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Apremilast 30 mg Twice Daily Evaluated vs Placebo
Ann Pharmacother; 2016 Apr; Haber, et al
Apremilast has a unique mechanism of action and is safe and effective for both psoriasis and psoriatic arthritis, according to an evaluation of controlled clinical trials involving the medication.
In studies involving use of the drug at 30 mg twice daily for psoriasis, ~30% to 40% of those receiving apremilast achieved at least 75% improvement in PASI score at week 16, vs ~5% to 6% of those taking placebo.
For psoriatic arthritis, ~40% of those receiving the drug at 30 mg twice a day achieved the American College of Rheumatology criteria for 20% improvement at 16 weeks. ~20% of those taking placebo achieved such.
The most common adverse effects seen in all trials were diarrhea, nausea, and headache.
The authors concluded that apremilast should be considered for those unable to take disease-modifying antirheumatic drugs.
Citation: Haber S, Hamilton S, Bank M, Leong S, Pierce E. Apremilast: A novel drug for treatment of psoriasis and psoriatic arthritis. Ann Pharmacother. 2016;50(4):282-290. doi:10.1177/1060028015627467.
Commentary: Apremilast has made a significant impact since its introduction in March 2014 for plaque psoriasis, mainly due to its oral route of administration and lack of significant side effects, except for diarrhea and nausea, in up to 20% of patients in the first 4 weeks of administration. In this interesting review from Midwestern University College of Pharmacy, the authors review 4 psoriasis trials and 2 Psoriatic arthritis trials. The primary end points (ie, PASI 75 for psoriasis and ACR 20 for psoriatic arthritis) were relatively low as compared to our current TNF alpha, IL-12/23 and IL-17 agents, but relatively similar to prior trials for methotrexate. The authors’ conclusions relating to apremilast use in patients with contraindications to DMARD’s has certainly been exemplified in clinical practice by dermatologists and particularly rheumatologists who frequently combine apremilast with biologic agents (eg, ustekinumab to maximize psoriatic arthritis outcomes). —Alan Menter, MD