WORK PRODUCTIVITY AND GENERAL HEALTH STATUS IMPROVEMENTS WITH SIRUKUMAB, AN ANTI-IL-6 CYTOKINE MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS DESPITE ANTI-TNF THERAPY- RESULTS FROM THE PHASE 3 SIRROUND-T STUDY
Author(s)
Tanaka Y1, Aletaha D2, Peterson S3, Ganguly R4, Kurrasch R4, Popik S3, Agarwal P3, Li N3
1University of Occupational & Environmental Health, Kitakyushu, Japan, 2Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 3Janssen Research & Development, LLC, Spring House, PA, USA, 4GlaxoSmithKline, Collegeville, PA, USA
OBJECTIVES: This study evaluated effects of sirukumab, a selective anti-IL-6 cytokine monoclonal antibody, on work productivity/interference and health status in patients with active rheumatoid arthritis (RA) despite treatment with anti-tumor necrosis factor (TNF) therapy. METHODS: In this randomized, double-blind, phase 3 trial, 878 eligible patients with active RA who were intolerant/refractory to anti-TNFs were randomized 1:1:1 to sirukumab subcutaneous (SC) 50mg every 4 weeks (q4w; n=292), sirukumab SC 100mg every 2 weeks (q2w; n=292), or placebo SC q2w (n=294). At Week 18, placebo patients were re-randomized to 1 of the sirukumab doses if insufficient (<20%) improvement; at Week 24, all patients remaining on placebo crossed over to sirukumab. The Work Limitations Questionnaire (WLQ) evaluated health-related job limitations and productivity loss in 4 domains (mental-interpersonal, output, physical demands, time management); the 3-level EuroQol-5 Dimension (EQ-5D) questionnaire measured 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). RESULTS: At Week 24, mean total WLQ scores improved significantly from baseline for sirukumab 50mg q4w and 100mg q2w versus placebo (mean change, –2.2 and –2.3 vs 0.2, respectively; both p<0.001), as did all 4 mean WLQ domain scores (all p≤
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PMS47
Topic
Economic Evaluation, Patient-Centered Research
Topic Subcategory
Health State Utilities, Patient-reported Outcomes & Quality of Life Outcomes, Work & Home Productivity - Indirect Costs
Disease
Musculoskeletal Disorders
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