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Tolerance and efficacy of azathioprine in pediatric Crohn's disease

  1. Laura Riello MD1,
  2. Cécile Talbotec MD1,
  3. Hélène Garnier-Lengliné MD1,2,
  4. Bénédicte Pigneur MD1,2,
  5. Johan Svahn MD1,
  6. Danielle Canioni MD, PhD1,2,
  7. Olivier Goulet MD, PhD1,2,
  8. Jacques Schmitz MD, PhD1,2,
  9. Frank M. Ruemmele MD, PhD1,2,*

Article first published online: 13 JAN 2011

DOI: 10.1002/ibd.21612

Issue

Inflammatory Bowel Diseases

Inflammatory Bowel Diseases

Volume 17, Issue 10, pages 2138–2143, October 2011

Additional Information

How to Cite

Riello, L., Talbotec, C., Garnier-Lengliné, H., Pigneur, B., Svahn, J., Canioni, D., Goulet, O., Schmitz, J. and Ruemmele, F. M. (2011), Tolerance and efficacy of azathioprine in pediatric Crohn's disease. Inflamm Bowel Dis, 17: 2138–2143. doi: 10.1002/ibd.21612

Author Information

  1. 1

    Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Paediatric Gastroenterology Unit, Paris, France

  2. 2

    University Paris Descartes, Faculty Necker, INSERM U989, Paris, France

*Paediatric Gastroenterology Unit, Hôpital Necker-Enfants Malades, INSERM U989, 149 Rue de Sèvres, F-75015 Paris, France

Publication History

  1. Issue published online: 11 SEP 2011
  2. Article first published online: 13 JAN 2011
  3. Manuscript Accepted: 17 NOV 2010
  4. Manuscript Received: 16 NOV 2010

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Keywords:

  • pediatric Crohn's disease;
  • azathioprine;
  • thiopurine methyl transferase

Abstract

Background:

Thiopurines are considered first-line immunomodulators for the prevention of relapse in moderate to severe pediatric Crohn's disease (CD). Early introduction of thiopurines was shown in a pediatric trial to maintain steroid-free remission in 90% of patients for 18 months. In the present study we analyzed the tolerance and efficacy of azathioprine (AZA) to maintain remission in a homogenous single-center observational cohort of children with CD.

Methods:

In all, 105 pediatric CD patients (male/female 68/37) were retrospectively evaluated for the efficacy of AZA (doses 1.4–4 mg/kg) to maintain remission at 6, 12, 18, and 24 months of follow-up. Overall, 93 children were included with active disease (pediatric Crohn's disease activity index [PCDAI] >30), steroid/enteral-nutrition dependency, or postileocecal resection. Remission was defined as PCDAI ≤10 without steroids. Patients requiring antitumor necrosis factor (TNF) medication, other immunomodulators, or surgery were considered to experience a relapse.

Results:

Based on PCDAI, steroid-free remission was achieved in 56/93 (60.2%), 37/93 (39.8%), 31/93 (33.3%), and 29/93 (31.2%) at visits month (M)6, M12, M18, and M24, respectively. Within the first 4 weeks, AZA was stopped in 10/93 patients due to adverse reactions (pancreatitis, nausea, vomiting, skin reactions, general weakness), or not introduced due to low thiopurine methyl transferase (TPMT) activity (n = 3). No neutropenia occurred in patients with normal TPMT activity. Three infectious episodes were documented requiring temporary AZA suspension.

Conclusions:

AZA is efficacious in maintaining remission in pediatric CD patients, but to a lesser extent than previously suggested. The majority of patients who are in steroid-free remission at 12 months remained in prolonged remission. Overall tolerance of AZA was excellent. Inflamm Bowel Dis 2011

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