Table 3.
Glucocorticoid dose reduction
| 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) |
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
aallocation concealment method not stated
bWide CI
cSingle study
dNot meeting OIS criteria
erandomisation method not stated
fselective reporting bias, multiple analyses of data