Rheumatology - Abstract
Many patients with rheumatoid arthritis (RA) experience sleep disturbances, commonly attributed to joint pain. Sleep disturbances could also influence pain. One mechanism may be through dysregulated pain processing, manifested by enhanced pain sensitivity. The present study was undertaken to examine the role of pain sensitization, measured by quantitative sensory testing (QST), as a mediator in the pathway of sleep disturbance leading to subsequent pain.We used longitudinal data from 221 patients with active RA who were followed for 12 weeks after initiating a disease-modifying antirheumatic drug. Baseline QST included pressure pain thresholds at articular (wrists, knees) and nonarticular (trapezius, thumbnails) sites, temporal summation (TS) at the wrist and forearm, and conditioned pain modulation (CPM). Baseline sleep disturbance and subsequent pain intensity were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). We evaluated correlations between sleep disturbance, QSTs, and subsequent pain intensity. Mediation analyses separately assessed each QST as a mediator, adjusting for baseline confounding factors.Sleep disturbance was correlated with all QST measures except wrist TS and CPM. Sleep disturbance significantly predicted subsequent pain (coefficient for a meaningful increase of 5 units in sleep disturbance = 0.32 (95% confidence interval 0.11, 0.50) in multiple regression. QST mediated 10-19% of this effect.Pain sensitization may be one mechanism through which sleep disturbance contributes to pain. The small magnitude of association indicates that unmeasured pathways may contribute to this relationship. Intervention studies are needed to establish causality and determine whether improving sleep can improve pain in patients with RA.
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- 2022
3. Machine Learning Applied to <scp>Patient‐Reported</scp> Outcomes to Classify <scp>Physician‐Derived</scp> Measures of Rheumatoid Arthritis Disease Activity
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Jeffrey R. Curtis, Yujie Su, Shawn Black, Stephen Xu, Wayne Langholff, Clifton O. Bingham, Shelly Kafka, and Fenglong Xie
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Rheumatology - Abstract
Patient-reported outcome (PRO) data have assumed increasing importance in the care of patients with rheumatoid arthritis (RA), yet physician-derived disease activity measures, such as Clinical Disease Activity Index (CDAI), remain the most accepted metrics to assess disease activity. The possibility that newer longitudinal PRO data might be used as a proxy for the CDAI has not been evaluated.Using data from a large pragmatic trial, we evaluated patients with RA initiating golimumab intravenous or infliximab. The classification target was low disease activity (LDA) (CDAI ≤10) at the first visit between months 3 and 12. Data were randomly partitioned into training (80%) and test (20%) data sets. Multiple machine learning (ML) methods (eg, random forests, gradient boosting, support vector machines) were used to classify CDAI disease activity category, conduct feature selection, and assess feature importance. Model performance evaluated cross-validated error, comparing different ML approaches using both training and test data.A total of 494 patients were analyzed, and 36.4% achieved LDA. The most important classification features included several Patient-Reported Outcomes Measurement Information System measures (social participation, pain interference, pain intensity, and physical function), patient global, and baseline CDAI. Among all ML methods, random forests performed best. Overall model accuracy and positive predictive values for all ML methods were approximately 80%.ML methods coupled with longitudinal PRO data appear useful and can achieve reasonable accuracy in classifying LDA among patients starting a new biologic. This approach has promise for real-world evidence generation in the common circumstance when physician-derived disease activity data are not available yet PRO measures are.
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- 2022
4. Comparative effectiveness of TNF inhibitor vs IL-6 receptor inhibitor as monotherapy or combination therapy with methotrexate in biologic-experienced patients with rheumatoid arthritis: An analysis from the CorEvitas RA Registry
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Anthony Sebba, Clifton O. Bingham, Vivian P. Bykerk, Stefano Fiore, Kerri Ford, Jud C. Janak, Dimitrios A. Pappas, Taylor Blachley, Swapna S. Dave, Joel M. Kremer, Miao Yu, and Ernest Choy
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Rheumatology ,General Medicine - Abstract
Objective Randomized controlled trials (RCTs) in biologic-naïve rheumatoid arthritis (RA) patients with high disease activity and inadequate response/intolerance to methotrexate have shown interleukin-6 (IL-6) receptor inhibitors (IL-6Ri) to be superior to tumor necrosis factor inhibitors (TNFi) as monotherapy. This observational study aimed to compare the effectiveness of TNFi vs IL-6Ri as mono- or combination therapy in biologic/targeted synthetic (b/ts) -experienced RA patients with moderate/high disease activity. Methods Eligible b/ts-experienced patients from the CorEvitas RA registry were categorized as TNFi and IL-6Ri initiators, with subgroups initiating as mono- or combination therapy. Mixed-effects regression models evaluated the impact of treatment on Clinical Disease Activity Index (CDAI), patient-reported outcomes, and disproportionate pain (DP). Unadjusted and covariate-adjusted effects were reported. Results Patients initiating IL-6Ri (n = 286) vs TNFi monotherapy (n = 737) were older, had a longer RA history and higher baseline CDAI, and were more likely to initiate as third-line therapy; IL-6Ri (n = 401) vs TNFi (n = 1315) combination therapy initiators had higher baseline CDAI and were more likely to initiate as third-line therapy. No significant differences were noted in the outcomes between TNFi and IL-6Ri initiators (as mono- or combination therapy). Conclusion This observational study showed no significant differences in outcomes among b/ts-experienced TNFi vs IL-6Ri initiators, as either mono- or combination therapy. These findings were in contrast with the previous RCTs in biologic-naïve patients and could be explained by the differences in the patient characteristics included in this study. Further studies are needed to help understand the reasons for this discrepancy in the real-world b/ts-experienced population. Key Points• Patients with rheumatoid arthritis (RA) often require switching between biologics or targeted synthetic (b/ts) disease-modifying anti-rheumatic drugs (DMARDs) to achieve their treatment target.• Head-to-head randomized controlled trials (RCTs) in biologic-naïve RA patients with high disease activity and inadequate response/intolerance to methotrexate have shown interleukin-6 receptor inhibitors (IL-6Ri) to be superior to tumor necrosis factor inhibitors (TNFi) as monotherapy; however, there are no RCTs comparing these therapies in a population previously treated with b/tsDMARDs (i.e., b/ts-experienced patients).• This observational study compared the effectiveness of TNFi vs IL-6Ri (as mono- or combination therapy) in b/ts-experienced RA patients with moderate or high disease activity and found no significant differences in clinical outcomes for the two treatments.• A discrepancy is noted between our study and RCTs, which have shown superiority of IL-6Ri therapy (albeit in biologic-naïve patients). Further analyses may help elucidate the reason for this discrepancy in the real-world b/ts-experienced population.
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- 2023
5. Stricter treat-to-target in RA does not result in less radiographic progression
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Sofia Ramiro, Robert Landewé, Désirée van der Heijde, Alexandre Sepriano, Oliver FitzGerald, Mikkel Østergaard, Joanne Homik, Ori Elkayam, J Carter Thorne, Maggie J Larché, Gianfranco Ferraccioli, Marina Backhaus, Gilles Boire, Bernard Combe, Thierry Schaeverbeke, Alain Saraux, Maxime Dougados, Maurizio Rossini, Marcello Govoni, Luigi Sinigaglia, Alain G Cantagrel, Cornelia F Allaart, Cheryl Barnabe, Clifton O Bingham, Dirkjan van Schaardenburg, Hilde B Hammer, Rana Dadashova, Edna Hutchings, Joel Paschke, and Walter P Maksymowych
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rheumatoid arthritis ,treat-to-target ,Rheumatology ,radiographic progression ,Pharmacology (medical) ,outcomes ,RA - Abstract
Objectives To investigate whether meticulously following a treat-to-target (T2T)-strategy in daily clinical practice will lead to less radiographic progression in patients with active RA who start (new) DMARD-therapy. Methods Patients with RA from 10 countries starting/changing conventional synthetic or biologic DMARDs because of active RA, and in whom treatment intensification according to the T2T principle was pursued, were assessed for disease activity every 3 months for 2 years (RA-BIODAM cohort). The primary outcome was the change in Sharp-van der Heijde (SvdH) score, assessed every 6 months. Per 3-month interval DAS44-T2T could be followed zero, one or two times (in a total of two visits). The relation between T2T intensity and change in SvdH-score was modelled by generalized estimating equations. Results In total, 511 patients were included [mean (s.d.) age: 56 (13) years; 76% female]. Mean 2-year SvdH progression was 2.2 (4.1) units (median: 1 unit). A stricter application of T2T in a 3-month interval did not reduce progression in the same 6-month interval [parameter estimates (for yes vs no): +0.15 units (95% CI: −0.04, 0.33) for 2 vs 0 visits; and +0.08 units (−0.06; 0.22) for 1 vs 0 visits] nor did it reduce progression in the subsequent 6-month interval. Conclusions In this daily practice cohort, following T2T principles more meticulously did not result in less radiographic progression than a somewhat more lenient attitude towards T2T. One possible interpretation of these results is that the intention to apply T2T already suffices and that a more stringent approach does not further improve outcome.
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- 2023
6. PROMIS Provides a Broader Overview of Health-related Quality of Life Than the ESSPRI in Evaluation of Sjögren Syndrome
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Dana D. DiRenzo, Susan Robinson, Clifton O. Bingham, Alan N. Baer, and Thomas Grader-Beck
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Adult ,Cross-Sectional Studies ,Sjogren's Syndrome ,Rheumatology ,Immunology ,Quality of Life ,Humans ,Pain ,Immunology and Allergy ,Patient Reported Outcome Measures ,Article ,Fatigue ,Information Systems - Abstract
ObjectiveSjögren syndrome (SS) has a significant impact on health-related quality of life (HRQOL). We sought to evaluate how the Patient Reported Outcome Measurement Information System (PROMIS) domains in SS may supplement the European League Against Rheumatism (EULAR) Sjögren Syndrome Patient Reported Index (ESSPRI).MethodsA cross-sectional evaluation was performed on consecutive adult patients during visits to an SS clinic between March 2018 and February 2020. Each patient completed PROMIS short forms related to HRQOL and the ESSPRI, and had a clinical assessment. Patients were either classified as SS by 2016 American College of Rheumatology (ACR)/EULAR criteria, or as “sicca not otherwise specified (NOS)” and used as a comparison group. Univariable and multivariable linear regression models were used to evaluate predictors of PROMIS fatigue (-F), pain interference (-PI), and ability to participate in social roles and activities (-APS).ResultsTwo hundred twenty-seven patients with SS and 85 with sicca NOS were included and did not differ in ESSPRI domains; 26% of the SS and 20% of the sicca NOS group had concurrent autoimmune disease. In SS, PROMIS-PI, PROMIS-F, and PROMIS physical function were at least one-half SD worse than US population normative values. PROMIS-PI (r = 0.73) and PROMIS-F (r = 0.80) were highly correlated with ESSPRI pain and fatigue subdomains. Fatigue and pain interference, but not dryness or mood disturbance, were the strongest predictors of social participation in multivariable analysis.ConclusionIn our SS cohort, PROMIS instruments identified a high disease burden of pain interference, fatigue, and physical function. PROMIS-F strongly predicted PROMIS-APS. PROMIS-PI and PROMIS-F scores correlated highly with their respective ESSPRI domains. PROMIS instruments should be considered to identify relevant HRQOL patterns in SS.
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- 2022
7. Maintenance of Patient-Reported Outcomes in Baricitinib-Treated Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Post Hoc Analyses from Two Phase 3 Trials
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Dalton, Sholter, Jianmin, Wu, Bochao, Jia, Hong, Zhang, Kirstin, Griffing, Julie, Birt, Paulo Jorge Simoes, Reis, Huaxiang, Liu, and Clifton O, Bingham
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Rheumatology ,Immunology and Allergy - Abstract
Baricitinib has been shown to improve patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) who are inadequate responders (IR) to conventional synthetic and biologic disease-modifying antirheumatic drugs (csDMARDs and bDMARDs, respectively). We assessed the ability of baricitinib 2-mg to maintain minimal clinically important differences (MCIDs) in PROs until week 24 among week 4 and 12 responders.Data were from two phase 3 trials, RA-BUILD (NCT01721057; csDMARD-IR patients) and RA-BEACON (NCT01721044; bDMARD-IR patients). PROs included Pain Visual Analogue Scale, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, Short-Form 36 Physical Component Score, and Patient's Global Assessment of Disease Activity. Outcomes were evaluated by proportions of patients achieving MCID improvements, number needed to treat (NNT) at weeks 4, 12, and 24, proportions of patients maintaining MCID responses at week 24 among week 4 or 12 responders, and median time to achieve substantial response with baricitinib 2-mg versus placebo.A higher proportion of baricitinib-treated patients achieved MCID improvements, with NNTs ranging from 5 to 8 for baricitinib 2-mg versus placebo at week 24. Generally, early MCID responses in PROs at weeks 4 or 12 were better maintained through week 24 in RA patients treated with baricitinib 2-mg versus placebo. Patients treated with baricitinib 2-mg also achieved substantial PRO responses or normative values more quickly than placebo.These results suggest baricitinib-treated patients with RA achieving MCID improvement in PROs at weeks 4 and 12 maintained those improvements over time and that substantial PRO responses were achieved quickly.
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- 2022
8. The evolution of instrument selection for inclusion in core outcome sets at OMERACT
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Zahi Touma, George A. Wells, Peter Tugwell, Shawna Grosskleg, Maarten Boers, Sarah L. Mackie, Lara J Maxwell, Christopher Hill, Catherine Hofstetter, Andrea S. Doria, Dorcas E. Beaton, Philip G. Conaghan, Beverley Shea, Robin Christensen, Clifton O. Bingham, Alexa Meara, Féline P B Kroon, Ernest Choy, Ying Ying Leung, Annelies Boonen, Maria Antonietta D'Agostino, Epidemiology and Data Science, AII - Inflammatory diseases, APH - Methodology, Interne Geneeskunde, MUMC+: MA Reumatologie (9), and RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation
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musculoskeletal diseases ,Diagnostic Imaging ,Settore MED/16 - REUMATOLOGIA ,GUIDELINES ,Outcome (game theory) ,Instrument selection ,RESPONSIVENESS ,Documentation ,Rheumatology ,Outcome Assessment, Health Care ,Medicine ,Humans ,Selection algorithm ,Selection (genetic algorithm) ,Information retrieval ,business.industry ,OF-LIFE INSTRUMENTS ,Methodology ,OMERACT ,Outcome measurement instruments ,humanities ,Core (game theory) ,Anesthesiology and Pain Medicine ,Filter (video) ,Core outcome sets ,Observational study ,business ,Inclusion (education) ,CLINICAL-TRIALS ,Rheumatic and musculoskeletal diseases - Abstract
INTRODUCTION: OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument Selection Algorithm' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials.METHODS: A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes.RESULTS: OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property.CONCLUSIONS: OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.
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- 2021
9. Predicting Disease Activity in Rheumatoid Arthritis with the Fibromyalgia Survey Questionnaire: Does the Severity of Fibromyalgia Symptoms Matter?
