Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial)

Abstract

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).

Addressing challenges associated with long‐term topical treatment and benefits of proactive management in patients with psoriasis

“…Data from PSO-LONG. 10 Note: patients who did not achieve physician's global assessment <2 after 4 weeks of once-daily rescue treatment following relapse were withdrawn from the trial but are included within this Kaplan-Meier curve. *30 patients in the proactive group vs. 6 patients in the reactive group finished the trial without experiencing first relapse but had their final visit prior to Day 364.…”

“…If PGA score 'clear'/'almost clear' was regained after 4 weeks' rescue treatment, maintenance treatment (twice-weekly Cal/BD foam) was resumed; if not, patients were withdrawn from the trial. 10 Sustained remission is not achievable with the current treatment approaches and relapse is inevitable. 16 Providing a proactive, intermittent treatment to maintain response following initial treatment success may be a suitable option to improve patient outcomes.…”

“…Few studies have assessed the efficacy and safety of long‐term use of topicals, and data from maintenance studies longer than 6 months are also lacking. Results from a randomised clinical study assessing Cal/BD foam as a proactive long‐term management approach for psoriasis vulgaris to prevent or reduce the occurrence of relapse over 52 weeks (PSO‐LONG) have been reported, and have the potential to address some of the challenges associated with long‐term management of psoriasis outlined here 10 …”

“…8,9 The Phase III PSO-LONG study (NCT02899962) assessed the efficacy and safety of longterm (52 weeks), twice-weekly proactive management with topical Cal/BD foam versus vehicle foam (reactive management with Cal/BD foam as rescue treatment) in the prevention of disease relapse in adults with psoriasis. 10 Here, we focus on providing a rationale for the potential benefits of proactive versus reactive treatment in the long-term management of psoriasis, using evidence from the PSO-LONG study.…”

“…Fixed‐dose combination calcipotriol 50 µg/g betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous aerosol foam (Enstilar ® ; LEO Pharma, Ballerup, Denmark) is approved in the US (in adults and adolescents) and EU (in adults) for the treatment of psoriasis vulgaris for 4 weeks 8,9 . The Phase III PSO‐LONG study (NCT02899962) assessed the efficacy and safety of long‐term (52 weeks), twice‐weekly proactive management with topical Cal/BD foam versus vehicle foam (reactive management with Cal/BD foam as rescue treatment) in the prevention of disease relapse in adults with psoriasis 10 . Here, we focus on providing a rationale for the potential benefits of proactive versus reactive treatment in the long‐term management of psoriasis, using evidence from the PSO‐LONG study.…”