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1. Defining domains: developing consensus-based definitions for foundational domains in OMERACT core outcome sets

Author: Maxwell, Lara J., Jones, Caitlin, Bingham, Clifton O, Boers, Maarten, Boonen, Annelie, Choy, Ernest, Christensen, Robin, Conaghan, Philip G., D'Agostino, Maria Antonietta, Doria, Andrea S., Grosskleg, Shawna, Hill, Catherine L., Hofstetter, Catherine, Horgan, Ben, Kroon, Féline, Leung, Ying Ying, Mackie, Sarah, Meara, Alexa, Shea, Beverley J, Simon, Lee S, Touma, Zahi, Tugwell, Peter, Wells, George A, Beaton, Dorcas E, D'Agostino, Maria Antonietta (ORCID:0000-0002-5347-0060), Maxwell, Lara J., Jones, Caitlin, Bingham, Clifton O, Boers, Maarten, Boonen, Annelie, Choy, Ernest, Christensen, Robin, Conaghan, Philip G., D'Agostino, Maria Antonietta, Doria, Andrea S., Grosskleg, Shawna, Hill, Catherine L., Hofstetter, Catherine, Horgan, Ben, Kroon, Féline, Leung, Ying Ying, Mackie, Sarah, Meara, Alexa, Shea, Beverley J, Simon, Lee S, Touma, Zahi, Tugwell, Peter, Wells, George A, Beaton, Dorcas E, and D'Agostino, Maria Antonietta (ORCID:0000-0002-5347-0060)
Abstract: Objective: To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. Methods: We identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. Results: One-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. Conclusion: Using a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.
Published: 2024

2. 2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases

Author: Bass, Anne R, Bass, Anne R, Chakravarty, Eliza, Akl, Elie A, Bingham, Clifton O, Calabrese, Leonard, Cappelli, Laura C, Johnson, Sindhu R, Imundo, Lisa F, Winthrop, Kevin L, Arasaratnam, Reuben J, Baden, Lindsey R, Berard, Roberta, Bridges, S Louis, Cheah, Jonathan TL, Curtis, Jeffrey R, Ferguson, Polly J, Hakkarinen, Ida, Onel, Karen B, Schultz, Grayson, Sivaraman, Vidya, Smith, Benjamin J, Sparks, Jeffrey A, Vogel, Tiphanie P, Williams, Eleanor Anderson, Calabrese, Cassandra, Cunha, Joanne S, Fontanarosa, Joann, Gillispie‐Taylor, Miriah C, Gkrouzman, Elena, Iyer, Priyanka, Lakin, Kimberly S, Legge, Alexandra, Lo, Mindy S, Lockwood, Megan M, Sadun, Rebecca E, Singh, Namrata, Sullivan, Nancy, Tam, Herman, Turgunbaev, Marat, Turner, Amy S, Reston, James, Bass, Anne R, Bass, Anne R, Chakravarty, Eliza, Akl, Elie A, Bingham, Clifton O, Calabrese, Leonard, Cappelli, Laura C, Johnson, Sindhu R, Imundo, Lisa F, Winthrop, Kevin L, Arasaratnam, Reuben J, Baden, Lindsey R, Berard, Roberta, Bridges, S Louis, Cheah, Jonathan TL, Curtis, Jeffrey R, Ferguson, Polly J, Hakkarinen, Ida, Onel, Karen B, Schultz, Grayson, Sivaraman, Vidya, Smith, Benjamin J, Sparks, Jeffrey A, Vogel, Tiphanie P, Williams, Eleanor Anderson, Calabrese, Cassandra, Cunha, Joanne S, Fontanarosa, Joann, Gillispie‐Taylor, Miriah C, Gkrouzman, Elena, Iyer, Priyanka, Lakin, Kimberly S, Legge, Alexandra, Lo, Mindy S, Lockwood, Megan M, Sadun, Rebecca E, Singh, Namrata, Sullivan, Nancy, Tam, Herman, Turgunbaev, Marat, Turner, Amy S, and Reston, James
Abstract: ObjectiveTo provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs).MethodsThis 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.ResultsThis 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.ConclusionApplication 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.
Published: 2023

3. Stricter treat-To-Target in RA does not result in less radiographic progression:A longitudinal analysis in RA BIODAM

Author: Ramiro, Sofia, Landewé, Robert, Van Der Heijde, Désireé, Sepriano, Alexandre, Fitzgerald, Oliver, Østergaard, Mikkel, Homik, Joanne, Elkayam, Ori, Carter Thorne, J., Larché, Maggie J., Ferraccioli, Gianfranco, Backhaus, Marina, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain G., Allaart, Cornelia F., Barnabe, Cheryl, Bingham, Clifton O., Van Schaardenburg, Dirkjan, Hammer, Hilde B., Dadashova, Rana, Hutchings, Edna, Paschke, Joel, Maksymowych, Walter P., Ramiro, Sofia, Landewé, Robert, Van Der Heijde, Désireé, Sepriano, Alexandre, Fitzgerald, Oliver, Østergaard, Mikkel, Homik, Joanne, Elkayam, Ori, Carter Thorne, J., Larché, Maggie J., Ferraccioli, Gianfranco, Backhaus, Marina, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain G., Allaart, Cornelia F., Barnabe, Cheryl, Bingham, Clifton O., Van Schaardenburg, Dirkjan, Hammer, Hilde B., Dadashova, Rana, Hutchings, Edna, Paschke, Joel, and Maksymowych, Walter P.
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., 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.
Published: 2023

4. Autoantibodies targeting telomere-associated proteins in systemic sclerosis.

Author: Adler, Brittany L, Adler, Brittany L, Boin, Francesco, Wolters, Paul J, Bingham, Clifton O, Shah, Ami A, Greider, Carol, Casciola-Rosen, Livia, Rosen, Antony, Adler, Brittany L, Adler, Brittany L, Boin, Francesco, Wolters, Paul J, Bingham, Clifton O, Shah, Ami A, Greider, Carol, Casciola-Rosen, Livia, and Rosen, Antony
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

5. Autoantibodies targeting telomere-associated proteins in systemic sclerosis.

Author: Adler, Brittany L, Adler, Brittany L, Boin, Francesco, Wolters, Paul J, Bingham, Clifton O, Shah, Ami A, Greider, Carol, Casciola-Rosen, Livia, Rosen, Antony, Adler, Brittany L, Adler, Brittany L, Boin, Francesco, Wolters, Paul J, Bingham, Clifton O, Shah, Ami A, Greider, Carol, Casciola-Rosen, Livia, and Rosen, Antony
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

6. Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE).

Author: Aletaha, Daniel, Aletaha, Daniel, Bingham, Clifton O, Karpouzas, George Athanasios, Takeuchi, Tsutomu, Thorne, Carter, Bili, Androniki, Agarwal, Prasheen, Hsu, Benjamin, Rao, Ravi, Brown, Kurt, Tanaka, Yoshiya, Aletaha, Daniel, Aletaha, Daniel, Bingham, Clifton O, Karpouzas, George Athanasios, Takeuchi, Tsutomu, Thorne, Carter, Bili, Androniki, Agarwal, Prasheen, Hsu, Benjamin, Rao, Ravi, Brown, Kurt, and Tanaka, Yoshiya
Abstract: Interleukin (IL)-6 is a pleiotropic cytokine involved in the pathophysiology of rheumatoid arthritis (RA). Sirukumab is a human monoclonal antibody that binds to IL-6 with high affinity and specificity. This long-term extension (LTE) study of the SIRROUND-D and SIRROUND-T studies assessed long-term safety and efficacy of sirukumab in adults with moderate-to-severe RA refractory to conventional disease-modifying antirheumatic drug therapy or antitumor necrosis factor agents. Patients received sirukumab 100 mg subcutaneously (SC) every 2 weeks (q2w) or sirukumab 50 mg SC every 4 weeks (q4w). 1820 patients enrolled in the LTE; median exposure was 2.34 and 2.07 years in sirukumab 50 mg q4w and 100 mg q2w groups, respectively. Adverse events (AEs) occurred in similar proportions between groups, with the exception of major adverse cardiovascular events (MACE), which were more common in the 50 mg q4w versus 100 mg q2w group (2.2% vs 1.0%), and injection-site reactions, more common in the 100 mg q2w group versus 50 mg q4w group (7.5% vs 3.7%). The most common serious AEs were infections (10% of the patients); 32 (1.8%) patients died during the study (primarily from serious infection and MACE). Malignancies were reported in 24 (1.3%) patients. Gastrointestinal perforations, hepatobiliary abnormalities and changes in laboratory parameters were rare. Reductions in RA signs and symptoms and improvements in physical function were maintained throughout the LTE. The safety profile of sirukumab in the LTE remained consistent with that reported in SIRROUND-D and SIRROUND-T and efficacy was maintained. NCT01856309.
Published: 2021

7. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors:Data from the International RA BIODAM Cohort

Author: Sepriano, Alexandre, Ramiro, Sofia, FitzGerald, Oliver, Østergaard, Mikkel, Homik, Joanne, van der Heijde, Désirée, Elkayam, Ori, Thorne, J Carter, Larché, Maggie J, Ferraccioli, Gianfranco, Backhaus, Marina, Burmester, Gerd R, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain, Barnabe, Cheryl, Bingham, Clifton O, Tak, Paul P, van Schaardenburg, Dirkjan, Hammer, Hilde Berner, Paschke, Joel, Dadashova, Rana, Hutchings, Edna, Landewé, Robert, Maksymowych, Walter P, Sepriano, Alexandre, Ramiro, Sofia, FitzGerald, Oliver, Østergaard, Mikkel, Homik, Joanne, van der Heijde, Désirée, Elkayam, Ori, Thorne, J Carter, Larché, Maggie J, Ferraccioli, Gianfranco, Backhaus, Marina, Burmester, Gerd R, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain, Barnabe, Cheryl, Bingham, Clifton O, Tak, Paul P, van Schaardenburg, Dirkjan, Hammer, Hilde Berner, Paschke, Joel, Dadashova, Rana, Hutchings, Edna, Landewé, Robert, and Maksymowych, Walter P
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].
Published: 2020

8. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA

Author: Maksymowych, Walter P, FitzGerald, Oliver, Østergaard, Mikkel, Homik, Joanne, van der Heijde, Désirée, Lambert, Robert G, Elkayam, Ori, Ramiro, Sofia, Thorne, J Carter, Larché, Maggie J, Ferraccioli, Gianfranco, Backhaus, Marina, Burmester, Gerd R, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain, Barnabe, Cheryl, Bingham, Clifton O, Tak, Paul P, van Schaardenburg, Dirkjan, Hammer, Hilde Berner, Paschke, Joel, Dadashova, Rana, Hutchings, Edna, Sepriano, Alexandre, Landewé, Robert, Maksymowych, Walter P, FitzGerald, Oliver, Østergaard, Mikkel, Homik, Joanne, van der Heijde, Désirée, Lambert, Robert G, Elkayam, Ori, Ramiro, Sofia, Thorne, J Carter, Larché, Maggie J, Ferraccioli, Gianfranco, Backhaus, Marina, Burmester, Gerd R, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain, Barnabe, Cheryl, Bingham, Clifton O, Tak, Paul P, van Schaardenburg, Dirkjan, Hammer, Hilde Berner, Paschke, Joel, Dadashova, Rana, Hutchings, Edna, Sepriano, Alexandre, and Landewé, Robert
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).
Published: 2020

9. Is treat-to-target really working in rheumatoid arthritis? a longitudinal analysis of a cohort of patients treated in daily practice (RA BIODAM)

Author: Ramiro, Sofia, Landewé, Robert B.M., Van Der Heijde, Désirée, Sepriano, Alexandre, Fitzgerald, Oliver, Ostergaard, Mikkel, Homik, Joanne, Elkayam, Ori, Thorne, J. Carter, Larche, Margaret, Ferraciolli, Gianfranco, Backhaus, Marina, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain G., Allaart, Cornelia F., Barnabe, Cheryl, Bingham, Clifton O., Tak, Paul P., Van Schaardenburg, Dirkjan, Hammer, Hilde Berner, Dadashova, Rana, Hutchings, Edna, Paschke, Joel, Maksymowych, Walter P., Ramiro, Sofia, Landewé, Robert B.M., Van Der Heijde, Désirée, Sepriano, Alexandre, Fitzgerald, Oliver, Ostergaard, Mikkel, Homik, Joanne, Elkayam, Ori, Thorne, J. Carter, Larche, Margaret, Ferraciolli, Gianfranco, Backhaus, Marina, Boire, Gilles, Combe, Bernard, Schaeverbeke, Thierry, Saraux, Alain, Dougados, Maxime, Rossini, Maurizio, Govoni, Marcello, Sinigaglia, Luigi, Cantagrel, Alain G., Allaart, Cornelia F., Barnabe, Cheryl, Bingham, Clifton O., Tak, Paul P., Van Schaardenburg, Dirkjan, Hammer, Hilde Berner, Dadashova, Rana, Hutchings, Edna, Paschke, Joel, and Maksymowych, Walter P.
Abstract: Objectives To 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. Methods RA 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 <1.6) as the target. Sustained T2T was defined as T2T followed in ≥2 consecutive visits. The main outcome was the achievement of DAS44 remission at the subsequent 3-month visit. Other outcomes were remission according to 28-joint disease activity score-erythrocyte sedimentation rate (DAS28-ESR), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definitions. The association between T2T and remission was tested in generalised estimating equations models. Results In 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). Conclusion In daily clinical practice, the correct application of a T2T-strategy (especially sustained T2T) in patients with RA leads to higher ra
Published: 2020

10. Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions

Author: Smolen, Josef S, Schoels, Monika M, Nishimoto, Norihiro, Breedveld, Ferdinand C, Burmester, Gerd R, Dougados, Maxime, Emery, Paul, Ferraccioli, Gianfranco, Gabay, Cem, Gibofsky, Allan, Gomez-Reino, Juan Jesus, Jones, Graeme, Kvien, Tore K, Murakami, Miho, Betteridge, Neil, Bingham, Clifton O, Bykerk, Vivian, Choy, Ernest H, Combe, Bernard, Cutolo, Maurizio, Graninger, Winfried, Lanas, Angel, Martin-Mola, Emilio, Montecucco, Carlomaurizio, Østergaard, Mikkel, Pavelka, Karel, Rubbert-Roth, Andrea, Sattar, Naveed, Scholte-Voshaar, Marieke, Tanaka, Yoshiya, Trauner, Michael, Valentini, Gabriele, Winthrop, Kevin L, de Wit, Maarten, van der Heijde, Désirée, Smolen, Josef S, Schoels, Monika M, Nishimoto, Norihiro, Breedveld, Ferdinand C, Burmester, Gerd R, Dougados, Maxime, Emery, Paul, Ferraccioli, Gianfranco, Gabay, Cem, Gibofsky, Allan, Gomez-Reino, Juan Jesus, Jones, Graeme, Kvien, Tore K, Murakami, Miho, Betteridge, Neil, Bingham, Clifton O, Bykerk, Vivian, Choy, Ernest H, Combe, Bernard, Cutolo, Maurizio, Graninger, Winfried, Lanas, Angel, Martin-Mola, Emilio, Montecucco, Carlomaurizio, Østergaard, Mikkel, Pavelka, Karel, Rubbert-Roth, Andrea, Sattar, Naveed, Scholte-Voshaar, Marieke, Tanaka, Yoshiya, Trauner, Michael, Valentini, Gabriele, Winthrop, Kevin L, de Wit, Maarten, and van der Heijde, Désirée
Abstract: BACKGROUND: Since approval of tocilizumab (TCZ) for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), interleukin 6 (IL-6) pathway inhibition was evaluated in trials of TCZ and other agents targeting the IL-6 receptor and ligand in various RA populations and other inflammatory diseases. This consensus document informs on interference with the IL-6 pathway based on evidence and expert opinion. METHODS: Preparation of this document involved international experts in RA treatment and RA patients. A systematic literature search was performed that focused on TCZ and other IL6-pathway inhibitors in RA and other diseases. Subsequently, incorporating available published evidence and expert opinion, the steering committee and a broader expert committee (both including RA patients) formulated the current consensus statement. RESULTS: The consensus statement covers use of TCZ as combination- or monotherapy in various RA populations and includes clinical, functional and structural aspects. The statement also addresses the second approved indication in Europe JIA and non-approved indications. Also early phase trials involving additional agents that target the IL-6 receptor or IL-6 were evaluated. Safety concerns, including haematological, hepatic and metabolic issues as well as infections, are addressed likewise. CONCLUSIONS: The consensus statement identifies points to consider when using TCZ, regarding indications, contraindications, screening, dose, comedication, response evaluation and safety. The document is aimed at supporting clinicians and informing patients, administrators and payers on opportunities and limitations of IL-6 pathway inhibition.
Published: 2013

11. Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions

Author: Smolen, Josef S, Schoels, Monika M, Nishimoto, Norihiro, Breedveld, Ferdinand C, Burmester, Gerd R, Dougados, Maxime, Emery, Paul, Ferraccioli, Gianfranco, Gabay, Cem, Gibofsky, Allan, Gomez-Reino, Juan Jesus, Jones, Graeme, Kvien, Tore K, Murakami, Miho, Betteridge, Neil, Bingham, Clifton O, Bykerk, Vivian, Choy, Ernest H, Combe, Bernard, Cutolo, Maurizio, Graninger, Winfried, Lanas, Angel, Martin-Mola, Emilio, Montecucco, Carlomaurizio, Østergaard, Mikkel, Pavelka, Karel, Rubbert-Roth, Andrea, Sattar, Naveed, Scholte-Voshaar, Marieke, Tanaka, Yoshiya, Trauner, Michael, Valentini, Gabriele, Winthrop, Kevin L, de Wit, Maarten, van der Heijde, Désirée, Smolen, Josef S, Schoels, Monika M, Nishimoto, Norihiro, Breedveld, Ferdinand C, Burmester, Gerd R, Dougados, Maxime, Emery, Paul, Ferraccioli, Gianfranco, Gabay, Cem, Gibofsky, Allan, Gomez-Reino, Juan Jesus, Jones, Graeme, Kvien, Tore K, Murakami, Miho, Betteridge, Neil, Bingham, Clifton O, Bykerk, Vivian, Choy, Ernest H, Combe, Bernard, Cutolo, Maurizio, Graninger, Winfried, Lanas, Angel, Martin-Mola, Emilio, Montecucco, Carlomaurizio, Østergaard, Mikkel, Pavelka, Karel, Rubbert-Roth, Andrea, Sattar, Naveed, Scholte-Voshaar, Marieke, Tanaka, Yoshiya, Trauner, Michael, Valentini, Gabriele, Winthrop, Kevin L, de Wit, Maarten, and van der Heijde, Désirée
Abstract: BACKGROUND: Since approval of tocilizumab (TCZ) for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), interleukin 6 (IL-6) pathway inhibition was evaluated in trials of TCZ and other agents targeting the IL-6 receptor and ligand in various RA populations and other inflammatory diseases. This consensus document informs on interference with the IL-6 pathway based on evidence and expert opinion. METHODS: Preparation of this document involved international experts in RA treatment and RA patients. A systematic literature search was performed that focused on TCZ and other IL6-pathway inhibitors in RA and other diseases. Subsequently, incorporating available published evidence and expert opinion, the steering committee and a broader expert committee (both including RA patients) formulated the current consensus statement. RESULTS: The consensus statement covers use of TCZ as combination- or monotherapy in various RA populations and includes clinical, functional and structural aspects. The statement also addresses the second approved indication in Europe JIA and non-approved indications. Also early phase trials involving additional agents that target the IL-6 receptor or IL-6 were evaluated. Safety concerns, including haematological, hepatic and metabolic issues as well as infections, are addressed likewise. CONCLUSIONS: The consensus statement identifies points to consider when using TCZ, regarding indications, contraindications, screening, dose, comedication, response evaluation and safety. The document is aimed at supporting clinicians and informing patients, administrators and payers on opportunities and limitations of IL-6 pathway inhibition.
Published: 2013

12. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report

Author: University of Michigan, Ann Arbor, Boston University School of Medicine, Boston, Massachusetts, Medical University of Vienna, Vienna, Austria ; Dr. Aletaha has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, UCB, Schering-Plough, Wyeth, and Roche (less than $10,000 each)., Arthritis Research UK, Chesterfield, UK, Ministry of Health, Auckland, New Zealand ; Dr. Naden has received consulting fees from the American College of Rheumatology in regard to the methodology of developing weighted scoring systems (more than $10,000)., University of Pittsburgh, Pittsburgh, Pennsylvania, Johns Hopkins University, Baltimore, Maryland ; Dr. Bingham has received consulting fees, speaking fees, and/or honoraria from UCB, Roche, Genentech, Celgene, and Merck Serono (less than $10,000 each); he has received research and/or educational grant support from Bristol-Myers Squibb, Genentech, UCB, Centocor, Abbott, and Amgen., California Pacific Medical Center and University of California, San Francisco ; Dr. Birnbaum has received consulting fees, speaking fees, and/or honoraria from Amgen, Pfizer, Centocor, Abbott, and UCB (less than $10,000 each)., Charit?? Hospital???University Medicine Berlin, Free University and Humboldt University, Berlin, Germany ; Dr. Burmester has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, Pfizer, UCB, and Roche (less than $10,000 each)., Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada ; Dr. Bykerk has received consulting fees, speaking fees, and/or honoraria from Amgen, Wyeth, Abbott, Schering-Plough, Roche, Bristol-Myers Squibb, and UCB (less than $10,000 each); her spouse is employed by Genzyme and owns stock in the company., National Jewish Medical and Research Center, Denver, Colorado ; Dr. Cohen has received consulting fees, speaking fees, and/or honoraria from UCB, Genentech, Bristol-Myers Squibb, and Human Genome Sciences (less than $10,000 each)., Lapeyronie Hospital and Montpellier I University, Montpellier, France ; Dr. Combe has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and Merck, Sharpe, and Dohme (less than $10,000 each)., Brigham and Women's Hospital and Harvard University, Boston, Massachusetts, Cochin Hospital, Assistance Publique H??pitaux de Paris, and Paris-Descartes University, Paris, France, University of Leeds and NIHR Leeds Biomedical Research Unit, Leeds, UK ; Dr. Emery has received consulting fees, speaking fees, and/or honoraria from Pfizer, Abbott, Centocor, UCB, Roche, Bristol-Myers Squibb, and Merck, Sharpe, and Dohme (less than $10,000 each)., School of Medicine, Catholic University of the Sacred Heart, Rome, Italy ; Dr. Ferraccioli holds a patent for T cell receptor clonotype analysis (PCT/IB 2008/053152 NP)., Erasmus Medical Center and University of Rotterdam, Rotterdam, The Netherlands, University of Colorado School of Medicine, Denver, Leiden University Medical Center, Leiden, The Netherlands ; Dr. Huizinga has received consulting fees, speaking fees, and/or honoraria from Schering-Plough, Bristol-Myers Squibb, UCB, Biotest AG, Wyeth/Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, and Axis-Shield (less than $10,000 each)., University of California, San Diego ; Dr. Kavanaugh has conducted clinical research for Amgen, Abbott, Bristol-Myers Squibb, UCB, Roche, Centocor, Genentech, and Sanofi-Aventis., UMassMemorial Medical Center and University of Massachusetts Medical School, Worcester ; Dr. Kay has received consulting fees from Array BioPharma, Bristol-Myers Squibb, Celgene, Centocor, Genentech, Roche, UCB, and Sanofi-Aventis (less than $10,000 each)., David Geffen School of Medicine at University of California, Los Angeles ; Dr. Khanna has received consulting fees, speaking fees, and/or honoraria from UCB and Abbott (less than $10,000 each)., Diakonhjemmet Hospital, Oslo, Norway, Swedish Medical Center and University of Washington, Seattle ; Dr. Mease has received consulting fees, speaking fees, and/or honoraria from Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Centocor, Roche, Genentech, UCB, Pfizer, Novartis, and Eli Lilly (less than $10,000 each)., McGill University Health Centre and McGill University, Montreal, Quebec, Canada ; Dr. M??nard has received unrestricted educational and research grants as well as consulting and speaking fees from Abbott, Amgen, Inova, Merck, Pfizer, Roche, Schering-Plough, UCB, and Wyeth (less than $10,000 each) and investigator-initiated research grants from Bristol-Myers Squibb, EuroImmun AG, and Roche (more than $10,000 each); he owns stock or stock options in Merck; and he has a license agreement with EuroImmun AG for an anti-Sa enzyme-linked immunosorbent assay., University of Pittsburgh, Pittsburgh, Pennsylvania ; Dr. Moreland has received consulting fees, speaking fees, and/or honoraria from Biogen Idec, Centocor, Pfizer, Takeda, KaloBios, ChemoCentryx, UCB, Genentech, Incyte, and Eli Lilly (less than $10,000 each)., University of North Carolina, Chapel Hill, New York University Hospital for Joint Diseases, New York, New York ; Dr. Pincus has received consulting fees, speaking fees, and/or honoraria from Amgen, Abbott, Bristol-Myers Squibb, Centocor, UCB, Wyeth, and Genentech (less than $10,000 each) and investigator-initiated research grants from Amgen, Bristol-Myers Squibb, UCB, and Centocor., Seattle Children's Hospital, Seattle, Washington, Medical University of Vienna, Vienna, Austria, Institute of Rheumatology, Warsaw, Poland ; Dr. Stanislawska-Biernat has received speaking fees from Abbott and Pfizer (less than $10,000 each)., University of Manchester, Manchester, UK, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands, UMassMemorial Medical Center and University of Massachusetts Medical School, Worcester, Institute of Rheumatology, Prague, Czech Republic ; Dr. Vencovsk?? has received speaking fees from Pfizer, UCB, Abbott, Roche, and Merck, Sharpe, and Dohme (less than $10,000 each)., National Data Bank for Rheumatic Diseases and University of Kansas, Wichita, Women's College Hospital and University of Toronto, Toronto, Ontario, Canada ; Department of Medicine, Women's College Hospital, 76 Grenville Street, 8th Floor, Room 815, Toronto, Ontario M5S 1B2, Canada, Neogi, Tuhina, Aletaha, Daniel, Silman, Alan J., Naden, Raymond L., Felson, David T., Aggarwal, Rohit, Bingham, Clifton O., Birnbaum, Neal S., Burmester, Gerd R., Bykerk, Vivian P., Cohen, Marc D., Combe, Bernard, Costenbader, Karen H., Dougados, Maxime, Emery, Paul, Ferraccioli, Gianfranco, Hazes, Johanna M. W., Hobbs, Kathryn, Huizinga, Tom W. J., Kavanaugh, Arthur, Kay, Jonathan, Khanna, Dinesh, Kvien, Tore K., Laing, Timothy, Liao, Katherine, Mease, Philip, M??nard, Henri A., Moreland, Larry W., Nair, Raj, Pincus, Theodore, Ringold, Sarah, Smolen, Josef S., Stanislawska-Biernat, Ewa, Symmons, Deborah, Tak, Paul P., Upchurch, Katherine S., Vencovsk??, Jir??, Wolfe, Frederick, Hawker, Gillian, University of Michigan, Ann Arbor, Boston University School of Medicine, Boston, Massachusetts, Medical University of Vienna, Vienna, Austria ; Dr. Aletaha has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, UCB, Schering-Plough, Wyeth, and Roche (less than $10,000 each)., Arthritis Research UK, Chesterfield, UK, Ministry of Health, Auckland, New Zealand ; Dr. Naden has received consulting fees from the American College of Rheumatology in regard to the methodology of developing weighted scoring systems (more than $10,000)., University of Pittsburgh, Pittsburgh, Pennsylvania, Johns Hopkins University, Baltimore, Maryland ; Dr. Bingham has received consulting fees, speaking fees, and/or honoraria from UCB, Roche, Genentech, Celgene, and Merck Serono (less than $10,000 each); he has received research and/or educational grant support from Bristol-Myers Squibb, Genentech, UCB, Centocor, Abbott, and Amgen., California Pacific Medical Center and University of California, San Francisco ; Dr. Birnbaum has received consulting fees, speaking fees, and/or honoraria from Amgen, Pfizer, Centocor, Abbott, and UCB (less than $10,000 each)., Charit?? Hospital???University Medicine Berlin, Free University and Humboldt University, Berlin, Germany ; Dr. Burmester has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, Pfizer, UCB, and Roche (less than $10,000 each)., Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada ; Dr. Bykerk has received consulting fees, speaking fees, and/or honoraria from Amgen, Wyeth, Abbott, Schering-Plough, Roche, Bristol-Myers Squibb, and UCB (less than $10,000 each); her spouse is employed by Genzyme and owns stock in the company., National Jewish Medical and Research Center, Denver, Colorado ; Dr. Cohen has received consulting fees, speaking fees, and/or honoraria from UCB, Genentech, Bristol-Myers Squibb, and Human Genome Sciences (less than $10,000 each)., Lapeyronie Hospital and Montpellier I University, Montpellier, France ; Dr. Combe has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough, and Merck, Sharpe, and Dohme (less than $10,000 each)., Brigham and Women's Hospital and Harvard University, Boston, Massachusetts, Cochin Hospital, Assistance Publique H??pitaux de Paris, and Paris-Descartes University, Paris, France, University of Leeds and NIHR Leeds Biomedical Research Unit, Leeds, UK ; Dr. Emery has received consulting fees, speaking fees, and/or honoraria from Pfizer, Abbott, Centocor, UCB, Roche, Bristol-Myers Squibb, and Merck, Sharpe, and Dohme (less than $10,000 each)., School of Medicine, Catholic University of the Sacred Heart, Rome, Italy ; Dr. Ferraccioli holds a patent for T cell receptor clonotype analysis (PCT/IB 2008/053152 NP)., Erasmus Medical Center and University of Rotterdam, Rotterdam, The Netherlands, University of Colorado School of Medicine, Denver, Leiden University Medical Center, Leiden, The Netherlands ; Dr. Huizinga has received consulting fees, speaking fees, and/or honoraria from Schering-Plough, Bristol-Myers Squibb, UCB, Biotest AG, Wyeth/Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, and Axis-Shield (less than $10,000 each)., University of California, San Diego ; Dr. Kavanaugh has conducted clinical research for Amgen, Abbott, Bristol-Myers Squibb, UCB, Roche, Centocor, Genentech, and Sanofi-Aventis., UMassMemorial Medical Center and University of Massachusetts Medical School, Worcester ; Dr. Kay has received consulting fees from Array BioPharma, Bristol-Myers Squibb, Celgene, Centocor, Genentech, Roche, UCB, and Sanofi-Aventis (less than $10,000 each)., David Geffen School of Medicine at University of California, Los Angeles ; Dr. Khanna has received consulting fees, speaking fees, and/or honoraria from UCB and Abbott (less than $10,000 each)., Diakonhjemmet Hospital, Oslo, Norway, Swedish Medical Center and University of Washington, Seattle ; Dr. Mease has received consulting fees, speaking fees, and/or honoraria from Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Centocor, Roche, Genentech, UCB, Pfizer, Novartis, and Eli Lilly (less than $10,000 each)., McGill University Health Centre and McGill University, Montreal, Quebec, Canada ; Dr. M??nard has received unrestricted educational and research grants as well as consulting and speaking fees from Abbott, Amgen, Inova, Merck, Pfizer, Roche, Schering-Plough, UCB, and Wyeth (less than $10,000 each) and investigator-initiated research grants from Bristol-Myers Squibb, EuroImmun AG, and Roche (more than $10,000 each); he owns stock or stock options in Merck; and he has a license agreement with EuroImmun AG for an anti-Sa enzyme-linked immunosorbent assay., University of Pittsburgh, Pittsburgh, Pennsylvania ; Dr. Moreland has received consulting fees, speaking fees, and/or honoraria from Biogen Idec, Centocor, Pfizer, Takeda, KaloBios, ChemoCentryx, UCB, Genentech, Incyte, and Eli Lilly (less than $10,000 each)., University of North Carolina, Chapel Hill, New York University Hospital for Joint Diseases, New York, New York ; Dr. Pincus has received consulting fees, speaking fees, and/or honoraria from Amgen, Abbott, Bristol-Myers Squibb, Centocor, UCB, Wyeth, and Genentech (less than $10,000 each) and investigator-initiated research grants from Amgen, Bristol-Myers Squibb, UCB, and Centocor., Seattle Children's Hospital, Seattle, Washington, Medical University of Vienna, Vienna, Austria, Institute of Rheumatology, Warsaw, Poland ; Dr. Stanislawska-Biernat has received speaking fees from Abbott and Pfizer (less than $10,000 each)., University of Manchester, Manchester, UK, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands, UMassMemorial Medical Center and University of Massachusetts Medical School, Worcester, Institute of Rheumatology, Prague, Czech Republic ; Dr. Vencovsk?? has received speaking fees from Pfizer, UCB, Abbott, Roche, and Merck, Sharpe, and Dohme (less than $10,000 each)., National Data Bank for Rheumatic Diseases and University of Kansas, Wichita, Women's College Hospital and University of Toronto, Toronto, Ontario, Canada ; Department of Medicine, Women's College Hospital, 76 Grenville Street, 8th Floor, Room 815, Toronto, Ontario M5S 1B2, Canada, Neogi, Tuhina, Aletaha, Daniel, Silman, Alan J., Naden, Raymond L., Felson, David T., Aggarwal, Rohit, Bingham, Clifton O., Birnbaum, Neal S., Burmester, Gerd R., Bykerk, Vivian P., Cohen, Marc D., Combe, Bernard, Costenbader, Karen H., Dougados, Maxime, Emery, Paul, Ferraccioli, Gianfranco, Hazes, Johanna M. W., Hobbs, Kathryn, Huizinga, Tom W. J., Kavanaugh, Arthur, Kay, Jonathan, Khanna, Dinesh, Kvien, Tore K., Laing, Timothy, Liao, Katherine, Mease, Philip, M??nard, Henri A., Moreland, Larry W., Nair, Raj, Pincus, Theodore, Ringold, Sarah, Smolen, Josef S., Stanislawska-Biernat, Ewa, Symmons, Deborah, Tak, Paul P., Upchurch, Katherine S., Vencovsk??, Jir??, Wolfe, Frederick, and Hawker, Gillian
Abstract: Objective The American College of Rheumatology and the European League Against Rheumatism have developed new classification criteria for rheumatoid arthritis (RA). The aim of Phase 2 of the development process was to achieve expert consensus on the clinical and laboratory variables that should contribute to the final criteria set. Methods Twenty-four expert RA clinicians (12 from Europe and 12 from North America) participated in Phase 2. A consensus-based decision analysis approach was used to identify factors (and their relative weights) that influence the probability of ???developing RA,??? complemented by data from the Phase 1 study. Patient case scenarios were used to identify and reach consensus on factors important in determining the probability of RA development. Decision analytic software was used to derive the relative weights for each of the factors and their categories, using choice-based conjoint analysis. Results The expert panel agreed that the new classification criteria should be applied to individuals with undifferentiated inflammatory arthritis in whom at least 1 joint is deemed by an expert assessor to be swollen, indicating definite synovitis. In this clinical setting, they identified 4 additional criteria as being important: number of joints involved and site of involvement, serologic abnormality, acute-phase response, and duration of symptoms in the involved joints. These criteria were consistent with those identified in the Phase 1 data-driven approach. Conclusion The consensus-based, decision analysis approach used in Phase 2 complemented the Phase 1 efforts. The 4 criteria and their relative weights form the basis of the final criteria set.
Published: 2010

13. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema.

Author: Lassere, Marissa N, Johnson, Kent R, Boers, Maarten, Tugwell, Peter, Brooks, Peter, Simon, Lee, Strand, Vibeke, Conaghan, Philip G, Ostergaard, Mikkel, Maksymowych, Walter P, Landewe, Robert, Bresnihan, Barry, Tak, Paul-Peter, Wakefield, Richard, Mease, Philip, Bingham, Clifton O, Hughes, Michael, Altman, Doug, Buyse, Marc, Galbraith, Sally, Wells, George, Lassere, Marissa N, Johnson, Kent R, Boers, Maarten, Tugwell, Peter, Brooks, Peter, Simon, Lee, Strand, Vibeke, Conaghan, Philip G, Ostergaard, Mikkel, Maksymowych, Walter P, Landewe, Robert, Bresnihan, Barry, Tak, Paul-Peter, Wakefield, Richard, Mease, Philip, Bingham, Clifton O, Hughes, Michael, Altman, Doug, Buyse, Marc, Galbraith, Sally, and Wells, George
Abstract: OBJECTIVE: There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to develop a hierarchical schema that systematically evaluates and ranks the surrogacy status of biomarkers and surrogates; and to obtain feedback from stakeholders. METHODS: After a systematic search of Medline and Embase on biomarkers, surrogate (outcomes, endpoints, markers, indicators), intermediate endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery, development, and approval. Udgivelsesdato: 2007-Mar, OBJECTIVE: There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to develop a hierarchical schema that systematically evaluates and ranks the surrogacy status of biomarkers and surrogates; and to obtain feedback from stakeholders. METHODS: After a systematic search of Medline and Embase on biomarkers, surrogate (outcomes, endpoints, markers, indicators), intermediate endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery, development, and approval.
Published: 2007

14. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema.

Author: Lassere, Marissa N, Johnson, Kent R, Boers, Maarten, Tugwell, Peter, Brooks, Peter, Simon, Lee, Strand, Vibeke, Conaghan, Philip G, Ostergaard, Mikkel, Maksymowych, Walter P, Landewe, Robert, Bresnihan, Barry, Tak, Paul-Peter, Wakefield, Richard, Mease, Philip, Bingham, Clifton O, Hughes, Michael, Altman, Doug, Buyse, Marc, Galbraith, Sally, Wells, George, Lassere, Marissa N, Johnson, Kent R, Boers, Maarten, Tugwell, Peter, Brooks, Peter, Simon, Lee, Strand, Vibeke, Conaghan, Philip G, Ostergaard, Mikkel, Maksymowych, Walter P, Landewe, Robert, Bresnihan, Barry, Tak, Paul-Peter, Wakefield, Richard, Mease, Philip, Bingham, Clifton O, Hughes, Michael, Altman, Doug, Buyse, Marc, Galbraith, Sally, and Wells, George
Abstract: OBJECTIVE: There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to develop a hierarchical schema that systematically evaluates and ranks the surrogacy status of biomarkers and surrogates; and to obtain feedback from stakeholders. METHODS: After a systematic search of Medline and Embase on biomarkers, surrogate (outcomes, endpoints, markers, indicators), intermediate endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery, development, and approval. Udgivelsesdato: 2007-Mar, OBJECTIVE: There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to develop a hierarchical schema that systematically evaluates and ranks the surrogacy status of biomarkers and surrogates; and to obtain feedback from stakeholders. METHODS: After a systematic search of Medline and Embase on biomarkers, surrogate (outcomes, endpoints, markers, indicators), intermediate endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery, development, and approval.
Published: 2007

15. Case Reports1. A Late Presentation of Loeys-Dietz Syndrome: Beware of TGFβ Receptor Mutations in Benign Joint Hypermobility

