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Objective: Comorbidities in rheumatoid arthritis (RA) can influence treatment selection, impact treatment persistency, and increase health care costs. This study assessed the magnitude of comorbidity burden via epidemiology (incidence and prevalence) and associated costs of select comorbidities in RA patients: anemia, malignancy, venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and infections, stratified by history of disease‐modifying antirheumatic drug (DMARD) exposure. Methods: From the IQVIA PharMetrics® Plus database, we selected adult patients with RA (2 or more RA diagnostic codes at least 30 days apart) at initiation of a new DMARD (DMARD‐naïve), after the first conventional synthetic DMARD (csDMARD) or after the first biologic DMARD (bDMARD). We assessed pre‐index prevalence (percentage) and on‐treatment incidence (per 100 patient‐years [P100PY]) of the aforementioned comorbidities. For patients with versus without incident conditions, we compared total all‐cause health care costs as unadjusted and adjusted for baseline characteristics and health care costs. Results: Prior to initiating a new treatment, among DMARD‐naïve patients (N = 28,201), csDMARD switchers (N = 7,816), or bDMARD switchers (N = 4,656), the overall prevalence ranged from 14.1% to 16.2% (anemia), from 1.3% to 5.2% (malignancy, evaluated in csDMARD and bDMARD switchers), from 1.5% to 2.1% (VTE), from 1.8% to 2.9% (MACE), and from 66.6% to 76.1% (infections). Once on index treatment, overall incidence (P100PY) among the cohorts ranged from 6.9 to 8.9 (anemia), from 2.0 to 2.3 (malignancy), from 0.7 to 0.9 (VTE), from 1.6 to 2.0 (MACE), and from 77.4 to 87.7 (infections). The incident comorbidities (except herpes zoster) were associated with increased adjusted health care costs. Conclusion: Anemia, malignancy, VTE, MACE, and infections affect patients with RA at all stages of their treatment journey and are associated with increased health care costs. [ABSTRACT FROM AUTHOR]

Objective: Electronic clinical quality measures (eCQMs) rely on computer algorithms to extract data from electronic health records (EHRs). On behalf of the American College of Rheumatology (ACR), we sought to develop and test eCQMs for rheumatoid arthritis (RA).Methods: Drawing from published ACR guidelines, a working group developed candidate RA process measures and subsequently assessed face validity through an interdisciplinary panel of health care stakeholders. A public comment period followed. Measures that passed these levels of review were electronically specified using the quality data model, which provides standard nomenclature for data elements (category, datatype, and value sets) obtained through an EHR. For each eCQM, 3 clinical sites using different EHR systems tested the scientific feasibility and validity of measures. Measures appropriate for accountability were presented for national endorsement.Results: Expert panel validity ratings were high for all measures (median 8-9 of 9). Health system performance on the eCQMs was 53.6% for RA disease activity assessment, 69.1% for functional status assessment, 93.1% for disease-modifying antirheumatic drug (DMARD) use, and 72.8% for tuberculosis screening. Kappa statistics, which evaluated whether the eCQM validly captured data obtained from manual EHR chart review, demonstrated moderate to substantial agreement (0.54 for functional status assessment, 0.73 for tuberculosis screening, 0.84 for disease activity, and 0.85 for DMARD use).Conclusion: Four eCQMs for RA have achieved national endorsement and are recommended for use in federal quality reporting programs. Implementation and further refinement of these measures is ongoing in the ACR's registry, the Rheumatology Informatics System for Effectiveness (RISE). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the measurement properties of the Psoriasis Symptom Inventory (PSI) in psoriatic arthritis (PsA).Methods: The PSI is an 8-item, patient-reported outcome measure of the severity of psoriasis signs and symptoms. This was a secondary analysis of pooled data from a phase II study evaluating the efficacy of brodalumab in patients with PsA. Unidimensionality and item evaluation were assessed using factor and Rasch analyses. Reliability was assessed using Cronbach's alpha (internal consistency) and intraclass correlation coefficients (ICCs) for PSI scores in patients with stable disease (test-retest). Construct validity was evaluated by correlations between PSI scores and body surface area (BSA) affected by psoriasis and selected Short Form 36 (SF-36) health survey domains. Known-groups validity was evaluated based on BSA severity categories, and the ability to detect change was evaluated based on improvement in the subject's global assessment (SGA).Results: The analysis sample (n = 154) was 93.5% white and 63.0% female. The mean ± SD baseline affected BSA was 10.4% ± 15.6%, and age was 52.2 ± 11.5 years. The PSI demonstrated unidimensionality, with good item fit and correctly ordered categories, excellent internal consistency (α = 0.95), good test-retest reliability (total score ICC 0.70; item ICCs range 0.67-0.81), convergent validity based on moderate correlations with BSA (r = 0.50), discriminant validity based on small baseline correlations (r <-0.3) with the SF-36 domains (role-physical, role-emotional, vitality), known groups validity based on significant differences between BSA groups, and responsiveness based on SGA improvements (P < 0.05).Conclusion: The PSI demonstrated excellent test-retest and internal consistency reliability and good construct validity in measuring psoriasis signs and symptoms severity in PsA. [ABSTRACT FROM AUTHOR]