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Alexander M. Gorzewski, Andrew C. Heisler, Tuhina Neogi, Lutfiyya N. Muhammad, Jing Song, Dorothy Dunlop, Clifton O. Bingham, Marcy B. Bolster, Daniel J. Clauw, Wendy Marder, and Yvonne C. Lee
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Rheumatology ,Immunology ,Immunology and Allergy - Abstract
ObjectiveTo determine if the degree of baseline fibromyalgia (FM) symptoms in patients with rheumatoid arthritis (RA), as indicated by the Fibromyalgia Survey Questionnaire (FSQ) score, predicts RA disease activity after initiation or change of a disease-modifying antirheumatic drug (DMARD).MethodsOne hundred ninety-two participants with active RA were followed for 12 weeks after initiation or change of DMARD therapy. Participants completed the FSQ at the initial visit. The Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) was measured at baseline and follow-up to assess RA disease activity. We evaluated the association between baseline FSQ score and follow-up DAS28-CRP. As a secondary analysis, we examined the relationship between the 2 components of the FSQ, the Widespread Pain Index (WPI) and Symptom Severity Scale (SSS), with follow-up DAS28-CRP. Multiple linear regression analyses were performed, adjusting for clinical and demographic variables.ResultsIn multiple linear regression models, FSQ score was independently associated with elevated DAS28-CRP scores 12 weeks after DMARD initiation (B = 0.04,P= 0.01). In secondary analyses, the WPI was significantly associated with increased follow-up DAS28-CRP scores (B = 0.08,P= 0.001), whereas the SSS was not (B = −0.03,P= 0.43).ConclusionHigher levels of FM symptoms weakly predicted worse disease activity after treatment. The primary factor that informed the FSQ’s prediction of disease activity was the spatial extent of pain, as measured by the WPI.
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- 2022
10. Baseline serum levels of cross-linked carboxy-terminal telopeptide of type I collagen predict abatacept treatment response in methotrexate-naive, anticitrullinated protein antibody-positive patients with early rheumatoid arthritis
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Chun Wu, Yanhua Hu, Peter Schafer, Sean E Connolly, Robert Wong, Signe Holm Nielsen, Anne-Christine Bay-Jensen, Paul Emery, Yoshiya Tanaka, Vivian P Bykerk, Clifton O Bingham, Thomas WJ Huizinga, Roy Fleischmann, and Jinqi Liu
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Abatacept ,Methotrexate ,Rheumatology ,Arthritis ,Rheumatoid ,Immunology ,Immunology and Allergy ,Anti-Citrullinated Protein Antibodies - Abstract
ObjectiveTo investigate correlations between biomarkers of bone remodelling and extracellular matrix turnover with baseline disease activity and treatment response in patients with early rheumatoid arthritis (RA).MethodsAssessingVeryEarlyRheumatoid arthritisTreatment-2 (AVERT-2;NCT02504268) included disease-modifying antirheumatic drug-naive, anti-citrullinated protein antibody (ACPA)-positive patients randomised to weekly subcutaneous abatacept+methotrexate (MTX) or abatacept placebo+MTX for 56 weeks. This post hoc exploratory subanalysis assessed the association between baseline disease activity and eight biomarkers (Spearman’s correlation coefficient), and whether baseline biomarkers (continuous or categorical variables) could predict treatment response at weeks 24 and 52 (logistic regression).ResultsPatient characteristics were similar between overall (n=752) and biomarker subgroup (n=535) populations and across treatments. At baseline, neoepitopes of matrix metalloproteinase-mediated degradation products of types III and IV collagen and of C reactive protein (CRP) showed the greatest correlations with disease activity; cross-linked carboxy-terminal telopeptide of type I collagen (CTX-I) showed weak correlation. Only CTX-I predicted treatment response; baseline CTX-I levels were significantly associated with achieving Simplified Disease Activity Index remission and Disease Activity Score in 28 joints (DAS28 (CRP)) ConclusionIn MTX-naive, ACPA-positive patients with early RA, baseline CTX-I predicted treatment response to abatacept+MTX but not abatacept placebo+MTX.
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- 2022
11. Fibromyalgianess and glucocorticoid persistence among patients with rheumatoid arthritis
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Dorothy D. Dunlop, Yvonne C. Lee, Clifton O. Bingham, Beth I Wallace, Tuhina Neogi, Andrew C. Heisler, Meriah N Moore, Jing Song, Lutfiyya N. Muhammad, Daniel J. Clauw, Wendy Marder, Alyssa Wohlfahrt, and Marcy B. Bolster
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musculoskeletal diseases ,medicine.medical_specialty ,Fibromyalgia ,Logistic regression ,Arthritis, Rheumatoid ,Rheumatology ,Prednisone ,Internal medicine ,Humans ,Medicine ,Pharmacology (medical) ,Glucocorticoids ,business.industry ,Odds ratio ,Clinical Science ,medicine.disease ,humanities ,Confidence interval ,Antirheumatic Agents ,Rheumatoid arthritis ,business ,Serostatus ,Glucocorticoid ,medicine.drug - Abstract
Objectives Over one-third of patients with RA exhibit evidence of fibromyalgianess, which is associated with higher rates of disability and inadequate responsiveness to RA treatment. Patients with RA often remain on glucocorticoids long-term, despite the known risk of dose-dependent morbidity. We undertook this study to examine the relationship between fibromyalgianess and glucocorticoid persistence among RA patients. Methods We followed participants with active RA on oral prednisone for ∼3 months after initiating a new DMARD. Fibromyalgianess was measured using the Fibromyalgia Survey Questionnaire (FSQ), previously shown to correlate with key FM features often superimposed upon RA. Severity of fibromyalgianess was stratified as follows: FSQ 10 high/very high. The association between baseline fibromyalgianess and glucocorticoid persistence, defined as prednisone use at 3-month follow-up visit after DMARD initiation, was assessed using multiple logistic regression adjusted for baseline demographics, RA duration, serostatus and inflammatory activity assessed using swollen joint count and CRP. Results Of the 97 participants on prednisone at baseline, 65% were still taking prednisone at follow-up. Fifty-seven percent of participants with low baseline fibromyalgianess had persistent glucocorticoid use, compared with 84% of participants with high or very high fibromyalgianess. After adjustment for non-inflammatory factors and inflammatory activity, participants with high/very high baseline fibromyalgianess were more likely to be taking prednisone at follow-up relative to those with low fibromyalgianess [odds ratio 4.99 (95% CI 1.20, 20.73)]. Conclusion High fibromyalgianess is associated with persistent glucocorticoid use, independent of inflammatory activity.
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- 2021
12. 2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases
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Anne R. Bass, Eliza Chakravarty, Elie A. Akl, Clifton O. Bingham, Leonard Calabrese, Laura C. Cappelli, Sindhu R. Johnson, Lisa F. Imundo, Kevin L. Winthrop, Reuben J. Arasaratnam, Lindsey R. Baden, Roberta Berard, S. Louis Bridges, Jonathan T. L. Cheah, Jeffrey R. Curtis, Polly J. Ferguson, Ida Hakkarinen, Karen B. Onel, Grayson Schultz, Vidya Sivaraman, Benjamin J. Smith, Jeffrey A. Sparks, Tiphanie P. Vogel, Eleanor Anderson Williams, Cassandra Calabrese, Joanne S. Cunha, Joann Fontanarosa, Miriah C. Gillispie‐Taylor, Elena Gkrouzman, Priyanka Iyer, Kimberly S. Lakin, Alexandra Legge, Mindy S. Lo, Megan M. Lockwood, Rebecca E. Sadun, Namrata Singh, Nancy Sullivan, Herman Tam, Marat Turgunbaev, Amy S. Turner, and James Reston
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Rheumatology ,Immunology ,Immunology and Allergy ,Article - Abstract
OBJECTIVE. To provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs). METHODS. This guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel included adult and pediatric rheumatology providers, infectious diseases specialists, and patient representatives. Consensus required ≥70% agreement on both the direction and strength of each recommendation. RESULTS. This guideline includes expanded indications for some vaccines in patients with RMDs, as well as guidance on whether to hold immunosuppressive medications or delay vaccination to maximize vaccine immunogenicity and efficacy. Safe approaches to the use of live attenuated vaccines in patients taking immunosuppressive medications are also addressed. Most recommendations are conditional and had low quality of supporting evidence. CONCLUSION. Application of these recommendations should consider patients’ individual risk for vaccine-preventable illness and for disease flares, particularly if immunosuppressive medications are held for vaccination. Shared decision-making with patients is encouraged in clinical settings.
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- 2022
13. Comparative safety and effectiveness of TNF inhibitors, IL6 inhibitors and methotrexate for the treatment of immune checkpoint inhibitor-associated arthritis
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Anne R Bass, Noha Abdel-Wahab, Pankti D Reid, Jeffrey A Sparks, Cassandra Calabrese, Deanna P Jannat-Khah, Nilasha Ghosh, Divya Rajesh, Carlos Andres Aude, Lydia Gedmintas, Lindsey MacFarlane, Senada Arabelovic, Adewunmi Falohun, Komal Mushtaq, Farah Al Haj, Adi Diab, Ami A Shah, Clifton O Bingham, Karmela Kim Chan, and Laura C Cappelli
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Rheumatology ,Immunology ,Immunology and Allergy ,General Biochemistry, Genetics and Molecular Biology - Abstract
ObjectivesTo compare the safety and effectiveness of biologic and conventional disease-modifying antirheumatic drugs (DMARDs) for immune checkpoint inhibitor-associated inflammatory arthritis (ICI-IA).MethodsThe retrospective multicentre observational study included patients with a diagnosis of ICI-IA treated with a tumour necrosis factor inhibitor (TNFi), interleukin-6 receptor inhibitor (IL6Ri) and/or methotrexate (MTX); patients with pre-existing autoimmune disease were excluded. The primary outcome was time to cancer progression from ICI initiation; the secondary outcome was time to arthritis control from DMARD initiation. Cox proportional hazard models were used to compare medication groups, adjusting for confounders.Results147 patients were included (mean age 60.3 (SD 11.9) years, 66 (45%) women). ICI-IA treatment was TNFi in 33 (22%), IL6Ri 42 (29%) and MTX 72 (49%). After adjustment for time from ICI initiation to DMARD initiation, time to cancer progression was significantly shorter for TNFi compared with MTX (HR 3.27 (95% CI 1.21 to 8.84, p=0.019)) while the result for IL6Ri was HR 2.37 (95% CI 0.94 to 5.98, p=0.055). Time to arthritis control was faster for TNFi compared with MTX (HR 1.91 (95% CI 1.06 to 3.45, p=0.032)) while the result for IL6Ri was HR 1.66 (95% CI 0.93 to 2.97, p=0.089). A subset analysis in patients with melanoma gave similar results for both cancer progression and arthritis control.ConclusionThe treatment of ICI-IA with a biologic DMARD is associated with more rapid arthritis control than with MTX, but may be associated with a shorter time to cancer progression.
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- 2023
14. Conversion of Functional Assessment of Chronic Illness Therapy–Fatigue to Patient‐Reported Outcomes Measurement Information System Fatigue Scores in Two Phase III Baricitinib Rheumatoid Arthritis Trials
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David Cella, Carol L Kannowski, Clifton O. Bingham, Amy M. DeLozier, Susan J. Bartlett, and Luna Sun
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Adult ,Male ,Patient-Reported Outcomes Measurement Information System ,medicine.medical_specialty ,Time Factors ,Baricitinib ,Standard score ,Placebo ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Predictive Value of Tests ,Health Status Indicators ,Humans ,Janus Kinase Inhibitors ,Multicenter Studies as Topic ,Medicine ,Patient Reported Outcome Measures ,Fatigue ,Aged ,Randomized Controlled Trials as Topic ,030203 arthritis & rheumatology ,Sulfonamides ,business.industry ,Remission Induction ,Scoring methods ,Middle Aged ,medicine.disease ,humanities ,Clinical trial ,Treatment Outcome ,Clinical Trials, Phase III as Topic ,Purines ,Antirheumatic Agents ,Rheumatoid arthritis ,Chronic Disease ,Physical therapy ,Azetidines ,Pyrazoles ,Female ,Active treatment ,business - Abstract
OBJECTIVE The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is validated for measuring fatigue in rheumatoid arthritis (RA). However, 10 of 13 FACIT-F items are identified as relevant to patients with RA. The Patient-Reported Outcomes Measurement Information System (PROMIS) uses an item response theory-calibrated T score metric. The PROMIS Fatigue item bank includes the FACIT-F items, enabling score conversion. The performance of converted PROMIS Fatigue scores has not been evaluated in RA populations or clinical trials. Our objective was to assess the performance of converted PROMIS Fatigue scores in 2 RA clinical trials of baricitinib. METHODS Crosswalk tables and pattern-scoring methods converted FACIT-F scores to PROMIS Fatigue for both the 13-item FACIT-F and the 10-item RA-optimized FACIT-F instrument, in 2 RA clinical trials evaluating baricitinib, RA-BEAM, and RA-BEACON. RA-BEAM patients had an inadequate response to methotrexate. RA-BEACON patients had an inadequate response or intolerance to ≥1 tumor necrosis factor inhibitor. Baricitinib was compared to all treatment arms via analysis of covariance on PROMIS Fatigue score conversions. RESULTS Baseline FACIT-F-derived PROMIS Fatigue scores reflected severe fatigue across treatment groups and were similar using different scoring methods. At week 24 in both studies, baricitinib was associated with clinically meaningful improvements in PROMIS Fatigue scores. PROMIS Fatigue scores were consistent for conversion methods and for the 13-item or 10-item FACIT-F. CONCLUSION All 4 conversion methods showed differentiation of active treatment compared with placebo from week 12, supporting the use of the PROMIS Fatigue and converting the 10-item FACIT-F to assess fatigue and demonstrate treatment benefit in RA clinical trials on a standardized metric.
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- 2021
15. Patients and clinicians define symptom levels and meaningful change for PROMIS pain interference and fatigue in RA using bookmarking
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Susan J. Bartlett, Anne Lyddiatt, Clifton O. Bingham, Mary Suzanne Schrandt, Alessandra Butanis, Michelle Jones, Karon F. Cook, Ana Maria Orbai, Vivian P. Bykerk, and Victoria Ruffing
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Adult ,Male ,medicine.medical_specialty ,Patient-Reported Outcomes Measurement Information System ,Pain Interference ,Severity of Illness Index ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Humans ,Medicine ,Pharmacology (medical) ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Fatigue ,Aged ,Pain Measurement ,030203 arthritis & rheumatology ,business.industry ,Bookmarking ,Lived experience ,Perspective (graphical) ,Middle Aged ,Clinical Science ,Social engagement ,Treatment efficacy ,Methotrexate ,Treatment Outcome ,Antirheumatic Agents ,Physical therapy ,Female ,Symptom Assessment ,business - Abstract
Objectives Using patient-reported outcomes to inform clinical decision-making depends on knowing how to interpret scores. Patient-Reported Outcome Measurement Information System® (PROMIS®) instruments are increasingly used in rheumatology research and care, but there is little information available to guide interpretation of scores. We sought to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspective of RA patients and clinicians. Methods We developed patient vignettes using the PROMIS item banks representing a continuum of Pain Interference and Fatigue levels. During a series of face-to-face ‘bookmarking’ sessions, patients and clinicians identified thresholds for mild, moderate and severe levels of symptoms and identified change deemed meaningful for making treatment decisions. Results In general, patients selected higher cut points to demarcate thresholds than clinicians. Patients and clinicians generally identified changes of 5–10 points as representing meaningful change. The thresholds and meaningful change scores of patients were grounded in their lived experiences having RA, approach to self-management, and the impacts on function, roles and social participation. Conclusion Results offer new information about how both patients and clinicians view RA symptoms and functional impacts. Results suggest that patients and providers may use different strategies to define and interpret RA symptoms, and select different thresholds when describing symptoms as mild, moderate or severe. The magnitude of symptom change selected by patients and clinicians as being clinically meaningful in interpreting treatment efficacy and loss of response may be greater than levels determined by external anchor and statistical methods.
