Patients with psoriasis who were treated with apremilast (Otezla) lost an average of nearly five pounds over a 52-week period, according to results of a pooled analysis published in the Journal of the American Academy of Dermatology.
Weight loss was observed in the ESTEEM 1 and ESTEEM 2 trials, which were designed to assess safety and efficacy of apremilast among patients, aged 18 years and older, with moderate to severe plaque psoriasis.
Most patients remained within 5% of their baseline weight during the placebo-controlled period of 16 weeks, and approximately 19% of patients lost more than 5% of their baseline weight by 52 weeks or less, according to results of a pooled analysis by Kristian Reich, MD, SCIderm Research Institute and Dermatologikum Hamburg in Germany, and colleagues.
Patients in the study were assigned to received randomized treatment (2:1) of apremilast 30 mg twice a day (n=832) or placebo (n=418) through week 16. All patients were treated with apremilast 30 mg twice a day through week 32, followed by a randomized treatment withdrawal phase through week 52.
At week 9, patients were then assigned apremilast or placebo. A total of 1,184 patients received apremilast (968 patients for at least 24 weeks and 564 for at least 52 weeks, including patients who switched from placebo to apremilast).
At the 16-week evaluation, the mean change from baseline in the weight of patients receiving apremilast 30 mg twice daily was -1.51 kg, or -3.33 lb. Mean change from baseline in weight in patients receiving placebo was -0.01 kg at week 16. At week 52, long-term mean change from baseline weight was -1.99 kg, or -4.38 lb, among patients receiving apremilast 30 mg BID.
A weight decrease of more than 5% of baseline weight was observed in 13.7% of patients who received apremilast and 5.5% of patients who received placebo during the first 16 weeks of the trial. Among those patients receiving apremilast for the full 52 weeks, 19.2% experienced weight decrease of more than 5% during that time.
Only 1.4% of patients treated with apremilast (0 to ≤52 weeks) reported weight loss as an adverse effect (AE). Weight decrease reported as an AE with placebo was 0.2%. No patient reported a serious AE of weight decrease (0 to ≤52 weeks), and two (0.2%) patients treated with apremilast discontinued treatment due to decreased weight during the 0 to 52-week period).
No association between weight loss and diarrhea or nausea/vomiting was identified, found the investigators. Although the exact mechanism for the observed weight loss with apremilast is unknown, it may be related to the phosphodiesterase (PDE4) inhibitory activity of apremilast, according to preclinical study data.
“Weight loss has been observed in ESTEEM; however, no patient had overt clinical consequences resulting from observed weight loss in the ESTEEM trials,” concluded the scientists.
- Reich K. J Amer Acad Dermatol. 2015;72(5) suppl 1: AB227.
This study was fully sponsored by Celgene, the makers of apremilast. Reich has received honoraria as a consultant and/or advisory board member and/or acted as a paid speaker and/or participated in clinical trials sponsored by Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, ScheringPlough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB.