Celgene Corporation said Monday that data from the phase III Relief clinical trial of Otezla in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting.
The company said that results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. Otezla (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).
Behçet’s Disease is a rare, chronic, multi-system inflammatory syndrome. Oral ulcers, the most common manifestation of Behçet’s Disease, can be disabling and have a substantial effect on quality of life. This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication.
“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,” said Gulen Hatemi, M.D., 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.”
Celgene said that it plans to submit supplemental New Drug Applications for apremilast 30 mg BID for the treatment of active Behçet’s Disease with oral ulcers in the U.S. and Japan in the second half of this year. The company also plans to submit a Type II Variation to the Marketing Authorization Application in the EU in 2019.
“The positive phase III findings in Behçet’s Disease reflect the unique aspects of the profile of Otezla 30 mg across inflammatory-related diseases,” said Terrie Curran, President, Celgene Inflammation and Immunology. “Otezla (apremilast) 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.”
Celgene noted that apremilast is not approved for the treatment of Behçet’s Disease in any country.