PMID- 24684739
OWN - NLM
STAT- MEDLINE
DCOM- 20141118
LR  - 20220311
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 28 Suppl 2
DP  - 2014 May
TI  - Pooled safety analysis of calcipotriol plus betamethasone dipropionate gel for 
      the treatment of psoriasis on the body and scalp.
PG  - 10-21
LID - 10.1111/jdv.12444 [doi]
AB  - 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.
CI  - (c) 2014 European Academy of Dermatology and Venereology.
FAU - Kragballe, K
AU  - Kragballe K
AD  - Department of Dermatology, Arhus University Hospital, Arhus, Denmark.
FAU - van de Kerkhof, P
AU  - van de Kerkhof P
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 0 (Ointments)
RN  - 0 (betamethasone dipropionate, calcipotriol drug combination)
RN  - 9842X06Q6M (Betamethasone)
RN  - FXC9231JVH (Calcitriol)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Betamethasone/adverse effects/*analogs & derivatives/therapeutic use
MH  - Calcitriol/adverse effects/*analogs & derivatives/therapeutic use
MH  - Dermatologic Agents/*adverse effects/therapeutic use
MH  - Drug Combinations
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ointments
MH  - Pharmacovigilance
MH  - Product Surveillance, Postmarketing
MH  - Psoriasis/*drug therapy
MH  - Scalp Dermatoses/*drug therapy
MH  - Treatment Outcome
EDAT- 2014/04/02 06:00
MHDA- 2014/11/19 06:00
CRDT- 2014/04/02 06:00
PHST- 2014/01/21 00:00 [received]
PHST- 2014/02/06 00:00 [accepted]
PHST- 2014/04/02 06:00 [entrez]
PHST- 2014/04/02 06:00 [pubmed]
PHST- 2014/11/19 06:00 [medline]
AID - 10.1111/jdv.12444 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2014 May;28 Suppl 2:10-21. doi: 10.1111/jdv.12444.