دورية أكاديمية
Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome
| العنوان: | Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome |
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| المؤلفون: | Mease, Philip J., Hatemi, Guelen, Paris, Maria, Cheng, Sue, Maes, Peter, Zhang, Wendy, Shi, Rebecca |
| بيانات النشر: | Adis Int Ltd |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Severe Plaque Psoriasis, Oral Phosphodiesterase-4 Inhibitor, Controlled-Trial, Phase-Iii, Efficacy, Moderate, Tolerability, Risk |
| الوصف: | Background Since US FDA approval in 2014, apremilast has consistently demonstrated a favorable benefit-risk profile in 706,585 patients (557,379 patient-years of exposure) worldwide across approved indications of plaque psoriasis, psoriatic arthritis, and Behcet's syndrome; however, long-term exposure across these indications has not been reported.Objective The aim of this study was to conduct a pooled analysis of apremilast data from 15 clinical studies with open-label extension phases, focusing on long-term safety.Methods We analyzed longer-term safety and tolerability of apremilast 30 mg twice daily across three indications for up to 5 years, focusing on adverse events of special interest, including thrombotic events, malignancies, major adverse cardiac events (MACE), serious infections, and depression. Data were pooled across 15 randomized, placebo-controlled studies and divided into placebo-controlled or all-apremilast-exposure groups. Treatment-emergent adverse events (TEAEs) were assessed.Results Overall, 4183 patients were exposed to apremilast (6788 patient-years). Most TEAEs were mild to moderate in the placebo-controlled period (96.6%) and throughout all apremilast exposure (91.6%). TEAE rates of special interest were similar between treatment groups in the placebo-controlled period and remained low throughout all apremilast exposure. Exposure-adjusted incidence rates per 100 patient-years during all apremilast exposure were MACE, 0.30; thrombotic events, 0.10; malignancies, 1.0; serious infections, 1.10; serious opportunistic infections, 0.21; and depression, 1.78. Safety findings were consistent across indications and regions. No new safety signals were identified.Conclusions The incidence of serious TEAEs and TEAEs of special interest was low despite long-term exposure, further establishing apremilast as a safe oral option for long-term use across indications with a favorable benefit-risk profile.{Graphical Abstract} ; Amgen Inc. ; Writing support was funded by Amgen Inc. and provided by Christina ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1175-0561 1179-1888 |
| العلاقة: | American Journal of Clinical Dermatology; Makale - Ulusal Hakemli Dergi - Kurum Öğretim Elemanı; https://doi.org/10.1007/s40257-023-00783-7Test; https://hdl.handle.net/20.500.12831/18268Test; WOS:001010474600001; 2-s2.0-85161852141 |
| DOI: | 10.1007/s40257-023-00783-7 |
| الإتاحة: | https://doi.org/10.1007/s40257-023-00783-7Test https://doi.org/20.500.12831/18268Test https://hdl.handle.net/20.500.12831/18268Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.AB4AFF23 |
| قاعدة البيانات: | BASE |
| تدمد: | 11750561 11791888 |
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| DOI: | 10.1007/s40257-023-00783-7 |