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Otezla demonstrates safety up to 3 years in patients with psoriasis

Otezla demonstrated an acceptable safety profile through at least 3 years of treatment among patients with psoriasis, according to recently published study results in the Journal of the American Academy of Dermatology.

Researchers studied safety findings from 0 to at least 156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2 trials.  In results through 1 year, Otezla (apremilast, Celgene) reduced signs and symptoms of moderate-to-severe psoriasis and had an acceptable safety profile. Patients were eligible to continue apremilast for up to 4 additional years.

There were 1,184 patients treated twice daily with apremilast 30 mg during the 0 to at least 156 week apremilast-exposure period. Diarrhea, nausea, upper respiratory tract infection, nasopharynges, tension headache, and headache were reported by at least 5% of patients from 0 to 52 weeks.

No new adverse events were reported from week 0 through at least 156 weeks.

Long-term exposure did not increase adverse events, serious adverse events or discontinuation of the study drug.

The rates of major cardiac events, malignancies, depression or suicide attempts did not increase through at least 156 weeks compared with the 0 up to 52-week period.

Threw were no reports of serious opportunistic infections, reactivation of tuberculosis or clinically meaningful effects on laboratory measure reported during the study period.

The researchers noted that a study limitation was a relatively high dropout rate: 21% of patients still ongoing at the 182-week data cutoff. However, 11.2% of patients discontinued because of adverse events, so the rate does not appear overly related to safety concerns.

Many of the patients had comorbid conditions that are typical to general psoriasis, including hypertension, obesity and depression.

“Apremilast, an oral PDE4 inhibitor, demonstrated an acceptable safety profile and was generally well tolerated for ≥ 156 weeks,” the researchers concluded. “No new safety concerns were identified with long-term exposure in this psoriasis patient population with several comorbidities. The benefit-risk profile of apremilast, including the oral route of administration, lack of monitoring requirements during treatment and lack of cumulative, specific organ toxicity, makes apremilast an attractive option for patients with psoriasis requiring long-term systemic therapy.” – by Bruce Thiel

Disclosure: The researchers report no relevant financial disclosures.