Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study.

BACKGROUND AND AIMS

Home self-injection of the human anti-TNFα monoclonal adalimumab complicates prospective serial-sampling studies. Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease patients, prospective real-world data from Ulcerative Colitis patients is lacking.

METHODS

A three-monthly home-visit program from induction was established prospectively for Ulcerative Colitis patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a Smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab treated Crohn's disease patients (POETIC1).

RESULTS

Fifty Ulcerative Colitis patients starting adalimumab (median follow-up 28 weeks) were compared to 98 adalimumab-treated Crohn's disease patients (median follow-up 44 weeks). Only 11/50 Ulcerative Colitis patients (22%) continued treatment to the end of the follow-up compared with 50/98 (51%) retention of Crohn's disease patients (OR=0.27, P=0.001). Loss of response was significantly more common in Ulcerative Colitis patients (P=0.001, OR=3.2).Seventeen patients (34%) in the Ulcerative Colitis cohort developed anti-adalimumab antibodies; 9/17 (52.9%) as early as week 2. There was no difference between between patient cohorts in the overall development of anti-adalimumab antibodies (34% versus 30.6% respectively, OR=1.67, P=0.67), nor was there a difference in early immunogenicity (OR=1.39, P=0.35). There was no difference in low drug levels (<3µg/ml) between the two cohorts (OR=0.87, P=0.83).

CONCLUSIONS

Loss of response to adalimumab therapy was significantly more common in the Ulcerative Colitis compared to the Crohn's disease cohort and was driven by a higher rate of non-immunogenic, pharmacodynamic parameters.

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: [e-mail].