Apremilast safe long-term in patients with psoriasis

By Will Boggs MD

NEW YORK (Reuters Health) - The phosphodiesterase 4 inhibitor apremilast is safe and well tolerated for three years and longer in patients with psoriasis, according to results from the ESTEEM trials.

"There were no new safety signals with continued apremilast exposure,” Dr. Jeffrey Crowley from Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield, California told Reuters Health by email. “Additionally, most of the up-front tolerability issues, such as nausea and diarrhea, decrease over time.”

In the phase 3 ESTEEM clinical program, apremilast significantly reduced the signs and symptoms of psoriasis and had an acceptable safety profile through week 52.

Dr. Crowley and colleagues assessed the overall safety and tolerability of apremilast 30 mg twice daily for at least 156 weeks in a pooled analysis of 1184 patients with moderate-to-severe psoriasis who participated in ESTEEM 1 and ESTEEM 2.

Overall, 11.2% of patients dropped out because of adverse events, the most common of which were diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, and headache.

Adverse event rates, particularly those for diarrhea and nausea, decreased over time, according to the April 14th Journal of the American Academy of Dermatology online report.

Serious adverse event rates were also comparable across exposure periods and did not increase with long-term apremilast exposure.

Discontinuation rates were less than 2% for any individual adverse event and occurred primarily during the first few weeks of treatment.

Major adverse cardiac events, malignancies, and serious infections were uncommon, and there were no cases of serious opportunistic infection, including tuberculosis reactivation.

Most patients taking apremilast maintained their body weight within 5% of baseline over three years and beyond.

“The long-term laboratory results reveal no significant impact on hepatic, renal, or hematologic parameters,” Dr. Crowley said. “Thus, routine lab monitoring for patients on apremilast is not necessary.”

“These safety data should continue to reassure providers and patients that PDE-4 inhibition is a safe and moderately effective long-term approach to treating psoriasis,” he concluded. “As the other oral options for psoriasis (methotrexate, acitretin, and cyclosporine) have significant safety concerns, particularly with long-term use, apremilast is a reasonable option for many patients desiring a pill.”

Dr. Nancy Dattola from University of Rome “Tor Vergata” in Italy, who recently evaluated the safety of apremilast in patients with psoriasis, told Reuters Health by email, "The very important message is that the drug is safe, is oral, and requires no injection. In particular, it is very safe in patients with comorbidity and for all patients that you cannot treat with biologics drugs.”

She added that apremilast is very easy to use and requires no screening for tuberculosis, and routine laboratory monitoring is unnecessary.

Celgene Corporation, which markets apremilast as Otezla, sponsored the study, employed four of the 11 authors, and had various relationships with five other authors, including Dr. Crowley.

SOURCE: http://bit.ly/2piEF7r

J Am Acad Dermatol 2017.

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