Title |
Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients
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Published in |
Arthritis Research & Therapy, March 2018
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DOI | 10.1186/s13075-018-1536-9 |
Pubmed ID | |
Authors |
Tsutomu Takeuchi, Hisashi Yamanaka, Masayoshi Harigai, Ryo Tamamura, Yuichi Kato, Yoshifumi Ukyo, Toshikazu Nakano, Benjamin Hsu, Yoshiya Tanaka |
Abstract |
Sirukumab, a high-affinity human monoclonal antibody that selectively binds to interleukin-6, has demonstrated efficacy in the treatment of rheumatoid arthritis (RA) in global phase 1 and phase 2 studies. The present study evaluated the safety and efficacy of sirukumab, as monotherapy in Japanese patients with RA refractory to methotrexate or sulfasalazine. In this phase 3, double-blind study, 122 patients (age ≥ 20 years) were randomized (1:1, 61 patients in each arm) to sirukumab administered subcutaneously: 50 mg once every 4 weeks (q4w) or 100 mg once every 2 weeks (q2w) through 52 weeks. Disease-modifying anti-rheumatic drugs were allowed after 24 weeks. Safety was assessed and efficacy was evaluated using American College of Rheumatology (ACR) responses, Disease Activity Score C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Amongst the 122 randomized patients, 99 (81.1%) patients completed the study. Adverse events (AEs) were reported in 114/122 (93.4%) patients and serious AEs were reported in 9/122 (7.4%) patients. No deaths, major cardiovascular AEs, serious gastrointestinal perforations or tuberculosis cases were reported during this study period. Grade 3 hematologic abnormalities (neutropenia and leukopenia) were reported in seven patients and no grade 4 abnormalities were observed. ACR20 responses were observed within 2 weeks, achieved in 47/61 (77.0%, 50 mg q4w) patients and 44/61 (72.1%, 100 mg q2w) patients at week 16 and maintained through week 52. ACR50/70, DAS28-CRP and HAQ-DI responses were also maintained through week 52 in both groups. Safety findings were comparable between the two treatment groups. The 52-week administration of sirukumab at 50 mg q4w and 100 mg q2w was generally tolerable and with measurable efficacy in Japanese patients with RA refractory to methotrexate and sulfasalazine. NCT01689532 . Registered 18 September 2012. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 82 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 10 | 12% |
Researcher | 9 | 11% |
Other | 6 | 7% |
Student > Doctoral Student | 6 | 7% |
Student > Bachelor | 6 | 7% |
Other | 19 | 23% |
Unknown | 26 | 32% |
Readers by discipline | Count | As % |
---|---|---|
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Other | 11 | 13% |
Unknown | 31 | 38% |