Abstract
Background: This study aimed to explore whether differences exist between males and females in a cohort of bio-experienced UC patients treated with vedolizumab (VDZ), ustekinumab (UST), or tofacitinib (TOFA) in a 48-week retrospective study. Methods: We evaluated intra- and inter-treatment sex-specific differences regarding clinical response, remission, steroid-free remission, sustained clinical response, late remission, and changes in faecal calprotectin and inflammatory markers at 8, 24, and 48 weeks, as well as endoscopic response and remission at 48 weeks. Results: Among 602 patients (50.2% female), males treated with UST had higher rates of clinical (p = 0.029) and steroid-free clinical remission (p = 0.013) at 24 weeks. Conversely, females on TOFA showed higher clinical remission at 8 weeks (p = 0.043). In males, VDZ demonstrated a superior clinical response over time (p < 0.05), while TOFA showed the highest remission rate at 48 weeks. In females, TOFA was superior for clinical remission at 8 and 24 weeks (p < 0.05). Males had a higher late remission rate (p = 0.04) with an increased likelihood (aOR 1.958, 95%CI 1.088-3.524, p = 0.025). Endoscopic outcomes and faecal calprotectin levels showed no significant sex-specific differences. Conclusions: Sex-based profiling may guide individualised therapeutic strategies in UC patients in this setting.