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Meta-Analysis
. 2015 Aug 10;2015(8):CD010497.
doi: 10.1002/14651858.CD010497.pub2.

Oral fumaric acid esters for psoriasis

Ausama Atwan  1 , John R Ingram, Rachel Abbott, Mark J Kelson, Timothy Pickles, Andrea Bauer, Vincent Piguet
Affiliations
Meta-Analysis

Oral fumaric acid esters for psoriasis

Ausama Atwan et al. Cochrane Database Syst Rev. .

Abstract

Background: Psoriasis is a chronic inflammatory skin condition that can markedly reduce life quality. Several systemic therapies exist for moderate to severe psoriasis, including oral fumaric acid esters (FAE). These contain dimethyl fumarate (DMF), the main active ingredient, and monoethyl fumarate. FAE are licensed for psoriasis in Germany but used off-licence in many countries.

Objectives: To assess the effects and safety of oral fumaric acid esters for psoriasis.

Search methods: We searched the following databases up to 7 May 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 4, 2015), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials. We handsearched six conference proceedings that were not already included in the Cochrane Skin Group Specialised Register.

Selection criteria: Randomised controlled trials (RCTs) of FAE, including DMF monotherapy, in individuals of any age and sex with a clinical diagnosis of psoriasis.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. Primary outcomes were improvement in Psoriasis Area and Severity Index (PASI) score and the proportion of participants discontinuing treatment due to adverse effects.

Main results: We included 6 studies (2 full reports, 2 abstracts, 1 brief communication, and 1 letter), with a total of 544 participants. Risk of bias was unclear in several studies because of insufficient reporting. Five studies compared FAE with placebo, and one study compared FAE with methotrexate. All studies reported data at 12 to 16 weeks, and we identified no longer-term studies. When FAE were compared with placebo, we could not perform meta-analysis for the primary outcome of PASI score because the three studies that assessed this outcome reported the data differently, although all studies reported a significant reduction in PASI scores with FAE. Only 1 small study designed for psoriatic arthritis reported on the other primary outcome of participants discontinuing treatment due to adverse effects (2 of 13 participants on FAE compared with none of the 14 participants on placebo; risk ratio (RR) 5.36, 95% confidence interval (CI) 0.28 to 102.1; 27 participants; very low-quality evidence). However, these findings are uncertain due to indirectness and a very wide confidence interval. Two studies, containing 247 participants and both only reported as abstracts, allowed meta-analysis for PASI 50, which showed superiority of FAE over placebo (RR 4.55, 95% CI 2.80 to 7.40; low-quality evidence), with a combined PASI 50 of 64% in those given FAE compared with a PASI 50 of 14% for those on placebo, representing a number needed to treat to benefit of 2. The same studies reported more participants achieving PASI 75 with FAE, but we did not pool the data because of significant heterogeneity; none of the studies measured PASI 90. One study reported significant improvement in participants' quality of life (QoL) with FAE, measured with Skindex-29. However, we could not compute the mean difference because of insufficient reporting in the abstract. More participants experienced adverse effects, mainly gastrointestinal disturbance and flushing, on FAE (RR 4.72, 95% CI 2.45 to 9.08; 1 study, 99 participants; moderate-quality evidence), affecting 76% of participants given FAE and 16% of the placebo group (representing a number needed to treat to harm of 2). The other studies reported similar findings or did not report adverse effects fully.One study of 54 participants compared methotrexate (MTX) with FAE. PASI score at follow-up showed superiority of MTX (mean Difference (MD) 3.80, 95% CI 0.68 to 6.92; 51 participants; very low-quality evidence), but the difference was not significant after adjustment for baseline disease severity. The difference between groups for the proportion of participants who discontinued treatment due to adverse effects was uncertain because of imprecision (RR 0.19, 95% CI 0.02 to 1.53; 1 study, 51 participants; very low-quality evidence). Overall, the number of participants experiencing common nuisance adverse effects was not significantly different between the 2 groups, with 89% of the FAE group affected compared with 100% of the MTX group (RR 0.89, 95% CI 0.77 to 1.03; 54 participants; very low-quality evidence). Flushing was more frequent in those on FAE, with 13 out of 27 participants affected compared with 2 out of 27 given MTX. There was no significant difference in the number of participants who attained PASI 50, 75, and 90 in the 2 groups (very low-quality evidence) whereas this study did not measure the effect of treatments on QoL. The included studies reported no serious adverse effects of FAE and were too small and of limited duration to provide evidence about rare or delayed effects.

Authors' conclusions: Evidence suggests that FAE are superior to placebo and possibly similar in efficacy to MTX for psoriasis; however, the evidence provided in this review was limited, and it must be noted that four out of six included studies were abstracts or brief reports, restricting study reporting. FAE are associated with nuisance adverse effects, including flushing and gastrointestinal disturbance, but short-term studies reported no serious adverse effects.

PubMed Disclaimer

Conflict of interest statement

Ausama Atwan: nothing to declare. John R Ingram: nothing to declare. Rachel Abbott: nothing to declare. Mark J Kelson: nothing to declare. Timothy Pickles: nothing to declare. Andrea Bauer: nothing to declare. Vincent Piguet has received departmental support from AbbVie, Johnson & Johnson, Pfizer, GSK, Novartis, and CEO. He has received honoraria from Johnson & Johnson, Novartis, and AbbVie. None of these companies produce any of the interventions listed in this review. His department benefits financially from the Dermatology Life Quality Index. Ben Carter, who was the statistics referee for this review, is based at the same institution as the lead author and contributed to their MSc basic statistics teaching programme.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.
3
3
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1 FAE vs placebo, Outcome 1 AEs leading to treatment discontinuation.
1.2
1.2. Analysis
Comparison 1 FAE vs placebo, Outcome 2 PASI 50.
1.3
1.3. Analysis
Comparison 1 FAE vs placebo, Outcome 3 Common nuisance AEs (not leading to treatment discontinuation).
2.1
2.1. Analysis
Comparison 2 FAE vs MTX, Outcome 1 PASI score.
2.2
2.2. Analysis
Comparison 2 FAE vs MTX, Outcome 2 AEs leading to treatment discontinuation.
2.3
2.3. Analysis
Comparison 2 FAE vs MTX, Outcome 3 PASI 50.
2.4
2.4. Analysis
Comparison 2 FAE vs MTX, Outcome 4 PASI 75.
2.5
2.5. Analysis
Comparison 2 FAE vs MTX, Outcome 5 PASI 90.
2.6
2.6. Analysis
Comparison 2 FAE vs MTX, Outcome 6 Common nuisance AEs (not leading to treatment discontinuation).
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD010497

References

References to studies included in this review

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EudraCT Number 2012‐000035‐82 {unpublished data only}
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References to other published versions of this review

Atwan 2013
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