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)

Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. Assess long-term safety of oral apremilast in psoriasis patients. Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluati...

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Veröffentlicht in:	Journal of the American Academy of Dermatology Jg. 77; H. 2; S. 310 - 317.e1
Hauptverfasser:	Crowley, Jeffrey, Thaçi, Diamant, Joly, Pascal, Peris, Ketty, Papp, Kim A., Goncalves, Joana, Day, Robert M., Chen, Rongdean, Shah, Kamal, Ferrándiz, Carlos, Cather, Jennifer C.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States Elsevier Inc 01.08.2017 Elsevier
Schlagworte:	Adult Anti-Inflammatory Agents, Non-Steroidal - adverse effects apremilast Cardiovascular Diseases - epidemiology clinical trial Depression - epidemiology Dermatology Diarrhea - chemically induced ESTEEM Female Headache - chemically induced Human health and pathology Humans Immunology Immunotherapy Incidence Life Sciences Male Middle Aged Nasopharyngitis - chemically induced Nausea - chemically induced Neoplasms - epidemiology phosphodiesterase 4 inhibitor psoriasis Psoriasis - drug therapy psoriatic arthritis Respiratory Tract Infections - chemically induced Rhumatology and musculoskeletal system safety Santé publique et épidémiologie Suicide, Attempted - statistics & numerical data Tension-Type Headache - chemically induced Thalidomide - adverse effects Thalidomide - analogs & derivatives Time Factors clinical trial ESTEEM GI AE EAIR psoriasis safety PDE4 phosphodiesterase 4 inhibitor psoriatic arthritis apremilast TB Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis tuberculosis adverse event gastrointestinal exposure-adjusted incidence rate phosphodiesterase 4
ISSN:	0190-9622, 1097-6787, 1097-6787
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Zusammenfassung:	Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. Assess long-term safety of oral apremilast in psoriasis patients. 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. 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. This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns. Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.
Bibliographie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0190-9622 1097-6787 1097-6787
DOI:	10.1016/j.jaad.2017.01.052