Takaisin

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

Näytönastekatsaukset
Raija Sipilä
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.

Table 1. Description of the included studies
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

Table 2. Patients reaching PASI90
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.
Table 3. sPGA score
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.
Table 4. Adverse 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)
«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.

References

  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 «PMID: 28197901»PubMed
  2. 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