Table 4 Adverse events
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 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) |