Calcipotriene/betamethasone dipropionate foam shows long-term efficacy in plaque psoriasis
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A twice-weekly dose of topical calcipotriene and betamethasone dipropionate increased the time in plaque psoriasis remission in the phase 3 PSO-LONG trial, according to a study published in Journal of the American Academy of Dermatology.
The 52-week, randomized, double-blind, maintenance phase trial assessed the long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.
Subjects who had achieved treatment success in a 4-week open-label lead-in phase were enrolled in the maintenance phase of the trial. They were then randomly assigned 1:1 to receive twice-weekly treatment or vehicle foam for 52 weeks.
In the treatment group, the estimated median time to first relapse was prolonged by 26 days compared with those in the vehicle group, 56 days vs. 30 days.
Relapse risk was reduced by 43% in the treatment group (HR, 0.57; 95% CI, 0.47-0.69; P < .001).
Thirty patients in the treatment group and six patients in the vehicle group did not have a relapse during the maintenance phase.
Subjects in the treatment group experienced significantly more days in remission over the year compared with the those in the vehicle group, with an estimated treatment difference of 11% (95% CI, 8%-14%; P < .001), or 41 extra days in remission.
“Long-term proactive management over 52 weeks with fixed-dose CAL/BD foam twice weekly was superior in prolonging time to first relapse, reducing number of relapses and increasing days in remission compared with vehicle foam in adults with plaque psoriasis,” the study authors wrote.
Adverse events incidence was similar between the two groups, with a rate of 168.6 per 100 patient-years in the treatment group and 158.4 per 100 patient-years in the vehicle group.
Serious adverse events were 8.3 and 7.9, respectively, per 100 patient-years. Treatment-related adverse events had a rate of 2.8 per 100 patient-years in the treatment group and 4.5 per 100 patient-years in the vehicle group.
The trial’s limitations included a “substantial but expected” dropout rate of 53.9%.
“The results of this novel trial are very promising and suggest that proactive management with fixed-dose Cal/BD foam could offer improved long-term control of plaque psoriasis over conventional reactive treatment,” the authors wrote.