Evaluation of the fragility of pivotal trials used to support US Food and Drug Administration approval for plaque psoriasis.

Abstract

Over the last 5 years, there has been a rapid growth in the number of clinical trials used to support a US Food and Drug Administration (FDA) approval for systemic therapies with labeled indications for plaque psoriasis. We aim to evaluate the fragility of clinical trial data used to support FDA approval of therapies for psoriasis. We reviewed the primary endpoints of the pivotal trials of all systemic medications with a labeled indication for plaque psoriasis available from Drugs@FDA. Sixty-nine clinical trial primary endpoints met inclusion criteria and were assessed for robustness, yielding a median fragility index of 72 and a median fragility quotient of 0.19. Efficacy and statistical analysis data for several approved medications were not available on the product label or on Drugs@FDA. When compared with randomized controlled trials for FDA approval across various diseases, pivotal trials in psoriasis appear quite robust to changes in outcomes.