Table 2.
Biologics compared to placebo for the treatment of Systemic Lupus Erythematosus measured by renal outcomes | |||||
---|---|---|---|---|---|
Patient or population: Systemic Lupus Erythematosus Setting: Inpatients then outpatients Intervention: Biologics Comparison: Standard of care, placebo | |||||
Outcomes | № of participants (studies) Follow-up |
Certainty of the evidence (GRADE) |
Relative effect (95% CI) |
Anticipated absolute effects | |
Risk with placebo | Risk difference with Renal outcomes | ||||
Partial and/or complete renal response by 1 year—Abatacept | 377 (2 RCTs) |
⨁⨁◯◯ Lowa,b,c,d |
RR 0.98 (0.78 to 1.23) | 436 per 1,000 | 9 fewer per 1,000 (96 fewer to 100 more) |
Partial and/or complete renal response by 1 year—Belimumab | 43 (1 RCT) |
⨁◯◯◯ Very lowc,d,e |
RR 1.28 (0.67 to 2.45) | 409 per 1,000 | 115 more per 1,000 (135 fewer to 593 more) |
Partial and/or complete renal response by 1 year—Obinutuzumab | 125 (1 RCT) |
⨁⨁⨁◯ Moderated |
RR 1.60 (1.27 to 2.02) | 565 per 1,000 | 339 more per 1,000 (152 more to 576 more) |
Partial and/or complete renal response by 1 year—Ocrelizumab | 223 (1 RCT) |
⨁⨁◯◯ Lowa,b,d,f |
RR 1.22 (0.97 to 1.55) | 547 per 1,000 | 120 more per 1,000 (16 fewer to 301 more) |
Partial and/or complete renal response by 1 year—Rituximab | 144 (1 RCT) |
⨁⨁⨁◯ Moderatea,b,d |
RR 1.24 (0.90 to 1.71) | 458 per 1,000 | 110 more per 1,000 (46 fewer to 325 more) |
Partial and/or complete renal response by 2 years—Belimumab | 488 (2 RCTs) |
⨁◯◯◯ Very lowd,g,h |
RR 1.28 (1.03 to 1.58) | 361 per 1,000 | 101 more per 1,000 (11 more to 209 more) |
Partial and/or complete renal response by 2 years—Obinituzumab | 125 (1 RCT) |
⨁⨁⨁◯ Moderatec,d |
RR 1.83 (1.06 to 3.16) | 226 per 1,000 | 187 more per 1,000 (14 more to 488 more) |
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
CI Confidence interval, RR Risk ratio
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)
Explanations
arandomisation method not specified
ballocation concealment method not specified
cWide CI
dNot meeting OIS criteria
enot blinded, open label
fattrition bias, premature termination of study with incomplete reporting of primary endpoints
gnot blinded, open label (Atisha Fregoso 2021)
hsignificant P value and 0% heterogeneity but CI from Atisha Fregoso wide and overlaps significant/non significance