Symptom Improvement of ulceRative colitis after an Induction dose of UStekinumab in Japanese clinical practice (SIRIUS), measured using patient-reported outcomes: a prospective observational study

BMJ Open. 2022 May 4;12(5):e060081. doi: 10.1136/bmjopen-2021-060081.ABSTRACTINTRODUCTION: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine. Ustekinumab is a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23 and has proven efficacy in inducing and maintaining remission in adult patients with moderate-to-severe UC. In the Symptom Improvement of ulceRative colitis after an Induction dose of Ustekinumab study, we will document the initial treatment response (daily patient-reported outcomes for 8 weeks from first infusion) and treatment patterns of patients wih UC receiving an induction dose of ustekinumab in the real-world setting in Japan. We will also investigate the relationship between the treatment response at week 8 and early indicators of response and determine patient factors that may define the appropriate dosing interval for maintenance therapy.METHODS AND ANALYSIS: For this single-arm, prospective observational study at 24 centres in Japan with a follow-up period of 16/20 weeks, we aim to recruit 140 patients with moderate-to-severe UC between July 2021 and July 2022. All surveys will be conducted in Japanese and patient-reported outcomes relating to rectal bleeding, stool frequency, abdominal pain, nocturnal diarrhoea, tenesmus and perception of UC symptoms will be recorded using a smartphone application, where the patients can enter their initial response to ustekinumab induction therapy on ...
Source: Pain Physician - Category: Anesthesiology Authors: Source Type: research