Table 3.

Nonmedical switching to CT-P13 compared to continuing on infliximab originator for stable IBD on originator infliximab: summary of findings table

Certainty assessment							No. of patients		Effect		Certainty	Importance
No. of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	CT-P13	infliximab originator	Relative (95% CI)	Absolute (95% CI)
Not in remission (follow up: mean 12 months; assessed with: Defined clinically)
2	Randomised trials	Serious a	Not serious	Not serious	Serious b	None	73/234 (31.2%)	59/214 (27.6%)	RR 0.89 (0.58–1.38)	30 fewer per 1,000 (from 116 fewer to 105 more)	⨁⨁◯◯ LOW	CRITICAL
loss of response or worsening of disease (follow up: mean 12 months; assessed with: clinical opinion)
2	randomised trials	serious a	not serious	serious c	serious b	none	57/234 (24.4%)	33/214 (15.4%)	RR 0.64 (0.44–0.94)	56 fewer per 1,000 (from 86 fewer to 9 fewer)	⨁◯◯◯ VERY LOW	CRITICAL
Adverse events (follow up: mean 12 months; assessed with: Assessed clinically (either all adverse events or serious adverse events))
2	Observational studies	Serious d	Not serious	Serious c	Serious b	None	33/142 (23.2%)	29/151 (19.2%)	RR 0.94 (0.74–1.21)	12 fewer per 1,000 (from 50 fewer to 40 more)	⨁◯◯◯ VERY LOW	CRITICAL

CI, confidence interval; RR, risk ratio.

^aOne of the two trials had an unclear risk of bias.

^b95% CI wide with number of events < 250.

^cEach trial defined loss of response differently.

^dTwo observational studies where decision to switch to CT-P13 is up to patient and clinician.