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| Authors: |
Louis E, Mary JY, Vernier-Massouille G, Grimaud JC, Bouhnik Y, Laharie D, Dupas JL, Pillant H, Picon L, Veyrac M, Flamant M, Savoye G, Jian R, Devos M, Porcher R, Paintaud G, Piver E, Colombel JF, Lemann M; Groupe D'etudes Thérapeutiques Des Affections Inflammatoires Digestives.
Centre Hospitalier Universitaire de Liège, Liège, Belgium. edouard.louis@ulg.ac.be
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| Title: |
Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped.
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| Citation: |
Gastroenterology, 2012 Jan;142(1):63-70
Abstract
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BACKGROUND & AIMS:
It is important to determine whether infliximab therapy can be safely interrupted in patients with Crohn's disease who have undergone a period of prolonged remission.
We assessed the risk of relapse after infliximab therapy was discontinued in patients on combined maintenance therapy with antimetabolites and
identified factors associated with relapse.
METHODS:
We performed a prospective study of 115 patients with Crohn's disease who were treated for at least 1 year with scheduled infliximab and an antimetabolite and
had been in corticosteroid-free remission for at least 6 months. Infliximab was stopped, and patients were followed up for at least 1 year. We associated demographic,
clinical, and biologic factors with time to relapse using a Cox model.
RESULTS:
After a median follow-up period of 28 months, 52 of the 115 patients experienced a relapse; the 1-year relapse rate was 43.9% +- 5.0%. Based on multivariable analysis,
risk factors for relapse included male sex, the absence of surgical resection, leukocyte counts >6.0 * 10(9)/L, and levels of hemoglobin <=145 g/L, C-reactive protein
>=5.0 mg/L, and fecal calprotectin >=300 µg/g. Patients with no more than 2 of these risk factors (approximately 29% of the study population) had a 15% risk of
relapse within 1 year. Re-treatment with infliximab was effective and well tolerated in 88% of patients who experienced a relapse.
CONCLUSIONS:
Approximately 50% of patients with Crohn's disease who were treated for at least 1 year with infliximab and an antimetabolite agent experienced a relapse within 1 year after
discontinuation of infliximab. However, patients with a low risk of relapse can be identified using a combination of clinical and biologic markers.
Comment by Prof Dr P. Michetti
Longterm anti-TNF therapy is still a matter of debate. On the one hand, the efficacy of maintenance therapy is demonstrated, but there are still
concerns about the safety of longterm exposure to these agents. Furthermore, patients experiencing high quality of life without relapse often
question the need to continue therapy. Finally there are costs concerns about keeping an ever growing cohort of patients on biological.
The study, know as the STORI study by the GETAID, provide useful results on the efficacy of a stopping strategy and defines factors associated
with a successful interruption of infliximab. In addition, the high proportion of successful re-introduction of infliximab provides reinsurance
in case a drug interruption strategy is followed. Another study by Rizzi et al (not yet reported in full, UEGW 2009) provided similar results.
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