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BACKGROUND: Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for treatment of ulcerative colitis (UC) following the phase 2b/3 SELECTION trial. Identification of patient populations and factors associated with long-term treatment response trajectories may improve UC management. OBJECTIVE: We aimed to identify and describe distinct patient subgroups of response to filgotinib based on partial Mayo Clinic Score (pMCS) trajectories over time. METHODS: In these post hoc analyses of SELECTION, group-based trajectory modeling (GBTM) was applied to pMCS to describe groups of distinct, symptom-based patient trajectories using data from patients who responded to filgotinib 200 or 100 mg and continued receiving filgotinib up to week 58. Patient demographics, disease characteristics, and week 10 response were compared between the groups. Achievement of a patient-level multi-component endpoint of comprehensive disease control (CDC) was assessed in each group. RESULTS: GBTM identified five distinct patient populations with different response trajectories; 67.5% of patients had beneficial trajectories. The beneficial trajectory groups generally had higher proportions of patients who were recently diagnosed (<1 year), were receiving filgotinib 200 mg and were biologic-naive versus the relapsing trajectory groups (4%-9% vs. 4%-5%; 43%-65% vs. 36%-46%; 54%-70% vs. 35%-58%, respectively). Furthermore, 55.4% of patients had sustained beneficial trajectories, with low baseline endoscopic subscores (≥43% of patients had a subscore of 2) and strong week 10 FCP responses (≥61% of patients with >50% decrease in FCP from baseline). Sustained beneficial trajectory groups had a higher probability of achieving CDC at week 58 than other groups (31%-32% vs. 0%-7%). CONCLUSIONS: Beneficial long-term response trajectories and achievement of CDC with filgotinib were associated with being biologic-naive and having less severe disease at baseline. Early estimation of sustained and CDC may facilitate patient identification and development of personalized management strategies in UC. GOV IDENTIFIER: NCT02914522.
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Background and Aim: The use of biologics and small molecules has been a concern for patients with inflammatory bowel disease (IBD) during the COVID-19 pandemic. We aimed to assess the association between the risk of COVID-19-related hospitalization and these agents. Methods: We made a systematic review and meta-analysis of all published studies from December 2019 to September 2021 to identify studies that reported COVID-19-related hospitalization in IBD patients receiving biologic therapies or tofacitinib. We calculated the risk ratio (RR) to compare the relative risk of COVID-19-related hospitalization in patients receiving these medications to those who were not, at the time of the study. Results: Eighteen studies were included. The relative risk of hospitalization was significantly lower in patients with IBD and COVID-19 who were receiving biologic therapy (RR = 0.47 [95% confidence interval, CI: 0.42-0.52, P < 0.00001]) compared to patients not receiving biologics. The RR was lower in patients receiving anti-tumor necrosis factors (TNFs) compared to those who were not (RR = 0.48 [95% CI: 0.41-0.55, P < 0.00001]). A similar finding was observed in patients taking ustekinumab (RR = 0.55 [95% CI: 0.43-0.72, P < 0.00001]). Combination therapy involving anti-TNF and an immunomodulator did not lower the risk of COVID-19-related hospitalization (RR = 0.98 [95% CI: 0.82-1.18, P = 0.84]). The use of vedolizumab (RR = 1.13 [95% CI: 0.75-1.73, P = 0.56]) or tofacitinib (RR = 0.81 [95% CI: 0.49-1.33, P = 0.40]) was not associated with a lower risk of COVID-19-related hospitalization. Conclusion: Regarding COVID-19-related hospitalization in IBD, anti-TNFs and ustekinumab were associated with decreased risk of hospitalization. In addition, vedolizumab and tofacitinib were not associated with COVID-19-related hospitalization.