Table 9

Randomised controlled trials (RCTs) and cohort studies of biological therapy in Crohn's disease where data were provided separately for patients with isolated colonic disease

AuthorYearType of studyStudy agentTotal number of patientsNumber with colonic CDEnd pointMain findingsp Value (for colonic vs other sites unless stated)Conclusion
Sandborn et al1632011RCTCertolizumab pegol (CZP)338120Week 6 remission (CDAI ≤150)23/63 (36.5%) CZP vs 10/57 (17.5%) placebo0.052 (colon vs other locations);
0.034 (active vs placebo)
Probable efficacy in colonic disease
Arnott et al1642003CohortInfliximab7426Week 4 response (fall in HBI by >3)23/26 (88%) response in colonic vs 6/11 (54%) in ileal0.042Better efficacy in colonic than ileal
Laharie et al1652005CohortInfliximab4418Week 8 response
(fall in CDAI by ≥100)
83.3% colonic CD vs 50% ileal/ileocolonic0.03Better efficacy in colonic than combined ileal/ileocolonic
Vermeire et al1662002CohortInfliximab24089Week 4 (luminal) or week 10 (fistulising) response (fall in CDAI by ≥70 or 50% decrease in draining fistulae81% response colonic CD vs 55% ileal CD vs 74% ileocolonic
OR 1.905, 95% CI 1.010 to 3.597
0.046Better efficacy in colonic than combined ileal/ileocolonic.
Remission also more likely in isolated colonic (p=0.019)
Dupont-Lucas et al1672016CohortInfliximab248 (children)63Loss of response to maintenance therapy (moderate or severe global assessment requiring cessation of therapy)Colonic 25/54 (46%) responders or remitters vs ileal/ileocolonic 148/185 (80%). HR 2.72 (95% CI 1.30 to 5.71) for loss of response in isolated colonic CD vs other sites0.008Isolated colonic disease more likely to lose response
Cohen et al1682012CohortAdalimumab7515Time to dose escalation13.2 weeks for colonic vs 34.6 weeks for other sites0.0062Isolated colonic disease required earlier dose escalation
Sandborn et al1692013RCTVedolizumab1115316 (273 active, 43 placebo)
Subgroup analysis based on 62 active and 43 placebo
Remission (CDAI ≤150) at week 6 over placebo, response (CDAI fall ≥100) week 6Remission difference from placebo: 5.9% for colonic vs 6.7% for ileal vs 8.9% for ileocolonic
Response: 10.6% for colonic vs minus 10.4% for ileal vs 7.1% for ileocolonic
0.30 remission
0.23 response
No difference between isolated colonic and other Crohn's for induction with vedolizumab
Sandborn et al1692013RCTVedolizumab461117Remission at week 52 over placeboRemission 8 weekly vedolizumab: 18.9% difference from placebo for colonic vs 11.8% for ileal vs 19.9% for ileocolonic
Remission 4 weekly vedolizumab: 12.7% for colonic vs 25.4% for ileal vs 12% for ileocolonic
0.11
0.19
No difference between isolated colonic and other Crohn's for maintenance with vedolizumab
  • CD, Crohn's disease; HBI, Harvey Brashaw Index.