کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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5648664 | 1587491 | 2017 | 9 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for â¥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2) Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for â¥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2)](/preview/png/5648664.png)
BackgroundRandomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis.ObjectiveAssess long-term safety of oral apremilast in psoriasis patients.MethodsSafety findings are reported for 0 to â¥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2.ResultsThe 0 to â¥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to â¤52 weeks, the adverse events (AEs) that occurred in â¥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to â¥156 weeks, no new AEs (affecting â¥5% of the population) were reported. AEs, serious AEs, and study drug discontinuations caused by AEs did not increase with long-term exposure. During the 0 to â¥156-week period, the rates of major cardiac events (exposure-adjusted incidence rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 patient-years) did not increase in comparison with the rates found during the 0 to â¤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported.LimitationsThis study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns.ConclusionsApremilast demonstrated an acceptable safety profile and was generally well tolerated for â¥156 weeks.
Journal: Journal of the American Academy of Dermatology - Volume 77, Issue 2, August 2017, Pages 310-317.e1