- Published
- 2021
16. Understanding Differences in Patient Descriptions of Rheumatoid Arthritis Flares Using OMERACT Core Domains
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Gabriela L. Maica, Christine Iannaccone, Vivi Feathers, Michelle L. Frits, Vivian P. Bykerk, Clifton O. Bingham, Michael Weinblatt, and Nancy A. Shadick
- Subjects
Rheumatology ,Immunology ,Immunology and Allergy - Abstract
ObjectiveRecently, there has been consensus on domains that constitute flares in rheumatoid arthritis (RA); however, variations in patients' flare descriptions continue to be observed. This study evaluates how demographic and clinical characteristics influence these differences.MethodsParticipants enrolled in a prospective RA registry completed a qualitative survey that included the open-ended question "What does a flare mean to you?" Responses were categorized into Outcome Measures in Rheumatology (OMERACT) core and research domains. Univariate analyses evaluated demographic and clinical characteristics. Regression analyses determined independent variables associated with flare description variations.ResultsAmong 645 participants, the median Disease Activity Score in 28 joints (DAS28) with C-reactive protein was 2.1 (IQR 1.6-2.9); 58% of the participants reported at least 1 flare in the past 6 months. Participants reported a median of 3 (IQR 2-5) OMERACT domains when describing flares. Fatigue was more commonly noted among females (odds ratio [OR] 6.12;P< 0.001). Older participants were less likely to report emotional distress (OR 0.97;P= 0.03), swollen joints (OR 0.99;P= 0.04), physical function decrease (OR 0.98;P= 0.02), and a general increase in RA symptoms (OR 0.98;P= 0.005). Participants with a higher DAS28 score were less likely to report symptoms of stiffness (OR 0.70;P= 0.009), and those who experienced a flare within the last 6 months were more likely to describe flares as pain (OR 2.53;P< 0.001) and fatigue (OR 2.00;P= 0.007).ConclusionVariations in patients' flare descriptions can be driven by a patient's disease activity, the experience of a recent flare, as well as different demographic characteristics, such as age and gender. Understanding the interplay of these characteristics can guide a physician's approach to the management of patients' RA flares.
- Published
- 2023
17. Identification of outcome domains in immune checkpoint inhibitor-induced inflammatory arthritis and polymyalgia rheumatica: A scoping review by the OMERACT irAE working group
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Nilasha Ghosh, Nina Couette, Wouter H. van Binsbergen, Sophia C. Weinmann, Bridget Jivanelli, Beverley Shea, Anne R. Bass, Karolina Benesova, Clifton O. Bingham, Cassandra Calabrese, Laura C. Cappelli, Karmela Kim Chan, Ernest Choy, Dimitrios Daoussis, Susan Goodman, Marie Hudson, Shahin Jamal, Jan Leipe, Maria A. Lopez-Olivo, Maria Suarez-Almazor, Conny J. van der Laken, Alexa Simon Meara, David Liew, and Marie Kostine
- Subjects
Anesthesiology and Pain Medicine ,Rheumatology - Abstract
Introduction: Immune checkpoint inhibitors (ICI), increasingly used cancer therapeutics, can cause off-target inflammatory effects called immune-related adverse events (irAEs), including ICI-induced inflammatory arthritis (ICI-induced IA) and polymyalgia rheumatica (ICI-induced PMR). There are no validated classification criteria or outcome measures for these conditions, and adaptation of treatment recommendations from corresponding rheumatic diseases may not be appropriate. We summarized clinical descriptors of ICI-induced IA and ICI-induced PMR and aggregated domains used for these conditions in order to inform the development of a core set of outcome domains. Methods: As the initial step of the core domain set generation process, we systemically searched Medline (Pubmed), EMBASE, Cochrane, and CINHL through March 2021 to identify all studies that provide both clinical descriptions and domains relevant to ICI-induced IA and ICI-induced PMR. Domains were mapped to core areas, such as pathophysiological manifestations, life impact, resource use, and longevity/survival, as suggested by the OMERACT 2.1 Filter. Results: We identified 69 publications, over a third of which utilized non-specific diagnoses of “arthritis,” “arthralgia,” and/or “PMR”. Other publications provided the number, the distribution and/or names of specific joints affected, while others labeled the irAE as the corresponding rheumatic disease, such as rheumatoid arthritis or spondyloarthritis. Most distinct domains mapped to the pathophysiology/manifestations core area (24 domains), such as signs/symptoms (13 domains), labs (6 domains), and imaging (5 domains), with harm domains of adverse effects from irAE treatment and fear of irAE treatment decreasing ICI efficacy. Forty-three publications also referenced irAE treatment and 35 subsequent response, as well as 32 tumor response. Conclusion: There is considerable heterogeneity in the domains used to clinically characterize ICI-induced IA and ICI-induced PMR. There were several domains mapped to the pathophysiologic manifestations core area, although several publications highlighted domains evenly distributed among the other core areas of life impact, longevity/survival and resource use.
- Published
- 2023
18. Association of Dysregulated Central Pain Processing and Response to Disease–Modifying Antirheumatic Drug Therapy in Rheumatoid Arthritis
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Clifton O. Bingham, Andrew C. Heisler, Dorothy D. Dunlop, Wendy Marder, Daniel J. Clauw, Alyssa Wohlfahrt, Jing Song, Marcy B. Bolster, Lutfiyya N. Muhammad, Yvonne C. Lee, and Tuhina Neogi
- Subjects
Adult ,Male ,Pain Threshold ,medicine.medical_specialty ,medicine.medical_treatment ,Immunology ,Pain ,Arthritis ,Summation ,Logistic regression ,Article ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,Disease-modifying antirheumatic drug ,Aged ,Pain Measurement ,030203 arthritis & rheumatology ,Central Nervous System Sensitization ,business.industry ,Odds ratio ,Middle Aged ,medicine.disease ,Confidence interval ,Antirheumatic Agents ,Rheumatoid arthritis ,Female ,business ,030217 neurology & neurosurgery ,Rheumatism - Abstract
Objective To determine the association between dysregulated central pain processing and treatment response in rheumatoid arthritis (RA). Methods One hundred eighty-two participants with active RA were followed up for 12 weeks after starting a disease-modifying antirheumatic drug (DMARD). To assess central pain processing, participants underwent quantitative sensory testing (QST), including assessment of pressure pain thresholds (PPTs) at the trapezius muscles, temporal summation, and conditioned pain modulation (CPM). QST measures were categorized as high central dysregulation versus low central dysregulation. The association between baseline central dysregulation and treatment response, as defined by the European League Against Rheumatism (EULAR) response criteria, was assessed using multiple logistic regression adjusted for demographic characteristics, RA-related variables, and psychosocial variables. Results A good EULAR response was achieved in fewer participants with high CPM dysregulation than participants with low CPM dysregulation (22.5% versus 40.3%; P = 0.01). A similar trend, though not significant, was noted when central dysregulation was assessed with PPT and temporal summation. The adjusted odds ratios (ORs) for the association between high central dysregulation and good EULAR response were 0.59 for PPTs (95% confidence interval [95% CI] 0.28-1.23), 0.60 for temporal summation (95% CI 0.27-1.34), and 0.40 for CPM (95% CI 0.19-0.83). In a model examining the combined effects of dysregulated temporal summation and CPM, dysregulation of both measures was associated with lower odds of achieving a good EULAR response (OR 0.23 [95% CI 0.07-0.73]). Conclusion Low CPM was significantly associated with lower odds of achieving a good EULAR response, suggesting that inefficient descending inhibitory mechanisms may be a potential treatment target for further study.
- Published
- 2020
19. What Does the Patient Global Health Assessment in Rheumatoid Arthritis Really Tell Us? Contribution of Specific Dimensions of Health‐Related Quality of Life
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Ethan T. Craig, Jeffrey R. Curtis, Scott L. Zeger, Susan J. Bartlett, Clifton O. Bingham, Vivian P. Bykerk, and Jamie Perin
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Adult ,Disease ,Article ,Arthritis, Rheumatoid ,Diagnostic Self Evaluation ,Disability Evaluation ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,Rheumatology ,medicine ,Humans ,Patient Reported Outcome Measures ,Depression (differential diagnoses) ,Aged ,030203 arthritis & rheumatology ,Sleep disorder ,business.industry ,Middle Aged ,medicine.disease ,Mood ,Cohort ,Linear Models ,Quality of Life ,Anxiety ,Observational study ,medicine.symptom ,Factor Analysis, Statistical ,business ,Clinical psychology - Abstract
Objective To estimate the contributions of health-related quality of life domains to the patient global assessment of disease activity (PtGA) in rheumatoid arthritis (RA). Methods Data are drawn from baseline visits of 2 observational RA cohorts. Participants completed forms for patient-reported outcome measures, including PtGA and measures from the Patient-Reported Outcomes Measurement Information System, and clinical data were collected. Factor analysis was used to identify latent variables, and multivariable linear regression was used to estimate determinants of the PtGA. Results Patients were mostly female (81%), white (78%), and had established disease (mean ± SD 12.3 ± 10.7 years), with 62% in remission or having low disease activity. In cohort 1 (n = 196), the following 2 factors emerged: 1) daily function (moderate-to-strong [i.e., >|0.65|] loadings of physical function, pain interference, social participation, and fatigue, and weak [>0.35] loadings of sleep disturbance); and 2) emotional distress (strong loadings of depression and anxiety). In crude analysis, daily function explained up to 53% and emotional distress up to 20% of the variance in PtGA. In both cohorts, in adjusted analyses, daily function and, to a much lesser extent, swollen joint count independently predicted PtGA; age was inversely related to PtGA in cohort 1 only. Conclusion These findings suggest that in patients with RA, PtGA ratings largely reflect the extent to which patients feel they can function in everyday roles and are not impacted by mood. This suggests that higher than expected PtGA scores may offer an opportunity to discuss patient expectations regarding roles and activities and the impact of their RA symptoms on daily function.
- Published
- 2020
20. Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group
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Dana DiRenzo, Didem Saygin, Ingrid de Groot, Clifton O. Bingham III, Ingrid E. Lundberg, Merrilee Needham, Jin Kyun Park, Malin Regardt, Catherine Sarver, Yeong Wook Song, Lara Maxwell, Dorcas Beaton, Marianne de Visser, Lisa Christopher-Stine, Christopher A. Mecoli, Helene Alexanderson, Neurology, AII - Infectious diseases, and Amsterdam Neuroscience - Neuroinfection & -inflammation
- Subjects
Anesthesiology and Pain Medicine ,Rheumatology - Abstract
Objective: Pain interference, fatigue, and impaired physical function are common features of idiopathic inflammatory myopathies (IIM). The objective of this study was to evaluate the construct validity and test-retest reliability of the Patient Reported Outcome Information System (PROMIS) Pain Interference 6av1.0, Fatigue 7av1.0, and Physical Function 8bv2.0 instruments. Methods: Patient-Reported Outcome Measures (PROMs) were deployed to adult IIM patients from OMERACT Myositis Working Group (MWG) international clinic sites via two online surveys (2019, 2021). Internal consistency of each PROM was analyzed by Cronbach's α. Construct validity was determined by a priori hypotheses generated by the MWG with >75% agreement for each hypothesis and calculated with Pearson correlations. Test-retest reliability was assessed using intraclass correlation coefficient with PROMIS instruments administered at time zero and 7 days. Results: Surveys were sent to 368 participants in total; participants who completed each questionnaire varied (n=65 to 263). For construct validity, 10 out of 13 a priori hypotheses were met supporting construct validity of PROMIS instruments (Pain Interference 3/4, fatigue 4/4, and Physical Function 3/5). Test-retest reliability was strong for all PROMIS instruments. All PROMIS instruments demonstrated excellent internal consistency. None of the measures demonstrated any ceiling or floor effects except for a ceiling effect in the Pain Interference instrument. Conclusions: This study presents test-retest reliability and construct validity evidence supporting PROMIS Pain Interference (6a v1.0), Fatigue (7a v1.0), and Physical Function (8b v2.0) using a large international cohort of patients with IIM. Internal consistency of these instruments was excellent. A ceiling effect was noted in the Pain Interference instrument.
- Published
- 2022
21. Association of Pain Centralization and Patient‐Reported Pain in Active Rheumatoid Arthritis
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Dorothy D. Dunlop, Yvonne C. Lee, Clifton O. Bingham, Wendy Marder, Daniel J. Clauw, Jing Song, Alyssa Wohlfahrt, Marcy B. Bolster, Kristine Phillips, Tuhina Neogi, and Andrew C. Heisler
- Subjects
Adult ,Male ,Pain Threshold ,medicine.medical_specialty ,Arthritis ,Summation ,Article ,Arthritis, Rheumatoid ,Rheumatology ,Internal medicine ,Threshold of pain ,medicine ,Humans ,Patient Reported Outcome Measures ,Aged ,Pain Measurement ,Central Nervous System Sensitization ,business.industry ,Quantitative sensory testing ,Middle Aged ,medicine.disease ,Arthralgia ,Confidence interval ,Intensity (physics) ,Conditioned pain modulation ,Rheumatoid arthritis ,Linear Models ,Female ,business - Abstract
Objective Pain is a significant burden for patients with rheumatoid arthritis (RA) despite advancements in treatment. We undertook this study to examine the independent contribution of pain centralization to the pain experience of patients with active RA. Methods A total of 263 RA patients with active disease underwent quantitative sensory testing (QST), including assessment of extraarticular pressure pain thresholds (PPTs), temporal summation (TS), and conditioned pain modulation (CPM). The pain experience was assessed by a pain intensity numeric rating scale and the Patient-Reported Outcomes Measurement Information System pain interference computerized adaptive test. We examined associations between QST measures and pain intensity and pain interference. Multiple linear regression models were adjusted for demographic and clinical variables, including swollen joint count and C-reactive protein level. Results Patients with the lowest PPTs (most central dysregulation) reported higher pain intensity than patients with the highest PPTs (adjusted mean difference 1.02 [95% confidence interval (95% CI) 0.37, 1.67]). Patients with the highest TS (most central dysregulation) had higher pain intensity than those with the lowest TS (adjusted mean difference 1.19 [95% CI 0.54, 1.84]). CPM was not associated with differences in pain intensity. PPT and TS were not associated with pain interference. Patients with the lowest CPM (most centrally dysregulated) had lower pain interference than patients with the highest CPM (adjusted mean difference -2.35 [95% CI -4.25, -0.44]). Conclusion Pain centralization, manifested by low PPTs and high TS, was associated with more intense pain. Clinicians should consider pain centralization as a contributor to pain intensity, independent of inflammation.
