Health-related Quality of Life Outcomes of Adalimumab for Patients with Early Rheumatoid Arthritis: Results from a Randomized Multicenter Study

Abstract

Objective.Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA.Methods.PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged ≥ 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient’s global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3).Results.Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p <0.0001), vitality (p = 0.0139), role limitations-physical (p = 0.0005)], SF-6D (p = 0.0152), VAS-PtGA (p < 0.0001), VAS-pain (p < 0.0001), FACIT-F (p < 0.0001), and HUI-3 (p = 0.0034) scores versus patients treated with MTX monotherapy. Both SF-6D and HUI-3 were found to be sensitive preference-based measures for assessing the effects of treatment on multidimensional function. No clinically meaningful differences between adalimumab and MTX monotherapy groups were observed for most measures. For each measure, there was significant association between HRQOL improvement and ACR clinical response.Conclusion.Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).

Patient‐Reported Outcomes From a Two‐Year Head‐to‐Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis

“…The results presented here are also consistent with published PRO data for adalimumab 27, 28, 29. In the Anti‐TNF Research Study Program of the Monoclonal Antibody Adalimumab trial, patients who had an inadequate response to MTX and were treated with adalimumab plus MTX demonstrated significant improvements in physical function from baseline to year 4 (mean Health Assessment Questionnaire disability index [HAQ DI] 0.7 and 1.5, respectively [ P < 0.001]) 27.…”

“…Similarly, in the DE019 adalimumab study, patients who had an inadequate response to MTX who received up to 10 years of adalimumab plus MTX therapy demonstrated a reduction in mean HAQ DI from 1.4 at baseline to 0.7 at year 10, while 42% of patients achieved HAQ DI <0.5 (normal functionality) at year 10 28. In the PREMIER study, significant improvements from baseline to year 2 in HAQ DI ( P < 0.0001), Short Form 36 health survey physical component summary score ( P < 0.0001), patient global assessment score ( P < 0.0001), and pain score ( P < 0.0001) were reported by patients with early RA treated with adalimumab plus MTX versus patients treated with MTX monotherapy 29.…”

Tofacitinib With Methotrexate in Third‐Line Treatment of Patients With Active Rheumatoid Arthritis: Patient‐Reported Outcomes From a Phase III Trial

“…Rheumatoid arthritis (RA) is a chronic, inflammatory disease characterized by progressive joint destruction and impairment in physical function and health-related quality of life (HRQOL) (1)(2)(3)(4). From a patient perspective, improvements in pain, physical function, fatigue, and HRQOL are more important and meaningful than improve-ments in joint swelling, tenderness, or inhibition of structural damage, when therapies for RA are evaluated (5).…”

Health-related quality of life in young adult patients with rheumatoid arthritis in Iran: reliability and validity of the Persian translation of the PedsQL™ 4.0 Generic Core Scales Young Adult Version

“…It has been used successfully in chronic diseases including RA [30][31] .It includes 36 items and covers eight subscales including physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP), general health perception (GH), social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), and mental health (MH) [19]. The SF-36 has been translated into various languages and is also available in Persian.…”