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Table 2 Renal outcomes

From: Safety and efficacy of biological agents in the treatment of Systemic Lupus Erythematosus (SLE)

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)

  1. GRADE Working Group grades of evidence
  2. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
  3. 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
  4. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
  5. 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
  6. CI Confidence interval, RR Risk ratio
  7. 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)
  8. Explanations
  9. arandomisation method not specified
  10. ballocation concealment method not specified
  11. cWide CI
  12. dNot meeting OIS criteria
  13. enot blinded, open label
  14. fattrition bias, premature termination of study with incomplete reporting of primary endpoints
  15. gnot blinded, open label (Atisha Fregoso 2021)
  16. hsignificant P value and 0% heterogeneity but CI from Atisha Fregoso wide and overlaps significant/non significance