PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.
Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.
Dr. Mark Lebwohl
He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.
The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.
The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.
Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.
The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.
This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.