Author: Mehta, Puja, Holder, Susan, Fisher, Benjamin, Vincent, Tonia, Nadesalingam, Kavitha, Maciver, Helen, Shingler, Wendy, Bakshi, Jyoti, Hassan, Sadon, D'Cruz, David, Chan, Antoni, Litwic, Anna E., McCrae, Fiona, Seth, Rakhi, Nandagudi, Anupama, Jury, Elizabeth, Isenberg, David, Karjigi, Uma, Paul, Anupam, Rees, Frances, O'Dowd, Emma, Kinnear, William, Johnson, Simon, Lanyon, Peter, Stevens, Richard, Narayan, Nehal, Marguerie, Christopher, Robinson, Helena, Ffolkes, Lorrette, Worsnop, Fiona, Ostlere, Lucy, Kiely, Patrick, Dharmapalaiah, Chethana, Hassan, Nada, Bharadwaj, Anurag, Skibinska, Malgorzata, Gendi, Nagui, Davies, Emma J., Akil, Mohammed, Kilding, Rachael, Ramachandran Nair, Jagdish, Walsh, Maeve, Farrar, Wendy, Thompson, Robert N., Borukhson, Liubov, McFadyen, Charles, Singh, Deepwant, Rajagopal, Vivek, Chan, Angela Marie L., Wearn Koh, Li, Christie, Jennifer D., Croot, Lorraine, Gayed, Mary, Disney, Benjamin, Singhal, Saket, Grindulis, Karl, Reynolds, Timothy D., Conway, Katie, Williams, Debbie, Quin, John, Dean, Gillian, Churchill, Duncan, Walker-Bone, Karen E., Goff, Iain, Reynolds, Gary, Grove, Matthew, Patel, Priya, Lazarus, Mark N., Roncaroli, Frederico, Gabriel, Carolyn, Kinderlerer, Anne R., Nikiphorou, Elena, Hall, Frances C., Bruce, Ellen, Gray, Leanne, Krutikov, Maria, Wig, Surabhi, Bruce, Ian, D'Agostino, Maria A., Wakefield, Richard, Berner Hammer, Hilde, Vittecoq, Olivier, Galeazzi, Mauro, Balint, Peter, Filippucci, Emilio, Moller, Ingrid, Iagnocco, Annamaria, Naredo, Esperanza, Ostergaard, Mikkel, Gaillez, Corine, Kerselaers, Wendy, Van Holder, Karina, Le Bars, Manuela, Stone, Millicent A., Williams, Francis, Wolber, Lisa, Karppinen, Jaro, Maatta, Juhani, Thompson, Ben, Atchia, Ismael, Lorenzi, Alice, Raftery, Graham, Platt, Phil, Platt, Philip N., Pratt, Arthur, Turmezei, Thomas D., Treece, Graham M., Gee, Andrew H., Poole, Kenneth E., Chandratre, Priyanka N., Roddy, Edward, Clarson, Lorna, Richardson, Jane, Hider, Samantha, Mallen, Christian, Lieberman, Abigail, Prouse, Peter J., Mahendran, Prini, Samarawickrama, Amanda, Ottery, Faith D., Yood, Robert, Wolfson, Marsha, Ang, Andrea, Riches, Philip, Thomson, Janet, Nuki, George, Humphreys, Jennifer, Verstappen, Suzanne M., Chipping, Jacqueline, Hyrich, Kimme, Marshall, Tarnya, Symmons, Deborah P., Roy, Matthew, Kirwan, John R., Marshall, Robert W., Matcham, Faith, Scott, Ian C., Rayner, Lauren, Hotopf, Matthew, Kingsley, Gabrielle H., Scott, David L., Steer, Sophia, Ma, Margaret H., Dahanayake, Chanaka, Kingsley, Gabrielle, Cope, Andrew, Wernham, Aaron, Ward, Lorna, Carruthers, David, Deeming, Alison, Buckley, Christopher, Raza, Karim, De Pablo, Paola, Carpenter, Lewis, Jayakumar, Keeranur, Solymossy, Csilla, Dixey, Josh, Young, Adam, Singh, Animesh, Penn, Henry, Ellerby, Nicholas, Mattey, Derek L., Packham, Jonathan, Dawes, Peter, Hider, Samantha L., Ng, Nora, Humby, Frances, Bombardieri, Michele, Kelly, Stephen, Di Cicco, Maria, Dadoun, Sabrina, Hands, Rebecca, Rocher, Vidalba, Kidd, Bruce, Pyne, Dev, Pitzalis, Costantino, Poore, Sophie, Hutchinson, David, Low, Audrey, Lunt, Mark, Mercer, Louise, Galloway, James, Davies, Rebecca, Watson, Kath, Dixon, Will, Symmons, Deborah, Watson, Kath D., Dixon, William G., Hyrich, Kimme L., Malik, Saadia P., Kelly, Clive, Hamilton, Jennifer, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Harris, Helen E., Tweedie, Fiona, Skaparis, Yiannis, White, Marie, Scott, Nicola, Samson, Kay, Mercieca, Cecilia, Clarke, Shane, Warner, Alexander J., Verstappen, Suzanne, Chan, Esther, Woodhead, Felix A., Nisar, Mohamed, Arthanari, S., Dawson, Julie, Sathi, Nav, Ahmad, Yasmeen, Koduri, Gouri, Cumming, Jo, Stannett, Peter, Hull, Richard, Metsios, George, Stavropoulos Kalinoglou, Antonios, Veldhuijzen van Zanten, Jet J., Nightingale, Peter, Koutedakis, Yiannis, Kitas, George D., Williams, Peter, Walsh, David, Perry, Elizabeth, de-Soyza, Anthony, Moullaali, Thomas, Eggleton, Paul, Stavropoulos-Kalinoglou, Antonios, Sandoo, Aamer, de Pablo, Paola, Maggs, Fiona, Faizal, Abdul, Pugh, Mark, Jobanputra, Paresh, Kehoe, Oksana, Cartwright, Alison, Askari, Ayman, El Haj, Alicia, Middleton, Jim, Aynsley, Sarah, Hardy, Jacob, Veale, Douglas, Fearon, Ursula, Wilson, Gerry, Muthana, Munitta, Fossati, G., Healy, L., Nesbitt, A., Becerra, Elena, Leandro, Maria J., De La Torre, Inmaculada, Cambridge, Geraldine, Nelson, P. N., Roden, D., Shaw, M., Davari Ejtehadi, Hora, Nevill, A., Freimanis, G., Hooley, P., Bowman, S., Alavi, A., Axford, J., Veitch, A. M., Tugnet, N., Rylance, P. B., Hawtree, Sarah, Mark Wilkinson, J., Wilson, Anthony G., Woon Kam, Ngar, Filter, Andrew, Croft, Adam P., Naylor, Amy, Zimmermann, Birgit, Hardie, Debbie, Desanti, Guillaume, Jaurez, Maria, Muller-Ladner, Ulf, Filer, Andrew, Neumann, Elena, Movahedi, Mohammad, Ray, David W., Burmester, Gerd R., Matucci-Cerinic, Marco, Navarro-Blasco, Francisco, Kary, Sonja, Unnebrink, Kristina, Kupper, Hartmut, Mukherjee, Sandeep, Cornell, Patricia, Richards, Selwyn, Rahmeh, Fouz, Thompson, Paul W., Westlake, Sarah L., Javaid, Muhammad K., Batra, Rajbir, Chana, Jasroop, Round, Gemma, Judge, Andrew, Taylor, Peter, Patel, Sanjeev, Cooper, Cyrus, Ravindran, Vinod, Bingham, Clifton O., Weinblatt, Michael E., Mendelsohn, Alan, Kim, Lilianne, Mack, Michael, Lu, Jiandong, Baker, Daniel, Westhovens, Rene, Hewitt, Jamie, Han, Chenglong, Keystone, Edward C., Fleischmann, Roy, Smolen, Josef, Emery, Paul, Genovese, Mark, Doyle, Mittie, Hsia, Elizabeth C., Hart, Jennifer C., Harland, Dave, Gibbons, Carl, Pang, Hok, Huertas, Catherine, Diamantopoulos, Alex, Dejonckheere, Fred, Clowse, M., Wolf, D., Stach, C., Kosutic, G., Williams, S., Terpstra, I., Mahadevan, U., Ferraccioli, G., Samborski, W., Berenbaum, F., Davies, O., Koetse, W., Bennett, B., Burkhardt, H., Luijtens, K., van der Heijde, Desiree, Mariette, X., van Vollenhoven, Ronald F., Bykerk, V., de Longueville, M., Arendt, C., Cush, J., Khan, Afsha, Maclaren, Zoe, Dubash, Sayam, Chalam, Venkat