The FDA has approved the phosphodiesterase-4 inhibitor apremilast (Otezla) for the treatment of psoriatic arthritis, Celgene Corporation announced today.
The oral phosphodiesterase 4 (PDE4) inhibitor apremilast (Otezla) has been approved by the FDA for treatment of adults with active psoriatic arthritis, Celgene Corporation announced today.
The drug treats psoriatic arthritis by a different mechanism than other available therapies, blocking an enzyme important in inflammation. Results from the series of PALACE trials that were the basis for the approval were announced last October to an overflow session at the American College of Rheumatology meeting in San Diego.
The three multicenter randomized trials found that 30 mg twice daily of oral apremilast achieved ACR20 responses in 38% of patients within 16 weeks, compared to only 19% of those on placebo. Treatment achieved improvement in all 7 ACR components measured, including dactylitis and enthesitis, as well as in disease-related physical function.
The most common adverse reactions occurred within the first 2 weeks and tended to resolve spontaneously. The most common effects leading to discontinuation (in 4.6% of those on the medication) were nausea, diarrhea, and headache. The rate of serious adverse events matched those in patients on placebo.
According to a Celgene press release, the drug will be dispensed through a network of specialist pharmacies. Further information is available at www.otezla.com.