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Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments

Atwan, A., Ingram, John R. ORCID:, Abbott, Rachel, Kelson, Mark James ORCID:, Pickles, Timothy E. ORCID:, Bauer, A. and Piguet, Vincent 2016. Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments. British Journal of Dermatology 175 (5) , pp. 873-881. 10.1111/bjd.14676

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Fumaric acid esters (FAE) are licensed for the treatment of moderate to severe psoriasis in Germany but are also used off-label in many other countries. We conducted this systematic review to synthesize the highest quality evidence for the benefits and risks of FAE for psoriasis. Our primary outcomes were change in PASI score and drop-out rates due to adverse effects. Randomised controlled trials (RCTs) of FAE or dimethyl fumarate were included, with no restriction on age or psoriasis subtype. We searched The Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library, MEDLINE, EMBASE, LILACS, five trials registers and handsearched six conference proceedings. Six RCTs with 544 participants were included, four of which were published only as abstracts or brief reports, limiting study reporting. Five RCTs compared FAE with placebo and all demonstrated benefit in favour of FAE but meta-analysis was only possible for PASI 50 after 12-16 weeks, which was achieved by 64% of participants on FAE compared to 14% on placebo (risk ratio (RR) 4.55; 95% CI 2.80 to 7.40; 2 studies; 247 participants; low quality evidence). There was no difference in drop-out rates due to adverse effects (RR 5.36, 95% CI 0.28 to 102.12; 1 study; 27 participants; very low-quality evidence and wide confidence interval). More participants experienced nuisance adverse effects with FAE (76%) compared to placebo (16%) (RR 4.72, 95% CI 2.45 to 9.08; 1 study; 99 participants; moderate-quality evidence), mainly abdominal pain, diarrhoea and flushing. One head-to-head study of very low quality evidence comparing FAE with methotrexate reported comparable efficacy and drop-out rates, although FAE caused more flushing. The evidence in this review was limited and must be interpreted with caution; better designed and reported studies are needed.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Dentistry
Publisher: Wiley-Blackwell
ISSN: 0007-0963
Date of First Compliant Deposit: 9 May 2016
Date of Acceptance: 12 April 2016
Last Modified: 12 Jun 2023 16:33

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