Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study

Abstract

Objective: To evaluate the efficacy of fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD).

Design: Patients were randomized (100:101:101) to receive Cal/BD foam, Cal foam, or BD foam once daily for four weeks.

Setting: Twenty-eight United States centers.

Participants: 302 patients (≥18 years) with Psoriasis vulgaris (plaque Psoriasis; ≥mild disease severity by physicians global assessment).

Measurements: Treatment success of the body ("clear"/"almost clear" from baseline moderate/severe disease; "clear" from baseline mild disease). Involved scalp treatment success was an additional endpoint.

Results: Most patients (76%) had moderate Psoriasis of the body (66% for scalp). At Week 4, 45 percent of Cal/BD foam patients achieved treatment success, significantly more than Cal foam (14.9%; OR 4.34 [95%CI 2.16,8.72] P<0.001) or BD foam (30.7%; 1.81 [1.00,3.26] P=0.047). Fifty-three percent of Cal/BD foam patients achieved treatment success of the scalp, significantly greater than Cal foam (35.6%; 1.91 [1.09,3.35] P=0.021), but not BD foam (47.5%; 1.24 [0.71,2.16] P=0.45). Mean modified Psoriasis area and severity index (population baseline 7.6) improved in all groups, with statistically significant differences in Week 4 Cal/BD foam score (2.37) versus Cal foam (4.39; mean difference -2.03 [-2.63][-1.43] P<0.001) and BD foam (3.37; -1.19 [-1.80][-0.59] P<0.001). Four (Cal/BD), 10 (Cal), and 8 (BD) adverse drug reactions were reported.

Conclusion: Cal/BD foam was significantly more effective than Cal foam and BD foam in providing treatment success at Week 4 and effective on involved scalp.

Trial registration: NCT01536938.

Figures

Figure 1.

Study design. In the case of an ongoing ADR, a further safety follow-up was performed 2 weeks after the patient’s last study Visit or until the final outcome was established, whichever occurred first. ADR=adverse drug reaction; BD=betamethasone dipropionate 0.064%; Cal=calcipotriene 0.005%

Figure 2.

Patient flow CONSORT diagram. *1 patient was nonadherent to treatment; 1 patient had a Visit scheduling error AE=adverse event; BD=betamethasone dipropionate 0.064%; Cal=calcipotriene 0.005%

Figure 3.

Proportion of patients achieving treatment success according to physician’s assessment of the A) body and B) scalp at Week 1 and 4 with Cal/BD, Cal, and BD aerosol foam (full analysis set). Treatment success was defined as “clear” or “almost clear” from baseline for patients with moderate/severe disease and “clear” from baseline for those with mild disease. Missing values were imputed by LOCF; P-values were determined using Cochran–Mantel–Haenszel test, adjusting for pooled centers. BD=betamethasone dipropionate 0.064%; Cal=calcipotriene 0.005%; LOCF=last observation carried forward

Figure 4.

Mean mPASI scores of body at baseline, Week 1 and 4 with Cal/BD, Cal, and BD aerosol foam (full analysis set). Missing values were imputed by LOCF; P-values were determined by ANCOVA, adjusting for pooled center and baseline mPASI. ANCO-VA=analysis of covariance; BD=betamethasone dipropionate 0.064%; Cal=calcipotriene 0.005%; L0CF=last Observation carried forward; mPASI=modified psoriasis area and severity index

Figure 5.

Treatment success according to patient-reported assessment at Week 1 and 4 with Cal/BD, Cal, and BD aerosol foam (full analysis set). Treatment success (by PaGA, considered body and scalp psoriasis together) was defined as “clear” or “very mild” disease. Missing values were imputed by LOCF for Week 4 comparisons; P-values were determined using Cochran–Mantel–Haenszel test, adjusting for pooled centers. BD=betamethasone dipropionate 0.064%; Cal=calcipotriene 0.005%; LOCF=last Observation carried forward; PaGA=patient’s assessment of disease severity