Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres
Background: Filgotinib, an oral Janus kinase 1 preferential inhibitor, has been shown to be an effective treatment for ulcerative colitis (UC) in pre-registration studies. We aimed to describe the treatment population, effectiveness and safety of filgotinib in a real-world cohort of patients with UC...
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| Format: | Article |
| Language: | English |
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BioExcel Publishing Ltd
2025-01-01
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| Series: | Drugs in Context |
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| Online Access: | https://www.drugsincontext.com/real-world-assessment-of-effectiveness-and-safety-of-filgotinib-in-286-patients-with-ulcerative-colitis-in-9-uk-centres/ |
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| author | David Young Sohail Rahmany Deborah Taylor Emma Davis Michael Colwill Sonia Kalyanji Mehta Roisin Campbell Karl Hazel Karishma Sethi-Arora Susan Ritchie Ashley I Heinson Helen Moyses Keith Bodger Emma Johnston Lucy Hicks Anjan Dhar Jimmy Limdi Rachel Cooney John Paul Seenan Kamal Patel Alissa Walsh Fraser Cummings |
| author_facet | David Young Sohail Rahmany Deborah Taylor Emma Davis Michael Colwill Sonia Kalyanji Mehta Roisin Campbell Karl Hazel Karishma Sethi-Arora Susan Ritchie Ashley I Heinson Helen Moyses Keith Bodger Emma Johnston Lucy Hicks Anjan Dhar Jimmy Limdi Rachel Cooney John Paul Seenan Kamal Patel Alissa Walsh Fraser Cummings |
| author_sort | David Young |
| collection | DOAJ |
| description | Background: Filgotinib, an oral Janus kinase 1 preferential inhibitor, has been shown to be an effective treatment for ulcerative colitis (UC) in pre-registration studies. We aimed to describe the treatment population, effectiveness and safety of filgotinib in a real-world cohort of patients with UC.
Methods: A retrospective observational cohort evaluation was conducted across nine UK inflammatory bowel disease centres. Baseline demographic and clinical data, clinical disease activity scores, endoscopic activity indices, and biomarkers (C-reactive protein and faecal calprotectin) were collected at baseline, at 8–12 weeks after initiation (post-induction) and during maintenance (the most recent review) where available. Effectiveness outcomes were assessed in patients with combined clinical disease activity and objective evidence of inflammation at filgotinib initiation.
Results: Data were analysed for a total of 286 patients with a median follow-up time of 229 (IQR 113–324) days. The median age at filgotinib initiation was 38 (IQR 27–51) years, 64% were men and median disease duration was 5.1 (IQR 1.9–10.5) years; 56% had previous exposure to advanced therapies (biologics and small molecule) and 6% previously received tofacitinib. At the post-induction review, clinical response and remission were achieved in 65% and 51% of patients, respectively. There was a reduction in biomarkers and 78% of patients using corticosteroids at baseline were steroid-free. Persistence on filgotinib at 12 months was 66%. Adverse events were recorded in 30 patients with 8 patients discontinuing filgotinib as a result of an adverse event.
Conclusions: In a large real-world cohort of patients with UC, filgotinib appears to be effective and welltolerated. |
| format | Article |
| id | doaj-art-b62f2f2c0f3242d18078cad330906ca2 |
| institution | Kabale University |
| issn | 1740-4398 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BioExcel Publishing Ltd |
| record_format | Article |
| series | Drugs in Context |
| spelling | doaj-art-b62f2f2c0f3242d18078cad330906ca22025-01-29T09:32:44ZengBioExcel Publishing LtdDrugs in Context1740-43982025-01-011411410.7573/dic.2024-11-1Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centresDavid YoungSohail RahmanyDeborah TaylorEmma DavisMichael ColwillSonia Kalyanji MehtaRoisin CampbellKarl HazelKarishma Sethi-AroraSusan RitchieAshley I HeinsonHelen MoysesKeith BodgerEmma JohnstonLucy HicksAnjan DharJimmy LimdiRachel CooneyJohn Paul SeenanKamal PatelAlissa WalshFraser CummingsBackground: Filgotinib, an oral Janus kinase 1 preferential inhibitor, has been shown to be an effective treatment for ulcerative colitis (UC) in pre-registration studies. We aimed to describe the treatment population, effectiveness and safety of filgotinib in a real-world cohort of patients with UC. Methods: A retrospective observational cohort evaluation was conducted across nine UK inflammatory bowel disease centres. Baseline demographic and clinical data, clinical disease activity scores, endoscopic activity indices, and biomarkers (C-reactive protein and faecal calprotectin) were collected at baseline, at 8–12 weeks after initiation (post-induction) and during maintenance (the most recent review) where available. Effectiveness outcomes were assessed in patients with combined clinical disease activity and objective evidence of inflammation at filgotinib initiation. Results: Data were analysed for a total of 286 patients with a median follow-up time of 229 (IQR 113–324) days. The median age at filgotinib initiation was 38 (IQR 27–51) years, 64% were men and median disease duration was 5.1 (IQR 1.9–10.5) years; 56% had previous exposure to advanced therapies (biologics and small molecule) and 6% previously received tofacitinib. At the post-induction review, clinical response and remission were achieved in 65% and 51% of patients, respectively. There was a reduction in biomarkers and 78% of patients using corticosteroids at baseline were steroid-free. Persistence on filgotinib at 12 months was 66%. Adverse events were recorded in 30 patients with 8 patients discontinuing filgotinib as a result of an adverse event. Conclusions: In a large real-world cohort of patients with UC, filgotinib appears to be effective and welltolerated.https://www.drugsincontext.com/real-world-assessment-of-effectiveness-and-safety-of-filgotinib-in-286-patients-with-ulcerative-colitis-in-9-uk-centres/colitisfilgotinibquality of lifeulcerative colitis |
| spellingShingle | David Young Sohail Rahmany Deborah Taylor Emma Davis Michael Colwill Sonia Kalyanji Mehta Roisin Campbell Karl Hazel Karishma Sethi-Arora Susan Ritchie Ashley I Heinson Helen Moyses Keith Bodger Emma Johnston Lucy Hicks Anjan Dhar Jimmy Limdi Rachel Cooney John Paul Seenan Kamal Patel Alissa Walsh Fraser Cummings Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres Drugs in Context colitis filgotinib quality of life ulcerative colitis |
| title | Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres |
| title_full | Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres |
| title_fullStr | Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres |
| title_full_unstemmed | Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres |
| title_short | Real-world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 UK centres |
| title_sort | real world assessment of effectiveness and safety of filgotinib in 286 patients with ulcerative colitis in 9 uk centres |
| topic | colitis filgotinib quality of life ulcerative colitis |
| url | https://www.drugsincontext.com/real-world-assessment-of-effectiveness-and-safety-of-filgotinib-in-286-patients-with-ulcerative-colitis-in-9-uk-centres/ |
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