Article Text

Download PDFPDF

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


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

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.