Results from a Phase III clinical trial showed that treatment with Otezla (apremilast) led to clinical improvements in patients with psoriatic arthritis for up to 13 months, including signs and symptoms, physical function, and psoriasis.
The study, titled “A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial,” was published in The Journal of Rheumatology.
Otezla (apremilast, Celgene Corp.) is an FDA-approved drug for the treatment of certain types of psoriasis and psoriatic arthritis that acts as a selective inhibitor of the enzyme phosphodiesterase 4 (PDE4) and inhibits spontaneous production of TNF-alpha from human rheumatoid synovial cells.
The new study, “PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PALACE2),” was conducted by Maurizio Cutolo and colleagues from the Research Laboratory and Division of Clinical Rheumatology, University of Genoa in Italy. It was a Phase III randomized controlled trial in which 484 patients with psoriatic arthritis were assigned randomly to receive Otezla 20 mg twice daily, Otezla 30 mg twice daily, or a placebo.
At Week 16, patients with swollen and tender joint count improvement of less than 20% entered early escape, and patients in the placebo group were re-randomized to Otezla 20 mg or 30 mg, while Otezla patients continued on their initial Otezla dose.
At Week 24, those patients who were still on the placebo were re-randomized to the drug 20 mg or 30 mg twice a day. The trial primary endpoint was the proportion of patients achieving greater than 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16.
The researchers found that at week 16, more patients in the Otezla 20-mg or Otezla 30-mg groups achieved ACR20 compared to placebo. At week 52, patients treated with either doses of the medicine had clinically meaningful improvements in signs and symptoms of psoriatic arthritis, physical function and psoriasis. The most commonly reported treatment-related adverse events were headache, nausea, diarrhea and upper respiratory tract infection, as well as rare and temporary laboratory abnormalities. No new safety concerns were identified.
Psoriatic arthritis is a type of inflammatory arthritis that will develop in up to 30 percent of people with psoriasis, which causes pain, stiffness and swelling in and around the joints. Psoriatic arthritis can develop at any time, but most commonly appears between the ages of 30 and 50. Genes, the immune system and environmental factors are believed to play a role in the onset of the disease.