Abstract Background The FilgoColitis study is a 24-month, prospective, non-interventional study of 202 patients with ulcerative colitis (UC) who initiated a new Filgotinib therapy. The study aims to evaluate the effectiveness of the therapy and novel patient-reported outcomes using wearable devices. This sub-analysis examines new outcomes using wearables, smartwatch and activity sensor data, at month 6 to discriminate between disease activity status (clinical remission (CR) vs. active disease). Methods Two devices were analysed: the SENS motion® activity sensor (SM; thigh-attached) and the Garmin® Vívosmart 4 smartwatch (GV4). For the SM device, data from four days or more after month six were included when three days or more were available. Activity patterns were categorised as either resting (sitting, lying or standing) or active (walking, running or cycling). For the GV4, inclusion required ≥20 minutes of analyzable data in 30-minute increments, with a ± 4-day window around month 6, and ≥3 valid days with ≥50% daily coverage and ≥3 hours of nighttime coverage (10 p.m. - 6 a.m.). Mean heart rate (HR), resting heart rate (RHR) and total steps were analysed. Clinical remission (CR) was defined as a partial Mayo score of ≤ 1 plus a bleeding subscore. Differences between patients with and without CR were analysed using t-tests. Results Data from the SM device were available for 40 patients at month 6 (mean steps per day: 12,872; active time: 3.6 hours per day). There were no differences in patient characteristics for the SM subgroup at baseline between the groups (21 CR vs. 19 non-CR; Table 1a). Daily means of wearable data showed no statistically significant differences in terms of steps or activity time between the two groups. GV4 data that met the inclusion criteria were available for 18 patients (RHR: 58.2 bpm; HR: 76.1 bpm; steps: 6,018 per day). Patient characteristics for the GV4 subgroup revealed no statistically significant differences at baseline (9 CR vs. 9 non-CR; Table 1b). Patients in CR at month 6 showed significantly lower RHR (55.1 vs. 63.3 bpm; p 0.05) and HR (73.7 vs. 81.5 bpm; p 0.05), while there were no significant differences in the number of steps recorded (Figure 1). Conclusion Wearable-measured RHR and HR have been shown to discriminate statistically between CR and active disease in UC patients receiving Filgotinib therapy. However, the steps showed only a numeric difference without statistical significance, which may be due to the relatively small number of patients and the limited available data. These findings suggest the potential of wearables for assessing novel outcomes in outpatient follow-up care in patients with ulcerative colitis. Conflict of interest: Bokemeyer, Bernd: Grant: Abbvie, Ferring, UCB, Given Imaging, Janssen, Takeda, Pfizer, Galapagos, Lilly Personal Fees: Abbvie, Ferring, MSD, Merckle, Falk, HLR, UCB, Shield Therapeutics, Pfizer, Celltrion, Takeda, Janssen, Mundipharma, Arena, Galapagos, BMS, Lilly Other: Abbvie, MSD, Shire, Ferring, Hospira, Takeda, Shield Therapeutics, Pfizer, Biogen, Janssen, Hexal, Cellgene, Boehringer, Allergan, Galapagos, Arena Lilly Wenske, Thomas: No conflict of interest Plachta-Danielzik, Sandra: No conflict of interest Popa, Ovidiu: No conflict of interest Ebenhöh, Oliver: No conflict of interest Hellms, Timo: No conflict of interest Landry, Wilfred: No conflict of interest Kahl, Matthias: No conflict of interest Ehehalt, Robert: No conflict of interest Zimmermann, Lars: No conflict of interest Schiffelholz, Anja: No conflict of interest Efken, Philipp: No conflict of interest Reiner, Johannes: No conflict of interest Fajardo Salmon, Samantha: No conflict of interest Schreiber, Stefan Wolfgang: Personal Fees: AbbVie, Alfasigma, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Theravance
Bokemeyer et al. (2026) studied this question.