Addition of an oral histamine antagonist to reduce adverse events associated with fumaric acid esters in the treatment of psoriasis: a randomized double-blind placebo-controlled trial

Balak, Deepak; Fallah-Arani, S.; Venema, CM; Neumann, H. A. M.; Thio, Hok Bing

doi:10.1111/bjd.13277

Cited by 8 publications

(12 citation statements)

References 27 publications

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“…The placebo‐controlled RCT for the treatment of psoriatic arthritis using FAEs found significant improvement in skin lesions but only modest improvement in arthritis . Only one RCT reported improvements in health‐related quality of life following treatment with FAEs …”

Section: Resultsmentioning

confidence: 99%

“…The addition of a topical vitamin D analogue (calcipotriol) resulted in greater and faster improvement of psoriasis severity compared with treatment using FAEs alone . In contrast, the addition of an oral histamine‐1 receptor antagonist (cetirizine) did not increase the efficacy of FAEs …”

Section: Resultsmentioning

confidence: 99%

“…41 Only one RCT reported improvements in health-related quality of life following treatment with FAEs. 38 The only head-to-head RCT compared FAEs with methotrexate and reported similar efficacy results following 16 weeks of treatment. 36 The RCT that directly compared an FAE formulation containing DMF and MEF with a DMF formulation reported equal short-term efficacy.…”

Section: Efficacy Outcomes Reported In Randomized Controlled Trialsmentioning

confidence: 97%

“…Our search results found seven RCTs published in the period 1990-2014. 18,19,[35][36][37][38] Of these, three trials compared FAEs with placebo, one trial compared two different FAE formulations with placebo, one trial compared FAEs with methotrexate, one trial compared the combination of FAEs and topical calcipotriol with FAEs monotherapy, and the most recent trial compared FAEs plus an oral histamine antagonist with FAEs monotherapy. Two RCTs from the Netherlands were published additionally in an extended version in a Dutch journal.…”

Section: Characteristics Of Randomized Controlled Trialsmentioning

confidence: 99%

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Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies

et al. 2016

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Fumaric acid esters (FAEs) are increasingly used as a systemic treatment for psoriasis, but there are still uncertainties regarding their suitability. The objective of this systematic review was to assess the evidence for the efficacy and safety of FAEs in psoriasis treatment. A systematic literature search was performed in seven databases up to 17 August 2015. Inclusion criteria were studies that reported clinical effects of FAEs in patients with psoriasis without restrictions in study design, language or publication date. Methodological quality of randomized controlled trials (RCTs) and overall level of quality were assessed using the Cochrane risk of bias tool and the Grading of Recommendation, Assessment, Development and Evaluation approach, respectively. A total of 68 articles were included. There were seven RCTs (total 449 patients) that had an unclear risk of bias and were too clinically heterogeneous to allow a meta-analysis. Overall, mean Psoriasis Area and Severity Index decreased by 42-65% following 12-16 weeks of treatment. There were 37 observational studies (a total of 3457 patients) that supported the RCT findings, but most were uncontrolled with a high risk of bias. Commonly reported adverse events included gastrointestinal complaints and flushing, leading to treatment withdrawal in 6-40% of patients. Several case-reports described rare adverse events, such as renal Fanconi syndrome and progressive multifocal leukoencephalopathy. There was a lack of studies focusing on long-term use and comparisons with other treatments. This review concluded that there is low-quality evidence to recommend the use of oral FAEs to treat plaque psoriasis in adult patients. Studies focusing on long-term safety and comparison with systemic psoriasis treatments could lead to a better understanding of the role of FAEs as a treatment for psoriasis.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Efficacy Outcomes Reported In Randomized Controlled Trialsmentioning

confidence: 97%

Section: Characteristics Of Randomized Controlled Trialsmentioning

confidence: 99%

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Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies

et al. 2016

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“…Of these, 11 potentially eligible studies were identified after screening the titles and abstracts. After reading the full texts, five articles were excluded due to failure to meet our prespecified inclusion criteria [11][12][13][14] and lack of evidence of randomization. 15 As a result, six studies with a total of 544 participants were included in our review; five compared FAE with placebo [16][17][18][19][20] and one used methotrexate as an active comparator.…”

Section: Description Of the Included Studiesmentioning

confidence: 99%

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

et al. 2016

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SummaryFumaric acid esters (FAEs) 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 FAEs for psoriasis. Our primary outcomes were change in Psoriasis Area and Severity Index score and dropout rates due to adverse effects. Randomized controlled trials (RCTs) of FAEs or dimethylfumarate 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 and five trials registers, and hand searched six conference proceedings. Six RCTs with a total of 544 participants were included, four of which were published only as abstracts or brief reports, limiting study reporting. Five RCTs compared FAEs with placebo, and all demonstrated benefit in favour of FAEs. However, meta‐analysis was possible only for PASI 50 response after 12–16 weeks, which was achieved by 64% of participants on FAEs compared with 14% on placebo: risk ratio (RR) 4·55, 95% confidence interval (CI) 2·80–7·40; two studies; 247 participants; low‐quality evidence). There was no difference in dropout rates due to adverse effects (RR 5·36, 95% CI 0·28–102·12; one study; 27 participants; very low‐quality evidence and wide CI). More participants experienced nuisance adverse effects with FAEs (76%) than with placebo (16%) (RR 4·72, 95% CI 2·45–9·08; one study; 99 participants; moderate‐quality evidence), mainly abdominal pain, diarrhoea and flushing. One head‐to‐head study of very low‐quality evidence comparing FAEs with methotrexate reported comparable efficacy and dropout rates, although FAEs caused more flushing. The evidence in this review was limited and must be interpreted with caution; studies with better design and outcome reporting are needed.

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Oral fumaric acid esters for psoriasis

Atwan

Ingram

Abbott

et al. 2015

Cochrane Database of Systematic Reviews

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Addition of an oral histamine antagonist to reduce adverse events associated with fumaric acid esters in the treatment of psoriasis: a randomized double-blind placebo-controlled trial

Abstract: Addition of oral cetirizine 10 mg once daily to FAE treatment did not reduce adverse events in patients with psoriasis during the first 12 weeks of treatment. The mechanisms underlying FAE-induced gastrointestinal and flushing symptoms likely involve mediators other than histamine.

Cited by 8 publications

References 27 publications

Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies

Efficacy, effectiveness and safety of fumaric acid esters in the treatment of psoriasis: a systematic review of randomized and observational studies

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

Oral fumaric acid esters for psoriasis

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