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

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