Table 1.

Reported Rates of PNR to Anti-TNF Agents in Patients With Inflammatory Bowel Disease

Anti-TNF Agent	Disease	Study Design	PNR, %	Definition of Response
Infliximab	CD	RCT7	42	≥70-point decrease in CDAI score from baseline and ≥25% reduction in the total score assessed at week 2 after a single infusion
	UC	RCT8	31	Decrease in Mayo score by ≥3 points and ≥30% from baseline, with an accompanying decrease in the rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1 assessed at week 8 after 3 doses
	CD	Cohort9	11	Symptom-free (complete response) or distinct clinical improvement with obvious decrease of disease activity (partial response) assessed within 10 weeks
	UC	Cohort10	18	No clinical improvement based on Truelove and Witts scale by ≥1 category compared with disease severity at the start of infliximab therapy assessed after induction
Adalimumab	CD	RCT11	42	≥70-point decrease in CDAI score from baseline assessed at week 4
	UC	RCT12	50	Decrease in Mayo score by ≥3 points and ≥30% from baseline, with an accompanying decrease in the rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1 assessed at week 8
	CD	Cohort13	18	Cessation of diarrhea and abdominal cramping and, in cases of patients with fistulae, cessation of fstula drainage and complete closure of all draining fistulae (complete response). Reduction in the amount of diarrhea and abdominal cramping and, in cases of patients with fistulae, a decrease in the drainage, size, or number of fistulae (partial response)
	UC	Cohort14	29	Decrease in Mayo score by ≥3 points and ≥30% from baseline, with an accompanying decrease in the rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1 assessed at week 12
Certolizumab pegol	CD	RCT15	63	≥100-point decrease in CDAI score with a baseline CRP level of ≥ 10 mg/L assessed at week 6
Golimumab	UC	RCT16	45	Decrease in Mayo score by ≥3 points and ≥30% from baseline (observed in the preceding induction study), with either a decrease in the rectal bleeding subscore by ≥1 point or a rectal bleeding subscore of 0 or 1
CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; PNR, primary nonresponse; RCT, randomized, controlled trial; TNF, tumor necrosis factor; UC, ulcerative colitis.