C., Sheeran, Tom, Price, Tom, Baskar, Sangeetha, Mulherin, Diarmuid, Molloy, Cauline, Keay, Fiona, Heritage, Caroline, Douglas, Barbara, Schiff, Michael H., Khanna, Dinesh, Furst, Daniel E., Maldonado, Michael A., Li, Wanying, Sasso, Eric H., Emerling, Daniel, Cavet, Guy, Ford, Kerri, Mackenzie-Green, Bronwen, Collins, David, Price, Elizabeth, Williamson, Lyn, Golla, Janardhana, Vagadia, Vipul, Morrison, Elaine, Tierney, Ann, Wilson, Hilary, Hunter, John, Reddy, Venkat, Moore, Samantha, Ehrenstein, Michael, Benson, Claire, Wray, Maria, Cairns, Andrew, Wright, Gary, Pendleton, Adrian, McHenry, Michelle, Taggart, Allister, Bell, Aubrey, Bosworth, Ailsa, Cox, Maureen, Johnston, Graeme, Shah, Preeti, O'Brien, Anne, Jones, Peter, Sargeant, Ify, Bukhari, Marwan, Nusslein, Hubert, Alten, Rieke, Lorenz, Hannes M., Boumpas, Dimitrios, Nurmohamed, Michael T., Bensen, William, Peter, Hans-Hartmut, Rainer, Franz, Pavelka, Karel, Chartier, Melanie, Poncet, Coralie, Rauch, Christiane, Lempp, Heidi, Hofmann, Darija, Adu, Aderonke, Congreve, Carron, Dobson, Joanne, Rose, Diana, Simpson, Carol, Wykes, Til, Ibrahim, Fowzia, Schiff, Michael, Nash, Peter, Durez, Patrick, Kaine, Jeffrey, Delaet, Ingrid, Kelly, Sheila, Maldonado, Michael, Patel, Salil, Jones, Graeme, Sebba, Anthony, Lepley, Denise, Devenport, Jenny, Bernasconi, Corrado, Smart, Devi, Mpofu, Chiedzo, Gomez-Reino, Juan J., Verma, Inderjeet, Kaur, Jaspreet, Syngle, Ashit, Krishan, Pawan, Vohra, Kanchan, Kaur, Ladbans, Garg, Nidhi, Chhabara, Monica, Gibson, Kellie, Woodburn, James, Telfer, Scott, Buckley, Felicity, Finckh, Axel, Huizinga, Tom W., Jansen, Jeroen P., Rubbert-Roth, Andrea, Scali, Juan J., Kremer, Joel M., Pitts, Laura, Vernon, Emma, Sharif, Mohammed I., Das, Sudipto, Helliwell, Philip, Sokoll, Katharina, Vital, Edward M., Mehta, Puja, Holder, Susan, Fisher, Benjamin, Vincent, Tonia, Nadesalingam, Kavitha, Maciver, Helen, Shingler, Wendy, Bakshi, Jyoti, Hassan, Sadon, D'Cruz, David, Chan, Antoni, Litwic, Anna E., McCrae, Fiona, Seth, Rakhi, Nandagudi, Anupama, Jury, Elizabeth, Isenberg, David, Karjigi, Uma, Paul, Anupam, Rees, Frances, O'Dowd, Emma, Kinnear, William, Johnson, Simon, Lanyon, Peter, Stevens, Richard, Narayan, Nehal, Marguerie, Christopher, Robinson, Helena, Ffolkes, Lorrette, Worsnop, Fiona, Ostlere, Lucy, Kiely, Patrick, Dharmapalaiah, Chethana, Hassan, Nada, Bharadwaj, Anurag, Skibinska, Malgorzata, Gendi, Nagui, Davies, Emma J., Akil, Mohammed, Kilding, Rachael, Ramachandran Nair, Jagdish, Walsh, Maeve, Farrar, Wendy, Thompson, Robert N., Borukhson, Liubov, McFadyen, Charles, Singh, Deepwant, Rajagopal, Vivek, Chan, Angela Marie L., Wearn Koh, Li, Christie, Jennifer D., Croot, Lorraine, Gayed, Mary, Disney, Benjamin, Singhal, Saket, Grindulis, Karl, Reynolds, Timothy D., Conway, Katie, Williams, Debbie, Quin, John, Dean, Gillian, Churchill, Duncan, Walker-Bone, Karen E., Goff, Iain, Reynolds, Gary, Grove, Matthew, Patel, Priya, Lazarus, Mark N., Roncaroli, Frederico, Gabriel, Carolyn, Kinderlerer, Anne R., Nikiphorou, Elena, Hall, Frances C., Bruce, Ellen, Gray, Leanne, Krutikov, Maria, Wig, Surabhi, Bruce, Ian, D'Agostino, Maria A., Wakefield, Richard, Berner Hammer, Hilde, Vittecoq, Olivier, Galeazzi, Mauro, Balint, Peter, Filippucci, Emilio, Moller, Ingrid, Iagnocco, Annamaria, Naredo, Esperanza, Ostergaard, Mikkel, Gaillez, Corine, Kerselaers, Wendy, Van Holder, Karina, Le Bars, Manuela, Stone, Millicent A., Williams, Francis, Wolber, Lisa, Karppinen, Jaro, Maatta, Juhani, Thompson, Ben, Atchia, Ismael, Lorenzi, Alice, Raftery, Graham, Platt, Phil, Platt, Philip N., Pratt, Arthur, Turmezei, Thomas D., Treece, Graham M., Gee, Andrew H., Poole, Kenneth E., Chandratre, Priyanka N., Roddy, Edward, Clarson, Lorna, Richardson, Jane, Hider, Samantha, Mallen, Christian, Lieberman, Abigail, Prouse, Peter J., Mahendran, Prini, Samarawickrama, Amanda, Ottery, Faith D., Yood, Robert, Wolfson, Marsha, Ang, Andrea, Riches, Philip, Thomson, Janet, Nuki, George, Humphreys, Jennifer, Verstappen, Suzanne M., Chipping, Jacqueline, Hyrich, Kimme, Marshall, Tarnya, Symmons, Deborah P., Roy, Matthew, Kirwan, John R., Marshall, Robert W., Matcham, Faith, Scott, Ian C., Rayner, Lauren, Hotopf, Matthew, Kingsley, Gabrielle H., Scott, David L., Steer, Sophia, Ma, Margaret H., Dahanayake, Chanaka, Kingsley, Gabrielle, Cope, Andrew, Wernham, Aaron, Ward, Lorna, Carruthers, David, Deeming, Alison, Buckley, Christopher, Raza, Karim, De Pablo, Paola, Carpenter, Lewis, Jayakumar, Keeranur, Solymossy, Csilla, Dixey, Josh, Young, Adam, Singh, Animesh, Penn, Henry, Ellerby, Nicholas, Mattey, Derek L., Packham, Jonathan, Dawes, Peter, Hider, Samantha L., Ng, Nora, Humby, Frances, Bombardieri, Michele, Kelly, Stephen, Di Cicco, Maria, Dadoun, Sabrina, Hands, Rebecca, Rocher, Vidalba, Kidd, Bruce, Pyne, Dev, Pitzalis, Costantino, Poore, Sophie, Hutchinson, David, Low, Audrey, Lunt, Mark, Mercer, Louise, Galloway, James, Davies, Rebecca, Watson, Kath, Dixon, Will, Symmons, Deborah, Watson, Kath D., Dixon, William G., Hyrich, Kimme L., Malik, Saadia P., Kelly, Clive, Hamilton, Jennifer, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Harris, Helen E., Tweedie, Fiona, Skaparis, Yiannis, White, Marie, Scott, Nicola, Samson, Kay, Mercieca, Cecilia, Clarke, Shane, Warner, Alexander J., Verstappen, Suzanne, Chan, Esther, Woodhead, Felix A., Nisar, Mohamed, Arthanari, S., Dawson, Julie, Sathi, Nav, Ahmad, Yasmeen, Koduri, Gouri, Cumming, Jo, Stannett, Peter, Hull, Richard, Metsios, George, Stavropoulos Kalinoglou, Antonios, Veldhuijzen van Zanten, Jet J., Nightingale, Peter, Koutedakis, Yiannis, Kitas, George D., Williams, Peter, Walsh, David, Perry, Elizabeth, de-Soyza, Anthony, Moullaali, Thomas, Eggleton, Paul, Stavropoulos-Kalinoglou, Antonios, Sandoo, Aamer, de Pablo, Paola, Maggs, Fiona, Faizal, Abdul, Pugh, Mark, Jobanputra, Paresh, Kehoe, Oksana, Cartwright, Alison, Askari, Ayman, El