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Risk Factors for Rescue Therapy in Crohn’s Patients Maintained on Infliximab After Withdrawal of the Immunomodulator: A Long-Term Follow-Up

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Abstract

Background

Usefulness of thiopurine and scheduled infliximab combination therapy in non-immunomodulator (IM)-naïve Crohn’s disease (CD) patients and the optimal length of dual therapy are still debated.

Aims

To determine proportion of patients developing disease flare requiring rescue therapy and risk factors associated with disease flare after de-escalation of IM from combination therapy.

Methods

Adult CD patients in clinical remission on combination therapy were identified from a large single-center database between 2002 and 2009. Patients who had their IM stopped in the absence of adverse events were included. Association between clinical and demographic variables and time until rescue therapy was analyzed using Cox-proportional hazard models.

Results

Forty-three CD patients on combination therapy in clinical remission at time of IM de-escalation were identified and followed up for a median duration of 61.6 months (range 5.4–129.5). Median duration of remission on combination therapy prior to IM de-escalation was 12.0 months (range 4–74). Thirty-one patients (72.1%) required rescue therapy during follow-up. On multivariable analysis, age at diagnosis < 16 years versus > 40 years (HR 4.55, 95% CI 1.18–17.62, p = 0.028), using methotrexate instead of azathioprine in combination with infliximab (HR 3.37, 95% CI 1.14, 9.96, p = 0.028), and duration of combination therapy < 6 months (HR 5.68, 95% CI 1.58, 20.36, p = 0.007) increased risk for rescue therapy.

Conclusions

A large proportion of CD patients on combination therapy experienced a flare following IM withdrawal. Young age at diagnosis, short duration of combination therapy, and methotrexate use were independent predictors of the need for rescue therapy.

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Indiana University, 550 N. University Blvd, Indianapolis, IN, 46202, USA

    Monika Fischer, Sarah C. Campbell & Debra J. Helper

  2. Department of Biostatistics, The Richard M. Fairbanks School of Public Health and School of Medicine, Indiana University, Indianapolis, IN, USA

    Cynthia S. J. Calley

  3. Division of Gastroenterology and Hepatology, Virginia Mason Medical Center, Seattle, WA, USA

    Michael V. Chiorean

  4. Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Butler University, 4600 Sunset Ave, Indianapolis, IN, 46208, USA

    Hala M. Fadda

Authors
  1. Monika Fischer
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  2. Sarah C. Campbell
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  3. Cynthia S. J. Calley
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  4. Debra J. Helper
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  5. Michael V. Chiorean
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  6. Hala M. Fadda
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Corresponding authors

Correspondence to Monika Fischer or Hala M. Fadda.

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Fischer, M., Campbell, S.C., Calley, C.S.J. et al. Risk Factors for Rescue Therapy in Crohn’s Patients Maintained on Infliximab After Withdrawal of the Immunomodulator: A Long-Term Follow-Up. Dig Dis Sci 62, 3131–3137 (2017). https://doi.org/10.1007/s10620-017-4771-z

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  • DOI: https://doi.org/10.1007/s10620-017-4771-z

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