Combined endpoint may support personalised medicine in ulcerative colitis

A combined clinical, biological, health-related quality of life, and endoscopic endpoint displayed improvements for participants with ulcerative colitis (UC) treated with filgotinib compared with placebo. In addition, the novel endpoint was strongly associated with general quality-of-life measures. Holistic assessments of participants via a combined endpoint are useful to identify super responders and may support personalised medicine.

Prof. Stefan Schreiber (Christian-Albrecht University, Germany) argued that traditional outcomes do not consider the comprehensiveness of the individual patients’ experience. Holistic assessments may help to identify patients in whom therapies demonstrate the largest effect and lead to disease control [1]. A combined endpoint was evaluated in the 200 mg filgotinib and placebo arms of the SELECTION trial (NCT02914522), a phase 2b/3 study that tested filgotinib in participants with UC. The combined endpoint was defined as achieving all of the following:

• clinical remission: partial Mayo score ≤2 and no subscore >1 (excluding endoscopy subscore);
• biologic remission: faecal calprotectin <150 μg/g;
• endoscopic improvement: Mayo endoscopic score of 0 or 1; and
• health-related quality-of-life: Inflammatory Bowel Disease questionnaire >170.

In the biologic-naïve filgotinib arm (n=245), 17.6% of the participants achieved the combined endpoint compared with 4.4% in the placebo arm (n=136; P<0.001). In the biologic-experienced cohort (n=260), the corresponding rates were 4.6% and 1.4% (n=141 for placebo arm; P=0.167). In addition, the combined endpoint displayed that improvements achieved during induction therapy were sustained during maintenance therapy (filgotinib 22.1% vs placebo 7.1%; P=0.002). Furthermore, participants who achieved the combined clinical endpoint were more likely to show higher minimal clinically important difference (MCID) improvements, the smallest change in measurement that signifies an important improvement, on physical and mental subscales of the 36-Item Short Form Survey (SF-36) and the EuroQol 5 Dimensions (EQ-5D) measure.

Prof. Schreiber argued that the low rate of participants who achieved the combined endpoint indicates that existing treatments need to be optimised. “Also, future studies should investigate the optimal components of a combined endpoint, characterise the trajectories of patients achieving this endpoint, and identify predictors of early and deep responses to therapy. In this way, combined endpoints may help to improve outcomes for our patients with UC.”

1. Schreiber S, et al. Exploring disease control by combining clinical, biological, and health-related quality of life remission with endoscopic improvements among Ulcerative Colitis patients treated with filgotinib: A post-hoc analysis from the SELECTION trial. OP07, ECCO 2022, 16–19 February.

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Posted on 12 April, 20228 April, 2024