Artikel
Improvements in Measures of Work Productivity/Interference and General Health Status with Sirukumab Treatment in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Anti-Rheumatic Drug Treatment
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Autoren
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Tsutomu Takeuchi
- Keio University School of Medicine, Tokyo, Japan
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George Karpouzas
- Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, USA
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Carter Thorne
- University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada
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Kelly McQuarrie
- Janssen Research & Development, LLC, Spring House, PA, USA
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Shihong Sheng
- Janssen Research & Development, LLC, Spring House, PA, USA
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Weichun Xu
- Janssen Research & Development, Inc., Malvern, USA
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Steve Peterson
- Janssen Research & Development, LLC, Spring House, PA, USA
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Rita Ganguly
- GlaxoSmithKline, King of Prussia, PA, USA
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Chenglong Han
- Janssen Global Services, L.L.C, Worldwide Market Access, Malvern, United States of America
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Kaiyin Fei
- Janssen Research & Development, LLC, Spring House, PA, USA
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Benjamin Hsu
- Janssen Research & Development, Inc., Spring House, United States of America
| Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: Treatment-related improvements in the ability to perform work and general health status are key outcomes from the perspective of a patient with rheumatoid arthritis (RA). Sirukumab is a human monoclonal antibody that selectively binds to the IL-6 cytokine with high affinity and is under development for RA and other diseases. The effects of sirukumab on work productivity/interference and general health status were evaluated in patients with active RA refractory to conventional, synthetic disease-modifying anti-rheumatic drugs (DMARDs).
Methods: In a randomized, double-blind, Phase 3 global study, patients with active RA and inadequate response to DMARDs were randomly assigned (1:1:1) to treatment with sirukumab SC 50 mg q4w, sirukumab SC 100 mg q2w, or placebo SC q2w. Patients on placebo with insufficient (<20%) improvement at Weeks 18 or 40 or who remained on placebo at Week 52 were re-randomized to receive treatment in 1 of the 2 sirukumab groups. The Work Limitations Questionnaire (WLQ) was used to evaluate health-related job limitations and productivity loss. The 3-level EuroQol-5 Dimension (EQ-5D) questionnaire was used to measure 5 dimensions of health status (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression). The changes from baseline in the WLQ scores, EQ-5D index score (based on UK TTO), and EQ-5D health state visual analog scale (VAS) scores at Weeks 24 and 52 were evaluated as secondary endpoints.
Results: Mean WLQ production loss scores improved significantly from baseline for both sirukumab 50 mg q4w and 100 mg q2w compared with placebo at Weeks 24 and 52 (all P<0.001). In addition, significantly greater improvements from baseline were also observed in all 4 mean WLQ domain scores (mental-interpersonal, output, physical demands, time management) for both doses of sirukumab compared with placebo at Weeks 24 and 52 (all P<0.05; Table 1 [Tab. 1]). Both the mean EQ-5D index and health state VAS improved significantly from baseline with both sirukumab doses compared with placebo at Weeks 24 and 52 (all P≤0.002).
Conclusion: In patients with active RA refractory to DMARDs, sirukumab treatment was associated with significant improvements in work-related productivity and general health status, consistent with disease improvement demonstrated with sirukumab treatment.
