Pooled safety analysis of calcipotriol plus betamethasone dipropionate gel for the treatment of psoriasis on the body and scalp

• Published in: Journal of the European Academy of Dermatology and Venereology 2014-05, Vol.28 (s2), p.10-21
• Main Authors: Kragballe, K., van de Kerkhof, P.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone - adverse effects; Betamethasone - analogs & derivatives; Betamethasone - therapeutic use; Calcitriol - adverse effects; Calcitriol - analogs & derivatives; Calcitriol - therapeutic use; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Drug Combinations; Female; Gels; Humans; Male; Middle Aged; Ointments; Pharmacovigilance; Product Surveillance, Postmarketing; Psoriasis - drug therapy; Scalp Dermatoses - drug therapy; Treatment Outcome
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.12444

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.