1. Medications should never be stopped for Crohn’s disease patients in remission
Thomas Ullman, M.D.
Chief Medical Officer
Mount Sinai Doctors Faculty Practice
The Mount Sinai School of Medicine
New York, NY

2. Reasons to Start Immunomodulators and Anti-TNF’s in Crohn’s Disease
Steroid-dependent/refractory disease
Penetrating/fistulizing disease
Symptomatic disease
Minimize mucosal inflammation
Prevention of:
Surgery
Hospitalization
Work/school absenteeism
Improvement of quality of life (QoL)

3. Reasons to Discontinue
Reasons to Continue
Minimize complications
Minimize steroid exposure
Maintain remission
Maintain quality of life
Avoid potential toxicity
Infections
Malignancy
Cost
Inconvenience
Reasons to Discontinue

4. What do the data tell us Results from the literature for the following
Stopping thiopurines as monotherapy: bad idea
Stopping thiopurines in combination therapy (thiopurine + anti-TNF): sort of bad idea
Stopping anti-TNF’s in monotherapy: really bad idea
Stopping anti-TNF’s in combination therapy (thiopurine + anti-TNF): bad idea
Results from the literature not yet there
Stopping methotrexate as mono- or combo-therapy
Stopping natalizumab/vedolizumab

5. Stopping Thiopurines in Monotherapy

6. Randomized Trial of AZA vs
Randomized Trial of AZA vs. PBO in Stable AZA using patients in remission
>42 months in remission (CDAI<150)
Oral prednisone < 10 mg/d
No biologics, budesonide, TPN, surgery, rectal steroids, antibiotics for Crohn’s, aminosalicylates for 6 months
63 patients Randomized 1:1, double blind
40 AZA; 43 PBO
Non-inferiority study
Proportion with relapse in 18 months
CDAI >250 or
CDAI for 3 consecutive weeks and increase >75 from baseline
Lemann, Gastro 2005; 128:

7. AZA withdrawal wasn’t non-inferior: Continue with
While K-M differences not statistically different, the difference was
Lemann, Gastro 2005; 128:

8. Stopping Thiopurine in Combination Therapy

9. Remission after IMM Discontinuation in Combination Therapy
Van Assche, Gastro 2008

10. Changes in CRP and IFX Levels?
Van Assche, Gastro 2008

11. Stopping Anti-TNF in Combination Therapy

12. STORI trial 115 patients in remssion on IFX for mean 2.2 years
96 on AZA/6MP, 19 on MTX
44% relapse at 1 year
Louis et al, Gastro 2012; 142:63-70

13. Cohort of Canadian Patients who voluntarily withdrew IFX: 50% relapse at 477 days
Waugh, APT, 2010

14. Endoscopic Recurrence
Among patients in surgical remission: “Deepest Remission,” as phrased by first author--DON’T STOP
5-year f/u of post-op infliximab (IFX) vs placebo in post-operative recurrence (Gastro 2009)
All subjects offered open label IFX and followed for additional 4 years
Outcomes
Endoscopic Recurrence (Rutgeerts Score i2 or greater at year 5)
Surgical Recurrence (need for re-operation)
Initial Group
Follow Up Group n
Endoscopic Recurrence
Surgical Recurrence
IFX
Continued IFX 7
0 of 7 (0%)
Stopped IFX 5
4 of 5 (80%)
Placebo
Started IFX 10
3 of 10 (30%)
Continued off IFX 2
2 of 2 (100%)

15. What do the data tell us Results from the literature for the following
Stopping thiopurines as monotherapy: bad idea
Stopping thiopurines in combination therapy (thiopurine + anti-TNF): sort of bad idea
Stopping anti-TNF’s in monotherapy: really bad idea
Stopping anti-TNF’s in combination therapy (thiopurine + anti-TNF): bad idea
Results from the literature not yet there
Stopping methotrexate as mono- or combo-therapy
Stopping natalizumab/vedolizumab

16. “If It Ain’t Broke Don’t Fix It”
Turns out this is not a Yogi-ism, but was popularized by Jimmy Carter’s first OMB Director: Bert Lance

17. Thank You