Matching-Adjusted Indirect Comparison of Long-Term Efficacy and Safety Outcomes for Calcipotriol Plus Betamethasone Dipropionate Foam Versus Halobetasol Proprionate Plus Tazarotene Lotion in the Treatment of Plaque Psoriasis

Abstract

Introduction: To date, there have been no head-to-head clinical studies comparing calcipotriol 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam and halobetasol propionate 0.01% plus tazarotene 0.045% (HP/Taz) lotion for the treatment of plaque psoriasis. However, the efficacy of 4 weeks of Cal/BD foam and 8 weeks of HP/Taz lotion has been compared using a matching-adjusted indirect comparison (MAIC) approach. Here, we compare the efficacy and safety of Cal/BD foam and HP/Taz lotion for up to 52 weeks.

Methods: An unanchored MAIC was conducted using individual patient data from the PSO-LONG Cal/BD foam trial and a 52-week, open-label phase 3 study of HP/Taz lotion (NCT02462083). Key outcomes of interest were Physician's Global Assessment (PGA) success (PGA 0/1 with ≥ 2-point improvement) after 4 or 8 weeks of open-label therapy; the proportion of patients who had body surface area affected (BSA) ≤ 3 after open-label therapy who maintained BSA ≤ 3 to week 52; and adverse events (AEs).

Results: After matching, patients were statistically significantly more likely to have PGA success after 4 weeks of Cal/BD foam than after 8 weeks of HP/Taz lotion (84.5% versus 54.4%; p < 0.01). At week 52, 92.5% and 92.4% of patients receiving proactive and reactive Cal/BD foam, respectively, maintained BSA ≤ 3, compared with 49.3% of those treated with HP/Taz lotion (both p < 0.01). Treatment-related AEs, AEs leading to withdrawal, and AEs associated with drug application (dermatitis, application site pain, and pruritus) were significantly rarer with Cal/BD foam than with HP/Taz lotion (all p < 0.01).

Conclusions: Cal/BD aerosol foam demonstrated significantly greater efficacy than HP/Taz lotion, and had a more favorable safety profile, compared with HP/Taz lotion, for up to 52 weeks. Proactive Cal/BD foam maintenance therapy and reactive use of Cal/BD foam following relapse both had significant advantages over HP/Taz lotion.

Keywords: Betamethasone dipropionate; Calcipotriol; Foam; Halobetasol propionate; Psoriasis; Tazarotene.

Fig. 1

Design of included RCTs. In PSO-LONG, treatment success was defined as PGA 0/1 with a ≥ 2-point improvement. In the HP/Taz trial, treatment success was defined as PGA 0/1 and improvement was defined as a ≥ 1-point improvement in PGA. BD betamethasone dipropionate, Cal calcipotriol, HP halobetasol proprionate, PGA Physician’s Global Assessment, Taz tazarotene

Fig. 2

Efficacy results. Numbers may be rounded to nearest integer number of patients. BD betamethasone dipropionate, BSA body surface area, Cal calcipotriol, CI confidence interval, HP halobetasol proprionate, OR odds ratio, PGA Physician’s Global Assessment, Taz tazarotene

Fig. 3

Safety results. *p < 0.05. **p < 0.01. Numbers may be rounded to nearest integer number of patients. BD betamethasone dipropionate, Cal calcipotriol, CI confidence interval, HP halobetasol proprionate, Taz tazarotene