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

BMC Rheumatology

Table 1 Composite outcomes

Biologics compared to placebo for the treatment of Systemic Lupus Erythematosus measured by composite responder rates
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
Outcomes	№ of participants (studies) Follow-up	Certainty of the evidence (GRADE)	Relative effect (95% CI)	Risk with Standard of care	Risk difference with Biologics
(SRI) 4 at 52 weeks—Anifrolumab	762 (2 RCTs)	⨁⨁⨁◯ Moderate^a^,^b^,^c^,^e	RR 1.40 (0.94 to 2.08)	350 per 1,000	140 more per 1,000 (21 fewer to 378 more)
(SRI) 4 at 52 weeks—Sifalimumab	431 (1 RCT)	⨁⨁⨁◯ Moderate^f	RR 1.28 (1.02 to 1.61)	454 per 1,000	127 more per 1,000 (9 more to 277 more)
(SRI) 4 at 52 weeks—Belimumab	3180 (4 RCTs)	⨁⨁⨁⨁ High^h	RR 1.27 (1.18 to 1.38)	415 per 1,000	112 more per 1,000 (75 more to 158 more)
(SRI) 4 at 52 weeks—Telitacicept	249 (1 RCT)	⨁⨁◯◯ Low^d^,^e^,^f^,^g	RR 2.12 (1.48 to 3.03)	339 per 1,000	379 more per 1,000 (163 more to 688 more)
BICLA response at 52 weeks—Anifrolumab	1121 (3 RCTs)	⨁⨁⨁◯ Moderate^a^,^b^,^c^,ⁱ	RR 1.56 (1.33 to 1.84)	293 per 1,000	164 more per 1,000 (97 more to 246 more)
BICLA response at 52 weeks—Sifalimumab	431 (1 RCT)	⨁⨁⨁◯ Moderate^e^,^f	RR 1.29 (0.98 to 1.71)	361 per 1,000	105 more per 1,000 (7 fewer to 256 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
^brandomisation method not stated
^cselective reporting, multiple analyses of data
^dWide CI
^esingle study
^fDid not meet OIS criterion
^gstudy protocols unavailable
^hI2 = 0, significant P and consistently overlapping CI
ⁱselective reporting, change in primary outcome resulting in significant outcome (Morand 2020)

ISSN: 2520-1026