Tacrolimus for the treatment of fistulas in patients with crohn’s disease: a randomized, placebo-controlled trial

Sandborn, William J.; Present, Daniel H.; Isaacs, Kim L.; Wolf, Douglas C.; Greenberg, E. P.; Hanauer, Stephen B.; Feagan, Brian G.; Mayer, Lloyd; Johnson, Therese; Galanko, Joseph A.; Martin, Christopher F.; Sandler, Robert S.

doi:10.1016/s0016-5085(03)00877-1

Cited by 310 publications

(182 citation statements)

References 34 publications

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“…Several uncontrolled series have reported benets from short-term treatment with cyclosporine (178,190,191) or tacrolimus (179,181,182,192) . One placebo-controlled trial has been conducted with tacrolimus (193) . Long-term data are lacking, and most patients require subsequent chronic maintenance therapy with azathioprine or 6-mercaptopurine (178,179,190,194) .…”

Section: Perianal and Fi Stulizing Diseasementioning

confidence: 99%

Management of Crohn's Disease in Adults

2009

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Guidelines for clinical practice are intended to suggest preferable approaches to particular medical problems as established by interpretation and collation of scientifi cally valid research, derived from extensive review of published literature. When data that will withstand objective scrutiny are not available, a recommendation may be made based on a consensus of experts. Guidelines are intended to apply to the clinical situation for all physicians without regard to specialty. Guidelines are intended to be fl exible, not necessarily indicating the only acceptable approach, and should be distinguished from standards of care that are infl exible and rarely violated. Given the wide range of choices in any health-care problem, the physician should select the course best suited to the individual patient and the clinical situation presented. These guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee. Expert opinion is solicited from the outset for the document. The quality of evidence upon which a specifi c recommendation is based is as follows: Grade A: Homogeneous evidence from multiple well-designed randomized (therapeutic) or cohort (descriptive) controlled trials, each involving a number of participants to be of suffi cient statistical power. Grade B: Evidence from at least one large well-designed clinical trial with or without randomization, from cohort or case -control analytic studies, or well-designed meta-analysis. Grade C: Evidence based on clinical experience, descriptive studies, or reports of expert committees. The Committee reviews guidelines in depth, with participation from experienced clinicians and others in related fi elds. The fi nal recommendations are based on the data available at the time of the production of the document and may be updated with pertinent scientifi c developments at a later time.

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Section: Perianal and Fi Stulizing Diseasementioning

confidence: 99%

Management of Crohn's Disease in Adults

2009

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“…14,15 Other immunosuppressive agents, such as ciclosporin and tacrolimus (FK506), have also shown considerable response rates, but their use is limited by significant toxicity or fistula recurrence when the route of administration is switched from intravenous to oral ciclosporin or when the drug is discontinued. [16][17][18][19] The recent introduction of infliximab, an anti-tumour necrosis factor monoclonal antibody, has opened up a new dimension for the treatment of fistulizing Crohn's disease. Sixty-eight per cent of patients treated with three infusions (5 mg/kg) of infliximab over a 6-week period experienced significant improvement of their external fistulas, with complete fistula closure in 55%.…”

Section: Introductionmentioning

confidence: 99%

Antibiotics and azathioprine for the treatment of perianal fistulas in Crohn's disease

Dejaco¹,

Harrer²,

Waldhoer³

et al. 2003

Aliment Pharmacol Ther

200

108

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SummaryBackground : Antibiotics and thiopurines have been employed in the management of fistulizing Crohn's disease, although evidence of their efficacy is rare.Aim : To evaluate, in a prospective, open‐label study, the influence of antibiotics and azathioprine on the clinical outcome of perianal fistulas in patients with Crohn's disease.Methods : Fifty‐two patients entered the study, starting with an 8‐week regimen of ciprofloxacin (500–1000 mg/day) and/or metronidazole (1000–1500 mg/day). Seventeen patients had already received daily azathioprine (2–2.5 mg/kg) at enrolment, whereas in 14 patients azathioprine was initiated after 8 weeks of antibiotic treatment. Outcome was evaluated by Fistula Drainage Assessment and the Perianal Disease Activity Index at weeks 8 and 20.Results : Overall, 26 patients (50%) responded to antibiotic treatment, with complete healing in 25% of patients at week 8. The Perianal Disease Activity Index decreased significantly from 8.4 ± 2.9 to 6.0 ± 4.0 (P < 0.0001). At week 20, the outcome was assessed in 49 patients (94%), 29 of whom (59%) had received azathioprine. Response was noted in 17 of the 49 patients (35%), with complete healing in nine patients (18%). Patients who received azathioprine were more likely to achieve a response (48%) than those without immunosuppression (15%) (P = 0.03). The Perianal Disease Activity Index was closely associated with treatment response and perianal disease activity.Conclusion : Antibiotics are useful to induce a short‐term response in perianal Crohn's disease, and may provide a bridging strategy to azathioprine, which seems to be essential for the maintenance of fistula improvement.

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“…Moreover, tacrolimus, which was administered to some patients with FCD in this study, might be an alternative therapy because it is reported to be effective not only as a bridge therapy until the efficacy of AZA or 6-MP appears (19,20), but also for long-term management of FCD (8,21). Recently, two contradictory reports were published in which the efficacy of tacrolimus for FCD patients was evaluated (7,8) In conclusion, the present study focused on a medical treatment for Japanese patients with FCD. External fistulas were more responsive to medical therapies than internal fistulas, consistent with previous reports (9,10 …”

Section: Discussionmentioning

confidence: 98%

“…Nevertheless, some patients with fistulizing Crohn's disease (FCD) are refractory, even to this new agent. Therefore, combination therapies using current and new options have been tried in such patients (7,8). Currently, few studies have examined the clinical effects of medical therapy in Japanese patients with FCD.…”

Section: Crohn's Disease (Cd) Is a Chronic Inflammatory Bowel Diseasementioning

confidence: 99%

The Effect of Medical Treatment on Patients with Fistulizing Crohn's Disease: A Retrospective Study

et al. 2008

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Tacrolimus for the treatment of fistulas in patients with crohn’s disease: a randomized, placebo-controlled trial

Abstract: Oral tacrolimus 0.2 mg. kg(-1). day(-1) is effective for fistula improvement, but not fistula remission, in patients with perianal Crohn's disease. Adverse events associated with tacrolimus can be managed by dose reduction. Lower doses of tacrolimus should be evaluated.

Cited by 310 publications

References 34 publications

Management of Crohn's Disease in Adults

Management of Crohn's Disease in Adults

Antibiotics and azathioprine for the treatment of perianal fistulas in Crohn's disease

The Effect of Medical Treatment on Patients with Fistulizing Crohn's Disease: A Retrospective Study

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