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Plachta-Danielzik S, Grasskemper L, Schmidt K, Schreiber S, Bokemeyer B
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
Real-world observational study of health status, quality of life, and psychosocial well-being including wearables data of patients with active ulcerative colitis receiving filgotinib therapy: Protocol of the FilgoColitis study
Sandra Plachta-Danielzik;
Lena Grasskemper;
Karen Schmidt;
Stefan Schreiber;
Bernd Bokemeyer
ABSTRACT
Background:
Filgotinib was approved in Germany for treating moderate to severe active ulcerative colitis (UC) patients 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).
Objective:
The study investigates quality of life (QoL) and psychosocial well-being of patients with active UC during long-term exposure to filgotinib. PROs related to QoL and psychometric profiles (fatigue, depression) are collected alongside with disease activity symptom scores. Physical activity data are collected from patients using wearables (SENS motion® leg sensor (accelerometry), and/ or Smartwatch, Garmin® vivosmart 4). 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, non-interventional, observational study with a sample size of 250 patients.
Results:
The enrollment started in December 2021 and was still open at the date of submission. 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 represents an additional observational tool for monitoring disease activity in IBD patients with newly defined outcomes.
Citation
Please cite as:
Plachta-Danielzik S, Grasskemper L, Schmidt K, Schreiber S, Bokemeyer B
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