Artikel
Health-related Physical and Emotional Well Being and Fatigue Improve Significantly With Sirukumab Treatment: Results of a Phase 3 Study in Patients With Active Rheumatoid Arthritis Refractory to Conventional Disease-Modifying Anti-Rheumatic Drugs
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Autoren
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Drake Remorray
- Doctors Inc, New York, NY, United States
| Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: Rheumatoid arthritis (RA) may have a substantial negative impact on physical and emotional well-being and fatigue. Sirukumab, a selective, high-affinity human anti-IL6 monoclonal antibody, is being evaluated for RA treatment.
Objective: To evaluate the effects of sirukumab on health-related physical and emotional well-being (based on Short Form-36 [SF-36] health survey) and fatigue (based on Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scale) in patients (pts) with RA refractory to Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Methods: This Phase 3 study evaluated 2 sirukumab doses in pts with active RA and inadequate response to DMARDs. Pts were randomized (1:1:1) to double-blind treatment with sirukumab subcutaneously (SC) 50 mg q4w, sirukumab SC 100 mg q2w, or placebo SC q2w. In the placebo group, pts with <20% improvement at Wks 18 or 40 or still on placebo at Wk 52 were re-randomized to treatment with 1 of the 2 sirukumab doses. Pts completed the SF-36 and FACIT-Fatigue at baseline (BL) and Wks 8, 16, 24, 36, and 52. Clinically meaningful improvements from BL were defined as ≥5-point increase for the SF-36 physical and mental component summary (PCS and MCS) scores and ≥4-point increase for the FACIT-Fatigue score.
Results: Significantly greater mean increases (improvements) from BL in mean SF-36 PCS and MCS scores, all 8 SF-36 domain scores, and the FACIT-Fatigue score were observed for sirukumab 50mg q4w and 100mg q2w vs placebo at Wks 8, 16, 24, 36, and 52 (all P<0.02; Table 1 [Tab. 1]). Also, significantly higher percentages of pts achieved clinically meaningful improvements from BL in the SF-36 PCS and MCS scores (≥5-point increase) and the FACIT-Fatigue score (≥4-point increase) with both sirukumab doses vs placebo at Wks 8, 16, 24, 36, and 52 (all P<0.05).
Conclusion: Sirukumab treatment in pts with active RA refractory to DMARDs was associated with significant and clinically meaningful improvements from BL in health-related physical and emotional well-being and fatigue as early as Wk 8 and maintained through Wk 52.
