Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period.

Clinical benefit at year is defined on the basis of symptomatic remission evaluated with the PRO2 score ≤1 (absence of rectal bleeding and a stool frequency score between 0 and 1)*. Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used oal corticosteroids for UC, (regardless of the treatment duration) during the 3 months preceding the end of the observation period.

The clinical benefit of tofacitinib is independent of the administration or not of 5-ASA, or corticosteroids (not complying with the above definition) during the observation period (between 0 and 1 year).

Clinical remission is defined as partial Mayo score (PMS) <2

Clinical response is defined as a reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).

Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)

endoscopic improvement is defined as endoscopic subscore of 0 or 1

Clinical remission is defined as partial Mayo score (PMS) <2 at 52 and 104 weeks

The clinical loss of response is defined by a recrudescence of the symptoms that lead to a systemic therapeutic intervention (return to previous dose of tofacitinib or corticosteroid therapy, or an immunosuppressant or biologic/other anti-JAK)

(self-assessment by patients)

Using MARS questionnaire

Reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1).