Immune presents updated 'positive' results from Phase 2 trial of bertilimumab
Immune Pharmaceuticals announced that updated data from its phase 2 study of bertilimumab in patients with moderate-to-extensive bullous pemphigoid are being presented today at the 2018 Pre-IID Pemphigus and Pemphigoid Symposium in Orlando, FL. These updated results include complete follow-up on all subjects enrolled in the study. Subjects in the study experienced a decline in the Bullous Pemphigoid Disease Area Index Activity Score of 81% at day 84 from a mean baseline score of 67, with 86% of subjects showing at least a 50% improvement in the BPDAI Activity Score and 57% showing at least a 90% improvement. Over the course of the study, subjects in the study also had improvements in pruritus, a very challenging symptom for patients with BP, and quality of life. These benefits were seen quickly, with a mean reduction in BPDAI Activity Score of 70% by day 42. For a subgroup of subjects within which lesion healing was assessed, all six showed healing of prior lesions by day 28. These improvements were observed despite subjects receiving only three doses of bertilimumab and modest doses of prednisone that were aggressively tapered. The mean starting dose of prednisone was 28 mg which was reduced to 17 mg by day 42 and to 12 mg by day 84. 40% of subjects had a prednisone dose of 10 mg/day or less by day 42, and 58% had achieved 10 mg/day or less by day 84. The standard of care for BP patients treated with systemic steroids is a starting dose of 0.5-1.0 mg/kg tapered slowly over the course of 6-12 months, and subjects in this study received on average approximately 2,900 mg less prednisone than called for by the regimen of Joly et al and 1,700 mg less prednisone than called for by British treatment guidelines.