Poor Drug Sustainability in Inflammatory Bowel Disease Patients in Clinical Remission on Thiopurine Monotherapy

Abstract

Background

Immunomodulator monotherapy is an important component in the treatment of inflammatory bowel disease (IBD). However, there is conflicting literature about thiopurines maintaining long-term remission in patients with active IBD.

Aim

To determine the durable clinical remission rate in adults with Crohn’s disease (CD) or ulcerative colitis (UC) on thiopurine monotherapy over 5 years.

Methods

We performed a retrospective analysis of adult patients identified at McGill University Health Centre from 2009 to 2012. We included IBD patients who initiated thiopurine monotherapy and were in remission for at least 3 months (Harvey–Bradshaw Index (HBI) < 5 points for CD and partial Mayo Score (pMS) < 2 points in UC). The primary endpoint was sustained clinical remission on thiopurines during a 5-year follow-up. This included patients who had not relapsed or discontinued the drug due to side effects. The secondary endpoint was clinical relapse over the follow-up period, which was defined as HBI > 5 in CD and pMS > 2 in UC.

Results

There were 148 patients included in the study (100 CD; 48 UC). At 5 years, 23% (34/148) patients remained in clinical remission on thiopurine monotherapy (25 CD and 9 UC patients). Thirty-three percent (33/100) of CD and 46% (22/48) of UC patients relapsed while on thiopurines. There was no difference in relapse rates between CD and UC patients. Eighty-four percent (42/50) of patients with CD with side effects and all UC (17/17) patients who experienced side effects discontinued the drug.

Conclusion

This analysis demonstrates that there is poor sustainability of clinical remission in IBD patients on thiopurine monotherapy given that a high proportion of patients discontinue thiopurines due to either relapse or side effects.

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Abbreviations

IBD:

Inflammatory bowel disease

UC:

Ulcerative colitis

CD:

Crohn’s disease

HBI:

Harvey–Bradshaw Index

pMS:

Partial Mayo Score

AZA:

Azathioprine

6-MP:

Mercaptopurine

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Correspondence to Bhairavi Balram.

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Conflict of interest

T. Bessissow has received honoraria and acted as a consultant for Janssen, AbbVie, Takeda, and Pfizer and acted as speaker for Janssen, AbbVie, Takeda, Ferring, Actavis, PendoPharm, and Shire. T. Bessissow has served as a speaker, a consultant, and an advisory board member for Janssen, AbbVie, Takeda, Pfizer, Ferring, PendoPharm, Shire and has received research funding from AbbVie and Janssen. PL Lakatos has been a speaker and/or advisory board member: AbbVie, EGIS, Falk Pharma, GmbH, Ferring, Genetech, Jansen, Kyowa, Hakko Kirin Pharma, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka Pharma, Pharmacosmos, Pfizer, Roche, Shire, and Takeda and has received unrestricted grants: AbbVie, MSD, and Pfizer. Waqqas Afif has served as a speaker and/or advisory board for AbbVie, Janssen, Takeda, Merck, Pfizer, Ferring, Shire, and received research grants from AbbVie, Theradiag, and Prometheus. Alain Bitton has received honorarium for participation in advisory boards from Allergan. Alain Bitton is a Consultant, Advisory Board: AbbVie, Janssen, Shire, Warner Chilcott, Takeda, and Speaker: AbbVie, Janssen, Shire, Warner Chilcott, Aptalis. GW has been a speaker and/or advisory board member for AbbVie, Janssen, Pfizer, Shire, and Takeda. B. Balram, Y. Theoret, and J. Lubov have no conflicts of interest to report.

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Balram, B., Lubov, J., Theoret, Y. et al. Poor Drug Sustainability in Inflammatory Bowel Disease Patients in Clinical Remission on Thiopurine Monotherapy. Dig Dis Sci (2020). https://doi.org/10.1007/s10620-020-06427-8

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Keywords

  • Thiopurine monotherapy
  • Relapse rates
  • Inflammatory bowel disease
  • Side effects