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Oral Molecule Maintains Safety and Efficacy Over 5 Years

A recent study showed participants with psoriatic arthritis (PsA) maintained clinical benefits from apremilast (Otezla) with no new safety signals over 5 years of treatment.

The study included 1493 participants with PsA who were enrolled in a phase III clinical trial. After a 24-week, randomized phase, and 28-week blinded active treatment phase, participants could enroll in an open label extension study for an additional 4 years.
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Among participants who continued apremilast treatment, response was sustained without any new safety issues, the researchers said. They found 67.2% of remaining participants achieved American College of Rheumatology (ACR) 20, 44.4% achieved ACR50, and 27.4% achieved ACR70 at week 260.

Likewise, 62.4% of participants with baseline enthesitis achieved Maastricht Ankylosing Spondylitis Enthesitis Score of 0 and 80.9% with baseline dactylitis achieved dactylitis count of 0.

In addition, 43.6% of participants with 3% or more body surface area involvement at baseline achieved a 75% or greater reduction in the Psoriasis Area and Severity Index scores.

Most commonly reported adverse events were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis. Diarrhea and nausea mostly occurred within the first 2 weeks of treatment and usually resolved within 4 weeks, the researchers said. Additionally, rates of depression were low (less than 1.8%) and the majority of participants maintained their weight within 5% of baseline during the study.

“No new safety concerns or increases in the incidence or severity of adverse events were observed over the long term,” the researchers concluded. “Apremilast maintained clinical benefit and a favorable safety profile for up to 5 years among patients with PsA.”

Reference

Kavanaugh A, Gladman DD, Edwards CJ, et al. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis. Arthritis Res Ther. 2019;21(1):118. doi:10.1186/s13075-019-1901-3

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