- Published
- 2020
22. Patient-reported outcomes in RA care improve patient communication, decision-making, satisfaction and confidence: qualitative results
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Victoria Ruffing, Elaine De Leon, T. Duncan, Uzma Haque, Rebecca L. Manno, Alessandra Butanis, Jamie Perin, Amye Leong, Ana Maria Orbai, Susan J. Bartlett, Katherine Clegg Smith, Clifton O. Bingham, and M. Jones
- Subjects
Adult ,Male ,medicine.medical_specialty ,Attitude of Health Personnel ,Clinical Decision-Making ,Decision Making ,Disease ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,Rheumatology ,Patient-Centered Care ,Humans ,Medicine ,Pharmacology (medical) ,Patient Reported Outcome Measures ,Prospective Studies ,030212 general & internal medicine ,Patient participation ,Prospective cohort study ,Qualitative Research ,Aged ,030203 arthritis & rheumatology ,Physician-Patient Relations ,business.industry ,Communication ,Middle Aged ,Clinical Science ,Focus group ,Patient Satisfaction ,Health Care Surveys ,Family medicine ,Female ,Patient communication ,Patient Participation ,business ,Psychosocial ,Qualitative research - Abstract
Objective To evaluate the impact of integrating patient-reported outcomes (PROs) into routine clinics, from the perspective of patients with RA, clinicians and other staff. Methods We conducted a prospective cohort study using a mixed methods sequential explanatory design at an academic arthritis clinic. RA patients completed selected Patient-Reported Outcomes Measurement Information System measures on tablets in the waiting room. Results were immediately available to discuss during the visit. Post-visit surveys with patients and physicians evaluated topics discussed and their impact on decision making; patients rated confidence in treatment. Focus groups or interviews with patients, treating rheumatologists and clinic staff were conducted to understand perspectives and experiences. Results Some 196 patients and 20 rheumatologists completed post-visit surveys at 816 and 806 visits, respectively. Focus groups were conducted with 24 patients, 10 rheumatologists and 4 research/clinic staff. PROs influenced medical decision-making and RA treatment changes (38 and 18% of visits, respectively). Patients reported very high satisfaction and treatment confidence. Impact on clinical workflow was minimal after a period of initial adjustment. PROs were valued by patients and physicians, and provided new insight into how patients felt and functioned over time. Reviewing results together improved communication, and facilitated patient-centred care, shared decision making, and the identification of new symptoms and contributing psychosocial/behavioural factors. Conclusion PRO use at RA visits was feasible, increased understanding of how disease affects how patients feel and function, facilitated shared decision-making, and was associated with high patient satisfaction and treatment confidence.
- Published
- 2019
23. Anti-RA33 antibodies are present in a subset of patients with immune checkpoint inhibitor-induced inflammatory arthritis
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Laura C. Cappelli, Patrick M. Forde, Clifton O. Bingham, Erika Darrah, Ami A. Shah, Jennifer S. Mammen, Megan D. Schollenberger, Julie R. Brahmer, Evan J. Lipson, and Valsamo Anagnostou
- Subjects
biology ,business.industry ,Immune checkpoint inhibitors ,Inflammatory arthritis ,Immunology ,medicine.disease ,Anti-Citrullinated Protein Antibodies ,Arthritis, Rheumatoid ,Rheumatology ,Rheumatoid Factor ,medicine ,biology.protein ,Immunology and Allergy ,Humans ,Antibody ,RA33 ,business ,Immune Checkpoint Inhibitors ,Autoantibodies - Abstract
ObjectivePatients with inflammatory arthritis (IA) associated with immune checkpoint inhibitor (ICI) treatment for cancer are typically seronegative for anti-cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor, but little is known about the presence of other autoantibodies in this patient population. We investigated the prevalence and characteristics of anti-RA33 antibodies in patients with ICI-induced IA.MethodsAnti-RA33 ELISAs were performed on sera from four groups of patients: 79 with ICI-induced IA, 52 with rheumatoid arthritis (RA), 35 treated with ICIs without IA during follow-up and 50 healthy controls. Anti-RA33 positivity and level, clinical and demographic data were compared across groups.ResultsAnti-RA33 antibodies were found in 9/79 (11.4%) patients with ICI-induced IA but in 0/35 patients treated with ICIs who did not develop IA (0%; p=0.04). Of the patients positive for anti-RA33, two had sera available from before ICI treatment; anti-RA33 antibodies were present in both pre-ICI treatments. In patients with RA, 7.7% were positive for anti-RA33 antibodies as were 2% of healthy controls. In ICI-induced IA, anti-RA33 antibodies were associated with anti-CCP antibodies (p=0.001). We found no statistically significant differences in other clinical characteristics in those with and without anti-RA33 antibodies.ConclusionsAnti-RA33 antibodies are present in a subset of patients with ICI-induced IA, absent in other ICI-treated patients and may be a biomarker for developing IA. Additional studies evaluating serial samples before and after ICI treatment will further establish the temporal relationship of these antibodies to IA development.
- Published
- 2021
24. Autoantibodies targeting telomere-associated proteins in systemic sclerosis
- Author
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Ami A. Shah, Clifton O. Bingham, Carol W. Greider, Livia Casciola-Rosen, Francesco Boin, Brittany L. Adler, Paul J. Wolters, and Antony Rosen
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0301 basic medicine ,Male ,Telomerase ,autoantibodies ,Pulmonary Fibrosis ,Autoimmunity ,Autoantigens ,Scleroderma ,Shelterin Complex ,Pathogenesis ,Idiopathic pulmonary fibrosis ,0302 clinical medicine ,Pulmonary fibrosis ,Immunology and Allergy ,2.1 Biological and endogenous factors ,scleroderma ,Aetiology ,Lung ,Middle Aged ,Telomere ,Respiratory ,Public Health and Health Services ,Female ,Adult ,Telomere-Binding Proteins ,Clinical Sciences ,Immunology ,Autoimmune Disease ,General Biochemistry, Genetics and Molecular Biology ,Article ,03 medical and health sciences ,Rare Diseases ,Rheumatology ,Clinical Research ,medicine ,Humans ,Autoantibodies ,Aged ,030203 arthritis & rheumatology ,Scleroderma, Systemic ,pulmonary fibrosis ,business.industry ,Inflammatory and immune system ,Autoantibody ,systemic ,medicine.disease ,Shelterin ,Fibrosis ,Idiopathic Pulmonary Fibrosis ,Arthritis & Rheumatology ,030104 developmental biology ,business - Abstract
ObjectivesSystemic sclerosis (SSc) is an autoimmune fibrotic disease affecting multiple tissues including the lung. A subset of patients with SSc with lung disease exhibit short telomeres in circulating lymphocytes, but the mechanisms underlying this observation are unclear.MethodsSera from the Johns Hopkins and University of California, San Francisco (UCSF) Scleroderma Centers were screened for autoantibodies targeting telomerase and the shelterin proteins using immunoprecipitation and ELISA. We determined the relationship between autoantibodies targeting the shelterin protein TERF1 and telomere length in peripheral leucocytes measured by qPCR and flow cytometry and fluorescent in situ hybridisation (Flow-FISH). We also explored clinical associations of these autoantibodies.ResultsIn a subset of patients with SSc, we identified autoantibodies targeting telomerase and the shelterin proteins that were rarely present in rheumatoid arthritis, myositis and healthy controls. TERF1 autoantibodies were present in 40/442 (9.0%) patients with SSc and were associated with severe lung disease (OR 2.4, p=0.04, Fisher’s exact test) and short lymphocyte telomere length. 6/6 (100%) patients with TERF1 autoantibodies in the Hopkins cohort and 14/18 (78%) patients in the UCSF cohort had a shorter telomere length in lymphocytes or leukocytes, respectively, relative to the expected age-adjusted telomere length. TERF1 autoantibodies were present in 11/152 (7.2%) patients with idiopathic pulmonary fibrosis (IPF), a fibrotic lung disease believed to be mediated by telomere dysfunction.ConclusionsAutoantibodies targeting telomere-associated proteins in a subset of patients with SSc are associated with short lymphocyte telomere length and lung disease. The specificity of these autoantibodies for SSc and IPF suggests that telomere dysfunction may have a distinct role in the pathogenesis of SSc and pulmonary fibrosis.
- Published
- 2021
25. Development of a patient-centered core domain set for prospective observational longitudinal outcome studies in rheumatoid arthritis: an OMERACT initiative
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Tiffany Westrich-Robertson, Niti Goel, Clifton O. Bingham, Maria E. Suarez-Almazor, Loreto Carmona, Beverley Shea, Sebastian Bruera, Christopher Hill, Peter Tugwell, Vibeke Strand, Robin Christensen, Lyn March, Amye Leong, Maria A. Lopez-Olivo, Jose B. Negron, and Francesca Ingegnoli
- Subjects
rheumatoid arthritis ,medicine.medical_specialty ,Consensus ,Delphi method ,Outcome (game theory) ,Core domain ,Domain (software engineering) ,Arthritis, Rheumatoid ,Rheumatology ,cohort studies ,patient-centered outcomes ,Patient-Centered Care ,Outcome Assessment, Health Care ,medicine ,Humans ,Medical physics ,Prospective Studies ,Set (psychology) ,observational studies ,business.industry ,Patient-centered outcomes ,OMERACT ,patient registries ,medicine.disease ,Anesthesiology and Pain Medicine ,Rheumatoid arthritis ,Observational study ,business - Abstract
Objectives To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis. Methods Our working group held a virtual meeting in November 2020 to review data from a literature review and patient qualitative interviews, and to discuss strategies to move forward on domain identification and selection using the OMERACT 2.1 domain selection process. Results Important candidate domains and subdomains were identified including in the areas of life impact. Consensus was reached on moving forward with a Delphi process. Conclusions The meeting provided future directions to identify and select a core set of domains for use in LOS.
- Published
- 2021
26. OMERACT 2020: A virtual (R)evolution
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Jasvinder A. Singh, Catherine Hofstetter, Lee S. Simon, Lyn March, Peter Tugwell, Phil Conaghan, George A. Wells, Bev Shea, Dorcas E. Beaton, Maria Antonietta D'Agostino, Clifton O. Bingham, Vibeke Strand, Lara J Maxwell, and Shawna Grosskleg
- Subjects
Anesthesiology and Pain Medicine ,Information retrieval ,Text mining ,Rheumatology ,business.industry ,Rheumatic Diseases ,MEDLINE ,Medicine ,Humans ,business - Published
- 2021
27. The Relationship Between Autonomic Dysfunction of the Gastrointestinal Tract and Emotional Distress in Patients With Systemic Sclerosis
- Author
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James W. Russell, Dana DiRenzo, Clifton O. Bingham, and Zsuzsanna H. McMahan
- Subjects
Male ,medicine.medical_specialty ,Gastrointestinal Diseases ,Autonomic Nervous System ,Psychological Distress ,Logistic regression ,Severity of Illness Index ,Article ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Severity of illness ,Humans ,Medicine ,030212 general & internal medicine ,Prospective cohort study ,Autoantibodies ,030203 arthritis & rheumatology ,Univariate analysis ,Scleroderma, Systemic ,Exosome Multienzyme Ribonuclease Complex ,business.industry ,Confounding ,Dysautonomia ,Odds ratio ,Middle Aged ,United States ,Gastrointestinal Tract ,Clinical trial ,Autonomic Nervous System Diseases ,Research Design ,Exoribonucleases ,Female ,Symptom Assessment ,medicine.symptom ,business - Abstract
BACKGROUND/OBJECTIVES We hypothesized that emotional distress in systemic sclerosis (SSc) patients with moderate to severe gastrointestinal (GI) dysfunction is associated with dysautonomia. We sought to determine (1) the clinical characteristics associated with emotional distress in SSc, (2) the odds of having dysautonomia in those with emotional distress, and (3) whether GI dysautonomia, as measured by the Survey of Autonomic Symptoms (SAS), correlates with GI dysautonomia on the Composite Autonomic Symptom Score-31 (COMPASS-31). METHODS Clinical and demographic features from our prospective cohort study were compared among SSc patients with and without GI-associated emotional distress (University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 well-being subscale >0.5 or ≤0.5) in cross-sectional analysis. Covariates/confounders independently associated with emotional distress were used to construct multivariable logistic regression models. The COMPASS-31 and SAS GI subdomains were compared with Spearman correlation. RESULTS Forty-six patients with SSc were enrolled in the study. In univariate analyses, age (odds ratio [OR], 1.06; p = 0.026), severity of GI dysautonomia (COMPASS-31: OR, 1.41; p = 0.003), anti-centromere (A/B) antibodies (OR, 3.60; p = 0.044), and anti-PM-Scl (75/100) antibodies (OR, 0.15; p = 0.035) were associated with emotional distress. In the adjusted model, those with more severe GI dysautonomia remained more likely to have emotional distress (OR, 1.85; p = 0.026); those with anti-PM-Scl (75/100) antibodies were less likely to have emotional distress (OR, 0.03; p = 0.031). The SAS and COMPASS-31 GI subdomains moderately correlated (ρ = 0.68, p < 0.001). CONCLUSIONS In SSc, increased symptom burden related to GI dysautonomia is associated with emotional distress. Multidisciplinary approaches addressing both the physical and emotional needs of the SSc patient may be warranted to optimize patient care.
- Published
- 2019
28. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy
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Cynthia E. Kartman, Maher Issa, Wendy J. Komocsar, Clifton O. Bingham, Rena Klar, John S. Bradley, and Kevin L. Winthrop
- Subjects
Male ,medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,Pneumococcal conjugate vaccine ,Arthritis, Rheumatoid ,Pneumococcal Vaccines ,Internal medicine ,Tetanus Toxoid ,medicine ,Humans ,Rheumatoid arthritis ,Adverse effect ,Aged ,Immunity, Cellular ,Sulfonamides ,Janus kinase inhibitors ,business.industry ,Vaccination ,Middle Aged ,medicine.disease ,Rheumatology ,Streptococcus pneumoniae ,Treatment Outcome ,Purines ,Tetanus vaccine ,Concomitant ,DMARDs (biologics) ,Azetidines ,Pyrazoles ,Female ,Methotrexate ,lcsh:RC925-935 ,business ,Research Article ,medicine.drug - Abstract
Background Clinical guidelines recommend pneumococcal and tetanus vaccinations in patients with rheumatoid arthritis (RA). Baricitinib is an oral, selective Janus kinase (JAK) 1/JAK 2 inhibitor and is approved for the treatment of moderately to severely active RA in adults in over 50 countries including European countries, the USA, and Japan. This substudy evaluated pneumococcal conjugate and tetanus toxoid vaccine (TTV) responses in patients with RA receiving baricitinib. These vaccines elucidate predominantly T cell-dependent humoral antibody response. Methods Eligible RA patients receiving baricitinib 2 mg or 4 mg with or without concomitant methotrexate (MTX) were enrolled in a phase 3 long-term extension trial (RA-BEYOND; ClinicalTrials.gov, NCT01885078) in USA/Puerto Rico. Patients were vaccinated with 13-serotype pneumococcal conjugate vaccine (PCV-13) and TTV. Primary endpoints were the proportion of patients achieving a satisfactory humoral response for PCV-13 (≥ 2-fold increase in anti-pneumococcal antibody concentrations in ≥ 6 serotypes) and TTV (≥ 4-fold increase in anti-tetanus concentrations) at 5 weeks post-vaccination. Secondary endpoints included humoral responses at 12 weeks and functional responses of serotypes 4, 6B, 14, and 23F (twofold and fourfold increases in opsonic indexes at 5 and 12 weeks). Results Of 106 patients with a mean duration of RA of approximately 12 years, 80% were female, 30% were taking corticosteroids, and 89% (N = 94) were taking baricitinib plus MTX; most patients (97% PCV-13/96% TTV) completed the evaluations. Overall, 68% (95% CI 58.4, 76.2) of patients achieved a satisfactory response to PCV-13, 43% (34.0, 52.8) achieved a ≥ 4-fold increase in anti-tetanus concentrations, and 74% (64.2, 81.1) achieved a ≥ 2-fold increase. PCV-13 response was similar for patients taking corticosteroids (71%; 53.4, 83.9) vs those not (67%; 55.2, 76.5). The percentage of sera with a ≥ 2-fold increase in post-vaccination opsonic indexes at week 5 ranged from 47% (serotype 14) to 76% (serotype 6B). Through 12 weeks post-vaccination, seven patients (6.6%) reported injection-site events. There were no deaths during the substudy, and three patients experienced a serious adverse event. Conclusions Approximately two thirds of patients on long-term baricitinib achieved satisfactory humoral and functional responses to PCV-13 vaccination, while TTV responses were less robust. PCV-13 response was not diminished in those taking concomitant corticosteroids. Trial registration ClinicalTrials.gov, NCT01885078. Registered on 24 June 2013.
