Takaisin

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

Näytönastekatsaukset
Raija Sipilä
15.6.2020

Level of evidence: B

Guselkumab treatment when compared to placebo, seems to increase the proportion of patients with moderate to severe plaque psoriasis to achieve a clinically meaningful improvement at 12 weeks of treatment.

It might be that there are not more adverse events in guselkumab treatment compared to placebo after 12 weeks of treatment but the level of evidence is low. The evidence is mainly based on 2 phase III RCT’s.

Table 1. Description of the included studies
Reference Study type Population Intervention and comparison Outcomes Risk of bias «Guselkumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo»1
RCT=randomized controlled trial; MA=meta-analysis; PGA/IGA=physician's Global Assessment / investicator Golbal Assessment; PASI=psoriasis area severity index
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 MA RCTs, adults (> 18 years) with moderate to severe plaque psoriasis treated with biologic agents.
N=1497
Guselkumab 100 mgvs.
Placebo
Primary: PASI-75, PGA 0-1 at 12-16 weeks
Secondary: PASI-90, safety
low
«Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic...»2 MA, Network analysis RCTs of systemic and biological treatments in adults (>18 years) with moderate to severe plaque psoriasis, at any stage of treatment, incomparison to placebo or another active agent. Primary: PASI-90, serious adverse effects.
Secondary: PASI-75, PGA0-1, DLQI, adverse events.
In one study high risk of bias: blinding

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
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs,867 / 464 16 weeks, outcomes reported at 12 weeks 733 (84.5) 36 (7.8) Risk ratio10.8 (7.9-14.9)
Level of evidence: moderate
The quality of evidence is downgraded due to study limitations.
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)
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs,867 / 464 16 weeks, outcomes reported at 12 weeks 516 (60,5) 17 (3,7) Risk ratio27.2 (15.5-47.6)
«Sbidian E, Chaimani A, Garcia-Doval I ym. Systemic...»2 3 RCTs, N=1502 12-16 weeks NA NA RR 21.03 (14.56 to 30.38)
Level of evidence: moderate
The quality of evidence is downgraded due to study limitations and indirectness (secondary outcome).

References

  1. Bilal J, Berlinberg A, Bhattacharjee S ym. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab and tildrakizumab for the treatment of moderate to severe plaque psoriasis. J Dermatolog Treat 2018;29:569-578 «PMID: 29532693»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