Background: Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse.Objective: Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.Methods: Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once daily) and a 52-week, randomized, double-blind, maintenance phase. A total of 545 patients achieved treatment success (physician's global assessment ''clear''/''almost clear,'' $2-grade improvement from baseline) and were randomized to proactive management (Cal/BD foam; n = 272) or reactive management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once daily for 4 weeks upon relapse. Primary endpoint was time to first relapse (physician's global assessment ''mild'' or higher).

No abstract

Introduction:The phase 3 PSO LONG study (NCT02899962) demonstrated superior efficacy of proactive (PM) versus reactive management (RM) using calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis. Here, we evaluated whether certain baseline parameters had an effect on time to first relapse (TTFR), number of relapses, and assessed interactions between treatment effect. 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 a 4-week once-daily Cal/BD foam rescue treatment for relapse. Baseline parameters analyzed using a stepwise variable selection procedure included body surface area, modified Psoriasis Area Severity Index (mPASI), Physician Global Assessment (PGA), body mass index, age, sex, Dermatology Life Quality Index, and duration of psoriasis. Continuous variables were divided into groups based on standard criteria. Results: Overall, the effect of treatment on TTFR did not vary across any baseline parameters. Variables with a statistically significant effect on TTFR were: treatment group (PM vs. RM hazard ratio [HR]: 0.56; p \ 0.001); PGA (moderate vs. mild HR: 1.42; severe vs. mild HR: 2.32; overall p = 0.009); mPASI (moderate vs. mild HR: 1.19; severe vs. mild HR: 1.77; overall p = 0.009); and sex (women vs. men HR: 1.26; p = 0.030). Variables with a significant effect on the number of relapses were: treatment group (PM vs. RM, rate ratio [RR] 0.52; p \ 0.001); PGA at baseline (moderate vs. mild, RR 1.38; severe vs. mild, RR 2.22; overall p \ 0.001); and mPASI (moderate vs. mild, RR 1.25; severe vs. mild, HR 1.70; overall p = 0.002). Conclusion: All patients benefitted from longterm PM versus RM with Cal/BD foam regardless of baseline characteristics, and the benefit of treatment increased with greater disease severity. Trial Registration: ClinicalTrials.gov identifier, NCT02899962.

Objective: In PSO-LONG, long-term proactive management (PAM) of psoriasis with fixed-dose combination calcipotriol 50 mg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) aerosol foam was superior to conventional reactive management. This post-hoc analysis investigated long-term PAM with Cal/BD foam in PSO-LONG patients who could be more susceptible to corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression. Methods: Efficacy and safety of PAM with Cal/BD foam (twice-weekly) versus reactive management (twice-weekly vehicle foam), with once-daily rescue Cal/BD foam for four weeks following relapse, was assessed in the HPA subgroup (n ¼ 66); patients had moderate-to-severe psoriasis (physician global assessment score 3; 10-30% body surface area affected). Primary endpoint was time to first relapse. Results: PAM with Cal/BD foam was associated with longer median time to first relapse (111 versus 31 days), reduced risk of first relapse (hazard ratio: 0.49; p ¼ .029), greater proportion of days in remission (17%; p ¼ .001) and reduced rate of relapse (60% reduction; p < .001) than reactive management. Adverse events occurred in 37.5% (PAM) and 47.1% (reactive management) of patients, with no new safety signals. No clinically significant HPA-axis suppression was observed. Conclusion: Efficacy of PAM with Cal/BD foam is maintained in patients with moderate-to-severe psoriasis, with no new safety signals.

No abstract