Article Text
Abstract
Objectives To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).
Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.
Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).
Conclusions Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.
Trial registration number NCT01721044; Results.
- DMARDs (synthetic)
- DMARDs (biologic)
- Patient perspective
- Rheumatoid Arthritis
- Outcomes research
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Footnotes
Handling editor Tore K Kvien
Contributors JSS, BC and CG have worked on the major parts of the manuscript and the revisions. All other authors have significantly contributed to the interpretation of the data, participated in the development of later stages of the manuscript and critically reviewed the final version.
Competing interests JSS has received grants for his institution from Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche and has provided expert advice to and/or had speaking engagements for Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Celtrion, GSK, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Novo-Nordisk, Pfizer, Roche, Samsung, Sanofi, UCB. JMK has received research grant support and consultation honoraria from Eli Lilly and Company. He is an officer and stockholder in Corrona. He has received research grant support from Abbvie, Novartis, Amgen and Pfizer. He is on the speaker's bureau for Genentech. CLG, AMD, DES, LX, IS and TR are full-time employees of Eli Lilly and Company and DES, LX, IS and TR are minor shareholders of Eli Lilly and Company. PB has received grants and consulting fees from Abbvie, Pfizer, Novartis, Eli Lilly and Company, Roche, BMS and Jannsen. JMSB has received grants and consulting fees from Abbvie, Pfizer, UCB and Gebro. MCG has received grants and consulting fees from Abbvie, Astellas, Eli Lilly and Company, Galapagos, Gilead, Pfizer and Vertex. BC has received honorarium from Abbvie, BMS, Eli Lilly and Company, MSD, Pfizer, Roche-Chugai and UCB.
Ethics approval All local ethical committees.
Provenance and peer review Not commissioned; externally peer reviewed.