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A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet((R))/Daivobet((R))/Taclonex((R))) in the treatment of psoriasis vulgaris

Kragballe, K ; Austad, J ; Barnes, L ; Bibby, A ; de la Brassinne, M ; Cambazard, F ; Fleming, C ; Heikkila, H ; Jolliffe, D and Peyri, J , et al. (2006) In British Journal of Dermatology 154(6). p.1155-1160
Abstract
The calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and... (More)
The calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
safety, controlled trial, randomized, psoriasis, betamethasone dipropionate, calcipotriol, two-compound product
in
British Journal of Dermatology
volume
154
issue
6
pages
1155 - 1160
publisher
Wiley-Blackwell
external identifiers
  • pmid:16704648
  • wos:000237515800018
  • scopus:33646590026
ISSN
1365-2133
DOI
10.1111/j.1365-2133.2006.07236.x
language
English
LU publication?
yes
additional info
The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Pediatrics/Urology/Gynecology/Endocrinology (013240400)
id
4cfe4e4d-2c8c-4c8c-bb31-f11a5e1e86d0 (old id 693247)
date added to LUP
2016-04-01 11:44:51
date last changed
2020-12-22 03:21:32
@article{4cfe4e4d-2c8c-4c8c-bb31-f11a5e1e86d0,
  abstract     = {The calcipotriol/betamethasone dipropionate two-compound product Dovobet (R)/Daivobet (R)/Taclonex (R)(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P &lt; 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment.},
  author       = {Kragballe, K and Austad, J and Barnes, L and Bibby, A and de la Brassinne, M and Cambazard, F and Fleming, C and Heikkila, H and Jolliffe, D and Peyri, J and Svensson, Åke and Toole, J and Wozel, G},
  issn         = {1365-2133},
  language     = {eng},
  number       = {6},
  pages        = {1155--1160},
  publisher    = {Wiley-Blackwell},
  series       = {British Journal of Dermatology},
  title        = {A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet((R))/Daivobet((R))/Taclonex((R))) in the treatment of psoriasis vulgaris},
  url          = {http://dx.doi.org/10.1111/j.1365-2133.2006.07236.x},
  doi          = {10.1111/j.1365-2133.2006.07236.x},
  volume       = {154},
  year         = {2006},
}