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 Effic...»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...»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 Effic...»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...»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...»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 Effic...»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...»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. |
|||||