Takaisin

Dimethyl fumarate in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo

Näytönastekatsaukset
Raija Sipilä
15.6.2020

Level of evidence: D

Dimethyl fumarate may increase the proportion of patients with moderate to severe psoriasis to achieve a clinically meaningful improvement at 16 weeks of tretament but the evidence is scarce. The number of adverse events may be higher than for placebo but the number of severe adverse events may be equal to placebo at 16 weeks of tretament.

The evidence is based on one RCT and a high risk of bias. There is no RCTs on long-term effectiveness.

Table 1. Description of the included studies
Reference Study type Population Intervention and comparison Outcomes Risk of bias «Dimethyl fumarate in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo»1
MA=meta-analysis
«Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic...»1 Network MA RCTs of systemic and biological treatments in adults (>18 years) with moderate to severe plaque psoriasis.
N=566/138.
Dimethylfumarate maximum daily dose of 720 mg.
Placebo
Primary: PASI-90, serious adverse effects. Secondary: PASI-75, PGA0-1, DLQI, adverse events. Incomplete dataSelective outcome reporting

Results

Table 2. PGA/IGA 0-1
Reference Number of studies and number of patients (I/C) Follow-up time Absolute number of events (%) I Absolute number of events (%) C Relative effect (95% CI)
I= intervention; C=comparison; CI=confidence interval
«Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic...»1 1 study (566/138) 16 weeks 190 (33.6) 17 (12.3) RR 2.73 (1.72 - 4.32)
Level of evidence: very low
The quality of evidence is downgraded due to study limitations and imprecision.
Table 3. PASI-90
Reference Number of studies and number of patients (I/C) Follow-up time Absolute number of events (%) I Absolute number of events (%) C Relative effect (95% CI)
I= intervention; C=comparison; CI=confidence interval
«Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic...»1 1 study (566/138) 16 weeks 110 (19.4) 6 (4.3) RR 4.47 (2.01 - 9.95)
Level of evidence: very low
The quality of evidence is downgraded due to study limitations, indirectness (secondary outcome measure), and imprecision.
Table 4. Adverese events
Reference Number of studies and number of patients (I/C) Follow-up time Absolute number of events (%) I Absolute number of events (%) C Relative effect (95% CI)
I= intervention; C=comparison; CI=confidence interval
«Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic...»1 1 study (566/138) 16 weeks Serious adverse events
17 (3.0)
Adverse events
472 (83.4)
5 (3.6)
82 (59.4)
RR 0.83 (0.31 - 2.21)
1.4 (1.22 - 1.62)
Level of evidence: very low
The quality of evidence is downgraded due to study limitations, indirectness (secondary outcome) and imprecision.

References

  1. Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 «PMID: 29271481»PubMed