title: Pooled safety analysis of calcipotriol plus betamethasone dipropionate gel for the treatment of psoriasis on the body and scalp.
abstract: The fixed combination calcipotriol plus betamethasone dipropionate gel is a first-line treatment for psoriasis vulgaris. The objective was to perform a large-scale assessment of tolerability of fixed combination gel (Cal/BD). Analysis was performed on pooled 8-week safety data from nine clinical trials evaluating once-daily Cal/BD treatment of scalp (n = 6) and body (n = 3) psoriasis. Pharmacovigilance data were also assessed. Patients were treated with Cal/BD [n = 1953 (scalp), n = 824 (body)], betamethasone dipropionate gel (BD; n = 1214, n = 562), calcipotriol gel (Cal; n = 979, n = 175), gel vehicle (VEH; n = 173, n = 226), calcipotriol scalp solution [n = 104 (scalp only)] and tacalcitol ointment [TAC; n = 184 (body only)]. Most adverse events (AEs) were mild-moderate severity. The proportion of scalp psoriasis patients with ≥1 AE was lowest with Cal/BD (35% versus 38-57%). A similar proportion was found with Cal/BD for body psoriasis (32%), however, lower proportions were reported with BD (24%) and Cal (29%). The most common AEs with Cal/BD included nasopharyngitis, pruritus and upper respiratory tract infection (2-5% of patients). Overall, only 5% of patients treated with Cal/BD reported ≥1 lesional/perilesional AEs: the lowest incidence versus scalp comparators (6-19%) and second lowest to BD (3%) for body psoriasis. Similarly, Cal/BD treatment resulted in the lowest incidence of ≥1 adverse drug reactions (ADRs) in scalp psoriasis patients (8% versus 9-27%) and second lowest to BD (6% versus 4%) for body psoriasis. Overall, incidence of serious AEs (SAEs) was low (0-1%). Data received postmarketing through spontaneous reporting revealed that SAEs reported more than once with Cal/BD treatment were psoriasis (n = 5); and alopecia, erythrodermic psoriasis, pruritus, skin atrophy and urticaria (n = 2 each). In this large subset of patients treated with Cal/BD, incidence of AEs and ADRs is consistently low. This analysis provides further evidence of the good tolerability of the fixed combination gel as treatment for psoriasis vulgaris.
authors.affiliation: Department of Dermatology, Århus University Hospital, Århus, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Kragballe
authors.forename: P
authors.initials: P
authors.lastname: van de Kerkhof
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001623:Betamethasone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D011565:Psoriasis / Q000188:drug therapy*; D012536:Scalp Dermatoses / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D009824:Ointments; C517164:betamethasone dipropionate, calcipotriol drug combination; D001623:Betamethasone; D002117:Calcitriol