Abstract Background The introduction of tumor necrosis factor (TNF) inhibitors, including adalimumab, has dramatically changed the treatment landscape for moderate-to-severe Crohn’s disease (CD). The availability of biosimilars has minimized the economic burden on patients and reduced global health inequalities while ensuring efficacy. However, the efficacy of adalimumab biosimilars for fistula CD is unclear. Methods Sixty patients with fistulas CD from July 2021 to July 2023 were included, and all of them were treated with adalimumab biosimilar treatment for 12 weeks (subcutaneous injection of 160 mg in the 0th week, 80 mg in the 2nd week, and 40 mg from the 4th to the 12th week), and the decision of whether to receive adalimumab conventional therapy (40 mg q2w) or incremental therapy (80 mg q2w) was made based on the patients’ traumatic response at the end of the 12-week period. The decision to follow up with regular (40 mg q2w) or incremental (80 mg q2w) treatment of adalimumab was made based on wound response after 12 weeks, and the dosage was again adjusted according to efficacy after 24 weeks, and the patients were followed up to 52 weeks. The primary outcome of this study was the fistula healing rate at 52 week. Secondary outcomes were fistula response rate, endoscopic response rate and endoscopic remission rate. Results A total of 60 patients with active fistula-type Crohn’s disease were enrolled in the study. Most of the enrolled patients were in the middle-aged and young age group, with a mean age of (26.8±9.5) years, 75.5% males, CDAI score (180.9±97.62), SES-CD score (15.69±7.79), and PDAI score (4.58±2.12). In the conventional treatment group, the fistula response rate was 57.89%, 65.22% and 73.91% at 12, 24 and 52 weeks, respectively; the fistula healing rate was 55.26%, 69.57% and 65.22%, respectively; the endoscopic response rate was 60.53%, 82.61% and 100%, respectively; and the endoscopic relief rate was 36.84%, 73.91% and 86.96%, respectively. In the incremental treatment group, the fistula response rate was 12.5%, 66.67% and 66.67% at 12, 24 and 52 weeks, respectively; the fistula healing rate was 12.5%, 66.67% and 0, respectively; the endoscopic response rate was 50%, 66.67% and 66.67%, respectively; and the endoscopic remission rate was 0, 0 and 16.67%, respectively. All patients had no adverse drug reactions or serious infections during treatment. Conclusion In the real world, adalimumab biosimilar dose escalation treatment may somewhat improve fistula response rates and endoscopic response rates in fistulous CD patients initially treated with biologics, but has a limited effect on fistula healing rates and endoscopic remission rates.
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