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)

Ketty Peris, Jeffrey Crowley, Diamant Thaçi, Pascal Joly, Kim A. Papp, Joana Goncalves, Robert M. Day, Rongdean Chen, Kamal Shah, Carlos Ferrándiz, Jennifer C. Cather

Risultato della ricerca: Contributo in rivistaArticolo in rivista

82 Citazioni (Scopus)

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 unrelated to safety concerns. Conclusions: Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
RivistaJournal of the American Academy of Dermatology
DOI
Stato di pubblicazionePubblicato - 2017

Keywords

  • 2708
  • Apremilast
  • Clinical trial
  • ESTEEM
  • Phosphodiesterase 4 inhibitor
  • Psoriasis
  • Psoriatic arthritis
  • Safety

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