Abstract
Background
Ulcerative colitis (UC) treatment is focused to achieve mucosal healing, avoiding disease progression. The study aimed to evaluate the real-world effectiveness of adalimumab (ADA) in UC and to identify predictors of remission to ADA.
Methods
This cohort study used data from the ENEIDA registry. Clinical response, clinical remission, endoscopic remission, adverse events (AE), colectomy, and hospitalisations were evaluated; baseline characteristics and biological parameters were compared to determine predictors of response.
Results
We included 263 patients (87 naïve and 176 previously exposed to anti-tumour necrosis factor alpha, TNF). After 12 weeks, clinical response, clinical remission, and endoscopic remission rates were 51, 26, and 14 %, respectively. The naïve group demonstrated better response to treatment than the anti-TNF-exposed group at short-term. Clinical and endoscopic remission within 1 year of treatment was better in the naïve group (65 vs. 49 and 50 vs. 35 %, respectively). The rates of AE, dose-escalation, hospitalisations, and colectomy during the first year were higher in anti-TNF-exposed patients (40, 43, and 27 % vs. 26, 21, and 11 %, respectively). Patients with primary failure and intolerance to the first anti-TNF and severe disease were associated with worse clinical response. Primary non-response to prior anti-TNF treatment and severe disease were predictive of poorer clinical remission. Low levels of C-reactive protein (CRP) and faecal calprotectin (FC) at baseline were predictors of clinical remission.
Conclusions
In clinical practice, ADA was effective in UC, especially in anti-TNF naïve patients. FC and CRP could be predictors of treatment effectiveness.
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Change history
24 November 2016
An erratum to this article has been published.
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Acknowledgments
All authors were involved in the acquisition of data and approval of the manuscript; Dr. Iborra was involved in the conception and design of the study, as well as the acquisition, analysis and interpretation of data; Drs. Iborra, Nos, and Pérez-Gisbert also oversaw the critical revision and incorporation of important intellectual content. Statistical assistance was provided by David Hervas, Unidad Bioestadística. Instituto de Investigación Sanitaria La Fe, Valencia. Editorial assistance (English language editing and formatting of the manuscript) was provided by Matt Weitz of Springer Healthcare Communications. This was funded by Abbvie ES.
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Dr. Gisbert has served as a speaker, a consultant and advisory member for or has received research funding from MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma. Dr. García-Sánchez has served as a speaker, a consultant and advisory member for MSD and Abbvie. Dr. López-Sanromán has served as a speaker, a consultant and advisory member for MSD and Abbvie. Dr. Jordi Guardiola has received grant support from Abbvie, MSD, and GE, advisory board fees from Abbvie, Ferring, Gebro Pharma and Kern Pharma, lecture fees from Abbvie, MSD, GE, Ferring, Shire, Gebro Pharma, Thermo Fisher and Tillots. Dr. Cabriada has served as a speaker for MSD, Abbvie and Otsuka. Dr. Nos has served as a speaker for MSD, Abbvie, and Ferring. The other authors have no conflicts of interest to disclose. This work was not supported by any funding.
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An erratum to this article is available at https://doi.org/10.1007/s00535-016-1293-y.
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Iborra, M., Pérez-Gisbert, J., Bosca-Watts, M.M. et al. Effectiveness of adalimumab for the treatment of ulcerative colitis in clinical practice: comparison between anti-tumour necrosis factor-naïve and non-naïve patients. J Gastroenterol 52, 788–799 (2017). https://doi.org/10.1007/s00535-016-1274-1
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DOI: https://doi.org/10.1007/s00535-016-1274-1