Conventional therapy for moderate to severe inflammatory bowel disease: A systematic literature review

Table 5 Meta-analyses included for induction of clinical response in ulcerative colitis

Study	Intervention	Comparator	Follow-up	n	Clinical response, RR (95%CI) or OR (95%CI)	Quality of evidence
Komaki et al[28]	Tacrolimus	Placebo	2 wks (RCT)	103	RR 4.61 (2.09-10.17)1	High
Baumgart et al[25]	Tacrolimus	Placebo	2 wk	63	OR 8.66 (1.79-42.00)2	High
Lasa et al[26]	Tacrolimus	Placebo	12 wk	127	RR 0.58 (0.45-0.73)3	High
Narula et al[29]	IFX	Cyclosporine	3 mo (RCT)	412	43.8% (IFX); 41.7% (C) OR 1.08 (0.73-1.60)4	Low
	IFX	Cyclosporine	3 mo (non RCT)	801	74.8% (IFX); 55.4% (C) OR 2.96 (2.12-4.14)5	Very low

¹Clinical response defined as reduction in Disease Activity Index (DAI) ≥ 4 with improvement of all categories;

²Clinical response (partial or complete response) based on the DAI score. A complete response was defined as complete resolution of all symptoms with a zero scored for all assessments of the DAI. A partial response was defined as a reduction of more than four points on the DAI with improvement in all categories, but not a complete response;

³Clinical response defined according to each individual study, and not shown by the meta-analysis;

⁴Definitions from individual studies: Failure to respond to treatment was combined end point of the absence of clinical response at day 7 (based on Lichtiger score < 10 and at least 3 points less than baseline), relapse between day 7 and 98, absence of steroid-free remission at day 98, severe adverse event leading to treatment interruption, colectomy; response based on Powell-Tuck index ≤ 3; doubling of the Crohn's and ulcerative colitis questionnaire-32 score at 3 mo;

⁵Definitions from individual studies: Failure to respond including ongoing or worsening symptoms of bloody diarrhea, abdominal pain and persistently elevated inflammatory markers, or the development of a complication (perforation, severe hemorrhage, toxic megacolon); good response to treatment was decrease in stool frequency (< 6/d), little or no blood in feces, absence of complications; clinical remission, as per clinical symptom questionnaire used locally at this institution; being discharged from hospital without surgery or additional rescue therapy; physician global assessment of patient response—those deemed medical failure were treated with colectomy; steroid-free clinical remission (mild or inactive based on the Montreal severity score) plus no need for second rescue therapy or colectomy; modified Truelove and Witts Severity Index score decrease ≥ 4points; remission based on Colitis Activity Index ≤ 4 within 4 wk; in 5 studies, treatment response was not reported. C: Cyclosporine; CI: Confidence interval; IFX: Infliximab; n: Number of patients; OR: Odds ratio; RCT: Randomized clinical trial; RR: Risk ratio.