Abstract

Introduction: The PSO-LONG study (NCT02899962) demonstrated superiority of proactive (PM) over reactive management (RM) using calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in prolonging time to first relapse in adults with psoriasis. This post hoc analysis investigates the time to second relapse to confirm the effect of PM is maintained over time. Methods: PSO-LONG included an initial 4-week open-label phase (once-daily Cal/BD foam) and a 52-week, maintenance phase where patients were randomized to twice-weekly Cal/BD (PM) or vehicle foam (RM), with 4-weeks once-daily Cal/BD foam rescue treatment for relapse (PGA≥2). The time to the second relapse during the maintenance phase was calculated as the number of days from randomization until PGA≥ 2 is confirmed either as a second relapse or at the end of the first relapse. For subjects who did not experience a second relapse according to this definition, the number of days until second relapse was treated as a censored observation at the end-of-trial visit. Results: The estimated median time to second relapse was prolonged by 79 days for patients in PM arm vs RM arm (169 days vs. 90 days, respectively) [hazard ratio, 0.53; 95% confidence interval (CI), 0.43 to 0.66; P < .001]. The results demonstrate continued benefit for PM as shown in time to first relapse (56 days vs. 30 days). Conclusion: PM of psoriasis with twice-weekly Cal/BD foam resulted in longer time to first and second relapses versus RM.

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