Maintenance Treatment With Azathioprine in Ulcerative Colitis: Outcome and Predictive Factors After Drug Withdrawal

Cassinotti, A.; Actis, Giovanni C; Duca, Piergiorgio; Massari, A.; Colombo, Elisabetta; Gai, Elisa; Annese, Vito; d’Albasio, G; Manes, Gianpiero; Travis, Simon; Porro, G. Bianchi; Ardizzone, Sandro

doi:10.1038/ajg.2009.410

Cited by 111 publications

(64 citation statements)

References 35 publications

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“…If it is stopped earlier than 1 year, which is mostly due to toxicity, 100% of the cases were found to be at risk of relapse (7). In third year of withdrawal, two-thirds of the cases relapsed, which is similar between two studies, and furthermore, the risk increased to 75% in the 5th year in one study (6,10).…”

Section: Resultssupporting

confidence: 58%

See 1 more Smart Citation

Can azathioprine/6-mercaptopurine treatment be withdrawn in patients with response in ulcerative colitis: What is the most appropriate time for this?

Kabaçam

Törüner²

2012

Turk J Gastroenterol

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Section: Resultssupporting

confidence: 58%

“…According to these studies, withdrawal of maintenance treatment during remission resulted in relapse of an almost constant rate of one-third of the cases in the first year in three of the studies (5,6,10). If it is stopped earlier than 1 year, which is mostly due to toxicity, 100% of the cases were found to be at risk of relapse (7).…”

Section: Resultsmentioning

confidence: 99%

Can azathioprine/6-mercaptopurine treatment be withdrawn in patients with response in ulcerative colitis: What is the most appropriate time for this?

Kabaçam

Törüner²

2012

Turk J Gastroenterol

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“…Azathioprine has been found eff ective in maintaining remission in controlled and uncontrolled drug withdrawal studies ( 231,232 ) and in a meta-analysis of seven placebo-controlled maintenance trials ( 233 ). Retrospective studies have shown the value of 6-MP and azathioprine in maintaining long-term remission ( 200,234 ), and it is generally well tolerated during long-term use ( 197,200,201,234 ).…”

Section: The Patient With Severe Colitis Refractory To Maximal Oral Tmentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,112

977

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Guidelines for clinical practice are aimed to indicate preferred approaches to medical problems as established by scientifi cally valid research. Double-blind placebo controlled studies are preferable, but compassionate-use reports and expert review articles are used in a thorough review of the literature conducted through Medline with the National Library of Medicine. When only data that will not withstand objective scrutiny are available, a recommendation is identifi ed as a consensus of experts. Guidelines are applicable to all physicians who address the subject regardless of specialty training or interests and are aimed to indicate the preferable but not necessarily the only acceptable approach to a specifi c problem. Guidelines are intended to be fl exible and must be distinguished from standards of care, which are infl exible and rarely violated. Given the wide range of specifi cs in any healthcare problem, the physician must always choose the course best suited to the individual patient and the variables in existence at the moment of decision. Guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the board of trustees. Each has been intensely reviewed and revised by the Committee, other experts in the fi eld, physicians who will use them, and specialists in the science of decision analysis. The recommendations of each guideline are therefore considered valid at the time of composition based on the data available. New developments in medical research and practice pertinent to each guideline will be reviewed at a time established and indicated at publication to assure continued validity. The recommendations made are based on the level of evidence found. Grade A recommendations imply that there is consistent level 1 evidence (randomized controlled trials), grade B indicates that the evidence would be level 2 or 3, which are cohort studies or case -control studies. Grade C recommendations are based on level 4 studies, meaning case series or poor-quality cohort studies, and grade D recommendations are based on level 5 evidence, meaning expert opinion.

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“…These comprised 5 RCTs 8-12 and 13 retrospective cohort studies [13][14][15][16][17][18][19][20][21][22][23][24][25] (one of which 20 was an extension study from a previous RCT 8 ). Eleven studies reported on immunomodulator withdrawal in CD [8][9][10][11]14,15,17,20,[23][24][25] and 8 in UC.…”

Section: De-escalation Of Immunomodulator Monotherapymentioning

confidence: 99%

Systematic Review of Effects of Withdrawal of Immunomodulators or Biologic Agents From Patients With Inflammatory Bowel Disease

et al. 2015

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Little is known about the optimal duration of therapy with an anti-tumor necrosis factor (TNF) agent and/or an immunomodulator for patients with inflammatory bowel disease (IBD). We performed a systematic search of the literature to identify studies reporting after de-escalation (drug cessation or dose reduction) of anti-TNF agents and/or immunomodulators in patients in remission from IBD. Studies were reviewed according to the type of IBD and drug. Rates of relapse, factors associated with relapse, and response to re-treatment were determined. Our search yielded 6315 unique citations; we analyzed findings from 69 studies (18 on de-escalation [drug cessation or dose reduction] of immunomodulator monotherapy, 8 on immunomodulator de-escalation from combination therapy, and 43 on de-escalation of anti-TNF agents, including 3 during pregnancy) comprising 4672 patients. Stopping immunomodulator monotherapy after a period of remission was associated with high rates of relapse in patients with Crohn's disease or ulcerative colitis (approximately 75% of patients experienced a relapse within 5 years after therapy was stopped). Most studies of patients with Crohn's disease who discontinued an immunomodulator after combination therapy found that rates of relapse did not differ from those of patients who continued taking the drug (55%-60% had disease relapse 24 months after they stopped taking the immunomodulator). The only study in patients with ulcerative colitis supported continued immunomodulator use. Approximately 50% of patients who discontinued anti-TNF agents after combination therapy maintained remission 24 months later, but the proportion in remission decreased with time. Markers of disease activity, poor prognostic factors, and complicated or relapsing disease course were associated with future relapse. In conclusion, based on a systematic review, 50% or more of patients with IBD who cease therapy have a disease relapse. Further studies are required to accurately identify subgroups of patients who are good candidates for discontinuation of treatment. The decision to withdraw a drug should be made for each individual based on patient preference, disease markers, consequences of relapse, safety, and cost.Keywords : Crohn's Disease ; Ulcerative Colitis ; Patient Management ; Cessation.Abbreviations used in this paper : anti-TNF, anti-tumor necrosis factor therapy ; CD, Crohn's disease ; CRP, C-reactive protein ; FC, fecal calprotectin ; IBD, inflammatory bowel disease ; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses ; RCT, randomized controlled trial ; TNF, tumor necrosis factor ; UC, ulcerative colitis.Therapeutic strategies in inflammatory bowel disease (IBD) have evolved considerably in the past few decades. The acknowledgment that subclinical and undertreated inflammation can lead to poor outcomes has underpinned a shift in treatment goals from symptomatic control to sustained clinical and endoscopic remission.1 Treatment strategies have changed accordingly, including the ear...

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Maintenance Treatment With Azathioprine in Ulcerative Colitis: Outcome and Predictive Factors After Drug Withdrawal

Cited by 111 publications

References 35 publications

Can azathioprine/6-mercaptopurine treatment be withdrawn in patients with response in ulcerative colitis: What is the most appropriate time for this?

Can azathioprine/6-mercaptopurine treatment be withdrawn in patients with response in ulcerative colitis: What is the most appropriate time for this?

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Systematic Review of Effects of Withdrawal of Immunomodulators or Biologic Agents From Patients With Inflammatory Bowel Disease

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