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FRI0246 Improvements in health-related quality of life with sirukumab are statistically significant, clinically meaningful, and meet or exceed normative values in rheumatoid arthritis patients with inadequate response to disease-modifying antirheumatic drugs: post hoc analyses of a phase 3 trial
  1. V Strand1,
  2. K McQuarrie2,
  3. N Li2,
  4. R Ganguly3
  1. 1Stanford University, Palo Alto, CA
  2. 2Janssen Research & Development, LLC, Spring House, PA
  3. 3GlaxoSmithKline, Collegeville, PA, United States

Abstract

Background Rheumatoid arthritis (RA) is associated with impaired health-related quality of life (HRQoL). Sirukumab (SIR) is an anti–interleukin-6 (IL-6) monoclonal antibody.

Objectives These post hoc analyses evaluated improvements in HRQoL compared with an age/gender-matched normative population in a phase 3 randomized, controlled trial of SIR in RA pts with inadequate response to conventional disease-modifying antirheumatic drugs (DMARD-IR; SIRROUND-D).

Methods 1670 pts received SIR 50mg every 4 weeks (q4w), SIR 100mg every 2 weeks (q2w), or placebo (pbo) q2w. Health-related physical/emotional well-being was 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 were comparable for pbo, SIR 50mg q4w and 100mg q2w (PCS: 33.8, 34.2, and 33.5; MCS: 40.5, 40.5, and 41.8) and indicative of substantial impairment. At Wk 24, treatment with SIR 50mg q4w and 100mg q2w resulted in significantly greater mean improvements from BL vs pbo in SF-36 PCS (5.4 and 5.9 vs 2.3) and MCS (4.9 and 4.2 vs 2.9) scores (all P<0.001), exceeding the minimum clinically important difference (MCID) of 2.5. Least squares mean changes in all SF-36 domain raw scores were significantly greater with both doses of SIR than pbo at Wk 24 and all >MCID of 5.0 (Table; Figure). Substantial proportions of pts treated with SIR 50mg q4w or 100mg q2w reported scores ≥normative values in SF-36 domains at Wk 24 (ranges: 20–33% and 21–36%) vs pbo (range: 10–28%). For pbo, SIR 50mg q4w, and SIR 100mg q2w, BL FACIT-F scores were 27.2, 27.1, and 27.5. Significantly greater proportions of pts reported clinically meaningful improvements in FACIT-F (MCID=4) with SIR 50mg q4w and 100mg q2w vs pbo (61.4 and 59.4% vs 43.9%; P<0.001). FACIT-F scores ≥normative values were reported by 33% of pts on SIR 50mg q4w and 100mg q2w vs 22% on pbo. HAQ-DI scores at BL were 1.56, 1.50, and 1.52 with pbo, SIR 50mg q4w, and 100mg q2w, with clinically meaningful improvements (MCID= -0.22) reported by 63.0 and 65.4% with SIR 50mg q4w and 100mg q2w vs 46.9% with pbo (P<0.001). HAQ-DI scores ≥normative values were reported by numerically more pts receiving SIR 50mg q4w (22%) and 100mg q2w (21%) vs pbo (10%).

Table 1.

Improvements in SF-36 Domain Scores at Wk 24 (all P≤0.006)

Conclusions Through 24 wks, SIR treatment resulted in greater improvements in HRQoL than pbo that were clinically meaningful and met or exceeded normative values in DMARD-IR RA pts, with similar effects observed with both doses of SIR.

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, K. McQuarrie Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, N. Li Shareholder of: Janssen Research & Development, LLC, Employee of: Janssen Research & Development, LLC, R. Ganguly Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline

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