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Volume 18
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10.3390/ph18040557
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Article

Effect of Tofacitinib on Hemostasis in Patients with Ulcerative Colitis: A Comparative Ex Vivo Study

by
Cristina Sánchez-Sánchez
1,†,
Fabio Suarez-Trujillo
1,†,
Cristina Ramírez
1,
Irene Soleto
1,
Jorge Mercado
1,
Macarena Orejudo
1,
Paula J. Martínez
1,
Celia Rubio Collado
2,
Mar Orts
3,
María Jesús Rubio Franco
2,
Antonio Planas
3,
Natalia Acedo
2,
Nora Butta
4,
María Chaparro
1,*,‡,
Javier P. Gisbert
1,§ and
Montse Baldán-Martín
1,*,‡,§
1
Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), 28006 Madrid, Spain
2
Servicio de Hematología, Hospital Universitario de La Princesa, 28006 Madrid, Spain
3
Servicio de Anestesiología y Reanimación, Hospital Universitario de La Princesa, 28006 Madrid, Spain
4
Grupo de Coagulopatías y Trastornos de la Hemostasia, Hospital Universitario de La Paz-IdiPAZ, 28046 Madrid, Spain
*
Authors to whom correspondence should be addressed.
†
First authors equal contribution.
‡
Current address: Inflammatory Bowel Disease Unit, Hospital Universitario de La Princesa, Diego de León, 62, 28006 Madrid, Spain.
§
Senior authors equal contribution.
Pharmaceuticals 2025, 18(4), 557; https://doi.org/10.3390/ph18040557
Submission received: 18 March 2025 / Revised: 2 April 2025 / Accepted: 8 April 2025 / Published: 10 April 2025
(This article belongs to the Section Pharmacology)
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Abstract

Background: Tofacitinib is effective for refractory ulcerative colitis (UC), a chronic inflammatory disease of the colonic mucosa. However, its use has been associated with an increased risk of thromboembolic events, prompting regulatory restrictions. Understanding the pathophysiological mechanisms contributing to these potential risks is critical for patient safety. We aim to evaluate and compare ex vivo the effects of tofacitinib and anti-TNF on coagulation parameters and platelet function. Methods: Whole blood and platelet-rich plasma from 10 active UC (aUC) and 10 quiescent UC (qUC) patients and 10 healthy controls (HC) were spiked ex vivo with tofacitinib, anti-TNF (as comparator), or a sterile solution. Coagulation kinetics were measured by rotational thromboelastometry (ROTEM), platelet aggregation by aggregometry, and platelet activation by flow cytometry. The study was conducted at Hospital Universitario de La Princesa. Results: Flow cytometry showed increased expression of activation markers CD62P and CD63 and higher PAC-1 binding in platelets from both aUC and qUC patients incubated with either tofacitinib or anti-TNF versus no drug. No differences were found between the drugs. CD63 expression also increased in HC after drug exposure, with no differences between anti-TNF or tofacitinib. Platelet aggregation and coagulation parameters did not differ between tofacitinib, anti-TNF, and no drug in aUC, qUC, and HC. Conclusions: Tofacitinib does not alter platelet function or coagulation in UC patients under ex vivo conditions compared to anti-TNF. The increased thromboembolic risk observed in some populations treated with tofacitinib cannot be attributed to these factors in UC patients.
Keywords: tofacitinib; ulcerative colitis; platelet aggregation; platelet activation; thromboelastometry tofacitinib; ulcerative colitis; platelet aggregation; platelet activation; thromboelastometry

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MDPI and ACS Style

Sánchez-Sánchez, C.; Suarez-Trujillo, F.; Ramírez, C.; Soleto, I.; Mercado, J.; Orejudo, M.; Martínez, P.J.; Rubio Collado, C.; Orts, M.; Rubio Franco, M.J.; et al. Effect of Tofacitinib on Hemostasis in Patients with Ulcerative Colitis: A Comparative Ex Vivo Study. Pharmaceuticals 2025, 18, 557. https://doi.org/10.3390/ph18040557

AMA Style

Sánchez-Sánchez C, Suarez-Trujillo F, Ramírez C, Soleto I, Mercado J, Orejudo M, Martínez PJ, Rubio Collado C, Orts M, Rubio Franco MJ, et al. Effect of Tofacitinib on Hemostasis in Patients with Ulcerative Colitis: A Comparative Ex Vivo Study. Pharmaceuticals. 2025; 18(4):557. https://doi.org/10.3390/ph18040557

Chicago/Turabian Style

Sánchez-Sánchez, Cristina, Fabio Suarez-Trujillo, Cristina Ramírez, Irene Soleto, Jorge Mercado, Macarena Orejudo, Paula J. Martínez, Celia Rubio Collado, Mar Orts, María Jesús Rubio Franco, and et al. 2025. "Effect of Tofacitinib on Hemostasis in Patients with Ulcerative Colitis: A Comparative Ex Vivo Study" Pharmaceuticals 18, no. 4: 557. https://doi.org/10.3390/ph18040557

APA Style

Sánchez-Sánchez, C., Suarez-Trujillo, F., Ramírez, C., Soleto, I., Mercado, J., Orejudo, M., Martínez, P. J., Rubio Collado, C., Orts, M., Rubio Franco, M. J., Planas, A., Acedo, N., Butta, N., Chaparro, M., Gisbert, J. P., & Baldán-Martín, M. (2025). Effect of Tofacitinib on Hemostasis in Patients with Ulcerative Colitis: A Comparative Ex Vivo Study. Pharmaceuticals, 18(4), 557. https://doi.org/10.3390/ph18040557

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