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Pooled safety analysis of calcipotriol plus betamethasone dipropionate gel for the treatment of psoriasis on the body and scalp
Author(s) -
Kragballe K.,
Kerkhof P.
Publication year - 2014
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.12444
Subject(s) - medicine , calcipotriol , betamethasone dipropionate , psoriasis , scalp , dermatology , adverse effect , betamethasone , tolerability , incidence (geometry) , physics , optics
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 ( AE s) 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 AE s 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 AE s: 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 ( ADR s) in scalp psoriasis patients (8% versus 9–27%) and second lowest to BD (6% versus 4%) for body psoriasis. Overall, incidence of serious AE s ( SAE s) was low (0–1%). Data received postmarketing through spontaneous reporting revealed that SAE s 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 AE s and ADR s is consistently low. This analysis provides further evidence of the good tolerability of the fixed combination gel as treatment for psoriasis vulgaris.