Summary of findings 3. Calcineurin inhibitors ± steroids versus placebo/no treatment/supportive treatment/steroids.
Calcineurin inhibitors ± steroids versus to placebo/no treatment/supportive treatment/steroids for primary membranous nephropathy in adults with nephrotic syndrome | |||||
Patient or population: primary membranous nephropathy in adults with nephrotic syndrome
Setting: primary care Intervention: calcineurin inhibitors ± steroids Comparison: control (placebo/no treatment/supportive treatment/steroids) | |||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | |
Risk with control | Risk with CNI | ||||
Death at final follow‐up (range: 9 to 60 months) |
15 per 1000 | 25 per 1000 (7 to 92) | RR 1.69 (0.46 to 6.14) | 296 (7) | ⊕⊖⊖⊖ Verylow1,2,3 |
End‐stage kidney disease at final follow‐up (range: 9 to 60 months) |
82 per 1000 | 97 per 1000 (44 to 263) | RR 1.18 (0.54 to 2.60) | 296 (7) | ⊕⊖⊖⊖ Verylow1,3,4 |
Total remission at final follow‐up (range: 9 to 60 months) |
416 per 1000 | 503 per 1000 (258 to 989) | RR 1.21 (0.62 to 2.38) | 206 (5) | ⊕⊕⊖⊖ Low1,5 |
Complete remission at final follow‐up (range: 9 to 60 months) |
146 per 1000 | 156 per 1000 (74 to 327) | RR 1.07 (0.51 to 2.24) | 206 (5) | ⊕⊕⊖⊖ Low1,5 |
Recurrence of disease (relapse) at final follow‐up (range: 18 to 60 months) |
259 per 1000 | 404 per 1000 (205 to 801) |
RR 1.56 (0.79 to 3.09) |
92 (2) | ⊕⊖⊖⊖ VeryLow1,4 |
100% increase in SCr at final follow‐up (range: 18 to 60 months) |
178 per 1000 | 149 per 1000 (66 to 331) |
RR 0.84 (0.37 to 1.86) |
117 (2) | ⊕⊖⊖⊖ VeryLow1,4 |
Adverse events ‐ temporary or permanent discontinuation/hospitalisation at final follow‐up (range: 9 to 60 months) |
0/63 | 2/98** | RR 5.45 (0.29 to 101.55) |
156 (5) | ⊕⊖⊖⊖ VeryLow1,4 |
Adverse events ‐ infection at 36 months | 54 per 1000 | 222 per 1000 (51 to 976) |
RR 4.11 (0.94 to 18.06) |
73 (1) | ⊕⊖⊖⊖ VeryLow1,4 |
Adverse events ‐ malignancy at 36 months | 0/38 | 2/69** | RR 2.79 (0.14 to 56.57) |
107 (1) | ⊕⊖⊖⊖ VeryLow1,2 |
*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). ** Event rate derived from the raw data. A 'per thousand' rate is non‐informative in view of the scarcity of evidence and zero events in the control group CI: Confidence interval; CNI: calcineurin inhibitors; RR: Risk 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 |
1 Study limitations: studies generally unclear or high risk of bias for many domains
2 Very serious imprecision (2 grades): few events, and estimate of effect includes negligible difference and considerable benefit and harm
3 Serious Indirectness: insufficient follow‐up for the outcome to occur ≤ 10 years
4 Very serious imprecision: few events and estimate of effect includes negligible difference and considerable benefit and harm
5 Serious imprecision: estimate of effect includes negligible difference and considerable benefit and harm
6 Serious imprecision: only one study