Celgen Corp's apremilast, which is pending approval in the USA for psioratic arthritis, is showing promise in the treatment of Behcet’s syndrome.
Phase II data has been presented at the American College of Rheumatology meeting in San Diego on apremilast for Behcet's, a rare and chronic inflammatory disorder characterised by oral and genital ulcers, as well as skin and eye lesions and joint inflammation.Prevalence is highest in the Middle East and Asia but also affects between 5,000-15,000 Americans.
In the study, 111 people with Behcet’s (who did not have any organs affected by disease and had at least two ulcers at the beginning) were randomly assigned to either take 30mg of apremilast or placebo twice a day for 12 weeks. After that, all participants were treated with the drug for an additional 12 weeks and observed 28 days after the last dose.
The data showed that showed that significantly more patients on apremilast achieved a complete response (were free from active oral ulcers) at week 12 compared with those on placebo (71% versus 29%). Among the 16 patients with genital ulcers, all of them had a complete response at week 12 compared with 50% of those on placebo.
Pain was significantly lower for those on apremilast and notably, the beneficial effect began within two weeks of starting the treatment and continued as long as the participants were receiving the drug. However the effect disappeared shortly after treatment with the phosphodiesterase 4 (PDE4) inhibitor was stopped at 24 weeks.
The drug was generally well tolerated and lead investigator Gulen Hatemi of the Cerrahpasa Medical School in Istanbul noted that improvement in quality of life as well as a decrease in disease activity was observed. Dr Hatem added that "considering the important down-regulating effect of apremilast on the inflammatory cascade", further studies "can also help us to better explain the disease mechanism(s) in Behçet’s".