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.
| 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
| 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. |
|||||
| 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). |
|||||