The latest phase three data on dupilumab suggests that this recently approved biologic treatment is safe and effective in adults with moderate to severe atopic dermatitis (AD) who previously received cyclosporine A (CSA), or in whom CSA was contraindicated.
Combined with topical corticosteroids (TCS), the injectable IL-4- and IL-13-inhibiting monoclonal antibody improved measures of overall disease severity vs placebo in patients who were inadequately controlled on CSA, intolerant of CSA, or did not receive the immunosuppressive treatment due to medical concerns.
“This study showed dupilumab is effective with TCS when compared to placebo with TCS, and could be a very good alternative to CSA in this difficult-to-treat population,” said investigator Diamant Thaçi, M.D., director of the Comprehensive Center for Inflammation Medicine, University Luebeck, Germany.
“For these patients, there are very few treatment options,” added Dr. Thaçi, secondary author on the study, which was presented in a late-breaking session at the European Academy of Dermatology and Venerology (EADV) Congress in Geneva, Switzerland.
Cyclosporine A is approved for the treatment of atopic dermatitis in most European countries and Japan, Dr. Thaçi noted. While it is not approved in the U.S. for this particular use, the American Academy of Dermatology (AAD) July 2014 guidelines of care for management of atopic dermatitis state that CSA is “an effective off-label treatment option for patients with AD refractory to conventional topical treatment.” Most patients who receive the broad immunosuppressant will experience a significant decrease in disease activity within 2 to 6 weeks after treatment is started, according to the AAD guideline authors.
However, usage of CSA in European countries is mainly restricted for use as a short-term intervention rather than continuous long-term treatment, mainly due to limitations in safety profile, according to Dr. Thaçi. “CSA is effective in daily practice, but with many limitations,” he said in an interview with Dermatology Times. “Since AD is a chronic disease, long-term control of signs and symptoms is more important than temporary improvement at any time point.”