Table 4.
Adverse events
| Biologics compared to placebo for the treatment of Systemic Lupus Erythematosus measured by adverse events | |||||
|---|---|---|---|---|---|
| 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 Adverse events | ||||
| AEs—Anifrolumab | 1124 (3 RCTs) |
⨁⨁⨁◯ Moderatea |
RR 1.09 (1.04 to 1.15) | 805 per 1,000 | 72 more per 1,000 (32 more to 121 more) |
| AEs—CC-220 | 330 (2 RCTs) |
⨁⨁◯◯ Lowa,b |
RR 1.23 (0.84 to 1.80) | 363 per 1,000 | 83 more per 1,000 (58 fewer to 290 more) |
| Serious AEs—Abatacept | 1017 (4 RCTs) |
⨁⨁⨁◯ Moderatea |
RR 1.17 (0.87 to 1.58) | 219 per 1,000 | 37 more per 1,000 (28 fewer to 127 more) |
| Serious AEs—Anifrolumab | 1124 (3 RCTs) |
⨁⨁⨁◯ Moderatea |
RR 0.68 (0.49 to 0.95) | 188 per 1,000 | 60 fewer per 1,000 (96 fewer to 9 fewer) |
| Serious AEs—Belimumab | 4122 (6 RCTs) |
⨁⨁⨁◯ Moderatee |
RR 0.88 (0.72 to 1.08) | 196 per 1,000 | 24 fewer per 1,000 (55 fewer to 16 more) |
| Serious AEs—Blisibimod | 987 (2 RCTs) |
⨁⨁⨁◯ Moderatea |
RR 0.73 (0.53 to 0.99) | 165 per 1,000 | 44 fewer per 1,000 (77 fewer to 2 fewer) |
| Treatment related AEs—Belimumab | 1989 (3 RCTs) |
⨁⨁⨁◯ Moderatea |
RR 1.12 (0.99 to 1.26) | 334 per 1,000 | 40 more per 1,000 (3 fewer to 87 more) |
| Treatment related AEs—Blisibimod | 987 (2 RCTs) |
⨁⨁⨁⨁ High |
RR 1.26 (0.89 to 1.78) | 314 per 1,000 | 82 more per 1,000 (35 fewer to 245 more) |
| Treatment related AEs—CC-220 | 330 (2 RCTs) | ⨁⨁⨁◯ Moderatea | RR 1.39 (1.02 to 1.90) | 319 per 1,000 | 124 more per 1,000 (6 more to 287 more) |
| Infusion related AE—Belimumab | 1716 (3 RCTs) |
⨁⨁◯◯ Lowa,c,d |
RR 1.15 (0.81 to 1.64) | 101 per 1,000 | 15 more per 1,000 (19 fewer to 65 more) |
| Infusion related AE—Blisibimod | 441 (1 RCT) |
⨁⨁⨁◯ Moderatea |
RR 1.85 (1.21 to 2.81) | 133 per 1,000 | 113 more per 1,000 (28 more to 240 more) |
| Infusion related AE—Tabalumab | 2283 (2 RCTs) |
⨁⨁⨁◯ Moderatea |
RR 1.63 (1.05 to 2.53) | 33 per 1,000 | 21 more per 1,000 (2 more to 50 more) |
| Infection related grade 3 or higher AE—Obinutuzumab | 125 (1 RCT) |
⨁⨁⨁◯ Moderatea |
RR 0.29 (0.10 to 0.85) | 213 per 1,000 | 151 fewer per 1,000 (192 fewer to 32 fewer) |
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
adidn't meet OIS criteria
bhigh heterogeneity
callocation concealment method not stated
dwide CI
ehigh heterogeneity and 2 studies suggesting reduction in events, 4 don't