Dimethyl fumarate in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo
Näytönastekatsaukset
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.
| 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 pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 »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
| 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 pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 »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. | |||||
| 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 pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 »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. | |||||
| 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 pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 2017;12:CD011535 »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
- 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