Sex-Specific Real-Life Profiling in Vedolizumab, Ustekinumab, and Tofacitinib Effectiveness in Ulcerative Colitis

TL;DR

This study found that male and female ulcerative colitis patients respond differently to certain medications, suggesting the need for sex-specific treatment strategies.

Contribution

The study identifies sex-specific differences in the effectiveness of vedolizumab, ustekinumab, and tofacitinib in ulcerative colitis patients.

Findings

Males on ustekinumab had higher clinical and steroid-free remission at 24 weeks.

Females on tofacitinib showed higher clinical remission at 8 weeks.

Tofacitinib was superior for female clinical remission at 8 and 24 weeks.

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.

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