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Table 3 Glucocorticoid dose reduction

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 glucocorticoid dose reduction

Patient or population: Systemic Lupus Erythematosus

1. 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 Glucocorticoid dose

number of patients with prednisone equivalent ≤ 7.5 mg/day, with reduction ≥ 25% from baseline—Belimumab

2317 (5 RCTs)

Moderatec,d

RR 1.45 (1.16 to 1.80)

121 per 1,000

54 more per 1,000 (19 more to 97 more)

number of patients with prednisone equivalent ≤ 7.5 mg/day, with reduction ≥ 25% from baseline—Tabalumab

999 (2 RCTs)

Very lowa,b,d,e

RR 1.21 (0.78 to 1.89)

144 per 1,000

30 more per 1,000 (32 fewer to 128 more)

number of patients with prednisone equivalent ≤ 10 mg/day—Anifrolumab

605 (3 RCTs)

Lowa,d,e,f

RR 1.46 (1.16 to 1.84)

301 per 1,000

139 more per 1,000 (48 more to 253 more)

number of patients with prednisone equivalent ≤ 10 mg/day—Rontalizumab

235 (1 RCT)

Moderatea,c,d

RR 1.21 (1.00 to 1.46)

633 per 1,000

133 more per 1,000 (0 fewer to 291 more)

number of patients with prednisone equivalent ≤ 10 mg/day—Blisibimod

442 (1 RCT)

Moderatec,d

RR 1.64 (1.07 to 2.52)

132 per 1,000

84 more per 1,000 (9 more to 201 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. aallocation concealment method not stated
  10. bWide CI
  11. cSingle study
  12. dNot meeting OIS criteria
  13. erandomisation method not stated
  14. fselective reporting bias, multiple analyses of data