Azathioprine maintains long-term steroid-free remission through 3 years in patients with steroid-dependent ulcerative colitis†

Chebli, Liliana Andrade; Chaves, Leonardo Duque de Miranda; Pimentel, F; Guerra, Dolores Martins; Barros, Renata Maria de Freitas; Gaburri, Pedro Duarte; Zanini, Alexandre; Chebli, Júlio Maria Fonseca

doi:10.1002/ibd.21083

Cited by 77 publications

(56 citation statements)

References 30 publications

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“…Serious infection occurred in approximately 3 % of infl iximab-treated patients in the ACT 1 and 2 trials. Additional information regarding risk of infection is available from the Th erapy, Resource, Evaluation, and Assessment Tool registry, an ongoing observational infl iximab safety registry in patients with CD, which contains approximately 6,000 patients with 16,000 years of long-term use results in steroid sparing ( 190 ), fewer admissions to hospital, and fewer operations ( 191 ). In a prospective 2-year trial, the addition of olsalazine did not enhance the effi cacy of azathioprine ( 192 ).…”

Section: Infectionsmentioning

confidence: 99%

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

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,156

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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Section: Infectionsmentioning

confidence: 99%

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

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,156

977

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“…Subsequently, remission was achieved with PSL alone, but relapse occurred after the discontinuation or decrease of PSL. Remission was achieved again after resuming treatment with PSL, and thus an administration of AZA was started as maintenance therapy [3,4]. However, hepatic dysfunction occurred after the AZA was started, and thus we discontinued it and the patient's liver dysfunction resolved spontaneously.…”

Section: Discussionmentioning

confidence: 99%

“…The second relapse was severe both clinically and endoscopically. Therefore, TAC add-on therapy was used for the steroid-dependent refractory UC [4,5].…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Induction of Remission and Maintenance Therapy with Tacrolimus in Refractory Ulcerative Colitis with Adverse Events from 5-ASA and Thiopurine

Ito¹,

Omori²,

Kogiso³

et al. 2017

J Clin Case Rep

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A 58-year-old Japanese woman was admitted to the hospital with fever, diarrhea, melena and lower abdominal pain. Colonoscopy showed moderate left-sided Ulcerative Colitis (UC). Administration of 5-aminosalicylic acid (5-ASA) (3600 mg) was started, but skin eruptions and hepatic dysfunction occurred. The drug lymphocyte stimulation test (DLST) was positive for 5-ASA, so this medication was discontinued. Prednisolone (PSL, initially 10 mg/day) was started, and remission was achieved. However, relapse occurred 5 months later after the discontinuation of PSL, and hospitalization was required again. Remission was achieved again by PSL, and azathioprine (AZA) (initially 25 mg/day) was started as maintenance therapy. Hepatic dysfunction was detected at 1 month after starting AZA and was judged to represent drug-induced hepatitis. Following the discontinuation of AZA, PSL (2 mg/day) monotherapy was continued. At 11 months after discharge from hospital, the patient developed diarrhea, melena, and abdominal pain, requiring hospitalization for the third time. Colonoscopy showed extensive ulceration and spontaneous bleeding, indicating a relapse of severe UC. Administration of tacrolimus (TAC) led to remission and the patient was discharged from hospital. Because she experienced adverse effects with 5-ASA and AZA, TAC alone was continued as maintenance therapy for ≥ 2 years after the discontinuation of PSL. Relapse did not occur during this period and repeat colonoscopy showed mucosal healing. During the TAC maintenance therapy, slight deterioration of renal function was observed, but there were no other adverse events. In conclusion, we experienced a rare patient who responded to TAC maintenance monotherapy for severe UC.

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“…Effectiveness data were drawn from a number of sources including RCTs and non-randomised studies. 49,[87][88][89][90][91][92][93][94][95][96][97][98][99] The effectiveness of IFX in inducing and maintaining response and remission was based on the results of the ACT1 and ACT2 studies. 49 The rate of developing colorectal cancer was derived from an observational study.…”

Section: Assessment Of Cost-effectivenessmentioning

confidence: 99%

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

Archer

Tappenden

Ren

et al. 2016

Health Technol Assess

143

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BackgroundUlcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients’ quality of life. The burden for the NHS is substantial.ObjectivesTo evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities.Data sourcesPeer-reviewed publications, European Public Assessment Reports and manufacturers’ submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals.Review methodsA systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model.ResultsTen randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade®, Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira®, AbbVie) or golimumab (GOL) (Simponi®, MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8–32 and 32–52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8–32 weeks and GOL 50 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32–52 weeks was significant. The greatest effects were associated with GOL (at 8–32 weeks) and ADA (at 32–52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained.LimitationsThe health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review.ConclusionsAdult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Azathioprine maintains long-term steroid-free remission through 3 years in patients with steroid-dependent ulcerative colitis†

Cited by 77 publications

References 30 publications

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

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

Induction of Remission and Maintenance Therapy with Tacrolimus in Refractory Ulcerative Colitis with Adverse Events from 5-ASA and Thiopurine

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

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