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Medications should never be stopped for Crohn’s disease patients in remission Thomas Ullman, M.D. Chief Medical Officer Mount Sinai Doctors Faculty Practice.

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Presentation on theme: "Medications should never be stopped for Crohn’s disease patients in remission Thomas Ullman, M.D. Chief Medical Officer Mount Sinai Doctors Faculty Practice."— Presentation transcript:

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 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. 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 Lemann, Gastro 2005; 128: While K-M differences not statistically different, the difference was

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 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 GroupnEndoscopic Recurrence Surgical Recurrence IFX Continued IFX70 of 7 (0%) Stopped IFX54 of 5 (80%) Placebo Started IFX103 of 10 (30%) Continued off IFX22 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


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