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Adalimumab Maintenance Treatment in Ulcerative Colitis: Outcomes by Prior Anti-TNF Use and Efficacy of Dose Escalation

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Abstract

Background

The impact of prior anti-TNF use on “real-life” outcomes of adalimumab therapy in ulcerative colitis (UC) is not well known.

Aim

To compare the influence of prior anti-TNF use on the outcomes of adalimumab maintenance treatment in UC patients. We also assessed the effectiveness of adalimumab dose escalation.

Methods

This retrospective multicenter cohort study included consecutive UC who advanced to an adalimumab maintenance regimen. Patients in whom adalimumab was discontinued prior to week eight of treatment were excluded. The co-primary efficacy endpoints were the cumulative probabilities of adalimumab failure-free survival and colectomy-free survival. We also assessed the need for and the effectiveness of adalimumab dose escalation.

Results

Of 184 UC on maintenance treatment with adalimumab, 116 (63%) had previous anti-TNF use. After a median follow-up of 23 months (interquartile range 13–49), 112 patients (60%) maintained corticosteroid-free clinical response. Sixty-nine patients (37%) had adalimumab failure, and 22 (12%) needed colectomy. Anti-TNF-naïve patients had significantly lower adjusted rates of adalimumab failure (hazard ratio [HR] 0.65; p < 0.001), adalimumab dose escalation (HR 0.35; p = 0.002), and need for colectomy (HR 0.26; p < 0.004). Seventy-six patients (41%) needed dose escalation after secondary loss of response, and 47% of these regained response after escalation. Short-term response after escalation was identified as a significant predictor of colectomy avoidance (HR 0.53; p = 0.007).

Conclusions

In this “real-life” cohort of UC patients on maintenance treatment with adalimumab, anti-TNF-naïve patients had significantly better long-term outcomes. Adalimumab dose escalation enabled recovery of response in nearly half of patients.

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Acknowledgments

The authors would like to thank Dr. C. Fernandez for her assistance in the statistical analysis and Dr. G. Morley for writing support and for reviewing the English manuscript.

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Authors and Affiliations

  1. Inflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico San Carlos, c/Profesor Martín Lagos s/n, 28040, Madrid, Spain

    Carlos Taxonera, David Olivares & Cristina Alba

  2. Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain

    Carlos Taxonera, David Olivares & Cristina Alba

  3. Hospital Reina Sofia, Córdoba, Spain

    Eva Iglesias

  4. Hospital Virgen Blanca, León, Spain

    Fernando Muñoz

  5. Hospital Puerta de Hierro, Madrid, Spain

    Marta Calvo

  6. Hospital Clínico, Santiago de Compostela, Spain

    Manuel Barreiro-de Acosta

  7. Hospital Josep Trueta, Girona, Spain

    David Busquets

  8. Corporació Sanitària Universitària Parc Taulí, Sabadell, Spain

    Xavier Calvet, Javier P. Gisbert & María Chaparro

  9. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

    Xavier Calvet

  10. Hospital Clínico, Salamanca, Spain

    Antonio Rodríguez

  11. Hospital Infanta Sofia, Madrid, Spain

    Ramón Pajares

  12. Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain

    Javier P. Gisbert & María Chaparro

  13. Hospital Universitario Fundación Alcorcón, Madrid, Spain

    Pilar López-Serrano & José Luís Pérez-Calle

  14. Hospital Infanta Leonor, Madrid, Spain

    Ángel Ponferrada

  15. Hospital de Cabueñes, Gijón, Spain

    Cristóbal De la Coba

  16. Hospital de Fuenlabrada, Madrid, Spain

    Fernando Bermejo

  17. Hospital Moncloa, Madrid, Spain

    Ignacio Fernández-Blanco

Authors
  1. Carlos Taxonera
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  2. Eva Iglesias
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  3. Fernando Muñoz
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  4. Marta Calvo
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  5. Manuel Barreiro-de Acosta
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  6. David Busquets
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  7. Xavier Calvet
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  8. Antonio Rodríguez
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  9. Ramón Pajares
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  10. Javier P. Gisbert
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  11. Pilar López-Serrano
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  12. José Luís Pérez-Calle
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  13. Ángel Ponferrada
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  14. Cristóbal De la Coba
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  15. Fernando Bermejo
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  16. María Chaparro
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  17. David Olivares
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  18. Cristina Alba
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  19. Ignacio Fernández-Blanco
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Corresponding author

Correspondence to Carlos Taxonera.

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Conflict of interest

CT, MB, AR, JLP, AP, FB, and IF have served as a speaker and/or consultant for or have received research funding from MSD and AbbVie. FM, MC, XC, JPG, and MCH have served as a speaker and/or consultant for or have received research funding from MSD, AbbVie, and Takeda. CdeC have served as a speaker and/or consultant for AbbVie. The remaining authors declare that they have nothing to disclose.

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Taxonera, C., Iglesias, E., Muñoz, F. et al. Adalimumab Maintenance Treatment in Ulcerative Colitis: Outcomes by Prior Anti-TNF Use and Efficacy of Dose Escalation. Dig Dis Sci 62, 481–490 (2017). https://doi.org/10.1007/s10620-016-4398-5

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  • DOI: https://doi.org/10.1007/s10620-016-4398-5

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