Brodalumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo
Näytönastekatsaukset
15.6.2020
Level of evidence: B
Brodalumab at dose of 210 mg, when compared to placebo, increases the proportion of patients with moderate to severe plaque psoriasis to achieve a clinically meaningful improvement at 12 weeks of treatment. The safety profile of brodalumad may be equal to placebo after 12 weeks treatment.
FDA have, however, approved brodalumab for psoriasis with notice about risk of suicide. During clinical trials, six patients treated with the drug committed suicide, a rate that was 3-4 times higher than that seen in other trials of biologics for psoriasis. The efficacy and safety evidence is mainly based on 3 phase III trials with placebo controlled induction phase and open-label extension.
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis; PASI=Psoriasis area severity index, PGA=Physician's Global Assessment; PSI=Psoriasis Symptom Inventory | |||||
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Brodalumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo»1 |
|---|---|---|---|---|---|
| «Attia A, Abushouk AI, Ahmed H ym. Safety and Efficacy of Brodalumab for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. Clin Drug Investig 2017;37:439-451 »1 | SR and MA | Patients with moderate-to-severe psoriasis, 5 RCTs. N=2455 | Brodalumab 210 mgPlacebo | PASI75, PASI90, PASI100Secondary: sPGA and PSI, adverse events | Bias of included studies:Allocation concealment, blinding |
| «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 »2 | Network MA | Patients with moderate-to-severe psoriasis, 6 RCTs. N=1010 | Brodalumab 70-280 mgPlacebo | PASI90, PGA0-1, Adverse events | Bias of included studies:Allocation concealment, blinding |
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 | |||||
| «Attia A, Abushouk AI, Ahmed H ym. Safety and Efficacy of Brodalumab for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. Clin Drug Investig 2017;37:439-451 »1 | 5 studies (1535/920) | 12 weeks | 771 (70.3) | 18 (2.0) | 34.0 (21.7-53.1) |
| «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 »2 | 3 studies(714/296) | 12 weeks | NA | NA | RR 25.5 (18.7-34.57) |
| Level of evidence: moderate 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 »2 | 3 studies(714/296) | 12 weeks | NA | NA | 15.3 (10.8-21.6) |
| Level of evidence: 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) |
|---|---|---|---|---|---|
| «Attia A, Abushouk AI, Ahmed H ym. Safety and Efficacy of Brodalumab for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. Clin Drug Investig 2017;37:439-451 »1 | 5 studies (3179/917) | 12 weeks | NA | NA | Overall AEs 1.13 (1.06-1.22)Serous AEs 1.06 (0.62-1.83) |
| «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 »2 | 3 studies(714/296) | 12 weeks | NA | NA | Serious AEs 1.04 (0.6-1.7) |
| Level of evidence: moderate The quality of evidence is downgraded due to study limitations. | |||||
References
- Attia A, Abushouk AI, Ahmed H ym. Safety and Efficacy of Brodalumab for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. Clin Drug Investig 2017;37:439-451 «PMID: 28197901»PubMed
- 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