Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis
Objective Mirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in a Phase 2 study (NCT02589665) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab’s impact on health-related quality of life (HRQoL).Design HRQoL was evaluated using t...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open Gastroenterology |
| Online Access: | https://bmjopengastro.bmj.com/content/10/1/e001115.full |
| _version_ | 1797371587274473472 |
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| author | Brian G Feagan Toshifumi Hibi Vipul Jairath Nathan Morris Bruce E Sands Marla C Dubinsky Vipin Arora April N Naegeli Trevor Lissoos Mingyang Shan Jay Tuttle Noah Agada |
| author_facet | Brian G Feagan Toshifumi Hibi Vipul Jairath Nathan Morris Bruce E Sands Marla C Dubinsky Vipin Arora April N Naegeli Trevor Lissoos Mingyang Shan Jay Tuttle Noah Agada |
| author_sort | Brian G Feagan |
| collection | DOAJ |
| description | Objective Mirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in a Phase 2 study (NCT02589665) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab’s impact on health-related quality of life (HRQoL).Design HRQoL was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ) and 36-Item Short Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS). Mixed effects models for repeated measures compared score changes between mirikizumab and placebo groups. Additional analyses evaluated associations between HRQoL score changes and achievement of efficacy endpoints at weeks 12 and 52.Results At week 12, IBDQ improved compared with placebo for all mirikizumab groups except mirikizumab 50 mg (50 mg, p=0.073; 200 mg, p<0.001; 600 mg, p<0.001). SF-36 PCS was significantly higher in all mirikizumab groups at week 12 (50 mg, p=0.011; 200 mg, p=0.022; 600 mg, p=0.002); MCS was significantly higher in mirikizumab 200 and 600 mg groups compared with placebo (50 mg, p=0.429; 200 mg, p=0.028; 600 mg, p<0.001). Achievement of clinical response and remission were associated with greater HRQoL improvements at week 12. Improvements in HRQoL scores were sustained through week 52. Of the clinical symptoms evaluated, reduction in rectal bleeding was associated with greater improvements in IBDQ and SF-36 scores.Conclusion Mirikizumab improved HRQoL in patients with moderately-to-severely active UC. |
| first_indexed | 2024-03-08T18:22:05Z |
| format | Article |
| id | doaj.art-d32d694829724ced8385109aced67187 |
| institution | Directory Open Access Journal |
| issn | 2054-4774 |
| language | English |
| last_indexed | 2024-03-08T18:22:05Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Gastroenterology |
| spelling | doaj.art-d32d694829724ced8385109aced671872023-12-30T19:00:08ZengBMJ Publishing GroupBMJ Open Gastroenterology2054-47742023-11-0110110.1136/bmjgast-2023-001115Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitisBrian G Feagan0Toshifumi Hibi1Vipul Jairath2Nathan Morris3Bruce E Sands4Marla C Dubinsky5Vipin Arora6April N Naegeli7Trevor Lissoos8Mingyang Shan9Jay Tuttle10Noah Agada11Department of Epidemiology and Biostatistics, Western University, London, Ontario, CanadaCenter for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Tokyo, JapanDepartment of Epidemiology and Biostatistics, Western University, London, Ontario, CanadaEli Lilly and Company, Indianapolis, Indiana, USADr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USADepartment of Pediatrics, Icahn School of Medicine, New York, New York, USAEli Lilly and Company, Indianapolis, Indiana, USAEli Lilly and Company, Indianapolis, Indiana, USAEli Lilly and Company, Indianapolis, Indiana, USAEli Lilly and Company, Indianapolis, Indiana, USALilly Biotechnology Center, San Diego, California, USAEli Lilly and Company, Indianapolis, Indiana, USAObjective Mirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in a Phase 2 study (NCT02589665) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab’s impact on health-related quality of life (HRQoL).Design HRQoL was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ) and 36-Item Short Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS). Mixed effects models for repeated measures compared score changes between mirikizumab and placebo groups. Additional analyses evaluated associations between HRQoL score changes and achievement of efficacy endpoints at weeks 12 and 52.Results At week 12, IBDQ improved compared with placebo for all mirikizumab groups except mirikizumab 50 mg (50 mg, p=0.073; 200 mg, p<0.001; 600 mg, p<0.001). SF-36 PCS was significantly higher in all mirikizumab groups at week 12 (50 mg, p=0.011; 200 mg, p=0.022; 600 mg, p=0.002); MCS was significantly higher in mirikizumab 200 and 600 mg groups compared with placebo (50 mg, p=0.429; 200 mg, p=0.028; 600 mg, p<0.001). Achievement of clinical response and remission were associated with greater HRQoL improvements at week 12. Improvements in HRQoL scores were sustained through week 52. Of the clinical symptoms evaluated, reduction in rectal bleeding was associated with greater improvements in IBDQ and SF-36 scores.Conclusion Mirikizumab improved HRQoL in patients with moderately-to-severely active UC.https://bmjopengastro.bmj.com/content/10/1/e001115.full |
| spellingShingle | Brian G Feagan Toshifumi Hibi Vipul Jairath Nathan Morris Bruce E Sands Marla C Dubinsky Vipin Arora April N Naegeli Trevor Lissoos Mingyang Shan Jay Tuttle Noah Agada Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis BMJ Open Gastroenterology |
| title | Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis |
| title_full | Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis |
| title_fullStr | Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis |
| title_full_unstemmed | Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis |
| title_short | Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis |
| title_sort | changes in health related quality of life and associations with improvements in clinical efficacy a phase 2 study of mirikizumab in patients with ulcerative colitis |
| url | https://bmjopengastro.bmj.com/content/10/1/e001115.full |
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