Transcript A finding of dysplasia necessitates colectomy in IBD

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
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)
Reasons to Continue
• Minimize complications
• Minimize steroid exposure
• Maintain remission
• Maintain quality of life
Reasons to Discontinue
•
•
•
Avoid potential toxicity
– Infections
– Malignancy
Cost
Inconvenience
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 combotherapy
– Stopping natalizumab/vedolizumab
Stopping
Thiopurines in
Monotherapy
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 150-250 for 3 consecutive weeks and increase
>75 from baseline
Lemann, Gastro 2005; 128:1812-1818
AZA withdrawal wasn’t non-inferior:
Continue with
While K-M differences not statistically different, the
difference was
Lemann, Gastro 2005; 128:1812-1818
Stopping Thiopurine in Combination
Therapy
Remission after IMM Discontinuation in
Combination Therapy
Van Assche, Gastro 2008
Changes in CRP and IFX Levels?
Van Assche, Gastro 2008
Stopping Anti-TNF in Combination
Therapy
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
Cohort of Canadian Patients who voluntarily
withdrew IFX: 50% relapse at 477 days
Waugh, APT, 2010
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
IFX
Placebo
Follow Up Group
n
Endoscopic Recurrence
Surgical
Recurrence
Continued IFX
7
0 of 7 (0%)
0 of 7 (0%)
Stopped IFX
5
4 of 5 (80%)
4 of 5 (80%)
Started IFX
10
3 of 10 (30%)
3 of 10 (30%)
Continued off IFX
2
2 of 2 (100%)
2 of 2 (100%)
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 combotherapy
– Stopping natalizumab/vedolizumab
“If It Ain’t Broke Don’t Fix It”
Turns out this is not a Yogiism, but was popularized
by Jimmy Carter’s first
OMB Director: Bert Lance
Thank You