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Effectiveness of adalimumab for the treatment of ulcerative colitis in clinical practice: comparison between anti-tumour necrosis factor-naïve and non-naïve patients

Journal of Gastroenterology volume 52, pages 788–799 (2017)Cite this article

An Erratum to this article was published on 24 November 2016

This article has been updated

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.

Author information

Affiliations

  1. Gastroenterology Department and CIBEREHD, Hospital Universitari i Politecnic La Fe, Avinguda de Fernando Abril Martorell, no 106, 46026, Valencia, Spain

    Marisa Iborra

  2. Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

    Javier Pérez-Gisbert

  3. Gastroenterology Department, Hospital Clínic Universitari de Valencia and INCLIVA Health Research Institute, Valencia, Spain

    Marta Maia Bosca-Watts

  4. Departamento de Gastroenterología, Hospital Clinic i Provincial, C/Villarroel 170, 08036, Barcelona, Spain

    Alicia López-García

  5. Hospital Reina Sofía, IMIBIC, Universidad de Córdoba, Córdoba, Spain

    Valle García-Sánchez

  6. Gastroenterology Department, Hospital Ramón y Cajal, Madrid, Spain

    Antonio López-Sanromán

  7. Servicio de Medicina Digestivo, Hospital de Manises, Valencia, Spain

    Esther Hinojosa

  8. Metgessa adjunta. Servei de Digestiu, Parc de Salut Mar, Barcelona, Spain

    Lucía Márquez

  9. Departamento de Gastroenterología, Hospital Universitario Miguel Servet, Saragossa, Spain

    Santiago García-López

  10. Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

    María Chaparro

  11. Hospital Universitari Mútua Terrassa, Plaça Doctor Robert, 08221, Terrassa, Barcelona, Spain

    Montserrat Aceituno

  12. Servei d’Aparell Digestiu, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

    Margalida Calafat

  13. Digestive Diseases Department, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain

    Jordi Guardiola

  14. Hospital San Jorge Huesca, Avenida Martínez de Velasco 36, 22004, Huesca, Spain

    Blanca Belloc

  15. Médico adjunto, Servicio de Aparato Digestivo, Hospital Clínico Universitario “Lozano Blesa”, IIS Aragón., CIBEREHD, Saragossa, Spain

    Yolanda Ber

  16. Department of Gastroenterology, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universidad del País Vasco (UPV/EHU), San Sebastián, Guipúzcoa, Spain

    Luis Bujanda

  17. Gastroenterology Department, Hospital Universitari i Politecnic La Fe, CIBEREHD, Valencia, Spain

    Belén Beltrán

  18. Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain

    Cristina Rodríguez-Gutiérrez

  19. Servicio de Gastroenterología, Hospital Universitario Río Hortega, C/Dulzaina, no 2, 47012, Valladolid, Spain

    Jesús Barrio

  20. Hospital de Galdakao, Galdakao, Bilbao, Spain

    José Luis Cabriada

  21. Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Montserrat Rivero

  22. Gastroenterology Department, Hospital Clínico Virgen de la Victoria, Málaga, Spain

    Raquel Camargo

  23. Hospital Universitario de Torrejón, C/Mateo Inurria, s/n, 28850, Torrejón de Ardoz, Madrid, Spain

    Manuel van Domselaar

  24. Servei de Malalties Digestives, Hospital Parc Tauli de Sabadell, Departament de Medicina, Universitat Autònoma de Barcelona, CIBEREHD-Instituto de Salud Carlos III, Barcelona, Spain

    Albert Villoria

  25. Hospital Nuestra Señora de la Candelaria, Tenerife, Islas Canarias, Spain

    Hugo Salata Schuterman

  26. Unidad Bioestadística, Instituto de Investigación Sanitaria La Fe, Valencia, Spain

    David Hervás

  27. Gastroenterology Department, CIBEREHD, Hospital Universitari i Politecnic La Fe, Valencia, Spain

    Pilar Nos

Authors
  1. Marisa Iborra
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  2. Javier Pérez-Gisbert
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  3. Marta Maia Bosca-Watts
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  4. Alicia López-García
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  5. Valle García-Sánchez
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  7. Esther Hinojosa
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Consortia

Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU).

Corresponding author

Correspondence to Marisa Iborra.

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Conflicts of interest and source of funding

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.

Additional information

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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Keywords

  • Adalimumab
  • Ulcerative colitis
  • Treatment