The efficacy of twice-weekly, fixed-dose combination calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam for the long-term maintenance of plaque psoriasis was supported in results from a clinical trial published in the Journal of the American Academy of Dermatology. Compared with patients who received placebo, those who used Cal/BD were more likely to remain in remission during 1 year of follow-up. The foam was well-tolerated, with few serious adverse events reported.
This 52-week, double-blind, randomized clinical trial enrolled patients with plaque psoriasis from 56 participating centers in the United States, Canada, United Kingdom, France, Poland, and Germany. Participants were eligible to enter the 52-week trial if they had achieved treatment success with once-daily Cal/BD foam during a 4-week open-label lead-in phase. Treatment response was defined as a as a Physician Global Assessment (PGA) score of less than 2 and a PGA change of 2 or greater from baseline. Patients were then randomly assigned to 52 weeks of either “proactive” management (twice-weekly Cal/BD foam) or “reactive” management (twice-weekly vehicle foam). Clinic visits were conducted every 4 weeks, during which patients were assessed for relapse (PGA score 2 or greater). Those who relapsed were given 4 weeks of rescue treatment with Cal/BD foam. The primary endpoint was time to first relapse. Following the 52-week maintenance phase, participants stopped all treatment for an 8-week follow-up period. Time to relapse during follow-up was also recorded. Cox proportional hazard models were used to estimate risk for relapse in each study condition.
A total of 251 patients completed the 52-week randomized clinical trial phase. Median time to relapse was 56 days in the Cal/BD condition, compared with 30 days in the placebo condition. The risk for first relapse was significantly reduced in the proactive vs reactive management condition (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.47-0.69; P <.001).
Patients in both groups responded to rescue treatment with once-daily Cal/BD foam: 75.9% in the proactive group and 81.0% in the reactive group. Patients who did not achieve a PGA score of less than 2 after rescue treatment were withdrawn from the study: 65 and 70 patients in the Cal/BD and vehicle foam groups, respectively. Among patients who completed the maintenance phase and entered the 8-week follow-up period, 30 patients in the proactive group and 6 patients in the reactive group did not experience relapse. The percentage of days spent in remission during the total trial was significantly higher for those who received Cal/BD foam vs placebo (P <.001). Compared with the placebo group, patients receiving proactive management had an additional 41 days of remission per year (P <.001). The number of relapses per year of exposure was estimated at 3.1 and 4.8 for the Cal/BD and placebo foam conditions, respectively.
Cal/BD foam was well-tolerated during the maintenance phase, the investigators reported. The rate of adverse events per 100 patient-years was 168.6 and 158.4 in the proactive and reactive groups, respectively. The most commonly reported adverse events were nasopharyngitis (8.1% proactive vs 7.0% reactive) and upper respiratory tract infection (5.9% vs 5.5%), although these events were determined to be unrelated to treatment. No adverse events of skin atrophy were reported. Pruritus was experienced by 1 participant in the placebo foam group. No changes in the hypothalamic-pituitary-adrenal (HPA) axis, or calcium metabolism were identified in patients receiving Cal/BD foam.
The primary study limitation was the high drop-out rate: 53.9% of participants did not complete all 52 weeks of maintenance treatment. However, drop-out rate did not differ significantly in the Cal/BD and vehicle conditions.
In this long-term maintenance study, treatment with Cal/BD foam was associated with a significant reduction in the rate of plaque psoriasis relapse. Cal/BD foam, compared with vehicle foam, also conferred a mean 41 extra days in remission per year. The foam was well-tolerated by participants, both when applied twice-weekly or once-daily. “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,” investigators wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
Lebwohl M, Kircik L, Lacour JP, et al. 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) [published online September 17, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.09.037