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- 2019
29. Responsiveness of Patient‐Reported Outcomes Measurement Information System Measures in Rheumatoid Arthritis Patients Starting or Switching a Disease‐Modifying Antirheumatic Drug
- Author
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Clifton O. Bingham, Yvonne C. Lee, Zhi Zhang, Larry W. Moreland, Kristine Phillips, Alyssa Wohlfahrt, Marcy B. Bolster, Tuhina Neogi, and Wendy Marder
- Subjects
Adult ,Male ,medicine.medical_specialty ,Patient-Reported Outcomes Measurement Information System ,medicine.medical_treatment ,Item bank ,Arthritis ,Article ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,medicine ,Humans ,Patient Reported Outcome Measures ,Prospective Studies ,Disease-modifying antirheumatic drug ,skin and connective tissue diseases ,Prospective cohort study ,Depression (differential diagnoses) ,Aged ,030203 arthritis & rheumatology ,business.industry ,medicine.disease ,Antirheumatic Agents ,Rheumatoid arthritis ,Physical therapy ,Female ,Observational study ,business - Abstract
Objective The Patient-Reported Outcomes Measurement Information System (PROMIS) is a calibrated item bank used to assess patient-reported outcomes across multiple domains. The purpose of this study was to describe the performance of selected PROMIS measures in patients with rheumatoid arthritis (RA) with active disease who were initiating a disease-modifying antirheumatic drug (DMARD). Methods Participants in an ongoing prospective observational study completed 8 PROMIS measures before and after DMARD initiation. Linear regression models were performed to identify cross-sectional associations between baseline PROMIS measures and disease activity, measured using the Clinical Disease Activity Index (CDAI). Paired t-tests were performed to evaluate responsiveness after 12 weeks of DMARD treatment. Associations between changes in PROMIS measures and changes in the CDAI score were assessed using linear regression. Results Among the 156 participants who completed the first study visit, the mean ± SD baseline CDAI score was 25.5 ± 14.0. Baseline scores for PROMIS measures of physical health, pain, and sleep were associated with the baseline CDAI score (P ≤ 0.05). Among the 106 participants with 12-week data, all PROMIS scores improved after DMARD initiation (P ≤ 0.05). With the exception of depression, changes in all assessed PROMIS measures were correlated with changes in the CDAI score (standardized βs from |0.23| to |0.38|). Conclusion These data provide support for the utility of PROMIS measures for the assessment of physical and mental health in individuals with active RA. All PROMIS measures improved significantly after DMARD initiation, with the magnitudes of association between changes in PROMIS measures and changes in the CDAI score in the low-to-moderate range.
- Published
- 2019
30. OMERACT 2018 Modified Patient-reported Outcome Domain Core Set in the Life Impact Area for Adult Idiopathic Inflammatory Myopathies
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Ingrid de Groot, Jin Kyun Park, Catherine Sarver, Beverly Shea, Christopher A. Mecoli, Lisa Christopher-Stine, Helene Alexanderson, Merrilee Needham, Marianne de Visser, Clifton O. Bingham, Yeong W. Song, Malin Regardt, and Ingrid E. Lundberg
- Subjects
Adult ,Male ,medicine.medical_specialty ,Consensus ,Delphi Technique ,Immunology ,Pain ,Severity of Illness Index ,Domain (software engineering) ,Rheumatology ,Internal medicine ,Outcome Assessment, Health Care ,medicine ,Humans ,Immunology and Allergy ,Patient Reported Outcome Measures ,Set (psychology) ,Exercise ,Impact area ,Fatigue ,Myositis ,Aged ,Core set ,business.industry ,Focus Groups ,Middle Aged ,medicine.disease ,Treatment Outcome ,Idiopathic inflammatory myopathies ,Quality of Life ,Physical therapy ,Female ,Patient-reported outcome ,business - Abstract
Objective.To present and vote on a myositis modified patient-reported outcome core domain set in the life impact area at the Outcome Measures in Rheumatology (OMERACT) 2018.Methods.Based on results from international focus groups and Delphi surveys, a draft core set was developed.Results.Domains muscle symptoms, fatigue, level of physical activity, and pain reached ≥ 70% consensus and were mandatory to assess in all trials. Domains lung, joint, and skin symptoms were mandatory in specific circumstances. This core set was endorsed by > 85% at OMERACT 2018.Conclusion.We propose a life impact core set for patients with idiopathic inflammatory myopathies and will proceed with instrument selections.
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- 2019
31. Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop
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Karine Toupin-April, Julia G. Harris, Jelena Vojinovic, Marion A J van Rossum, Silvia Magni-Manzoni, Beverley Shea, Esi M. Morgan, Nicolino Ruperto, Richard Vesely, Angelo Ravelli, Daniel B. Horton, Brian M. Feldman, Clifton O. Bingham, Pamela F. Weiss, Susan Shenoi, Jennifer Horonjeff, Vibeke Strand, Nikolay Tzaribachev, Homaira Rahimi, Jane E Munro, Melissa L. Mannion, Natalie J. Shiff, Daniel J. Lovell, Alessandro Consolaro, Susan Thornhill, Sarah Ringold, Ben Horgan, Alessandra Alongi, M. Suzanne Schrandt, Hermine I. Brunner, Hayyah Clairman, General Paediatrics, and AII - Inflammatory diseases
- Subjects
musculoskeletal diseases ,Male ,medicine.medical_specialty ,Adolescent ,Immunology ,Delphi method ,ODB++ ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Randomized controlled trial ,Quality of life ,law ,Outcome Assessment, Health Care ,medicine ,Humans ,Immunology and Allergy ,Patient Reported Outcome Measures ,030212 general & internal medicine ,030203 arthritis & rheumatology ,Response rate (survey) ,Clinical Trials as Topic ,business.industry ,Australia ,Special Interest Group ,Arthritis, Juvenile ,United States ,Clinical trial ,Treatment Outcome ,Italy ,Antirheumatic Agents ,Family medicine ,Female ,Observational study ,business - Abstract
Objective.The current Juvenile Idiopathic Arthritis (JIA) Core Set used in randomized controlled trials (RCT) and longitudinal observational studies (LOS) was developed without the input of patients/parents. At the Outcome Measures in Rheumatology (OMERACT) 2016, a special interest group voted to reconsider the core set, incorporating broader input. We describe subsequent work culminating in an OMERACT 2018 plenary and consensus voting.Methods.Candidate domains were identified through literature review, qualitative surveys, and online discussion boards (ODB) held with patients with JIA and parents in Australia, Italy, and the United States. A Delphi process with parents, patients, healthcare providers, researchers, and regulators served to edit the domain list and prioritize candidate domains. After the presentation of results, OMERACT workshop participants voted, with consensus set at > 70%.Results.Participants in ODB were 53 patients with JIA (ages 15–24 yrs) and 55 parents. Three rounds of Delphi considering 27 domains were completed by 190 (response rate 85%), 201 (84%), and 182 (77%) people, respectively, from 50 countries. There was discordance noted between domains prioritized by patients/parents compared to others. OMERACT conference voting approved domains for JIA RCT and LOS with 83% endorsement. Mandatory domains are pain, joint inflammatory signs, activity limitation/physical function, patient’s perception of disease activity (overall well-being), and adverse events. Mandatory in specific circumstances: inflammation/other features relevant to specific JIA categories.Conclusion.Following the OMERACT methodology, we developed an updated JIA Core Domain Set. Next steps are to identify and systematically evaluate best outcome measures for these domains.
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- 2019
32. OMERACT filter 2.1: Elaboration of the conceptual framework for outcome measurement in health intervention studies
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Peter Tugwell, Dorcas E. Beaton, Lee S. Simon, Clifton O. Bingham, Lara J Maxwell, George A. Wells, Maarten de Wit, Maria Antonietta D'Agostino, Philip G. Conaghan, Susan J. Bartlett, Laure Gossec, Beverley Shea, Maarten Boers, Jasvinder A. Singh, Vibeke Strand, Lyn March, Epidemiology and Data Science, Rheumatology, APH - Methodology, and AII - Inflammatory diseases
- Subjects
Settore MED/16 - REUMATOLOGIA ,Outcome Assessment ,Process (engineering) ,Measurement model ,Immunology ,Theoretical framework ,Health status indicator ,Health intervention ,Outcome (game theory) ,Rheumatology ,Rheumatic Diseases ,Outcome Assessment, Health Care ,Immunology and Allergy ,Medicine ,Health Status Indicators ,Humans ,Set (psychology) ,Elaboration ,Core set ,Clinical Trials as Topic ,business.industry ,OMERACT ,Patient outcome ,Health Care ,Risk analysis (engineering) ,Filter (video) ,Antirheumatic Agents ,The Conceptual Framework ,business - Abstract
Objective.The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of “measurable aspects of health conditions” from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).Methods.At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.Results.The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.Conclusion.We expect that the Filter 2.1 framework will improve the process of core set development.
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- 2019
33. Patients with checkpoint inhibitor‐induced inflammatory arthritis do not become seropositive for anti‐cyclic citrullinated peptide when followed over time
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Erika Darrah, Laura C. Cappelli, Ami A. Shah, and Clifton O. Bingham
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RC925-935 ,Rheumatology ,business.industry ,Immune checkpoint inhibitors ,Inflammatory arthritis ,Immunology ,Concise Communications ,Medicine ,Diseases of the musculoskeletal system ,business ,medicine.disease ,Anti-cyclic citrullinated peptide - Published
- 2021
34. Successful Methotrexate Treatment of Chronic Chikungunya Arthritis
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Robert T. Schoen, Clifton O. Bingham, and J. Kennedy Amaral
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030203 arthritis & rheumatology ,Methotrexate treatment ,medicine.medical_specialty ,business.industry ,Arthritis ,medicine.disease ,medicine.disease_cause ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,030212 general & internal medicine ,Chikungunya ,business - Published
- 2018
35. Phenotypic characterization of patients with rheumatologic manifestations of common variable immunodeficiency
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Ramsay Fuleihan, Kathleen E. Sullivan, Clifton O. Bingham, and Maria J. Gutierrez
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Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Adolescent ,Autoimmunity ,Logistic regression ,medicine.disease_cause ,Article ,Young Adult ,03 medical and health sciences ,Sex Factors ,0302 clinical medicine ,Immunophenotyping ,Immune system ,Rheumatology ,Internal medicine ,medicine ,Humans ,Registries ,Child ,Immunodeficiency ,Aged ,Retrospective Studies ,Aged, 80 and over ,030203 arthritis & rheumatology ,business.industry ,Common variable immunodeficiency ,Incidence (epidemiology) ,Middle Aged ,medicine.disease ,Phenotype ,Common Variable Immunodeficiency ,030104 developmental biology ,Anesthesiology and Pain Medicine ,Child, Preschool ,Female ,Symptom Assessment ,business - Abstract
Patients with common variable immunodeficiency (CVID) have a higher incidence of rheumatologic disorders. To delineate this clinical association, we investigated the phenotypic features of patients with CVID affected by these conditions. METHODS: We conducted a retrospective analysis of 870 pediatric and adult patients with CVID included in the United States Immunodeficiency Network (USIDNET) registry. Outcomes included clinical characteristics (age, gender, ethnicity, rheumatologic diagnosis, comorbidities), infectious history and basic immunophenotype (serum immunoglobulin levels, CD19+ B cells and CD4/CD8 ratio) in patients with CVID and rheumatologic disorders compared to those with non-inflammatory CVID. Demographic and clinical data were compared using chi-square, Fisher’s exact or Wilcoxon-Mann-Whitney tests. Non-parametric tests, single and multiple logistic regression models were used to evaluate the relationship between CVID-associated rheumatologic disorders and basic immunophenotypic parameters (IgA, IgM, CD19+ B-cell counts and CD4/CD8 ratios) RESULTS: Physician-reported rheumatic diseases were present in 5.9% of patients with CVID (n=51) included in the registry. Although CVID affects both sexes equally, and patients are of predominantly White-Caucasian ethnicity, there were more females (3.3:1 female to male ratio) and increased proportion of non-white patients in the rheumatologic disease group (p
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- 2018
36. Immune-related adverse events with immune checkpoint inhibitors affecting the skeleton: a seminal case series
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Ami A. Shah, Laura C. Cappelli, Geoffrey T. Gibney, Clifton O. Bingham, Patrick M. Forde, William H. Sharfman, Evan J. Lipson, Jarushka Naidoo, Michael A. Carducci, and Kendall F. Moseley
- Subjects
Oncology ,Male ,Cancer Research ,Lung Neoplasms ,Skin Neoplasms ,medicine.medical_treatment ,Programmed Cell Death 1 Receptor ,Case Report ,Bone resorption ,0302 clinical medicine ,Antineoplastic Agents, Immunological ,Renal cell carcinoma ,Immune-related adverse events ,Carcinoma, Non-Small-Cell Lung ,Immunology and Allergy ,CTLA-4 Antigen ,Melanoma ,medicine.diagnostic_test ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Kidney Neoplasms ,3. Good health ,Nivolumab ,030220 oncology & carcinogenesis ,Erythrocyte sedimentation rate ,Molecular Medicine ,Female ,Immunotherapy ,Bone Diseases ,medicine.medical_specialty ,Immunology ,lcsh:RC254-282 ,03 medical and health sciences ,Immune system ,Internal medicine ,medicine ,Humans ,Adverse effect ,Carcinoma, Renal Cell ,Aged ,030203 arthritis & rheumatology ,Pharmacology ,business.industry ,Cancer ,medicine.disease ,Ipilimumab ,Rheumatology ,Fracture ,business - Abstract
Background The use of immune checkpoint inhibitors is increasing in cancer therapy today. It is critical that treatment teams become familiar with the organ systems potentially impacted by immune-related adverse events associated with these drugs. Here, we report adverse skeletal effects of immunotherapy, a phenomenon not previously described. Case presentations In this retrospective case series, clinical, laboratory and imaging data were obtained in patients referred to endocrinology or rheumatology with new fractures (n = 3) or resorptive bone lesions (n = 3) that developed while on agents targeting PD-1, CTLA-4 or both. The average age of patients was 59.3 (SD 8.6), and five were male. Cancer types included melanoma, renal cell carcinoma and non-small cell lung cancer. All fracture patients had vertebral compression, and two of the three had multiple fracture sites involved. Sites of resorptive lesions included the shoulder, hand and clavicle. Biochemically, elevated or high-normal markers of bone resorption were seen in five of the six patients. Erythrocyte sedimentation rate was elevated in three of the four patients where checked. Conclusions This case series represents the first description of potential skeletal adverse effects related to immune checkpoint inhibitors. These findings are important for providers caring for patients who experience musculoskeletal symptoms and may merit additional evaluation.
