Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohnʼs disease

Florent, C; Cortot, Antoine; Quandale, P; Sahmound, T; Modigliani, R; Sarfaty, Elad; Valleur, Patrice; Dupas, Jean‐Louis; Daurat, Morgane; Faucheron, J.‐L.; Lerebours, Éric; Michot, F; Belaiche, J; Jacquet, Nicolas; Soulé, J C; Rothman, Nathaniel; Jp, Gendre; Malafosse, M

doi:10.1097/00042737-199603000-00008

Cited by 90 publications

(39 citation statements)

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“…Severe endoscopic recurrence was however recorded less frequently in the treatment group (14%) than in the placebo group (50%; p < 0.002). Mesalazine (Pentasa, 3,000 mg/day, 106 patients) introduced 15 days after ‘curative’ resection did not reduce the rate of endoscopic recurrence at 3 months compared to placebo (50 vs. 63%, p = 0.16) [34]. …”

Section: Treatmentmentioning

confidence: 99%

Maintenance of Surgically Induced Remission of Crohn’s Disease

Froehlich¹,

Juillerat²,

Pittet³

et al. 2007

Digestion

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At 1 year after a first resection, up to 80% of patients show an endoscopic recurrence, 10–20% have clinical relapse, and 5% have surgical recurrence. Smoking is one of the most important risk factors for postoperative recurrence. Preoperative disease activity and the severity of endoscopic lesions in the neoterminal ileum within the first postoperative year are predictors of symptomatic recurrence. Mesalazine is generally the first-line treatment used in the postoperative setting but still provokes considerable controversy as to its efficacy, in spite of the results of a meta-analysis. Immunosuppressive treatment (azathioprine, 6-mercaptopurine) is based on scant evidence but is currently used as a second-line treatment in postsurgical patients at high risk for recurrence, with symptoms or with early endoscopic lesions in the neoterminal ileum. Nitroimidazole antibiotics (metronidazole, ornidazole) are also effective in the control of active Crohn’s disease in the postoperative setting. Given their known toxicity, they may be used as a third-line treatment as initial short-term prevention therapy rather than in the long term. Conventional corticosteroids, budesonide or probiotics have no proven role in postoperative prophylaxis. Infliximab has not as yet been studied for use in the prevention of relapse after surgery.

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Section: Treatmentmentioning

confidence: 99%

Maintenance of Surgically Induced Remission of Crohn’s Disease

Froehlich¹,

Juillerat²,

Pittet³

et al. 2007

Digestion

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“…2 In Crohn's ileocolitis, 5-ASA was better than placebo in one trial, 2 and was not signi®cantly different from placebo in seven. 3,6,8,10,12,15,17 Third, of seven trials in which recurrence rates in previously operated patients are reported, 5-ASA was better than placebo in six 3,8,9,13,14,16 and worse in one. 4 Other discrepancies emerge when one examines the relationship between duration of remission prior to enrolment and recurrence rate.…”

Section: Discussionmentioning

confidence: 97%

Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Franchis

Omodei

Ranzi

et al. 1997

Aliment Pharmacol Ther

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Background Recent data indicate that 5‐aminosalicylic acid (5‐ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrolment. Aim To evaluate the efficacy of oral 5‐ASA treatment, started immediately after achieving steroid‐induced remission, in preventing clinical relapses of Crohn's disease. Methods Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5‐ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5‐ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. Results Final analysis included 117 patients (58 taking 5‐ASA and 59 taking placebo; follow‐up 9.2 ± 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5‐ASA patients and 31% and 52% in placebo patients, respectively (rate difference + 0.095; 95% CI = −0.085– + 0.274). Subgroups analysis showed that 5‐ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. Conclusions Contrary to previous results, in our study early introduction of treatment with oral 5‐ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.

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“…This metaanalysis was later updated to include the study by Lochs et al 35 The results still showed a significant benefit in favor of mesalamine, although reduced from the initial estimate (Ϫ10.0%, 95% CI: Ϫ16.9% to Ϫ3.2%, P ϭ 0.0041), with a number needed to treat of 10 to prevent 1 relapse. 40 The results of the meta-analysis do not include the more recent study by Hanauer et al 34 from 2004 and excluded the study by Florent et al 33 because of a short study duration.…”

Section: Mesalaminementioning

confidence: 99%

Postoperative Therapy for Crohnʼs Disease

Blum

Katz

2009

Inflammatory Bowel Diseases

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Prevention of the postoperative recurrence of Crohn's disease (CD) remains a challenging clinical problem. The majority of patients with CD will need surgery for treatment of the disease, most of these patients will develop recurrent symptoms within 5 years postoperatively, and many patients will need reoperation within 10 years. In patients with an ileocolic anastomosis, endoscopic recurrence precedes clinical recurrence and the severity of endoscopic recurrence correlates with the risk of clinical recurrence. Despite multiple studies, the best postoperative prophylactic therapy remains uncertain. Numerous randomized controlled trials of 5-aminosalicylates have shown only modest effect. Antibiotics, including metronidazole and ornidazole, decrease short-term, but not long-term endoscopic recurrence and are limited by side effects. Immunomodulators have yet to be extensively evaluated, although limited data suggest possible efficacy in preventing postoperative recurrence, particularly in high-risk patients. This review will evaluate the current state of the art therapy for postoperative prophylaxis in CD, with an emphasis on critical analysis of the available randomized controlled trials.

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Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohnʼs disease

Cited by 90 publications

References 0 publications

Maintenance of Surgically Induced Remission of Crohn’s Disease

Maintenance of Surgically Induced Remission of Crohn’s Disease

Controlled trial of oral 5‐aminosalicylic acid for the prevention of early relapse in Crohn's disease

Postoperative Therapy for Crohnʼs Disease

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