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Data insufficient for recommending anti-TNF discontinuation in IBD remission
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A recent systematic review identified factors that increase risk for relapse after discontinuation of anti-tumor necrosis factor therapy in patients with IBD who achieved remission, but determined that strong recommendations cannot be made until additional data from controlled studies become available.
“For reasons of cost and safety, discontinuation of anti-TNF treatment could be considered in IBD patients who achieve remission,” Javier P. Gisbert, MD, PhD, from La Princesa University Hospital in Madrid, told Healio Gastroenterology. “The aim of this systematic review was to evaluate the factors associated with relapse of IBD after discontinuation of anti-TNF therapy.”
Javier P. Gisbert
Gisbert and colleagues performed a systematic review of literature investigating risk for relapse in IBD patients in remission who stopped Remicade (infliximab, Janssen), Humira (adalimumab, AbbVie) or Cimzia (certolizumab pegol, UCB) published up to January 2015, and 27 studies were included in the meta-analysis.
They determined that around one-third of IBD patients in remission relapsed 1 year after discontinuation of anti-tumor necrosis factor (TNF) therapy. Risk for relapse after anti-TNF discontinuation was 44% for Crohn’s disease (follow-up range, 6-125 months) and 38% for ulcerative colitis (follow-up range, 6-24 months).
Based on limited evidence, factors associated with increased risk for relapse included:
- age 25 years or younger at diagnosis (HR = 1.83; 95% CI, 1.03-3.25);
- smoking (OR = 2.74; 95% CI, 0.99-7.59; HR = 1.91; 95% CI, 1.11-3.27);
- longer disease duration;
- fistulizing perianal Crohn’s disease;
- hemoglobin levels 145 g/L or lower (HR = 6; 95% CI, 2.2-6.5);
- high C-reactive protein levels;
- high fecal calprotectin;
- high leukocyte count (greater than 6 x 109/L; HR = 2.4; 95% CI, 1.2-4.7); and
- high serum anti-TNF levels (infliximab 2 µg/mL or greater, HR = 2.5; 95% CI, 1.1-5.4).
Mucosal healing appeared to reduce risk for relapse after discontinuation (26% risk for relapse at 1 year with mucosal healing vs. 42% without), but data were conflicting. Risk for relapse was also found to be greater than 75% in patients whose dose was escalated or if they received anti-TNF for prevention of postoperative Crohn’s disease recurrence. Finally, readministration of anti-TNF in patients who relapsed after discontinuation was found to be safe and effective.
“In conclusion, available data are insufficient to make strong recommendations on when anti-TNF therapy could be stopped,” the researchers wrote. “We feel that no definitive recommendation should be made until data from controlled studies are available. In the meantime, the decision to discontinue anti-TNF therapy should be individualized, and the benefits and risks should always be discussed extensively with the patient. An argument in favor of discontinuation is that response to retreatment with the same anti-TNF drug is generally effective and safe in patients who relapse.” – by Adam Leitenberger
Disclosure: Gisbert and another researcher report they have served as speakers, consultants and advisory members for and have received research funding from MSD and AbbVie. The remaining researcher reports no relevant financial disclosures.
Editor's Note: This article was updated on August 31 to reflect additional information.
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