Background Patients (pts) with rheumatoid arthritis (RA) experience reduced health-related quality of life (HRQoL). Sirukumab (SIR) is an anti–interleukin-6 (IL-6) monoclonal antibody.
Objectives These post hoc analyses evaluated improvements over time in HRQoL relative to an age/gender-matched normative population in RA pts with inadequate responses to tumor necrosis factor inhibitors (TNF-IR) from the phase 3 SIRROUND-T trial.
Methods 878 pts received SIR 50mg every 4 weeks (q4w), SIR 100mg every 2 weeks (q2w), or placebo (pbo) q2w. Health-related physical/emotional well-being were measured at baseline (BL) and Wk 24 by the 36-item Short Form Questionnaire (SF-36), fatigue by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (FACIT-F), and physical function by Health Assessment Questionnaire-Disability Index (HAQ-DI).
Results SF-36 physical and mental component summary (PCS and MCS) mean scores at BL for pbo, SIR 50mg q4w, and 100mg q2w indicated substantial impairment (PCS: 33.2, 31.8, and 32.4; MCS: 41.9, 41.2, and 42.1). Significantly greater improvements from BL were reported at Wk 24 with SIR 50mg q4w and 100mg q2w vs pbo in PCS (4.8 and 5.1 vs 1.7) and MCS (3.9 and 4.0 vs 1.1) mean scores (all P<0.001), exceeding the minimum clinically important difference (MCID) of 2.5. Significantly greater least squares mean changes in the 8 SF-36 domain raw scores were reported with both doses of SIR vs pbo at Wk 24; all were >MCID of 5.0 (Table; Figure). More pts receiving SIR 50mg q4w or 100mg q2w reported SF-36 domain scores ≥normative values (ranges: 11–34% and 13–42%) vs pbo (range: 6–29%). For pbo, SIR 50mg q4w, and SIR 100mg q2w, BL FACIT-F scores were 26.0, 24.2, and 25.2; clinically meaningful improvements ≥MCID (4 points) were reported by 54.3 and 51.4% of pts receiving SIR 50mg q4w and 100mg q2w vs 33.7% with pbo (P<0.001). Numerically greater percentages of pts reported scores ≥normative values with both doses of SIR vs pbo (27 and 28% vs 16%). BL HAQ-DI scores were 1.57, 1.65, and 1.61 with pbo, SIR 50mg q4w, and 100mg q2w. Clinically meaningful improvements (change of ≤-0.22) were reported by significantly higher proportions of pts receiving SIR 50mg q4w (52.2%) or 100mg q2w (54.8%) vs pbo (37.4%; P<0.001). Numerically more pts reported HAQ-DI scores ≥normative values with SIR 50mg q4w and 100mg q2w vs pbo (13 and 16% vs 9%).
Conclusions In TNF-IR RA pts, SIR treatment resulted in greater and clinically meaningful improvements in HRQoL vs pbo that met or exceeded population normative values, with similar results for SIR 50mg q4w and 100mg q2w.
Disclosure of Interest V. Strand Consultant for: Abbvie, Amgen, AstraZeneca, BiogenIdec, Boehringer Ingelheim, Celltrion, Crescendo, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sanofi and UCB, R. Ganguly Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, N. Li Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, K. McQuarrie Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC