Home Blog of Signal Transduction Epigenetics JAK Health Status, Quality of Life, Psychosocial Well-being, and Wearables Data of Patients With Active Ulcerative Colitis Receiving Filgotinib Therapy (FilgoColitis Study): Protocol for a Real-world Observational Study

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Health Status, Quality of Life, Psychosocial Well-being, and Wearables Data of Patients With Active Ulcerative Colitis Receiving Filgotinib Therapy (FilgoColitis Study): Protocol for a Real-world Observational Study

Background: Filgotinib was approved in Germany for treating patients with moderate to severe active ulcerative colitis in November 2021. It represents a preferential Janus kinase 1 inhibitor. The FilgoColitis study began recruiting immediately after approval and aims to assess filgotinib effectiveness under real-world conditions with a particular focus on patient-reported outcomes (PROs). The novelty of the study design is the optional inclusion of 2 innovative wearables, which could provide a new layer of patient-derived data.

Objective: The study investigates quality of life (QoL) and psychosocial well-being of patients with active ulcerative colitis during long-term exposure to filgotinib. PROs related to QoL and psychometric profiles (fatigue and depression) are collected alongside with disease activity symptom scores. We aim to evaluate physical activity patterns collected by wearables as an addition to traditional PROs, patient-reported health status, and QoL in different phases of disease activity.

Methods: This is a prospective, single-arm, multicentric, noninterventional, observational study with a sample size of 250 patients. QoL is assessed with validated questionnaires: the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) for the disease-specific QoL, the EQ-5D for the general QoL, and the fatigue questionnaire (Inflammatory Bowel Disease-Fatigue [IBD-F]). Physical activity data are collected from patients using wearables (SENS motion leg sensor [accelerometry] and smartwatch, GARMIN vívosmart 4).

Results: The enrollment started in December 2021 and was still open at the date of submission. After 6 months of study initiation, 69 patients were enrolled. The study is expected to be completed in June 2026.

Conclusions: Real-world data for novel drugs are important to assess effectiveness outside of highly selected populations represented by randomized controlled trials. We examine whether patients' QoL and other PROs can be supplemented with physical activity patterns measured objectively. Use of wearables with newly defined outcomes represents an additional observational tool for monitoring disease activity in patients with inflammatory bowel disease.

 

Comments:

This study, called the FilgoColitis study, aims to evaluate the quality of life (QoL) and psychosocial well-being of patients with active ulcerative colitis who are undergoing long-term treatment with filgotinib, a Janus kinase 1 inhibitor. The study is designed to assess the effectiveness of filgotinib in real-world conditions, with a particular focus on patient-reported outcomes (PROs).

The study design includes the optional use of two innovative wearables, the SENS motion leg sensor (accelerometry) and a smartwatch (specifically the GARMIN vívosmart 4), to collect physical activity data from the patients. These wearables provide an additional layer of patient-derived data, which can complement the traditional PROs, patient-reported health status, and QoL assessments.

The study is prospective, single-arm, multicentric, noninterventional, and observational, involving a sample size of 250 patients. It utilizes validated questionnaires such as the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) for disease-specific QoL assessment, the EQ-5D for general QoL assessment, and the Inflammatory Bowel Disease-Fatigue (IBD-F) questionnaire for evaluating fatigue.

Enrollment for the study began in December 2021 and was ongoing at the time of the submission. As of six months after the study initiation, 69 patients had been enrolled. The study is projected to be completed in June 2026.

The study aims to generate real-world data to assess the effectiveness of filgotinib outside of the highly selected populations typically represented in randomized controlled trials. Additionally, it explores whether physical activity patterns, objectively measured through the use of wearables, can supplement patients' QoL and other PROs. The inclusion of wearables with newly defined outcomes serves as an additional observational tool for monitoring disease activity in patients with inflammatory bowel disease.

Related Products

Cat.No. Product Name Information
S7605 Filgotinib (GLPG0634) Filgotinib (GLPG0634) is a selective JAK1 inhibitor with IC50 of 10 nM, 28 nM, 810 nM, and 116 nM for JAK1, JAK2, JAK3, and TYK2, respectively. Phase 2.

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JAK