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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

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

by
Antonio Tursi
1,2,*,†,
Raffaele Pellegrino
3,†,
Giammarco Mocci
4,
Edoardo Vincenzo Savarino
5,
Giovanni Maconi
6,
Walter Elisei
7,
Antonietta Gerarda Gravina
3 and
Italian Network for Inflammatory Bowel Diseases (IN-IBD)
‡
1
Barletta-Andria-Trani (BAT) Local Health Agency, 76123 Andria, Italy
2
Department of Medical and Surgical Sciences, Catholic University of Rome, 00168 Rome, Italy
3
Hepatogastroenterology Division, Department of Precision Medicine, University of Campania Luigi Vanvitelli, 80138 Naples, Italy
4
Division of Gastroenterology, AORN “Brotzu” Hospital, 09134 Cagliari, Italy
5
Gastroenterology Unit, Azienda Ospedale-Università di Padova (AOUP), 35128 Padua, Italy
6
Gastroenterology Unit, Department of Biomedical and Clinical Sciences, “L. Sacco” University Hospital, 20157 Milan, Italy
7
Division of Gastroenterology, A.O. “S. Camillo-Forlanini”, 00152 Rome, Italy
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work and share the first authorship.
‡
The members of the IN-IBD collaborative study group are listed in Appendix A.
J. Clin. Med. 2025, 14(21), 7476; https://doi.org/10.3390/jcm14217476
Submission received: 26 September 2025 / Revised: 16 October 2025 / Accepted: 18 October 2025 / Published: 22 October 2025
(This article belongs to the Special Issue Clinical Research and Personalized Medicine in Inflammatory Bowel Disease)
Versions Notes

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.
Keywords: sex; ulcerative colitis; tofacitinib; vedolizumab; ustekinumab sex; ulcerative colitis; tofacitinib; vedolizumab; ustekinumab

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MDPI and ACS Style

Tursi, A.; Pellegrino, R.; Mocci, G.; Savarino, E.V.; Maconi, G.; Elisei, W.; Gravina, A.G.; Italian Network for Inflammatory Bowel Diseases (IN-IBD). Sex-Specific Real-Life Profiling in Vedolizumab, Ustekinumab, and Tofacitinib Effectiveness in Ulcerative Colitis. J. Clin. Med. 2025, 14, 7476. https://doi.org/10.3390/jcm14217476

AMA Style

Tursi A, Pellegrino R, Mocci G, Savarino EV, Maconi G, Elisei W, Gravina AG, Italian Network for Inflammatory Bowel Diseases (IN-IBD). Sex-Specific Real-Life Profiling in Vedolizumab, Ustekinumab, and Tofacitinib Effectiveness in Ulcerative Colitis. Journal of Clinical Medicine. 2025; 14(21):7476. https://doi.org/10.3390/jcm14217476

Chicago/Turabian Style

Tursi, Antonio, Raffaele Pellegrino, Giammarco Mocci, Edoardo Vincenzo Savarino, Giovanni Maconi, Walter Elisei, Antonietta Gerarda Gravina, and Italian Network for Inflammatory Bowel Diseases (IN-IBD). 2025. "Sex-Specific Real-Life Profiling in Vedolizumab, Ustekinumab, and Tofacitinib Effectiveness in Ulcerative Colitis" Journal of Clinical Medicine 14, no. 21: 7476. https://doi.org/10.3390/jcm14217476

APA Style

Tursi, A., Pellegrino, R., Mocci, G., Savarino, E. V., Maconi, G., Elisei, W., Gravina, A. G., & Italian Network for Inflammatory Bowel Diseases (IN-IBD). (2025). Sex-Specific Real-Life Profiling in Vedolizumab, Ustekinumab, and Tofacitinib Effectiveness in Ulcerative Colitis. Journal of Clinical Medicine, 14(21), 7476. https://doi.org/10.3390/jcm14217476

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