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Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2)
Crowley, Jeffrey (Bakersfield Dermatology)
Thaçi, Diamant (Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein)
Joly, Pascal (Department of Dermatology, Hôpital Charles Nicolle, Université de Rouen)
Peris, Ketty (Universitá Cattolica del Sacro Cuore, Roma)
Papp,Kim A. (Probity Medical Research, Waterloo)
Gonçalves, Joana (Celgene Corporation)
Day, Robert M. (Celgene Corporation)
Chen, Rongdean (Celgene Corporation)
Shah, Kamal (Celgene Corporation)
Ferrándiz, Carlos (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cather, Jennifer C. (Modern Research Associates, Dallas)
Universitat Autònoma de Barcelona

Date: 2017
Abstract: BACKGROUND: Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. OBJECTIVE: Assess long-term safety of oral apremilast in psoriasis patients. METHODS: Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2. RESULTS: The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902. 2 patient-years). During 0 to ≤52 weeks, the adverse events (AEs) that occurred in ≥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to ≥156 weeks, no new AEs (affecting ≥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 ≥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 ≤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported. Limitations: This study had a high dropout rate (21% of patients ongoing [156 weeks); most were $1 56 weeks, no new AEs (affecting $5 % of the population) were reported. LIMITATIONS: This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns. CONCLUSIONS: Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.
Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Language: Anglès.
Document: article ; recerca ; publishedVersion
Subject: Apremilast ; Clinical trial ; ESTEEM ; Phosphodiesterase 4 inhibitor ; Psoriasis ; Psoriatic arthritis ; Safety
Published in: Journal of the American Academy of Dermatology, Vol. 77 Núm. 2 (2017) , p. 310

DOI: 10.1016/j.jaad.2017.01.052

9 p, 310.0 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (scientific output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles

 Record created 2018-10-09, last modified 2020-04-25

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