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Retention Rate, Persistence and Safety of Adalimumab in Inflammatory Bowel Disease: A Real-Life, 9-Year, Single-Center Experience in Italy

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Abstract

Background

“Real-life” data of retention rate and persistence of adalimumab in inflammatory bowel disease are still limited.

Aims

To analyze retention rate, persistence, and safety of adalimumab in a 9-year real-life cohort of inflammatory bowel disease patients.

Methods

In this observational, retrospective single-center study, all adult patients treated with adalimumab as the first- and second-line biological treatment for steroid-dependent or refractory inflammatory bowel disease between March 2008 and March 2017 were included. Primary outcomes were persistence, retention rate, and adverse events; the secondary outcome was the identification of predictors of withdrawal.

Results

Ninety-six out of 181 patients (53%) withdrew their first course of adalimumab. The retention rate was 47% and 46.9% in Crohn’s disease and ulcerative colitis patients, respectively; median persistence was 26 and 24 months in CD and UC patients, respectively. The cumulative probability of treatment persistence was 80.2%, 54.5%, and 29.6% and 69.6%, 40.4%, and 21.5% in CD and UC patients, respectively. The incidence rate of any adverse event was 12.5/100 patients-year; severe adverse events were 1.7/100 patients-year. The Cox regression revealed that CD patients with baseline disease duration > 72 months have a higher likelihood for withdrawal due to failure and/or adverse events (HR 1.62, 95% CI 1–2.62, p = 0.04); no predictors of discontinuation were found in UC.

Conclusions

Adalimumab showed a great persistence in the first 12 months of therapy and excellent safety profile. Early treatment of CD patients could increase efficacy and reduce the adverse event rate.

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Authors and Affiliations

  1. Department of Medical and Surgical Sciences, Sant’Orsola-Malpighi Hospital, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy

    Alessandro Sartini, Eleonora Scaioli, Elisa Liverani, Matteo Bellanova, Luigi Ricciardiello, Franco Bazzoli & Andrea Belluzzi

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  1. Alessandro Sartini
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  2. Eleonora Scaioli
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  3. Elisa Liverani
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  4. Matteo Bellanova
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  6. Franco Bazzoli
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Correspondence to Andrea Belluzzi.

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Sartini, A., Scaioli, E., Liverani, E. et al. Retention Rate, Persistence and Safety of Adalimumab in Inflammatory Bowel Disease: A Real-Life, 9-Year, Single-Center Experience in Italy. Dig Dis Sci 64, 863–874 (2019). https://doi.org/10.1007/s10620-018-5329-4

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  • DOI: https://doi.org/10.1007/s10620-018-5329-4

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