Summary of findings 11. Guselkumab compared to placebo for chronic palmoplantar pustulosis.
| Guselkumab compared to placebo for chronic palmoplantar pustulosis | ||||||
| Patient or population: chronic palmoplantar pustulosis Setting: outpatients/hospital Intervention: guselkumab Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with guselkumab | |||||
| Proportion of participants cleared or almost cleared assessed with: PGA Follow‐up: 16 weeks | Study population | RR 1.17 (0.15 to 9.30) | 154 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,b | ‐ | |
| 65 per 1000 | 76 per 1000 (10 to 604) | |||||
| Proportion of participants with adverse effects serious or severe enough to have caused withdrawal Follow‐up: over 24 weeks | Study population | RR 2.88 (0.32 to 25.80) | 49 (1 RCT) | ⊕⊕⊝⊝ Lowc | ‐ | |
| 42 per 1000 | 120 per 1000 (13 to 1000) | |||||
| Proportion of participants with at least 50% improvement in their quality of life ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Proportion of participants achieving a 50% reduction in disease severity assessed with PPPASI Follow‐up: 16 weeks | Study population | RR 2.88 (1.24 to 6.69) | 49 (1 RCT) | ⊕⊕⊕⊝ Moderated | ‐ | |
| 208 per 1000 | 600 per 1000 (258 to 1000) | |||||
| Proportion of participants without relapse in the long term ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Proportion of participants with adverse effects ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Ease of compliance to an intervention or a treatment ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PGA: physicians' global assessment; PPPASI: Palmo‐Plantar Pustular Area and Severity Index; RCT: randomised controlled trial; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence. High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded by two levels to low‐quality evidence because of imprecision (only two trials, 154 participants) and large CI.
bDowngraded by one level for inconsistency (different direction of treatment effect in the two studies; I² = 59%).
cDowngraded by two levels to low‐quality evidence because of imprecision (only one trial, 49 participants).
dDowngraded by one level to low‐quality evidence because of imprecision (only one trial, 49 participants).