Summary of findings 3. Infliximab compared to rituximab for adults with refractory GPA ANCA‐associated vasculitis.
| Infliximab compared to rituximab for adults with refractory GPA ANCA‐associated vasculitis | ||||||
| Patient or population: adults (age 18 years and older) with refractory GPA ANCA‐associated vasculitis Setting: hospitals Intervention: infliximab (3 mg/kg on days 1 and 14, before the response assessment on day 42; further treatment depending on the response) Comparison: rituximab (0.375g/m2 on days 1, 8, 15 and 22 before the response assessment at month 2; further treatment depending on the response) | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| With rituximab | With infliximab | Difference | ||||
| Mortality follow‐up: 12 months Number of participants: 17 (1 RCT) | Peto OR 0.88 (0.05 to 15.51) | 12.5% | 11.0% (0.6 to 193.9) | 1.5% fewer (11.9 fewer to 181.4 more) | ⊕⊝⊝⊝ VERY LOW 1 2 | One death was reported in each group. The evidence is very uncertain about the effect of infliximab when compared to rituximab on mortality. |
| Remission assessed with: BVAS=0 follow‐up: 12 months Number of participants: 17 (1 RCT) | RR 0.44 (0.11 to 1.81) | 50.0% | 22.0% (5.5 to 90.5) | 28.0% fewer (44.5 fewer to 40.5 more) | ⊕⊝⊝⊝ VERY LOW 1 2 | The evidence is very uncertain about the effect of infliximab when compared with rituximab on remission at month 12. |
| Durable remission during additional follow‐up beyond 12 months follow‐up: mean 30.6 months Number of participants: 17 (1 RCT) | RR 0.22 (0.03 to 1.60) | 50.0% | 11.0% (1.5 to 80) | 39.0% fewer (48.5 fewer to 30 more) | ⊕⊝⊝⊝ VERY LOW 1 2 | The evidence is very uncertain about the effect of infliximab when compared with rituximab on durable remission during additional follow‐up beyond 12 months. |
| Disease flare/relapse | This outcome was not reported in included trial. | |||||
| Any adverse event | The total number of any AEs was not reported in the study. | |||||
| Any severe AEs assessed with: the World Health Organization classification (2003) follow‐up: 12 months Number of participants: 17 (1 RCT) | RR 1.78 (0.20 to 16.10) | 12.5% | 22.3% (2.5 to 100) | 9.8% more (10 fewer to 188.8 more) | ⊕⊝⊝⊝ VERY LOW 1 2 | The evidence is very uncertain about the effect of infliximab when compared with rituximab on any severe AEs. |
| Any withdrawals due to AEs assessed with: the World Health Organization classification (2003) follow‐up: 12 months Number of participants: 17 (1 RCT) | RR 2.70 (0.13 to 58.24) | 0.0% | 0.0% (0 to 0) | 0.0% fewer (0 fewer to 0 fewer) | ⊕⊝⊝⊝ VERY LOW 1 2 | The evidence is very uncertain about the effect of infliximab when compared with rituximab on any withdrawals due to AEs. |
| *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; GPA: granulomatosis with polyangiitis; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1Downgraded by one level due to risk of bias – unclear randomisation and concealment, no blinding and unclear selective outcome reporting
2Downgraded by two levels for imprecision: optimal information size (OIS) not met and CI indicates both harm and benefit; and/or low number of events
AE ‐ adverse event
ANCA – antineutrophil cytoplasmic antibody
BVAS – Birmingham Vasculitis Activity Score
GPA – granulomatosis with polyangiitis
OR ‐ odds ratio
RCT ‐ randomized controlled trial
RR ‐ relative risk