Objective To compare the efficacy, safety, and tolerability of 5 doses of oral tofacitinib (CP-690,550) or adalimumab monotherapy with placebo for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response to disease-modifying antirheumatic drugs. Methods In this 24-week, double-blind, phase IIb study, patients with RA (n = 384) were randomized to receive placebo, tofacitinib at 1, 3, 5, 10, or 15 mg administered orally twice a day, or adalimumab at 40 mg injected subcutaneously every 2 weeks (total of 6 injections) followed by oral tofacitinib at 5 mg twice a day for 12 weeks. The primary end point was the responder rate according to the American College of Rheumatology 20% improvement criteria (ACR20) at week 12. Results Treatment with tofacitinib at a dose of ≥3 mg twice a day resulted in a rapid response with significant efficacy when compared to placebo, as indicated by the primary end point (ACR20 response at week 12), achieved in 39.2% (3 mg; P ≤ 0.05), 59.2% (5 mg; P < 0.0001), 70.5% (10 mg; P < 0.0001), and 71.9% (15 mg; P < 0.0001) in the tofacitinib group and 35.9% of patients in the adalimumab group ( P = 0.105), compared with 22.0% of patients receiving placebo. Improvements were sustained at week 24, according to the ACR20, ACR50, and ACR70 response rates as well as classifications of remission according to the 3-variable Disease Activity Score in 28 joints (DAS28) using C-reactive protein and the 4-variable DAS28 using the erythrocyte sedimentation rate. The most common treatment-emergent adverse events (AEs) in patients across all tofacitinib treatment arms (n = 272) were urinary tract infection (7.7%), diarrhea (4.8%), headache (4.8%), and bronchitis (4.8%). Conclusion Tofacitinib monotherapy at ≥3 mg twice a day was efficacious in the treatment of patients with active RA over 24 weeks and demonstrated a manageable safety profile. [ABSTRACT FROM AUTHOR]

The article evaluates efficacy and safety of R788 (fostamatinib disodium), an inhibitor of spleen tyrosine kinase (Syk), in patients with rheumatoid arthritis (RA) who were not responsive to biological therapies. A total of 219 patients were enrolled in a 3-month placebo-controlled trial of R788. At month 3, the ACR20 response in R788 100 mg twice daily group was 38 percent, against 37 percent in the placebo group. The studies indicate difference between the R788 and placebo groups in the secondary end points.

Objective: To develop updated guidelines for the pharmacologic management of rheumatoid arthritis., Methods: We developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising clinicians and patients achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations., Results: The guideline addresses treatment with disease-modifying antirheumatic drugs (DMARDs), including conventional synthetic DMARDs, biologic DMARDs, and targeted synthetic DMARDs, use of glucocorticoids, and use of DMARDs in certain high-risk populations (i.e., those with liver disease, heart failure, lymphoproliferative disorders, previous serious infections, and nontuberculous mycobacterial lung disease). The guideline includes 44 recommendations (7 strong and 37 conditional)., Conclusion: This clinical practice guideline is intended to serve as a tool to support clinician and patient decision-making. Recommendations are not prescriptive, and individual treatment decisions should be made through a shared decision-making process based on patients' values, goals, preferences, and comorbidities., (© 2021, American College of Rheumatology.)