Severe sepsis caused by serious gastrointestinal infection in sJIA patients treated with IL-6 receptor antagonist: a case report

Table 2 Serious adverse events recorded by previous studies after TCZ infusion in sJIA patients

Authors and references	Years	Study design	Duration	No. of patients	SAEs no. of events	Serious infections no. of events	Serious GI infections no. of events	sepsis no. of events
Yokota et al. [6]	2005	OL, Phase II	14 weeks	11	0	0	0	0
Woo et al. [7]	2005	OL, Phase II	4–8 weeks	15	5	2	0	0
Yokota et al. [8]	2008	R, DB, PC, Phase III	6 weeks OL lead-in phase 12 weeks DB phase 48 weeks OL- extension phase	56	15	Unknown^b	Unknown^b	0
De Benedetti et al. [2]	2012	R, DB, PC, Phase III	12 weeks DB phase 96 weeks OL extension phase	112	39	18	5	1
Yokota et al. [9]	2014	Long-term extension study of their 2 previous studies	168 weeks	67	78	30	13	0
Yokota et al. [10]	2016	Post marketing surveillance	52 weeks	417	222	74	9	3
Horneff et al. [11]	2017	Retrospective study	2000–2015	71^a	14	2	0	0
Kimura et al. [12]	2017	Pilot study	9 months	10^a	1	0	0	0
Bielak et al. [13]	2018	Retrospective study	7/2009–4/2014	46	2	0	0	0

OL open-label, R randomized, DB double blind, PC placebo-controlled, SAEs serious adverse events, GI gastrointestinal
^anumber of patients involved in the sJIA group of the study
^bthe article did not clearly list the number of serious infection or serious GI infection, but only indicated that 2 cases of serious GI infections resolved with antibiotic treatment

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