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Asymptomatic UC patients on an immunomodulator with persistent moderate mucosal inflammation should either add a biologic or switch to a biologic. William J. Sandborn, MD Professor & Chief, Division of Gastroenterology Director, UCSD IBD Center.

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william j sandborn md professor chief division of gastroenterology director ucsd ibd center

Asymptomatic UC patients on an immunomodulator with persistent moderate mucosal inflammation should either add a biologic or switch to a biologic

William J. Sandborn, MD

Professor & Chief, Division of Gastroenterology

Director, UCSD IBD Center

arguments for treating to target in ulcerative colitis
Arguments for treating to target in ulcerative colitis
  • It is feasible
  • It is associated with a reduced rate of colectomy and an increased rate of steroid-free remission
  • It is associated with a reduced rate of colorectal dysplasia and cancer
  • It is logical and obviously the right thing to do
study population
Study population

144 patients

31 patients

Bougen G, Levesque B,

Sandborn W.

Inflam Bowel Dis

2014 (In Press)

53 patients

60 patients

STUDY POPULATION

45 patients

15 patients

endoscopic procedures
Endoscopicprocedures

159 endoscopic procedures

92 colonoscopy

67 flexible sigmoidoscopy

60 patients had at least 2 consecutive endoscopic procedures

26 patients (43%): 3 consecutive procedures

8 patients (13%): 4 consecutive procedures

2 patients (3%): 5 consecutive procedures

median follow-up of 76 weeks

(IQR75 54-92)

Endoscopy 1

Median time

19 weeks

Endoscopy 2

Median time

17 weeks

Endoscopy 3

Median time

20 weeks

Endoscopy 4

Bougen G, Levesque B, Sandborn W.

Inflam Bowel Dis 2014 (In Press)

adjustment in medical therapy and surgery
Adjustment in medicaltherapy and surgery

Overall cohort :

5-ASA introduction: 2 events

5-ASA increase dose: 6 events

Oral steroids introduction: 11 events

Anti-TNF Introduction: 20 events

Anti-TNF Optimization/switch: 11 events

Immunosuppression introduction: 18 patients

Surgery: 7 patients

MEDIAN FOLLOW-UP = 76 weeks (IQR75 44-79)

MEDIAN TIME BETWEEN PROCEDURE = 25 weeks (16-42)

Bougen G, Levesque B, Sandborn W.

Inflam Bowel Dis 2014 (In Press)

cumulative probability of reaching mucosal healing and histologic healing
Cumulative probability of reaching mucosal healing and histologic healing

Bougen G, Levesque B, Sandborn W.

Inflam Bowel Dis 2014 (In Press)

slide9
Reaching mucosal healing according to medical management during follow up multivariate analysis: adjustments in medical therapy

Bougen G, Levesque B, Sandborn W.

Inflam Bowel Dis 2014 (In Press)

it is associated with a reduced rate of colectomy and an increased rate of steroid free remission
It is associated with a reduced rate of colectomy and an increased rate of steroid-free remission
mucosal healing after treatment as predictor of subsequent disease course in ulcerative colitis

Pts with MH at 1 year

p=0.02

Pts without MH at 1 year

Mucosal Healing after treatment as predictor of subsequent disease course in ulcerative colitis

Frøslie KF, et al. Gastroenterology. 2007;133:412-422.

mucosal healing and time to colectomy in infliximab treated patients endoscopy subscore
Mucosal Healing and Time to Colectomy in Infliximab-treated Patients: Endoscopy Subscore

0 = NORMAL

1 = MILD

2 = MODERATE

3 = SEVERE

Colombel JF, Sandborn WJ, et al. Gastroenterology 2011;141:1194-1201.

slide13

Association Between Week 8 Mayo Endoscopy Sub-score and and Corticosteroid-Free Symptomatic Remission at Week 30 During Anti-TNF Antibody Therapy

Colombel JF, Sandborn WJ. Gastroenterology 2011

predicting cancer risk in uc
Predicting cancer risk in UC

12

P<0.001

Odds ratio for colorectal cancer (95% CI)

10

Disease extent

PSC

Disease duration

Family history of CRC

8

6

P=0.001

OR=5.13

4

OR=2.54

2

0

Histological inflammation score

Colonoscopy inflammation score

OR for each 1 point increase in inflammatory score

Rutter et al Gastroenterology 2004;126:451

slide17
Parachute use to prevent death and major trauma related to gravitational challenge: a systematic review of randomized controlled trials
  • Objectives: To determine whether parachutes are effective in preventing major trauma related to gravitational challenge
  • Design: Systematic review of randomized controlled trials
  • Data sources: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists
  • Study selection: Studies showing the effects of using a parachute during free fall
  • Main outcome measure: Death or major trauma, defined as an injury severity score > 15

Gordon CS. BMJ 2003

slide18
Parachute use to prevent death and major trauma related to gravitational challenge: a systematic review of randomized controlled trials
  • Results: We were unable to identify any randomized controlled trials of parachute intervention
  • Conclusions: As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomized controlled trials. Advocates of evidence based medicine have criticized the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organized and participated in a double blind, randomized, placebo controlled, crossover trial of the parachute

Gordon CS. BMJ 2003

it is logical and obviously the right thing to do1
It is logical and obviously the right thing to do
  • You don’t need a randomized controlled trial to determine that using a parachute is the right thing to do
  • Do you need a randomized controlled trial to determine that healing the colon is the right thing to do?
treating to mucosal healing in ulcerative colitis
Treating to Mucosal Healing in Ulcerative Colitis
  • It is feasible
  • It is associated with a reduced rate of colectomy and an increased rate of steroid-free remission
  • It is associated with a reduced rate of colorectal dysplasia and cancer
  • It is logical and obviously the right thing to do
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