A Comparative Study of Different Biological Drugs in First-Line Therapy in Crohn's Disease: A Multicenter Descriptive Analysis.

Background and

Objectives

Biologic agents have emerged as the most important therapeutic weapon in the treatment of Crohn's disease (CD). The aim of this study is to describe the population of patients who received different molecules as first-line therapy and their persistence on first-line therapy. Materials and

Methods

622 patients from six gastroenterology departments from Bucharest, Iasi and Cluj treated between 2006 and 2024 were included in the study. A total of 87 (14%) were excluded because they received only mesalazine. A total of 535 were included in the final analysis. The main outcomes were clinical response and remission at 12 weeks of treatment and serious adverse events.

Results

Three groups of patients were identified based on the first-line treatment: 45% of patients received adalimumab, 40% were treated with infliximab, and in 12.6% ustekinumab was given. Regarding the clinical and demographic characteristics, there are significant differences among the three patient groups in terms of age, disease extent, disease phenotype, proportion of individuals with perianal fistulas, clinical severity and the proportion of patients who underwent surgery. Median therapy duration was 48 months (6 ÷ 330). The three biologics studied (adalimumab, infliximab and ustekinumab) had a similar rate of clinical remission of 80%, the non-response rate also being similar (6.5%), but persistence on therapy at 2 years was better for adalimumab (66%) and infliximab (60%) compared to ustekinumab (45%) (p = 0.06). Serious adverse events leading to therapy discontinuation were more frequent in those treated with infliximab (10%) compared to adalimumab (3%) and ustekinumab (6%) (p = NS).

Conclusions

There were significant baseline differences between the treatment groups, so this study represents an unadjusted comparison between the results obtained with different biologics in first-line treatment for Crohn's disease. All three biological agents used in real life for Crohn's disease therapy show similar efficacy, with an early clinical remission rate of approximately 80% and a non-response rate of 6.5%.