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Celgene reveals strong P3 Otezla data in rare inflammatory condition

Published on 19/02/18 at 09:54am

Celgene has lifted the curtain on strong new Phase 3 data for its phosphodiesterase 4 (PDE4) inhibitor Otezla (apremilast) in the treatment of Behçet's disease, a rare immune condition characterised by a wide range of symptoms as a result of blood vessel inflammation.

Drawn from a study of 207 patients to determine the drug’s efficacy in the treatment of oral ulcers brought on by the disease, the data was presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting. It was found that Otezla demonstrated “statistically significant reductions in oral ulcers” compared to placebo after 12 weeks of treatment, according to the area under the curve (AUC), which assesses the change in number of recurrent oral ulcers over time.

Additionally, Celgene reported that “statistically significant” improvements were seen in the trial’s secondary endpoints, including oral ulcer pain, overall disease activity and quality of life.

"The positive phase III findings in Behçet's Disease reflect the unique aspects of the profile of Otezla 30 mg across inflammatory-related diseases," commented Terrie Curran, President, Celgene Inflammation and Immunology. "Otezla 30 mg has the potential to provide a clinically meaningful new treatment option for patients and doctors and to become the first product indicated specifically for the treatment of active Behçet's Disease with oral ulcers."

Symptoms of Behçet's disease can include recurrent oral and genital ulcers, skin lesions, arthritis, vasculopathy and uveitis. The root cause of the condition is unknown.

"Reducing oral ulcers, which are painful and can negatively impact quality of life, is an important goal in the treatment of people with Behçet's syndrome," added Dr Gulen Hatemi, Associate Professor, Istanbul University Cerrahpassa Medical School. "These findings suggest that apremilast, which reduced oral ulcers and oral ulcer pain, and improved disease activity in this pivotal study, has the potential to be a treatment option for patients with active Behçet's syndrome with oral ulcers, for which few treatment alternatives exist."

Matt Fellows

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