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Observational study...
Observational study of tofacitinib in Ulcerative Colitis in Sweden (ODEN) - Interim analysis of health-related quality of life and fatigue
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- Nyberg, L. (author)
- Lund University, Department of Clinical Sciences, Lund, Sweden; Skane University Hospital, Department of Gastroenterology, Lund/Malmö, Sweden
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- Söderling, J. (author)
- Karolinska Institutet, Clinical Epidemiology, Stockholm, Sweden
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- Olén, O. (author)
- Karolinska Institutet, Clinical Epidemiology, Stockholm, Sweden
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- Strid, H. (author)
- Karolinska University Hospital, Department of Gastroenterology, Department of Gastroenterology, Sweden
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- Jäghult, S. (author)
- Karolinska Institutet, Department of Clinical Sciences, Stockholm, Sweden
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- Halfvarson, Jonas, 1970- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper
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- Hedin, C. (author)
- Karolinska institutet, Department of Medicine, Stockholm, Sweden
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- Jónsdóttir, S. (author)
- Karolinska university hospital, Department of Gastroenterology, Stockholm, Sweden
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- Hjortswang, H. (author)
- University of Linköping, Department of Clinical and Experimental Medicine, Linköping, Sweden
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- Cappelleri, J. C. (author)
- Pfizer Inc, Statistical Research and Data Science Center, Groton Connecticut, United States
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- Henrohn, D. (author)
- Pfizer AB, Department of Medical Affairs, Stockholm, Sweden; University of Uppsala, Department of Medical Sciences, Uppsala, Sweden
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- Seddighzadeh, M. (author)
- Pfizer AB, Department of Medical Affairs, Stockholm, Sweden
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- Marsal, J. (author)
- Lund University, Department of Clinical Sciences, Lund, Sweden; Skane University Hospital, Department of Gastroenterology, Lund/Malmö, Sweden
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- Grip, O. (author)
- Skane University Hospital, Department of Gastroenterology, Lund/Malmö, Sweden
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(creator_code:org_t)
- Oxford University Press, 2024
- 2024
- English.
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In: Journal of Crohn's & Colitis. - : Oxford University Press. - 1873-9946 .- 1876-4479. ; 18:Suppl. 1, s. I1887-I1889
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Background: Ulcerative colitis (UC) has a major impact on daily life. The Janus Kinas (JAK) inhibitor tofacitinib is effective in achieving remission in UC, but prospective real-world evidence concerning the effect on health-related quality of life (HRQoL) and fatigue are still scarce. Fatigue is a component of UC that is notoriously difficult to treat and not unambiguously related to inflammatory activity. ODEN is an ongoing Swedish multicentre prospective observational study of tofacitinib in UC. In this interim analysis, we assessed the effectiveness on HRQoL and fatigue during the first 16 weeks.Methods: Patients with UC and active inflammation were enrolled 2020-2023 when starting tofacitinib as per clinical indication. To measure various aspects of impairment of daily life, the validated questionnaires Short Health Scale (SHS), EQ-5D-5L [Swedish value set], and IBD-fatigue scale (IBD-F) were used. These data and information concerning clinical, biochemical, and endoscopic outcomes were collected in an e-CRF linked to the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). For HRQoL outcomes, per protocol analysis was applied. Paired t-test and Wilcoxon’s signed-rank test were used for mean and median differences, respectively.Results: In total, 103 patients were included. Baseline data are shown in Table 1a. For patients still on tofacitinib treatment, all four dimensions of the SHS (symptoms, social function, disease related worry, and general well-being) improved significantly, Table 1b. A median decrease of one point from baseline was seen at week 8 in each of the parameters, which was maintained through week 16 with a tendency towards further improvement. EQ-5D-5L showed an impairment mainly in the aspects of pain/discomfort and ability to participate in common daily activities. Improvement in these dimensions was seen from baseline to week 16. The overall EQ-5D-5L index improved significantly from baseline (0.80) to week 8 (0.86) and week 16 (0.89), as did the EQ VAS 0-100 reflecting overall health (58, 71, and 74, respectively). A significant improvement in IBD-F part 1 and 2 was seen at week 8 and 16, Figure 1.Conclusion: This study demonstrates that tofacitinib treatment covariates with positive changes in a variety of measures of patients’ quality of life, including improvements in self-assessed overall wellbeing. Finally, fatigue significantly improved during tofacitinib treatment. Thus, tofacitinib treatment shows association with meaningful improvements in multiple aspects of quality of life during the first 16 weeks of treatment.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Publication and Content Type
- vet (subject category)
- art (subject category)
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- By the author/editor
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Nyberg, L.
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Söderling, J.
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Olén, O.
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Strid, H.
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Jäghult, S.
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Halfvarson, Jona ...
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show more...
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Hedin, C.
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Jónsdóttir, S.
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Hjortswang, H.
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Cappelleri, J. C ...
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Henrohn, D.
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Seddighzadeh, M.
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Marsal, J.
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Grip, O.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Gastroenterology ...
- Articles in the publication
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Journal of Crohn ...
- By the university
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Örebro University