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- 2018
37. RISK FACTORS FOR INFECTION AND HEALTH IMPACTS OF THE COVID-19 PANDEMIC IN PEOPLE WITH AUTOIMMUNE DISEASES
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Carlos A. Pardo, Samantha Harris, Brindusa Truta, Ami A. Shah, Ellen M. Mowry, Shiv Saidha, Kathryn C. Fitzgerald, Edward S. Chen, Julie J. Paik, Brittany L. Adler, Ana Maria Orbai, Barney J. Stern, Lisa Christopher-Stine, Allan C. Gelber, Homa Timlin, Jemima Albayda, Berna Aravidis, Arun Venkatesan, Elias S. Sotirchos, Eleni Tiniakou, Michelle Sharp, Thomas E. Lloyd, Scott D. Newsome, Morgan Douglas, Ahmet Hoke, Christopher A. Mecoli, Edward K. Kasper, Pavan Bhargava, Michelle Petri, Nisha A. Gilotra, Clifton O. Bingham, Vinay Chaudhry, Alan N. Baer, and Mark Lazarev
- Subjects
medicine.medical_specialty ,business.industry ,Disease ,medicine.disease ,Comorbidity ,Mental health ,Rheumatology ,AcademicSubjects/MED00290 ,Pulmonology ,Diabetes mellitus ,Internal medicine ,Health care ,Major Article ,medicine ,Intensive care medicine ,business ,Kidney disease - Abstract
BackgroundPeople with autoimmune or inflammatory conditions who take immunomodulatory/suppressive medications may have a higher risk of novel coronavirus disease 2019 (COVID-19). Chronic disease care has also changed for many patients, with uncertain downstream consequences.ObjectiveAssess whether COVID-19 risk is higher among those on immunomodulating or suppressive agents and characterize pandemic-associated changes to care.DesignLongitudinal registry studyParticipants4666 individuals with autoimmune or inflammatory conditions followed by specialists in neurology, rheumatology, cardiology, pulmonology or gastroenterology at Johns HopkinsMeasurementsPeriodic surveys querying comorbidities, disease-modifying medications, exposures, COVID-19 testing and outcomes, social behaviors, and disruptions to healthcareResultsA total of 265 (5.6%) developed COVID-19 over 9 months of follow-up (April-December 2020). Patient characteristics (age, race, comorbidity, medication exposure) were associated with differences in social distancing behaviors during the pandemic. Glucocorticoid exposure was associated with higher odds of COVID-19 in multivariable models incorporating behavior and other potential confounders (OR: 1.43; 95%CI: 1.08, 1.89). Other medication classes were not associated with COVID-19 risk. Diabetes (OR: 1.72; 95%CI: 1.08, 2.73), cardiovascular disease (OR: 1.68; 95%CI: 1.24, 2.28), and chronic kidney disease (OR: 1.76; 95%CI: 1.04, 2.97) were each associated with higher odds of COVID-19. Pandemic-related disruption to care was common. Of the 2156 reporting pre-pandemic utilization of infusion, mental health or rehabilitative services, 975 (45.2%) reported disruptions. Individuals experiencing changes to employment or income were at highest odds of care disruption.LimitationsResults may not be generalizable to all patients with autoimmune or inflammatory conditions. Information was self-reported.ConclusionsExposure to glucocorticoids may increase risk of COVID-19 in people with autoimmune or inflammatory conditions. Disruption to healthcare and related services was common. Those with pandemic-related reduced income may be most vulnerable to care disruptions.
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- 2021
38. EULAR points to consider for the diagnosis and management of rheumatic immune-related adverse events due to cancer immunotherapy with checkpoint inhibitors
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Timothy R D J Radstake, Marie Kostine, Jacques-Eric Gottenberg, Clifton O. Bingham, Thierry Schaeverbeke, Jan Leipe, Shahin Jamal, Andrew P. Cope, Axel Finckh, Olivier Lambotte, Yves Allenbach, James Larkin, K. Visser, Karolina Benesova, Cindy Rusthoven, Aurélien Marabelle, Ernest Choy, Leonard H. Calabrese, Hendrik Schulze-Koops, Marianne de Visser, John B. A. G. Haanen, Xavier Mariette, and Lone Thomasen
- Subjects
medicine.medical_specialty ,IDIOPATHIC INFLAMMATORY MYOPATHY ,IPILIMUMAB THERAPY ,medicine.medical_treatment ,CELL LUNG-CANCER ,Immunology ,Arthritis ,POLYMYALGIA-RHEUMATICA ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,0302 clinical medicine ,SERONEGATIVE SYMMETRICAL SYNOVITIS ,ADVANCED MELANOMA ,Rheumatology ,Cancer immunotherapy ,Immunology and Allergy ,Medicine ,Medical diagnosis ,Adverse effect ,Intensive care medicine ,MYASTHENIA-GRAVIS ,PREEXISTING AUTOIMMUNE ,Myositis ,ddc:616 ,030203 arthritis & rheumatology ,treatment ,business.industry ,autoimmunity ,Cancer ,multidisciplinary team care ,medicine.disease ,OPEN-LABEL ,Systematic review ,arthritis ,inflammation ,030220 oncology & carcinogenesis ,PSORIATIC-ARTHRITIS ,business ,Rheumatism - Abstract
BackgroundRheumatic and musculoskeletal immune-related adverse events (irAEs) are observed in about 10% of patients with cancer receiving checkpoint inhibitors (CPIs). Given the recent emergence of these events and the lack of guidance for rheumatologists addressing them, a European League Against Rheumatism task force was convened to harmonise expert opinion regarding their identification and management.MethodsFirst, the group formulated research questions for a systematic literature review. Then, based on literature and using a consensus procedure, 4 overarching principles and 10 points to consider were developed.ResultsThe overarching principles defined the role of rheumatologists in the management of irAEs, highlighting the shared decision-making process between patients, oncologists and rheumatologists. The points to consider inform rheumatologists on the wide spectrum of musculoskeletal irAEs, not fulfilling usual classification criteria of rheumatic diseases, and their differential diagnoses. Early referral and facilitated access to rheumatologist are recommended, to document the target organ inflammation. Regarding therapeutic, three treatment escalations were defined: (1) local/systemic glucocorticoids if symptoms are not controlled by symptomatic treatment, then tapered to the lowest efficient dose, (2) conventional synthetic disease-modifying antirheumatic drugs, in case of inadequate response to glucocorticoids or for steroid sparing and (3) biological disease-modifying antirheumatic drugs, for severe or refractory irAEs. A warning has been made on severe myositis, a life-threatening situation, requiring high dose of glucocorticoids and close monitoring. For patients with pre-existing rheumatic disease, baseline immunosuppressive regimen should be kept at the lowest efficient dose before starting immunotherapies.ConclusionThese statements provide guidance on diagnosis and management of rheumatic irAEs and aim to support future international collaborations.
- Published
- 2021
39. Diminished cytokine-induced Jak/STAT signaling is associated with rheumatoid arthritis and disease activity
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Chander Raman, Jason Ptacek, Christopher C. Striebich, James R. O'Dell, Alessandra Cesano, Garry P. Nolan, Nancy A. Shadick, E. William St. Clair, Franak Batliwalla, S. Louis Bridges, Guy Cavet, Marc C. Levesque, William H. Robinson, Mark C. Genovese, Geoffrey M. Thiele, Erik Evensen, Barbara B. Mittleman, Cynthia Aranow, Maria I. Danila, Betty Diamond, Houman Khalili, Stacey S. Cofield, Dongmei Sun, Clifton O. Bingham, Larry W. Moreland, Matthew Hale, Peter K. Gregersen, Jeffrey R. Curtis, Rachael E. Hawtin, Peter A. Nigrovic, Richard A. Furie, Meggan Mackay, and Brent Louie
- Subjects
Male ,Cell signaling ,B Cells ,Physiology ,medicine.medical_treatment ,Cancer Treatment ,Signal transduction ,Severity of Illness Index ,Monocytes ,Pathogenesis ,Arthritis, Rheumatoid ,White Blood Cells ,Animal Cells ,Immune Physiology ,Medicine and Health Sciences ,Medicine ,Phosphorylation ,Aged, 80 and over ,Innate Immune System ,Multidisciplinary ,T Cells ,Middle Aged ,Interleukin-10 ,STAT signaling ,Cytokine ,STAT1 Transcription Factor ,Oncology ,Rheumatoid arthritis ,Biomarker (medicine) ,Cytokines ,Tumor necrosis factor alpha ,Female ,medicine.symptom ,Cellular Types ,Research Article ,Adult ,STAT3 Transcription Factor ,Science ,Immune Cells ,Immunology ,Inflammation ,Rheumatoid Arthritis ,Cytokine Therapy ,Autoimmune Diseases ,Abatacept ,Immune system ,Rheumatology ,Humans ,Antibody-Producing Cells ,Aged ,Autoimmune disease ,Blood Cells ,business.industry ,Arthritis ,Biology and Life Sciences ,Interferon-alpha ,Cell Biology ,Molecular Development ,medicine.disease ,Methotrexate ,Immune System ,Case-Control Studies ,Leukocytes, Mononuclear ,Clinical Immunology ,Clinical Medicine ,business ,Biomarkers ,Developmental Biology - Abstract
Rheumatoid arthritis (RA) is a systemic and incurable autoimmune disease characterized by chronic inflammation in synovial lining of joints. To identify the signaling pathways involved in RA, its disease activity, and treatment response, we adapted a systems immunology approach to simultaneously quantify 42 signaling nodes in 21 immune cell subsets (e.g., IFNα→p-STAT5 in B cells) in peripheral blood mononuclear cells (PBMC) from 194 patients with longstanding RA (including 98 patients before and after treatment), and 41 healthy controls (HC). We found multiple differences between patients with RA compared to HC, predominantly in cytokine-induced Jak/STAT signaling in many immune cell subsets, suggesting pathways that may be associated with susceptibility to RA. We also found that high RA disease activity, compared to low disease activity, was associated with decreased (e.g., IFNα→p-STAT5, IL-10→p-STAT1) or increased (e.g., IL-6→STAT3) response to stimuli in multiple cell subsets. Finally, we compared signaling in patients with established, refractory RA before and six months after initiation of methotrexate (MTX) or TNF inhibitors (TNFi). We noted significant changes from pre-treatment to post-treatment in IFNα→p-STAT5 signaling and IL-10→p-STAT1 signaling in multiple cell subsets; these changes brought the aberrant RA signaling profiles toward those of HC. This large, comprehensive functional signaling pathway study provides novel insights into the pathogenesis of RA and shows the potential of quantification of cytokine-induced signaling as a biomarker of disease activity or treatment response.
- Published
- 2021
40. Identifying Minimal and Meaningful Change in a Patient-Reported Outcomes Measurement Information System for Rheumatoid Arthritis: Use of Multiple Methods and Perspectives
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Anna Kristina Gutierrez, M. Jones, Kathleen M Andersen, Clifton O. Bingham, Uzma Haque, Ana Maria Orbai, Susan J. Bartlett, Vivian P. Bykerk, and Jeffrey R. Curtis
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Adult ,Male ,medicine.medical_specialty ,Pain Interference ,Pain ,Multiple methods ,Physical function ,Arthritis, Rheumatoid ,Short Forms ,Rheumatology ,medicine ,Humans ,Social determinants of health ,Patient Reported Outcome Measures ,skin and connective tissue diseases ,Fatigue ,business.industry ,medicine.disease ,Rheumatoid arthritis ,Cohort ,Physical therapy ,Observational study ,Female ,sense organs ,business ,Information Systems - Abstract
Rheumatoid arthritis (RA) is chronic, painful, disabling condition resulting in significant impairments in physical, emotional, and social health. Our objective was to use different methods and perspectives to evaluate the responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) short forms (SFs) and to identify minimal and meaningful score changes.Adults with RA who were enrolled in a multisite prospective observational cohort completed PROMIS physical function, pain interference, fatigue, and participation in social roles/activities SFs, the PROMIS 29-item form (PROMIS-29), and pain and patient global assessment, and rated change in specific symptoms and RA (a little versus lot better or worse) at the second visit. Physicians recorded joint counts, physician global assessment, and change in RA at visit 2. We compared mean score differences for minimal and meaningful improvement/worsening using patient and physician change ratings and distribution-based methods, and we visually inspected empirical cumulative distribution function curves by change categories.The 348 adults were mostly female (81%) with longstanding RA. Using patient ratings, generally 1-3-point differences were observed for minimal change and 3-7 points for meaningful change. Larger differences were observed with patient versus physician ratings and for symptom-specific versus RA change. Mean differences were similar among SF versions. Prespecified hypotheses about change in PROMIS physical function, pain interference, fatigue, and participation and legacy scales were supported.PROMIS SFs and the PROMIS-29 profiles are responsive to change and generally distinguish between minimal and meaningful improvement and worsening in key RA domains. These data add to a growing body of evidence demonstrating the robust psychometric properties of PROMIS and supporting its use in RA care, research, and decision-making.
- Published
- 2020
41. Assessing the content validity of patient-reported outcome measures in adult myositis: A report from the OMERACT myositis working group
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Jin Kyun Park, Tina Esfandiary, Catherine Sarver, Ingrid de Groot, Ingrid E. Lundberg, Dana DiRenzo, Merrilee Needham, Yeong Wook Song, Clifton O. Bingham, Marianne de Visser, Lisa Christopher-Stine, Christopher A. Mecoli, Malin Regardt, Helene Alexanderson, Amsterdam Neuroscience - Neuroinfection & -inflammation, Neurology, and AII - Inflammatory diseases
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Adult ,medicine.medical_specialty ,Prom ,Severity of Illness Index ,Article ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Content validity ,Humans ,Patient Reported Outcome Measures ,030212 general & internal medicine ,Cognitive interview ,Fatigue ,Myositis ,030203 arthritis & rheumatology ,Patient-reported outcomes ,business.industry ,Outcome assessment Patient ,medicine.disease ,Comprehension ,Anesthesiology and Pain Medicine ,Idiopathic inflammatory myositis ,Physical therapy ,Patient-reported outcome ,business ,Qualitative research - Abstract
Objective To investigate the content validity of several patient-reported outcome measures (PROMs) in patients with idiopathic inflammatory myopathies (IIM). Methods Seven individual PROM instruments were selected by the Outcome Measures in Rheumatology (OMERACT) Myositis Working Group relating to the following domains: pain, fatigue, physical function and physical activity. Twenty patients from the Johns Hopkins Myositis Center were selected for one-on-one face-to-face or phone interviews for cognitive interviewing of individual PROMs to assess comprehension and content validity. Additionally, patients were asked if they thought muscle symptoms, an area originally identified in qualitative studies, were encapsulated by the other four domains. Results The majority of patients (>70%) felt that each of the instruments was clear, easy to read and understand, and could be used for assessment of its domain. Two-thirds (66%) of patients felt that ‘muscle symptoms’ were captured by the other domains. Conclusions We provided evidence to support adequate content validity for several PROMs. Further research is needed to determine whether ‘muscle symptoms’ warrant a separate domain.