Haj, Alicia, Middleton, Jim, Aynsley, Sarah, Hardy, Jacob, Veale, Douglas, Fearon, Ursula, Wilson, Gerry, Muthana, Munitta, Fossati, G., Healy, L., Nesbitt, A., Becerra, Elena, Leandro, Maria J., De La Torre, Inmaculada, Cambridge, Geraldine, Nelson, P. N., Roden, D., Shaw, M., Davari Ejtehadi, Hora, Nevill, A., Freimanis, G., Hooley, P., Bowman, S., Alavi, A., Axford, J., Veitch, A. M., Tugnet, N., Rylance, P. B., Hawtree, Sarah, Mark Wilkinson, J., Wilson, Anthony G., Woon Kam, Ngar, Filter, Andrew, Croft, Adam P., Naylor, Amy, Zimmermann, Birgit, Hardie, Debbie, Desanti, Guillaume, Jaurez, Maria, Muller-Ladner, Ulf, Filer, Andrew, Neumann, Elena, Movahedi, Mohammad, Ray, David W., Burmester, Gerd R., Matucci-Cerinic, Marco, Navarro-Blasco, Francisco, Kary, Sonja, Unnebrink, Kristina, Kupper, Hartmut, Mukherjee, Sandeep, Cornell, Patricia, Richards, Selwyn, Rahmeh, Fouz, Thompson, Paul W., Westlake, Sarah L., Javaid, Muhammad K., Batra, Rajbir, Chana, Jasroop, Round, Gemma, Judge, Andrew, Taylor, Peter, Patel, Sanjeev, Cooper, Cyrus, Ravindran, Vinod, Bingham, Clifton O., Weinblatt, Michael E., Mendelsohn, Alan, Kim, Lilianne, Mack, Michael, Lu, Jiandong, Baker, Daniel, Westhovens, Rene, Hewitt, Jamie, Han, Chenglong, Keystone, Edward C., Fleischmann, Roy, Smolen, Josef, Emery, Paul, Genovese, Mark, Doyle, Mittie, Hsia, Elizabeth C., Hart, Jennifer C., Harland, Dave, Gibbons, Carl, Pang, Hok, Huertas, Catherine, Diamantopoulos, Alex, Dejonckheere, Fred, Clowse, M., Wolf, D., Stach, C., Kosutic, G., Williams, S., Terpstra, I., Mahadevan, U., Ferraccioli, G., Samborski, W., Berenbaum, F., Davies, O., Koetse, W., Bennett, B., Burkhardt, H., Luijtens, K., van der Heijde, Desiree, Mariette, X., van Vollenhoven, Ronald F., Bykerk, V., de Longueville, M., Arendt, C., Cush, J., Khan, Afsha, Maclaren, Zoe, Dubash, Sayam, Chalam, Venkat C., Sheeran, Tom, Price, Tom, Baskar, Sangeetha, Mulherin, Diarmuid, Molloy, Cauline, Keay, Fiona, Heritage, Caroline, Douglas, Barbara, Schiff, Michael H., Khanna, Dinesh, Furst, Daniel E., Maldonado, Michael A., Li, Wanying, Sasso, Eric H., Emerling, Daniel, Cavet, Guy, Ford, Kerri, Mackenzie-Green, Bronwen, Collins, David, Price, Elizabeth, Williamson, Lyn, Golla, Janardhana, Vagadia, Vipul, Morrison, Elaine, Tierney, Ann, Wilson, Hilary, Hunter, John, Reddy, Venkat, Moore, Samantha, Ehrenstein, Michael, Benson, Claire, Wray, Maria, Cairns, Andrew, Wright, Gary, Pendleton, Adrian, McHenry, Michelle, Taggart, Allister, Bell, Aubrey, Bosworth, Ailsa, Cox, Maureen, Johnston, Graeme, Shah, Preeti, O'Brien, Anne, Jones, Peter, Sargeant, Ify, Bukhari, Marwan, Nusslein, Hubert, Alten, Rieke, Lorenz, Hannes M., Boumpas, Dimitrios, Nurmohamed, Michael T., Bensen, William, Peter, Hans-Hartmut, Rainer, Franz, Pavelka, Karel, Chartier, Melanie, Poncet, Coralie, Rauch, Christiane, Lempp, Heidi, Hofmann, Darija, Adu, Aderonke, Congreve, Carron, Dobson, Joanne, Rose, Diana, Simpson, Carol, Wykes, Til, Ibrahim, Fowzia, Schiff, Michael, Nash, Peter, Durez, Patrick, Kaine, Jeffrey, Delaet, Ingrid, Kelly, Sheila, Maldonado, Michael, Patel, Salil, Jones, Graeme, Sebba, Anthony, Lepley, Denise, Devenport, Jenny, Bernasconi, Corrado, Smart, Devi, Mpofu, Chiedzo, Gomez-Reino, Juan J., Verma, Inderjeet, Kaur, Jaspreet, Syngle, Ashit, Krishan, Pawan, Vohra, Kanchan, Kaur, Ladbans, Garg, Nidhi, Chhabara, Monica, Gibson, Kellie, Woodburn, James, Telfer, Scott, Buckley, Felicity, Finckh, Axel, Huizinga, Tom W., Jansen, Jeroen P., Rubbert-Roth, Andrea, Scali, Juan J., Kremer, Joel M., Pitts, Laura, Vernon, Emma, Sharif, Mohammed I., Das, Sudipto, Helliwell, Philip, Sokoll, Katharina, and Vital, Edward M.
Abstract: Background: Thoracic aortic aneurysms (TAA) and dissections are not uncommon causes of sudden death in young adults. Loeys-Dietz syndrome (LDS) is a rare, recently described, autosomal dominant, connective tissue disease characterized by aggressive arterial aneurysms, resulting from mutations in the transforming growth factor beta (TGFβ) receptor genes TGFBR1 and TGFBR2. Mean age at death is 26.1 years, most often due to aortic dissection. We report an unusually late presentation of LDS, diagnosed following elective surgery in a female with a long history of joint hypermobility. Methods: A 51-year-old Caucasian lady complained of chest pain and headache following a dural leak from spinal anaesthesia for an elective ankle arthroscopy. CT scan and echocardiography demonstrated a dilated aortic root and significant aortic regurgitation. MRA demonstrated aortic tortuosity, an infrarenal aortic aneurysm and aneurysms in the left renal and right internal mammary arteries. She underwent aortic root repair and aortic valve replacement. She had a background of long-standing joint pains secondary to hypermobility, easy bruising, unusual fracture susceptibility and mild bronchiectasis. She had one healthy child age 32, after which she suffered a uterine prolapse. Examination revealed mild Marfanoid features. Uvula, skin and ophthalmological examination was normal. Results: Fibrillin-1 testing for Marfan syndrome (MFS) was negative. Detection of a c.1270G > C (p.Gly424Arg) TGFBR2 mutation confirmed the diagnosis of LDS. Losartan was started for vascular protection. Conclusions: LDS is a severe inherited vasculopathy that usually presents in childhood. It is characterized by aortic root dilatation and ascending aneurysms. There is a higher risk of aortic dissection compared with MFS. Clinical features overlap with MFS and Ehlers Danlos syndrome Type IV, but differentiating dysmorphogenic features include ocular hypertelorism, bifid uvula and cleft palate. Echocardiography and MR

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15 results on '"Bingham, Clifton O."'

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15. Case Reports1. A Late Presentation of Loeys-Dietz Syndrome: Beware of TGFβ Receptor Mutations in Benign Joint Hypermobility

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15 results on '"Bingham, Clifton O."'

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