Dupilumab
Dupilumab (Dupixent, REGN668/SAR231893), an IL4R-targeted IgG4 monoclonal antibody, was approved by the FDA on April 28, 2017, and by THE EMA on September 28, 2017, respectively, for the treatment of atopic dermatitis. Dupixent's approval was based on LIBERTY, an atopic dermatitis study that included three clinical trials of SOLO1, SOLO2 and CHRONOS. In SOLO1 and SOLO2, patients were treated with either 300mg Dupixent or placebo once a week, or with 300mg Dupixent every two weeks, respectively, and switched to placebo. The efficacy of Dupixent combined with corticosteroid was studied by CHRONOS test with placebo as control. The primary end point of the trial was the proportion of patients with a reduction of more than two points from baseline in the investigator's Overall Evaluation (IGA) score (0/1) at week 16. The results showed that, after 16 weeks of Dupixent monotherapy, the IGA compliance was significantly higher than that of the placebo group, with 37% of SOLO1 and 36% of SOLO2. Similarly, by CHRONOS, the dupilumab+ corticosteroid combination treatment was 39% and the placebo + steroid combination treatment was 12%. Because of its outstanding efficacy, this product has been recognized by FDA as a breakthrough therapy for atopic dermatitis. In addition to atopic dermatitis, Dupilumab is currently in phase III clinical development for indications for asthma and nasal polyps. In September 2017, Sanofi/Regeneration announced that dupilumab's LIBERTY ASTHMA QUEST (NCT02414854) trial for uncontrolled persistent ASTHMA had reached its therapeutic endpoint. Two other clinical trials on nasal polyp treatment (NCT02912468, NCT02898454) will also reach their endpoints in 2018. More encouragingly, this product can also be used in the treatment of eosinophilic esophagitis, and the current research is in the clinical phase II, and has been recognized as an orphan drug by FDA.
