P370 Prospective withdrawal trial of azathioprine (AZA) in ulcerative colitis (UC)

Praticò, Chiara; Capozzi, Nunzia; Rizzello, Fernando; Calafiore, A.; Brugnera, Ramona; Straforini, G.; Fornarini, G. Spuri; Campieri, Massimo; Calabrese, C.; Gionchetti, Paolo

doi:10.1016/s1873-9946(14)60490-6

Cited by 3 publications

(6 citation statements)

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“…Other cohort studies with marked heterogeneity in study design and follow-up have reported relapse rates ranging from 21% to 100% at 2 years 192. A prospective study in patients with UC stopping azathioprine after a minimum of 3 years of therapy in clinical, biological, and endoscopic remission showed a relapse rate of 37% after a mean follow-up of 55 months 193. The risks of relapse are likely to be much lower in patients with prolonged remission (5–10 years) and the benefits of continuing therapy are likely to be less than the risk of drug toxicity, including lymphoma.…”

Section: Ulcerative Colitismentioning

confidence: 99%

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

Lamb

Kennedy

Raine

et al. 2019

Gut

1,466

1,577

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Ulcerative colitis and Crohn’s disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn’s and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn’s disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn’s disease, including patients, their families and friends.

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Section: Ulcerative Colitismentioning

confidence: 99%

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

Lamb

Kennedy

Raine

et al. 2019

Gut

1,466

1,577

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“…13,17 In one prospective study, published as an abstract, patients with UC stopping azathioprine after a minimum of 3 years of therapy in clinical, biological, and endoscopic remission (Mayo score of 0) had a relapse rate of 37% after a mean follow-up of 55 months. 21 The mean time to relapse was 26.4 months (12-72 months).…”

Section: De-escalation Of Immunomodulator Monotherapymentioning

confidence: 98%

“…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%

“…Eleven studies reported on immunomodulator withdrawal in CD [8][9][10][11]14,15,17,20,[23][24][25] and 8 in UC. 12,13,[17][18][19]21,22,24 One study by Fraser et al reported on long-term outcomes of patients treated with methotrexate and presented relapse rates for IBD with no distinction between CD and UC. De-escalation of an immunomodulator in CD.…”

Section: De-escalation Of Immunomodulator Monotherapymentioning

confidence: 99%

“…One RCT 12 and 7 cohort studies 13,[17][18][19]21,22,24 reported on the rates of relapse in UC after immunomodulator withdrawal. In the only RCT, Hawthorne et al reported a relapse rate of almost 60% by the end of the first year in those who discontinued the drug while in corticosteroid-free clinical remission compared with 36% on continued thiopurine therapy.…”

Section: De-escalation Of Immunomodulator Monotherapymentioning

confidence: 99%

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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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Immunosuppressants and immune modulators in luminal gastroenterology

Forbes

2021

Best Practice & Research Clinical Gastroenterology

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P370 Prospective withdrawal trial of azathioprine (AZA) in ulcerative colitis (UC)

Cited by 3 publications

References 0 publications

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

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

Immunosuppressants and immune modulators in luminal gastroenterology

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