Fixed Combination Calcipotriene and Betamethasone Dipropionate (Cal/BD) Foam for Beyond-Mild Psoriasis: A Possible Alternative to Systemic Medication

August 2020 | Volume 19 | Issue 8 | Original Article | 723 | Copyright © August 2020


Published online July 31, 2020

Leon Kircik MD,a Linda Stein Gold MD,b Joyce Teng MD PhD,c Angela Moore MD,d Wendy Cantrell DNP CRNP,e Javier Alonso-Llamazares MD PhD,f John Koo MDg

aIcahn School of Medicine at Mount Sinai, New York, NY bHenry Ford Health System, Detroit, MI cStanford University Department of Dermatology, Palo Alto, CA dArlington Research Center, Arlington, TX and Baylor University Medical Center, Dallas, TX eVillage Dermatology, Mountain Brook, AL fDepartment of Dermatology, VA Medical Center, Miami, FL gDepartment of Dermatology, University of San Francisco, San Francisco, CA

as week 2 (Table 3).18 These results show that Cal/BD foam is effective in treating beyond-mild psoriasis regardless of how baseline disease severity is assessed. Additionally, existing safety data are consistent with the general safety profile of Cal/ BD foam (Table 3).17,18
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Oral treatments are frequently used to treat moderate-to-severe psoriasis.1-3 There are no high-quality, head-to-head trials comparing Cal/BD foam with oral agents in psoriasis. In the absence of randomized comparative studies, matching-adjusted indirect comparison (MAIC) analyses have been used.32,33 The analyses involved matching the baseline characteristics of individual patient-level (IPL) data from Cal/BD foam clinical trials with aggregate data from published studies of oral agents so that treatment outcomes may be indirectly compared. In one such MAIC analysis comparing pooled data from four Cal/ BD foam trials with published data of apremilast, acitretin, and fumaric acid esters (FAE), variable matching resulted in an increase in mean baseline PASI of the Cal/BD foam group (from 7.3 to 8.2, 11.9, and 11.6 in the MAICs with apremilast, acitretin, and FAE, respectively), reflecting patient populations with greater disease severity (Table 4).32 Importantly, Cal/BD foam efficacy following matching adjustment was significantly greater than that of apremilast and acitretin and comparable to that of FAE.32

Combination Therapy With Cal/BD Foam
Use of Cal/BD foam as adjunctive treatment was investigated in two studies involving patients with beyond-mild psoriasis.19,20 In 28 patients with moderate psoriasis, Cal/BD foam plus apremilast significantly improved PASI75, PGA, and pruritus at week 4 compared with apremilast alone; numerical improvements were also observed in BSA and DLQI (Table 5).19 Discontinuing Cal/BD foam at week 4 dramatically reduced efficacy, but the efficacy was restored upon reintroduction of Cal/BD foam. Notably, improvements in BSA, PGA, and PASI75 at week 16 were equal to or greater than those observed at week 4, suggesting no loss in the level of response when Cal/BD foam was reinitiated after discontinuation. The combination therapy was considered well tolerated.19 In a study of 25 adults with