This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice
TO FAst is a non-interventional study in France with primary objective to describe the clinical benefit of tofacitinib 1 year after its initiation for the treatment of moderate to severe UC in routine clinical practice. The study will also make it possible to report the clinical benefit 2 years after its initiation, to search for predictors of clinical benefit, improve our understanding of the efficacy of treatment in a real-life setting (in terms of response and speed of response), describe the characteristics of patients starting a treatment by tofacitinib, its real-life patterns of use as well as patient adherence to treatment.
Study Type
OBSERVATIONAL
Enrollment
152
Observational study
Proportion of patients with clinical benefit one year after initiation of tofacitinib treatment.
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).
Time frame: Week 52
Proportion of patients with clinical benefit of tofacitinib at 2 years
Time frame: week 104
Predictors of the clinical benefit at one year identified from the available baseline data
Time frame: Week 52
Proportion of patients in clinical remission and still receiving tofacitinib
Clinical remission is defined as partial Mayo score (PMS) \<2
Time frame: Week 52 and Week 104
Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC)
Time frame: Week 52 and week 104
Proportion of patients with short-term clinical response for patients still treated with tofacitinib
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinique de l Europe
Amiens, France
Hopital Sud
Amiens, France
Hopital Jean Minjoz
Besançon, France
Hopital de La Cote de Nacre
Caen, France
Centre Hospitalier de Cahors
Cahors, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Hopital Trousseau
Chambray-lès-Tours, France
Hopital D'Estaing
Clermont-Ferrand, France
Aphp - Hopital Beaujon
Clichy, France
Ch Intercommunal de Creteil
Créteil, France
...and 28 more locations
Time frame: Approximately week 8 and 16
Proportion of patients with biological response during the observation period
Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP)
Time frame: Week 52 and 104
Proportion of patients with endoscopic improvement during the observation period
endoscopic improvement is defined as endoscopic subscore of 0 or 1
Time frame: Week 52 and 104
Proportion of patients in sustained clinical remission
Clinical remission is defined as partial Mayo score (PMS) \<2 at 52 and 104 weeks
Time frame: Week 52 and 104
Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction
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)
Time frame: Week 8, 16, 24, 72, 52 and 104
Proportion of patients with extraintestinal manifestations at each visit
Time frame: Week 8, 16, 24, 72, 52, 104
Proportion of patients with a colectomy during study follow-up and time of occurrence
Time frame: Week 8, 16, 24, 72,52 and 104
Characteristics of patients and UC, on the basis of all the data collected at baseline
Time frame: Week 104
Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy
(self-assessment by patients)
Time frame: 14 days
Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years
Time frame: Week 52, Week 52 to week 104 and week 104
Change in adherence to tofacitinib treatment during each visit
Using MARS questionnaire
Time frame: Week 8, 16, 24, 72, 52, 104
Proportion of patients with serious and non-serious adverse events.
Time frame: Week 8, 16, 24,72,52 and 104