Psoriasis Therapy Effective for Psoriatic Arthritis

Apremilast improved the signs and symptoms of psoriatic arthritis (PsA) for 52 weeks, according to the findings of a recent study.

The study included 527 participants who had not received disease-modifying antirheumatic drugs (DMARDs) with a mean PsA duration of 3.4 years and high disease activity. Participants were randomly assigned to either placebo or 20 mg or 30 mg of apremilast administered 2 times per day for 16 weeks. At week 16 or 24, participants who received placebo were randomly assigned to 1 of the apremilast groups. Participants continued to receive apremilast for 52 weeks, with an extension of up to 4 years. The proportion of participants who achieved a 20% improvement in the American College of Rheumatology (ACR) response criteria (ACR20) at week 16 was assessed as the primary endpoint. In addition, mean changes in Health Assessment Questionnaire Disability Index (HAQ-DI) at week 16 were assessed.
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At week 16, more participants who received apremilast achieved ACR20 compared with placebo. Additionally, both apremilast doses showed significant ACR50 responses at week 16 and improvements in other secondary efficacy measures, including swollen and tender joint counts, and psoriasis assessments compared with placebo. These improvements were sustained through week 52. The mean HAQ-DI improvements for 20 mg and 30 mg of apremilast were -0.17 and -0.21, respectively, compared with 0.03 for placebo.

Diarrhea, nausea, headache, and upper respiratory tract infection were the most common adverse events throughout the 52-week study period, most of which were mild or moderate. Additionally, laboratory abnormalities were infrequent and transient, and serious adverse events and adverse events leading to discontinuation were comparable between groups.

“In DMARD-naive [participants], apremilast monotherapy improved PsA signs/symptoms over 52 weeks and was generally well tolerated,” the researchers concluded.

Reference

Wells AF, Edwards CJ, Kivitz AJ, et al. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial [published online April 4, 2018]. Rheumatology. https://doi.org/10.1093/rheumatology/key032