دورية أكاديمية
Apremilast in a Japanese subgroup with Behçet’s syndrome: Results from a Phase 3, randomised, double-blind, placebo-controlled study
| العنوان: | Apremilast in a Japanese subgroup with Behçet’s syndrome: Results from a Phase 3, randomised, double-blind, placebo-controlled study |
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| المؤلفون: | Takeno, Mitsuhiro, Dobashi, Hiroaki, Tanaka, Yoshiya, Kono, Hajime, Sugii, Shouji, Kishimoto, Mitsumasa, Cheng, Sue, McCue, Shannon, Paris, Maria, Chen, Mindy, Ishigatsubo, Yoshiaki |
| المساهمون: | Celgene. Amgen Inc |
| المصدر: | Modern Rheumatology ; volume 32, issue 2, page 413-421 ; ISSN 1439-7595 1439-7609 |
| بيانات النشر: | Oxford University Press (OUP) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Rheumatology |
| الوصف: | Objectives Apremilast efficacy and safety was assessed in a prespecified subgroup of Japanese patients with oral ulcers associated with Behçet’s syndrome from a Phase 3 randomized, placebo-controlled, double-blind study of apremilast (RELIEF). Methods The primary end point was area under the curve for number of oral ulcers during the 12-week placebo-controlled phase (AUCWk0–12). Key secondary end points were change from baseline in oral ulcer pain, complete oral ulcer resolution, and measures of disease activity and quality of life (QoL). Results Thirty-nine Japanese patients were randomised (apremilast 30 mg BID: n = 19; placebo: n = 20). Improvements at Week 12 were observed for apremilast vs. placebo in AUCWk0–12 for the number of oral ulcers (115.9 vs. 253.3; nominal P = 0.0168); 57.9% vs. 25.0% achieved complete oral ulcer resolution, 47.4% vs. 0.0% achieved oral ulcer resolution by Week 6 and maintained oral ulcer-free status for ≥6 additional weeks; mean change from baseline in BSAS was −10.5 vs. 0.5. Favourable effects were observed for apremilast vs. placebo in other secondary end points, including QoL. Clinical benefits were sustained over 28 weeks of continued apremilast treatment. Adverse events were consistent with apremilast’s known safety profile. Conclusions Apremilast reduced the number of oral ulcers and overall disease activity in this Japanese subgroup with Behçet’s syndrome. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1093/mr/roab008 |
| DOI: | 10.1093/mr/roab008/41746027/roab008.pdf |
| الإتاحة: | https://doi.org/10.1093/mr/roab008Test https://academic.oup.com/mr/article-pdf/32/2/413/42644825/roab008.pdfTest |
| حقوق: | https://creativecommons.org/licenses/by-nc/4.0Test/ |
| رقم الانضمام: | edsbas.5815FB15 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/mr/roab008 |
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