Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events

Inclusion criteria

• EX VIVO STUDY IN PATIENTS WITH UC
• PATIENTS WITH UC:
• Over 18 years old.
• Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).
• Previous treatments are allowed, provided they have remained stable for the past 3 months.
• In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).
• Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are:
• Intrauterine device (IUD).
• Bilateral tubal occlusion.
• Couple with vasectomy.
• Sexual abstinence.
• INDIVIDUALS WITHOUT UC:
• Over 18 years old.
• Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases.
• Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are:
• Intrauterine device (IUD).
• Bilateral tubal occlusion.
• Couple with vasectomy.
• Sexual abstinence.
• IN VIVO STUDY IN PATIENTS WITH UC
• PATIENTS WITH UC:
• Over 18 years old.
• Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).
• Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib.
• Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action.
• Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).
• Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study
• Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are:
• Intrauterine device (IUD).
• Bilateral tubal occlusion.
• Couple with vasectomy.
• Sexual abstinence.
• INDIVIDUALS WITHOUT UC:
• Over 18 years old.
• Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases.
• Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are:
• Intrauterine device (IUD).
• Bilateral tubal occlusion.
• Couple with vasectomy.
• Sexual abstinence.

Exclusion criteria

• EX VIVO STUDY IN PATIENTS WITH UC
• PATIENTS WITH UC:
• Under 18 years old.
• Immune-mediated disease, neoplasm or active infection.
• Pregnancy or lactation.
• Alcohol or drug abuse.
• Ostomy.
• Abdominal surgery in the last 6 months.
• Colectomy.
• Active infection with hepatitis B, C or HIV virus.
• Medical history of thromboembolic events.
• Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.
• Use of combined hormonal contraceptives or hormone replacement therapy.
• Hereditary coagulation disorders.
• Refusal to give consent for participation in the study.
• INDIVIDUALS WITHOUT UC:
• Under 18 years of age.
• Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.
• Pregnancy or lactation.
• Alcohol or drug abuse.
• Ostomy.
• Abdominal surgery in the last 6 months.
• Colectomy.
• Active infection with hepatitis B, C or HIV virus.
• Medical history of thromboembolic events.
• Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.
• Use of combined hormonal contraceptives or hormone replacement therapy.
• Hereditary coagulation disorders.
• Refusal to give consent for participation in the study.
• IN VIVO STUDY IN PATIENTS WITH UC
• PATIENTS WITH UC:
• Under 18 years old.
• Immune-mediated disease.
• Neoplasm or active infection.
• Pregnancy or lactation.
• Alcohol or drug abuse.
• Ostomy.
• Colectomy.
• Active infection with hepatitis B, C or HIV virus.
• Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.
• Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors)
• Medical history of thromboembolic events.
• Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.
• Use of combined hormonal contraceptives or hormone replacement therapy.
• Hereditary coagulation disorders.
• Refusal to give consent for participation in the study.
• INDIVIDUALS WITHOUT UC:
• Under 18 years of age.
• Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.
• Pregnancy or lactation.
• Alcohol or drug abuse.
• Active infection with hepatitis B, C or HIV virus.
• Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy.
• Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.
• Medical history of thromboembolic events.
• Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.
• Use of combined hormonal contraceptives or hormone replacement therapy.
• Hereditary coagulation disorders.
• Refusal to give consent for participation in the study.
• Abdominal surgery in the last 6 months.