Details
Dupilumab is a monoclonal antibody used for management of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and Chronic Obstructive Pulmonary Disease. The FDA initiated a study in Sentinel using a self-controlled risk interval analysis and tree-based scan statistics to monitor for new safety concerns among new users of dupilumab. A pre/post and a temporal cluster analysis were conducted.
After evaluating the statistical alerts generated by this study in the context of other information, the FDA determined no further evaluation is warranted at this time. Statistical alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).