Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and/or vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
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).
Under 18 years old.
Immune-mediated disease, neoplasm or active infection.
Pregnancy or lactation.
Alcohol or drug abuse.
Parallel
Tofacitinib
DrugTofacitinib 5 MG/day per clinical practice
Infliximab Adalimumab y Golimumab
DrugInfliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice or or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice.
platelet activation
Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation
Endoscopic activity
It will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥ 2.
Endoscopic response
It will be defined as a decrease of ≥ 1 point in the Mayo endoscopic sub-score 3 months after starting treatment.
Endoscopic remission
It will be defined as an endoscopic subscore ≤1, 3 months after starting treatment.
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