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Celgene reports primary endpoint significance in apremilast trial for psoriatic arthritis patients
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Statistical significance was achieved for primary endpoint at week 16 for patients with psoriatic arthritis being treated with apremilast monotherapy, Celgene International Sàrl, a subsidiary of Celgene Corp., reported this week.
Apremilast, an oral small-molecule that inhibits phosphodiesterase 4, works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. Results were from the first Celgene-sponsored trial that studied patients with psoriatic arthritis who had not previously received an oral disease-modifying antirheumatic drug (DMARD), according to a press release.
The ongoing PALACE 4 trial is one of four investigational phase 3 multicenter, double blind, placebo-controlled studies evaluating apremilast therapy for patients with psoriatic arthritis. More than 500 DMARD-naive patients were randomly assigned to20 mg twice daily, 30 mg twice daily or placebo for 24 weeks, followed by an extended period when all patients were assigned apremilast. Primary endpoint was the proportion of patients who achieved American College of Rheumatology criteria for 20% improvement at week 16, compared with baseline.
Treated patients “also achieved significant benefit over placebo in key secondary endpoints, as demonstrated in various measures of physical function and sign and symptoms, including enthesitis,” the release said.
“Despite advances in the treatment of psoriatic arthritis, there remains a significant need for more oral DMARD treatment options for DMARD-naive patients,” Randall Stevens, MD, vice president of clinical research and development for inflammation and immunology at Celgene, said in the release. “PALACE 4 is now the fourth major randomized apremilast phase 3 study to provide promising results for patients with psoriatic arthritis.”
There were fewer adverse events (AEs) and significant AEs reported than in the first three trials, with no new safety and tolerability signals identified, according to the release. No systemic opportunistic infections or lymphoma were observed through week 24, with no increase in risk for cardiovascular events. Nausea, diarrhea and headache were the most common AEs.