Author(s)
Takeuchi T1, Karpouzas G2, Thorne C3, McQuarrie K4, Sheng S4, Xu W4, Peterson S4, Ganguly R5, Han C4, Fei K4, Hsu B4
1Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 2Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, USA, 3University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada, 4Janssen Research & Development, LLC, Spring House, PA, USA, 5GlaxoSmithKline, Collegeville, PA, USA
OBJECTIVES: This study evaluated effects of sirukumab, a selective, high-affinity anti-IL-6 cytokine monoclonal antibody, on the key treatment-related outcomes of work productivity/interference and general health status in patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying anti-rheumatic drugs (DMARDs). METHODS: Eligible patients were randomized 1:1:1 to sirukumab subcutaneous (SC) 50mg q4w, sirukumab SC 100mg q2w, or placebo SC q2w. Patients receiving placebo with <20% improvement at Weeks 18 or 40 or still on placebo at Week 52 were re-randomized to 1 of the 2 sirukumab dosages. The Work Limitations Questionnaire (WLQ) evaluated health-related job limitations and productivity loss; the 3-level EuroQol-5 Dimension (EQ-5D) questionnaire measured 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Additional endpoints included changes from baseline in WLQ scores, EQ-5D index scores, and EQ-5D health state visual analog scale (VAS) scores at Weeks 24 and 52. RESULTS: There were significant improvements in mean WLQ production loss scores from baseline for sirukumab 50mg q4w and 100mg q2w compared with placebo at Weeks 24 and 52 (both P<0.001; mean Week 52 change, -3.06 and -2.94 vs -0.73, respectively). Both doses of sirukumab led to significantly greater improvements from baseline in all 4 mean WLQ domain scores (mental-interpersonal, output, physical demands, time management) compared with placebo at Weeks 24 and 52 (all P<0.05). The mean EQ-5D index and health state VAS scores improved significantly from baseline at Weeks 24 and 52 with both doses of sirukumab compared with placebo (all P≤0.002; mean Week 52 index change, 0.20 and 0.20 vs 0.13, respectively; mean Week 52 VAS change, 16.80 and 17.14 vs 8.30, respectively). CONCLUSIONS:
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PMS67
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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