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- 2020
42. POS1459-HPR IDENTIFYING MEANINGFUL CHANGE IN THE RA FLARE QUESTIONNAIRE SCORES IN RHEUMATOID ARTHRITIS
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Glen Hazlewood, Diane Tin, Marie-France Valois, Clifton O. Bingham, Louis Bessette, Carol A. Hitchon, E.C. Keystone, Janet E. Pope, Carter Thorne, Susan J. Bartlett, V.P. Bykerk, Gilles Boire, and Orit Schieir
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medicine.medical_specialty ,business.industry ,Immunology ,Swollen joints ,Disease ,Physical function ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Large cohort ,Disease activity ,Rheumatology ,Rheumatoid arthritis ,Early ra ,Physical therapy ,medicine ,Immunology and Allergy ,business - Abstract
Background:The RA-FQ is a patient-reported measure of current disease activity in RA that can be used to identify disease flares. The RA-FQ queries pain, physical function, fatigue, stiffness, and participation and yields a score from 0-50. We previously reported on reliability, validity, and responsiveness.Objectives:To identify changes in RA-FQ that represent minimal and meaningful improvement or worsening from the perspective of people with RA, treating rheumatologists, and in relation to disease activity indices. We hypothesized thatMethods:Data were from adults with early RA (sx Results:The 808 adults were mostly white (84%) women (71%) with a mean (SD) age of 55 (15) and moderate-high CDAI level (85%) at enrollment. Most (79%) reported their RA had changed; 59% were better and 20% worse. Patients who were a lot worse had a mean increase of 8.9 points whereas those who rated themselves as a lot better had a -6.0 decrease on the RA-FQ (Figure 1). Minimal worsening and improvement were associated with 4.7 and -1.8 change in RA-FQ scores, respectively, while patients who rated their RA unchanged had stable RA-FQ scores (Table 1).Similar changes were evident in CDAI, SDAI, and DAS indices (Table 1). Larger differences were observed with patient vs. physician global scores and tender vs. swollen joints. Across measures, the change associated with worsening was greater than for improvement. Results supported all prespecified hypotheses ab.Table 1.Spearman’s correlation coefficients of PsAQoL with the other parameters for construct validityDomainA Lot Better(N=346; 43%)A Little Better(N=132; 16%)The Same(N=174; 21%)A Little Worse(N=94; 12%)A Lot Worse(N=62; 8%)Δ95% CISDΔ95% CISDΔ95% CISDΔ95% CISDΔ95% CISDRA-FQ Total (0-50)-6.0(-7.1, -4.9)10.3-1.8(-3.2, -0.3)8.4-0.1(-1.3, 1.1)8.14.7(2.9, 6.6)9.18.9(5.1, 12.7)15.0 Pain-1.2(-1.4, -0.9)2.4-0.4(-0.8, 0.0)2.30.0(-0.2, 0.3)1.81.3(0.8, 1.7)2.22.0(1.2, 2.9)3.3 Physical Function-1.3(-1.6, -1.1)2.4-0.3(-0.6, 0.1)2.10.0(-0.3, 0.3)2.10.9(0.4, 1.4)2.41.8(0.8, 2.7)3.7 Fatigue-1.1(-1.4, -0.8)2.6-0.4(-0.7, 0.0)1.90.0(-0.3, 0.3)2.10.7(0.3, 1.1)2.11.3(0.5, 2.1)3.2 Stiffness-1.1(-1.4, -0.9)2.4-0.4(-0.7, 0.0)2.0-0.1(-0.4, 0.2)2.01.1(0.6, 1.5)2.21.8(1.0, 2.7)3.3 Participation-1.2(-1.5, -1.0)2.5-0.1(-0.5, 0.3)2.1-0.1(-0.4, 0.2)2.20.8(0.4, 1.3)2.22.0(1.1, 2.8)3.4Disease ActivityCDAI*-5.3(-6.3, -4.3)9.1-3.3(-5.4, -1.3)11.5-0.8(-2.0, 0.5)8.11.7(-0.1, 3.5)8.86.8(3.7, 9.8)12.0SDAI-5.6(-6.8, -4.4)9.2-3.5(-6.1, -0.9)12.2-1.9(-3.6, -0.2)8.91.5(-0.7, 3.7)9.24.7(1.0, 8.4)12.2DAS28-CRP-0.7(-0.8, -0.6)1.01-0.5(-0.7, -0.2)1.2-0.2(-0.4, 0.0)1.00.3(0.1, 0.5)1.00.5(0.2, 0.9)1.2Patient Global (0-10)-1.3(-1.5, -1.0)2.7-0.5(-0.9, -0.1)2.1-0.1(-0.4, 0.2)2.11.3(0.8, 1.8)2.42.9(2.1, 3.6)3.1MD Global (0-10)-1.2(-1.4, -1.0)1.9-0.7(-1.1, -0.3)-0.1-0.1(-0.4, 0.2)1.90.1(-0.3, 0.5)2.80.7(0.0, 1.5)2.8Swollen Joints (28)-1.4(-1.7, 1.0)3.2-1.0(-1.8, -0.2)4.6-0.4(-0.9, 0.0)3.00.0(-0.7, 0.7)3.41.3(0.2, 2.5)4.6Tender Joints (28)-1.5(-1.9, -1.1)3.9-1.3(-2.2, -0.3)5.50.0(-0.7, 0.6)4.30.3(-0.7, 1.2)4.52.2(0.8, 3.5)5.4Conclusion:In this large cohort of adults with ERA, the RA-FQ was responsive to change and generally distinguish between minimal and meaningful improvement and worsening. These data add to a growing evidence demonstrating robust psychometric properties of the RA-FQ and offer initial guidance about the amount of change associated with improvement or worsening, supporting its use in RA care, research and decision-making.Acknowledgements:The CATCH study was designed and implemented by the investigators and financially supported through unrestricted research grants from: Amgen and Pfizer Canada - Founding sponsors since January 2007; AbbVie Corporation and Hoffmann-LaRoche since 2011; Medexus Inc. since 2013;, Merck Canada since 2017, Sandoz Canada, Biopharmaceuticals since 2019,Gilead Sciences Canada since 2020 and Fresenius Kabi Canada Ltd. since 2021. Previously funded by Janssen Biotech from 2011-2016, UCB Canada and Bristol-Myers Squibb Canada from 2011-2018, Sanofi Genzyme from 2016-2017, and Eli Lilly Canada from 2016-2020.Disclosure of Interests:None declared
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- 2021
43. Expert Perspective: Immune Checkpoint Inhibitors and Rheumatologic Complications
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Laura C. Cappelli and Clifton O. Bingham
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musculoskeletal diseases ,medicine.medical_specialty ,Myocarditis ,medicine.medical_treatment ,Inflammatory arthritis ,Immunology ,Article ,Polymyalgia rheumatica ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Neoplasms ,Rheumatic Diseases ,medicine ,Immunology and Allergy ,Humans ,Adverse effect ,Immune Checkpoint Inhibitors ,Myositis ,030203 arthritis & rheumatology ,business.industry ,medicine.disease ,Myasthenia gravis ,030220 oncology & carcinogenesis ,Plasmapheresis ,Immunotherapy ,Differential diagnosis ,business - Abstract
Rheumatologists increasingly receive consults for patients treated with immune checkpoint inhibitors (ICIs) for cancer. ICIs can cause inflammatory syndromes known as immune-related adverse events (IRAEs). Several rheumatic IRAEs have been reported, including inflammatory arthritis, polymyalgia rheumatica, and myositis. For patients who present with musculoskeletal symptoms while receiving ICI therapy, it is important to have an algorithm for evaluation. The differential diagnosis includes a range of musculoskeletal syndromes, such as crystalline arthritis, mechanical issues, and osteoarthritis, in addition to IRAEs. After diagnosing a rheumatic IRAE, rheumatologists must work with the patient and the oncologist to form a treatment plan. Treatment of IRAEs is guided by severity. Evidence for management is limited to observational studies. Inflammatory arthritis and polymyalgia rheumatica are treated with nonsteroidal antiinflammatory drugs in mild cases, glucocorticoids for moderate-to-severe cases, and sometimes require other disease-modifying antirheumatic drugs. Myositis due to ICIs can be accompanied by myocarditis or myasthenia gravis. Glucocorticoids and withholding the ICI are usually required to treat myositis; some patients with severe myositis require intravenous immunoglobulin or plasmapheresis. Further research is needed to optimize treatment of IRAEs that does not compromise the antitumor effect of ICIs.
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- 2020
44. Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States-Based Rheumatoid Arthritis Registry
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Heather J. Litman, Andrea Shapiro, Christine J. Barr, Clifton O. Bingham, Jeff Greenberg, Carol A. Connell, Arthur Kavanaugh, Dimitrios A. Pappas, Jamie Geier, Jose Luis Rivas, Alina Onofrei, Laura C. Cappelli, Joel M. Kremer, Kimberly J. Dandreo, and Ann Madsen
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medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,Tofacitinib ,business.industry ,Proportional hazards model ,Hazard ratio ,Original Articles ,medicine.disease ,Confidence interval ,Rheumatology ,Rheumatoid arthritis ,Internal medicine ,Medicine ,Original Article ,lcsh:RC925-935 ,business ,Adverse effect ,Mace ,Janus kinase inhibitor - Abstract
Objective Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5-year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease-modifying antirheumatic drugs (bDMARDs) within the United States (US) Corrona RA registry. Methods IRs (number of first events/100 patient-years) of major adverse cardiovascular events (MACE), serious infection events (SIEs), herpes zoster (HZ), malignancies, and death were estimated among tofacitinib and bDMARD initiators, regardless of dose/schedule, between November 6, 2012 (US Food and Drug Administration tofacitinib approval), and July 31, 2018 (follow-up through January 31, 2019). Propensity score (PS) methods were used to control for nonrandom prescribing practices. Hazard ratios (HRs) were calculated to compare rates using multivariable-adjusted Cox regression. Different risk windows were used for acute (MACE, SIEs, HZ, and venous thromboembolic events [VTEs]) and long-term (malignancy and death) events. VTEs were assessed descriptively. Results For MACE, SIEs, and HZ, 1999 (3152.1 patient-years) and 8358 (12 869.4 years) tofacitinib and bDMARD initiators were included, respectively; for malignancy/death, 1999 (4505.6 patient-years) and 6354 (16 670.8 patient-years) initiators were included, respectively. AE rates were similar across cohorts, except for HZ, which was significantly higher with tofacitinib versus bDMARDs (PS-trimmed adjusted HR 2.32; 95% confidence interval [CI] 1.43-3.75). There were 45 (zero serious) and 88 (five serious) HZ events with tofacitinib and bDMARDs, respectively. Sensitivity analyses demonstrated similar results. VTE IRs (95% CI) were 0.29 (0.13-0.54) and 0.33 (0.24-0.45) for tofacitinib and bDMARDs, respectively. Conclusion In this registry analysis, both cohorts had similar MACE, SIE, malignancy, death, and VTE rates; HZ rates were higher for tofacitinib initaitors than for bDMARD initiators.
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- 2020
45. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort
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Marina Backhaus, Ori Elkayam, J. Carter Thorne, Gianfranco Ferraccioli, Paul P. Tak, Mikkel Østergaard, M. Govoni, Joanne Homik, Clifton O. Bingham, Walter P. Maksymowych, Hilde Berner Hammer, Dirkjan van Schaardenburg, Alexandre Sepriano, Maxime Dougados, Joel Paschke, Désirée van der Heijde, Sofia Ramiro, Robert Landewé, Alain Cantagrel, Alain Saraux, Cheryl Barnabe, Oliver FitzGerald, Maggie Larché, Luigi Sinigaglia, E. Hutchings, Maurizio Rossini, Thierry Schaeverbeke, Gerd R Burmester, Bernard Combe, Gilles Boire, R. Dadashova, Leiden University Medical Center (LUMC), Zuyderland Hospital [Heerlen, The Netherlands], St Vincent's University Hospital, Rigshospitalet [Copenhagen], Copenhagen University Hospital, University of Alberta, Tel Aviv Sourasky Medical Center [Te Aviv], The Arthritis Program Research Group, McMaster University [Hamilton, Ontario], Università cattolica del Sacro Cuore [Piacenza e Cremona] (Unicatt), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Université de Sherbrooke (UdeS), Département de Rhumatologie[Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie, CHU de Bordeaux Pellegrin [Bordeaux], Centre National de Référence CERAINO, Service de Rhumatologie (Hôpital de la Cavale Blanche), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocytes B, Autoimmunité et Immunothérapies (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-LabEX IGO Immunothérapie Grand Ouest, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Università degli studi di Verona = University of Verona (UNIVR), Università degli Studi di Ferrara = University of Ferrara (UniFE), Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, parent, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), University of Calgary, Johns Hopkins University School of Medicine [Baltimore], VU University Medical Center [Amsterdam], Diakonhjemmet Hospital, CaRE Arthritis Ltd, Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Salvy-Córdoba, Nathalie, Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University of Verona (UNIVR), Università degli Studi di Ferrara (UniFE), Hôpital Pierre-Paul Riquet [Toulouse], CHU Toulouse [Toulouse], Clinical Immunology and Rheumatology, and AII - Inflammatory diseases
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0301 basic medicine ,medicine.medical_specialty ,MESH: Antirheumatic Agents ,MESH: Remission Induction ,MESH: Rheumatoid Factor ,Immunology ,Best Treatment Practices ,Rheumatoid Arthritis ,Severity of Illness Index ,Longitudinal model ,Gee ,NO ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Rheumatoid Factor ,Internal medicine ,MESH: Severity of Illness Index ,medicine ,Humans ,Immunology and Allergy ,Generalized estimating equation ,MESH: Treatment Outcome ,030203 arthritis & rheumatology ,MESH: Arthritis, Rheumatoid ,[SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,MESH: Humans ,business.industry ,Remission Induction ,Protocol Requirement ,Baseline model ,Treat to target ,rheumatoid arthritis, T2T. rheumatology ,medicine.disease ,T2T. rheumatology ,Treatment Outcome ,030104 developmental biology ,Rheumatoid Arthritis, Best Treatment Practices, Treat-to-target ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,Antirheumatic Agents ,Rheumatoid arthritis ,Cohort ,Tumor Necrosis Factor Inhibitors ,Treat-to-Target ,MESH: Tumor Necrosis Factor Inhibitors ,business - Abstract
Objective.Compelling evidence supports a treat-to-target (T2T) strategy for optimal outcomes in rheumatoid arthritis (RA). There is limited knowledge regarding the factors that impede implementation of T2T, particularly in a setting where adherence to T2T is protocol-specified. We aimed to assess clinical factors that associate with failure to adhere to T2T.Methods.Patients with RA from 10 countries who were starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required per protocol to adhere to the T2T strategy. Factors influencing adherence to T2T low disease activity (T2T-LDA; 44-joint count Disease Activity Score ≤ 2.4) were analyzed in 2 types of binomial generalized estimating equations models: (1) including only baseline features (baseline model); and (2) modeling variables that inherently vary over time as such (longitudinal model).Results.A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. Failure of adherence to T2T-LDA was noted in 1765 visits (40.5%). In the baseline multivariable model, a high number of comorbidities (OR 1.10, 95% CI 1.02–1.19), smoking (OR 1.32, 95% CI 1.08–1.63) and high number of tender joints (OR 1.03, 95% CI 1.02–1.04) were independently associated with failure to implement T2T, while anticitrullinated protein antibody/rheumatoid factor positivity (OR 0.63, 95% CI 0.50–0.80) was a significant facilitator of T2T. Results were similar in the longitudinal model.Conclusion.Lack of adherence to T2T in the RA BIODAM cohort was evident in a substantial proportion despite being a protocol requirement, and this could be predicted by clinical features. [Rheumatoid Arthritis (RA) BIODAM cohort; ClinicalTrials.gov: NCT01476956].
