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CC BY 4.0 · Journal of Coloproctology 2024; 44(03): e187-e195
DOI: 10.1055/s-0044-1789223
Original Article

Certolizumab Pegol in Crohn's Disease Management: A Multicentric Brazilian Observational Study

Authors

  • Thaisa Kowalski Furlan 

    1   Department of Gastroenterology, Clinics Hospital, Federal University of Paraná (UFPR), Curitiba, PR, Brazil

  • Marcello Imbrizi

    2   IBD Outpatient Clinics, Mário Gatti Municipal Hospital, Curitiba, PR, Brazil

  • Daniela Magro

    3   Department of Surgery, Campinas State University (UNICAMP), Curitiba, PR, Brazil

  • Paula C. Senger de Castro

    4   Department of Gastroenterology, Nossa Senhora das Graças Hospital, Curitiba, PR, Brazil

  • Rodrigo Bremer Nones

    4   Department of Gastroenterology, Nossa Senhora das Graças Hospital, Curitiba, PR, Brazil

  • Eron Fabio Miranda

    5   School of Medicine, Pontifical Catholic University of Paraná (PUCPR), Curitiba, PR, Brazil

  • Paulo G. Kotze

    6   Health Sciences Postgraduate Program, School of Medicine, Pontifical Catholic University of Paraná (PUCPR), Curitiba, PR, Brazil
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Abstract

Introduction and Objectives Certolizumab Pegol (CZP) is an anti-TNF agent approved in Brazil for Crohn's disease (CD). There is a lack of data in Brazil and Latin America detailing real-world experiences with CZP. The primary objective was clinical remission in weeks 26 and 54. The secondary endpoints were clinical response in weeks 26 and 54, endoscopic remission, biological switch rates, rates of CD-related surgery, persistence with treatment over time, and adverse events. Remission and clinical response were defined as HBI ≤4 and ≥3 points reduction of HBI, respectively. Endoscopic remission was defined as the complete healing of the intestinal mucosa.

Methods This observational and retrospective study included patients with CD from 4 Brazilian centers who received CZP during their disease course.

Results Forty-five patients were included. The median age was 42.16 years old, 53.3% had perianal involvement, 37.8% had undergone previous surgery, and 71.1% of patients were anti-TNF naïve. Clinical remission was observed in 73.2% and 62.5% of patients at weeks 26 and 54, respectively. Clinical response was observed in 14.63% and 18.75% in weeks 26 and 54, respectively. Endoscopic remission was observed in 36.4% of patients. A switch to biological therapy was performed in 57.8% of patients. Eleven patients underwent abdominal surgery; 62.25% discontinued treatment with CZP, with a median of 16 months, and 22.2% presented drug-related adverse events.

Conclusions CZP in CD was associated with clinical remission and response rates compatible with international real-world case series. Most patients needed to switch to biological therapy due to inadequate disease control.

Keywords

inflammatory bowel disease - Crohn's disease - monoclonal antibodies - certolizumab pegol

Ethical considerations

This study was approved by the Research Ethics Committee from the Catholic University of Paraná and all additional centers under reference number CAAE: 30359020.8.0000.0020, from the Ministry of Health National Ethics Board. Clinical research protocols and data confidentiality demands were followed, keeping the anonymity of each patient's data.


Authors' Contributions

Study concept and design (Thaisa Kowalski Furlan, Paulo Gustavo Kotze), acquisition of data (Thaisa Kowalski Furlan, Marcello Imbrizi, Paula Cenira Senger de Castro, Rodrigo Bremmer Nones, Eron Fábio Miranda) analysis and interpretation of data (Thaisa Kowalski Furlan, Daniela Magro, Paulo Gustavo Kotze), drafting of the manuscript (Thaisa Kowalski Furlan), critical revision of the manuscript for important intellectual content (Thaisa Kowalski Furlan, Paulo Gustavo Kotze), administrative, technical, and material support (Thaisa Kowalski Furlan, Paulo Gustavo Kotze), and study supervision (Paulo Gustavo Kotze, Daniela Magro). All authors have made a significant contribution to this study and have approved the final manuscript.


Supplementary Material



Publication History

Received: 09 June 2024

Accepted: 18 July 2024

Article published online:
04 September 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/)

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