Adjunctive Topical Foam Plus Biologics Effective for Refractory Psoriasis

Adjunctive 0.005% calcipotriene and 0.064% betamethasone dipropionate (Cal/BD) foam, along with biologic therapies, is associated with improvements in every aspect of disease activity for patients with psoriasis who do not show adequate response to biologics alone, according to a study published in Journal of Drugs in Dermatology.

This open-label, prospective, single-arm study of patients with less than 5% body surface area chronic plaque-type psoriasis sought to evaluate the safety and efficacy of combining Cal/BD foam with biologics. All participants (N=25; 7 women and 18 men) had been treated with biologic therapies for more than 24 weeks and had not obtained adequate response. For the first 4 weeks of the study, participants received Cal/BD foam once daily, followed by a maintenance regimen of twice-weekly consecutive day use for 12 weeks. Primary end point goals, evaluated at weeks 4 and 16, included the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9), the Dermatology Life Quality Index (DLQI), body surface area (BSA), Physician’s Global Assessment (PGA), and PGAxBSA, as well as assessments of adverse events and local skin reactions.

At baseline, the median values of disease activity for study participants were 3% BSA, 3 for PGA, and 8 for PGAxBSA. After 4 weeks of Cal/BD foam therapy and 16 weeks maintenance, patients showed significant improvements in PGA scores (1 and 1, respectively, P <.01), BSA involvement (1% and 1%, P <.01), and PGAxBSA (1 and 1, P<.01). The majority of participants achieved PGA≤1 and BSA≤1% at week 4 (76% for both), and at week 16 (68% for both), compared to 4% PGA and 12% BSA at baseline. Quality of life improvements with high treatment satisfaction were seen at both weeks 4 and 16 (P <.01, medial DLQI=1). The mean scores for TSQM-9 for global satisfaction were 76.3 for week 4 and 64.0 for week 16. The mean scores for TSQM-9 convenience and effectiveness were 80.9 and 76.7 at week 4 and 82.4 and 67.6 at week 16, respectively. The foam was also generally well-tolerated and safe. Nine adverse events were reported by 6 of the 25 patients, all of grade 1 severity, excepting 1 renal hematoma and 1 bone fracture, both of which were grade 2. No serious or treatment-related adverse events were reported.

Study investigators concluded, “Cal/BD foam is a pragmatic solution that provides an adequate disease control level and may prevent or delay a treatment switch in patients on stable biologic therapy for moderate to severe psoriasis.”

Reference

Bagel J, Zapata J, Nelson E. A prospective, open-label study evaluating adjunctive calcipotriene 0.005%/betamethasone dipropionate 0.064% foam in psoriasis patients with inadequate response to biologic therapy. J Drugs Dermatol. 2018;17(8):845-850