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- 2020
46. Response to: Correspondence on 'Immune checkpoint inhibitor-induced inflammatory arthritis persists after immunotherapy cessation' by Braaten
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Tawnie Braaten, Ami A. Shah, Laura C. Cappelli, and Clifton O. Bingham
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0301 basic medicine ,Inflammatory arthritis ,Immune checkpoint inhibitors ,medicine.medical_treatment ,Immunology ,Arthritis ,Inflammation ,Disease ,medicine.disease_cause ,General Biochemistry, Genetics and Molecular Biology ,Article ,Autoimmunity ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,medicine ,Immunology and Allergy ,Humans ,Immunologic Factors ,Immune Checkpoint Inhibitors ,030203 arthritis & rheumatology ,business.industry ,Immunotherapy ,medicine.disease ,030104 developmental biology ,medicine.symptom ,business - Abstract
We were interested to read the letter by Ceccarelli et al regarding their experience with Immune checkpoint inhibitor (ICI)-induced inflammatory arthritis (IA) at Sapienza University.1 Their findings support that ICI-induced IA is a heterogeneous disease with differing outcomes. The differences in the cohorts studied may also give us insight into the risk factors …
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- 2020
47. Is treat-to-target really working in rheumatoid arthritis? a longitudinal analysis of a cohort of patients treated in daily practice (RA BIODAM)
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Joel Paschke, Sofia Ramiro, E. Hutchings, Cheryl Barnabe, Dirkjan van Schaardenburg, Thierry Schaeverbeke, Alexandre Sepriano, Désirée van der Heijde, Bernard Combe, Robert Landewé, Marina Backhaus, Maurizio Rossini, Margaret Larche, Joanne Homik, Marcello Govoni, Walter P. Maksymowych, Cornelia F Allaart, Ori Elkayam, Clifton O. Bingham, Alain Saraux, J. Carter Thorne, Oliver FitzGerald, Luigi Sinigaglia, Gilles Boire, Hilde Berner Hammer, R. Dadashova, Gianfranco Ferraciolli, Paul P. Tak, Maxime Dougados, Alain Cantagrel, Mikkel Østergaard, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, Ramiro, Sofia [0000-0002-8899-9087], van der Heijde, Désirée [0000-0002-5781-158X], Sepriano, Alexandre [0000-0003-1954-0229], Boire, Gilles [0000-0003-2481-5821], Saraux, Alain [0000-0002-8454-7067], Rossini, Maurizio [0000-0001-9692-2293], Bingham, Clifton O [0000-0002-4752-5029], Tak, Paul P [0000-0002-3532-5409], Maksymowych, Walter P [0000-0002-1291-1755], Apollo - University of Cambridge Repository, Leiden University Medical Center (LUMC), Zuyderland Hospital [Heerlen, The Netherlands], Amsterdam Rheumatology & Immunology Center - ARC [Amsterdam, the Netherlands] (Amsterdam UMC), NOVA Medical School - Faculdade de Ciências Médicas (NMS), Universidade Nova de Lisboa = NOVA University Lisbon (NOVA), St Vincent's University Hospital, Copenhagen Center for Arthritis Research,Copenhagen (Center for Rheumatology and Spine Diseases), Rigshospitalet [Copenhagen], Copenhagen University Hospital, University of Alberta, Tel Aviv Sourasky Medical Center [Te Aviv], University of Toronto, McMaster University [Hamilton, Ontario], Università cattolica del Sacro Cuore [Roma] (Unicatt), Park-Klinik Weissensee, CIUSSS de l'Estrie - CHUS, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Aquitaine’s Care and Research organisation for inflammatory and Immune-Mediated diseases [CHU Bordeaux] (FHU ACRONIM), CHU Bordeaux [Bordeaux], CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University of Verona (UNIVR), Azienda Ospedaliero-Universitaria Sant'Anna Hospital of Ferrara, Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, parent, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, University of Calgary, Johns Hopkins University School of Medicine [Baltimore], Ghent University Hospital, Cambridge University Hospitals - NHS (CUH), University of Cambridge [UK] (CAM), Diakonhjemmet Hospital, and CaRE Arthritis Ltd
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Male ,rheumatoid arthritis ,MESH: Remission Induction ,MESH: Antirheumatic Agents ,treat-to-target ,Patient Care Planning ,Arthritis, Rheumatoid ,Cohort Studies ,remission ,0302 clinical medicine ,Daily practice ,Rheumatoid ,Immunology and Allergy ,Medicine ,030212 general & internal medicine ,Longitudinal Studies ,MESH: Longitudinal Studies ,MESH: Cohort Studies ,MESH: Aged ,MESH: Arthritis, Rheumatoid ,MESH: Middle Aged ,MESH: Clinical Decision-Making ,Remission Induction ,Middle Aged ,3. Good health ,Clinical Practice ,C-Reactive Protein ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,Rheumatoid arthritis ,Antirheumatic Agents ,Cohort ,Joint damage ,MESH: Tumor Necrosis Factor Inhibitors ,Female ,Adult ,medicine.medical_specialty ,MESH: Rheumatoid Factor ,Immunology ,Clinical Decision-Making ,Blood Sedimentation ,General Biochemistry, Genetics and Molecular Biology ,NO ,Disease activity ,03 medical and health sciences ,Rheumatology ,Rheumatoid Factor ,Internal medicine ,MESH: Patient Care Planning ,MESH: C-Reactive Protein ,Humans ,In patient ,MESH: Blood Sedimentation ,Aged ,030203 arthritis & rheumatology ,MESH: Humans ,business.industry ,Tumor Necrosis Factor Inhibitors ,Arthritis ,MESH: Adult ,Treat to target ,medicine.disease ,MESH: Male ,business ,MESH: Female - Abstract
ObjectivesTo investigate whether following a treat-to-target (T2T)-strategy in daily clinical practice leads to more patients with rheumatoid arthritis (RA) meeting the remission target.MethodsRA patients from 10 countries starting/changing conventional synthetic or biological disease-modifying anti-rheumatic drugs were assessed for disease activity every 3 months for 2 years (RA BIODAM (BIOmarkers of joint DAMage) cohort). Per visit was decided whether a patient was treated according to a T2T-strategy with 44-joint disease activity score (DAS44) remission (DAS44 ResultsIn total 4356 visits of 571 patients (mean (SD) age: 56 (13) years, 78% female) were included. Appropriate application of T2T was found in 59% of the visits. T2T (vs no T2T) did not yield a higher likelihood of DAS44 remission 3 months later (OR (95% CI): 1.03 (0.92 to 1.16)), but sustained T2T resulted in an increased likelihood of achieving DAS44 remission (OR: 1.19 (1.03 to 1.39)). Similar results were seen with DAS28-ESR remission. For more stringent definitions (CDAI, SDAI and ACR/EULAR Boolean remission), T2T was consistently positively associated with remission (OR range: 1.16 to 1.29), and sustained T2T had a more pronounced effect on remission (OR range: 1.49 to 1.52).ConclusionIn daily clinical practice, the correct application of a T2T-strategy (especially sustained T2T) in patients with RA leads to higher rates of remission.
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- 2020
48. Outcomes and findings of the international rheumatoid arthritis (RA) BIODAM cohort for validation of soluble biomarkers in RA
- Author
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Hilde Berner Hammer, G. Boire, Ori Elkayam, Bernard Combe, Joel Paschke, Sofia Ramiro, Joanne Homik, Walter P. Maksymowych, E. Hutchings, Maxime Dougados, Marina Backhaus, Maurizio Rossini, Alain Cantagrel, Désirée van der Heijde, Paul P. Tak, Cheryl Barnabe, Gianfranco Ferraccioli, Maggie Larché, Alexandre Sepriano, J. Carter Thorne, Dirkjan van Schaardenburg, M. Govoni, Thierry Schaeverbeke, Robert G. W. Lambert, Luigi Sinigaglia, Clifton O. Bingham, R. Dadashova, Mikkel Østergaard, Alain Saraux, Oliver FitzGerald, Gerd R Burmester, Robert Landewé, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, University of Alberta, CaRE Arthritis Ltd, St Vincent's University Hospital, Copenhagen Center for Arthritis Research,Copenhagen (Center for Rheumatology and Spine Diseases), Rigshospitalet [Copenhagen], Copenhagen University Hospital, Leiden University Medical Center (LUMC), Tel Aviv Sourasky Medical Center [Te Aviv], Zuyderland Hospital [Heerlen, The Netherlands], University of Toronto, McMaster University [Hamilton, Ontario], Università cattolica del Sacro Cuore [Piacenza e Cremona] (Unicatt), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Université de Sherbrooke (UdeS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU de Bordeaux Pellegrin [Bordeaux], CHRU Brest - Service de Rhumatologie (CHU - BREST - Rhumato), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Equipe 4 : ECaMO - Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), University of Verona (UNIVR), Azienda Ospedaliero-Universitaria Sant'Anna Hospital of Ferrara, Clinica Ortopedica, ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, parent, Hôpital Pierre-Paul Riquet [Toulouse], CHU Toulouse [Toulouse], University of Calgary, Johns Hopkins University School of Medicine [Baltimore], VU University Medical Center [Amsterdam], Vrije Universiteit Amsterdam [Amsterdam] (VU), Diakonhjemmet Hospital, and University of Amsterdam [Amsterdam] (UvA)
- Subjects
0301 basic medicine ,BIOMARKER ,MESH: Antirheumatic Agents ,PROGNOSIS ,Radiography ,Severity of Illness Index ,Arthritis, Rheumatoid ,0302 clinical medicine ,Clinical endpoint ,Immunology and Allergy ,Prospective Studies ,Prospective cohort study ,MESH: Arthritis, Rheumatoid ,MESH: Middle Aged ,OMERACT ,risk assessment ,Middle Aged ,3. Good health ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,Rheumatoid arthritis ,Antirheumatic Agents ,Cohort ,Disease Progression ,Biomarker (medicine) ,MESH: Disease Progression ,Female ,medicine.medical_specialty ,Soluble Biomarkers, Rheumatoid Arthritis, radiographic progression, risk assessment ,OMERACT, rheumatoid arthritis, BIODAM ,Immunology ,Soluble Biomarkers ,Rheumatoid Arthritis ,NO ,03 medical and health sciences ,Rheumatology ,Internal medicine ,MESH: Severity of Illness Index ,medicine ,Rheumatoid factor ,Humans ,030203 arthritis & rheumatology ,MESH: Humans ,business.industry ,Mean age ,medicine.disease ,MESH: Prospective Studies ,BIODAM ,030104 developmental biology ,radiographic progression ,MESH: Biomarkers ,business ,MESH: Female ,Biomarkers - Abstract
Objective.The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.Methods.Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.Results.A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor–positive or anticitrullinated protein antibody–positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.Conclusion.The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956)
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- 2020
49. Patient-Reported Outcomes in Adult Idiopathic Inflammatory Myopathies
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Christopher A. Mecoli, Clifton O. Bingham, and Dana DiRenzo
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0301 basic medicine ,medicine.medical_specialty ,Physical function ,Severity of Illness Index ,Article ,Disability Evaluation ,03 medical and health sciences ,0302 clinical medicine ,Quality of life (healthcare) ,Rheumatology ,Internal medicine ,medicine ,Humans ,Patient Reported Outcome Measures ,Clinical care ,Intensive care medicine ,Myositis ,030203 arthritis & rheumatology ,business.industry ,Construct validity ,medicine.disease ,030104 developmental biology ,Idiopathic inflammatory myopathies ,Health assessment ,Quality of Life ,business - Abstract
Idiopathic inflammatory myopathies (IIM) have considerable impact on patient symptoms and quality of life. We have reviewed the evolution of patient-centered care and use of patient-reported outcome measures (PROMs) for adults with IIM. Use of PROMs in myositis care and research is limited, although the importance of incorporation into routine practice and trials has become increasingly recognized. Several key domains/measures have been identified including the patient global assessment of disease activity, physical function as measured by the health assessment questionnaire-disability index (HAQ-DI), Short Form Health Survey-36 (SF-36), or the Patient-Reported Outcome Measurement Information System ® (PROMIS®) in adult IIM. Data are limited for these instruments concerning their reliability, content and construct validity, and responsiveness. Incorporation of the patient perspective into clinical care and research may be used to address the unmet/unaddressed needs of the patient living with myositis. Several ongoing projects aim to bring validated PROMs to the IIM community.
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- 2019
50. Pain and Catastrophizing in Patients With Rheumatoid Arthritis
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Kristine Phillips, Larry W. Moreland, Ezra M. Cohen, Robert R. Edwards, Daniel J. Clauw, Alyssa Wohlfahrt, Marcy B. Bolster, Yvonne C. Lee, Tuhina Neogi, Wendy Marder, and Clifton O. Bingham
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Adult ,Male ,medicine.medical_specialty ,Arthritis ,Activity index ,Severity of Illness Index ,Article ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Severity of illness ,medicine ,Humans ,In patient ,030212 general & internal medicine ,skin and connective tissue diseases ,Aged ,Pain Measurement ,030203 arthritis & rheumatology ,business.industry ,Catastrophization ,Middle Aged ,Clinical disease ,medicine.disease ,Antirheumatic Agents ,Rheumatoid arthritis ,Female ,Observational study ,sense organs ,business ,Cohort study - Abstract
BACKGROUND: The aims of this study were to define changes in catastrophizing that occur with initiation of a new disease-modifying antirheumatic drug (DMARD) and to examine the relationship between changes in Clinical Disease Activity Index (CDAI) and changes in catastrophizing. METHODS: Participants in an ongoing multi-site, prospective observational study completed the Pain Catastrophizing Scale (PCS) before and 12-weeks after DMARD initiation. We used multivariable linear regression models to examine the association between changes in CDAI as the exposure and change in pain catastrophizing as the outcome. We also assessed the relationship between changes in each component of CDAI and change in PCS, using multivariable linear regression models. RESULTS: Among the 165 RA patients with data on CDAI at both time points, CDAI decreased from 22 to 11.5 on a 76-point scale (P
- Published
- 2018
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