≥156-week apremilast safety in psoriasis and psoriatic arthritis patients: Pooled analysis of the ESTEEM and PALACE phase 3 trials



Introduction: We report long-term safety and tolerability of apremilast (APR) 30 mg BID (APR30) in a pooled analysis of five phase 3 trials in moderate to severe psoriasis (ESTEEM 1 and 2 [NCT01194219, NCT01232283]) and psoriatic arthritis (PsA; PALACE 1-3 [NCT01172938, NCT01212757, NCT01212770]).
Methods: Safety findings are reported for placebo (PBO) vs. APR30 for 0 to 16 weeks and for patients receiving APR30 during the APR-exposure period (0 to ≥156 weeks).
Results: 2,242 patients were included in the safety analysis for 0 to 16 weeks (PBO: n=913; APR30: n=1,329); 1,905 received APR30 in the APR-exposure period and 30.2% (n=575) received >156 weeks of APR30. During 0 to 16 weeks, rates of severe and serious adverse events (AEs) with APR30 were low and comparable to PBO. Common AEs (≥5%) with APR30 during 0 to 16 weeks were diarrhea, nausea, headache, URTI, and nasopharyngitis. During the APR-exposure period (3,527.5 patient-years), exposure-adjusted incidence rates (EAIR)/100 patient-years for AEs, serious AEs, and discontinuations due to AEs did not increase based on analysis of cumulative and year-by-year exposure. EAIR/100 patient-years of MACE, malignancies, and serious infections for APR30 were comparable to PBO during 0 to 16 weeks and remained low for ≥156 weeks. No serious opportunistic infections or clinically meaningful effects on laboratory measurements were reported. Weight loss with APR30 did not lead to overt medical sequelae.
Conclusions: APR30 demonstrated an acceptable safety profile, with no new safety signals observed during ≥156 weeks of exposure in patients with moderate to severe plaque psoriasis and PsA.


Dr. Jeffrey Crowley

Bakersfield Dermatology and Skin Cancer Medical Group

Dr. Jeffrey Crowley earned BS and MS degrees from Stanford University in biological science and continued at Stanford to receive his MD. He completed residency in the Department of Dermatology at Stanford University Affiliated Hospitals, including 1 year as chief resident. He is board certified by the American Board of Dermatology and a Fellow of the American Academy of Dermatology. He has served as clinical faculty for the University of California, Los Angeles, and Stanford University Departments of Dermatology. Dr. Crowley has been principal investigator for over 50 phase 2 and 3 clinical trials for psoriasis, atopic dermatitis, and hidradenitis suppurativa. He has more than 50 peer-reviewed publications, including articles in the New England Journal of Medicine. In 2016, he graduated with commendation from the Harvard Global Scholars Clinical Research Training Program, a postdoctoral fellowship. He practices at Bakersfield Dermatology and Skin Cancer Medical Group in California.