≥156-week apremilast safety and tolerability in patients with moderate to severe psoriasis and cardiometabolic comorbidities: ESTEEM pooled analysis



Introduction: The safety and tolerability of apremilast 30 mg BID (APR) for ≥156 weeks were examined in patients with moderate to severe plaque psoriasis with and without select cardiometabolic comorbidities (CC) in a pooled analysis of phase 3 ESTEEM 1 and 2 data.
Methods: Patients were stratified by presence of ≥1 CC (glucose metabolism disorder/diabetes, lipid metabolism disorder, BMI ≥30 kg/m2, and/or hypertension). Safety findings are reported for 0 to 16, 0 to ≤52, and 0 to ≥156 weeks (overall APR-exposure period).
Results: Of 1,250 patients (0 to 16 weeks), most had ≥1 CC at baseline (placebo [PBO]: 295/418 [70.6%]; APR: 563/832 [67.7%]); 1,184 patients (CC: n=811; no CC: n=373) received APR during the 0 to ≥156 week APR-exposure period. During 0 to 16 weeks, adverse event (AE) profiles were similar between APR-treated patients with and without CC; incidences of serious AEs and AEs leading to study drug discontinuation were low in patients receiving APR, with and without CC, and comparable to PBO. The nature, severity, and incidence of AEs remained comparable between patients with and without CC during 0 to ≤52 weeks and 0 to ≥156 weeks. The exposure-adjusted incidence rate/100 patient-years for major adverse cardiac events was low with APR in patients with and without CC (0.6, 0.0) during 0 to 16 weeks and did not increase during 0 to ≥156 weeks (CC: 0.7; no CC: 0.2).
Conclusions: APR demonstrated acceptable safety with prolonged exposure for ≥156 weeks in patients with moderate to severe plaque psoriasis and CC.


Dr. Jennifer Cather

Modern Dermatology and Modern Research Associates

Dr. Jennifer C. Cather earned her BA in Chemistry from the University of Texas, graduating Magna Cum Laude, and her MD from the University of Texas Southwestern Medical School at Dallas. She is licensed to practice in Texas and California, and is certified by the American Board of Dermatology. Dr. Cather has been an investigator in more than 200 clinical research trials in the areas of psoriasis and cutaneous T-cell lymphoma, and has authored or coauthored numerous abstracts and manuscripts. Her writing has appeared in such publications as the Journal of the American Academy of Dermatology, British Journal of Dermatology, Journal of Drugs in Dermatology, Cutis, Dermatologic Therapy, and Dermatologic Clinics. Dr. Cather lectures on investigational therapies in psoriasis, cutaneous T-cell lymphoma, and melanoma, and frequently serves as a consultant within these disciplines. She is the Medical Director at Modern Dermatology and Modern Research Associates in Dallas, Texas.