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Ustekinumab Is Asso...
Ustekinumab Is Associated with Real-World Long-Term Effectiveness and Improved Health-Related Quality of Life in Crohn's Disease
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- Forss, Anders (author)
- Karolinska Institutet
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- Clements, Mark (author)
- Karolinska Institutet
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- Myrelid, Pär (author)
- Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US
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- Strid, Hans (author)
- Department of Internal Medicine, Södra Älvsborg Hospital, Borås, Sweden,Sodra Alvsborg Hosp, Sweden
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- Söderman, Charlotte (author)
- Karolinska Institutet
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- Wagner, Agnieszka (author)
- Department of Internal Medicine, Blekinge Hospital, Karlskrona, Sweden,Blekinge Hosp, Sweden
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- Andersson, David (author)
- Department of Internal Medicine, Danderyd University Hospital, Stockholm, Sweden,Danderyd Hosp, Sweden
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- Hjelm, Fredrik (author)
- Janssen Cilag AB, Solna, Sweden
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- Olén, Ola (author)
- Karolinska Institutet
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- Halfvarson, Jonas, 1970- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology,Orebro Univ, Sweden
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- Ludvigsson, Jonas F., 1969- (author)
- Karolinska Institutet
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(creator_code:org_t)
- 2022-04-22
- 2023
- English.
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In: Digestive Diseases and Sciences. - : Kluwer Academic Publishers. - 0163-2116 .- 1573-2568. ; 68:1, s. 65-76
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Abstract
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- BACKGROUND: Prospectively and systematically collected long-term real-world clinical data on ustekinumab (anti-interleukin-12/23) are still scarce.AIMS: To assess the long-term effectiveness of ustekinumab in patients with active Crohn's disease (CD).METHODS: This is a prospective multicenter study of adult patients with CD initiating ustekinumab according to recommended doses at 20 Swedish hospitals. The primary outcome was clinical remission (Harvey-Bradshaw Index (HBI) ≤ 4 points) at weeks 52 and 104. Secondary outcomes included clinical response (≥ 3-point-decrease in HBI among patients with initial HBI ≥ 5 points), treatment retention, and biomarkers (C-reactive protein (CRP), hemoglobin, fecal-calprotectin) at weeks 52 and 104 compared to baseline. We also reported Health-related Quality of Life (HRQoL) measures.RESULTS: Of 114 included patients, 107 (94%) had previously failed ≥ 1 and 58 (51%) ≥ 2 anti-tumor necrosis factor agents. Forty (35%) had failed anti-integrin agents. Ustekinumab retention rates at weeks 52 and 104 were 70% (n = 80/114) and 61% (n = 69/114), respectively. Clinical response was seen in 36% (n = 25/69) and 29% (n = 20/69) of the patients, and remission was achieved in 32% (n = 31/96) and 29% (n = 28/96) at weeks 52 and 104, respectively. Median HBI and CRP levels decreased significantly at both timepoints as compared to baseline. Significant improvements were also observed in HRQoL. Adverse events were reported in 11% (n = 13/114) of the patients, including five cases of severe adverse events. No malignancies were observed.CONCLUSIONS: In this nationwide prospective real-world 104-week-follow-up study of adult patients with active CD, ustekinumab was associated with long-term clinical effectiveness and improvement in HRQoL measures when used in routine clinical care.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Keyword
- Crohn’s disease
- Inflammatory bowel disease
- Observational study
- Ustekinumab
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Forss, Anders
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Clements, Mark
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Myrelid, Pär
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Strid, Hans
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Söderman, Charlo ...
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Wagner, Agnieszk ...
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Andersson, David
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Hjelm, Fredrik
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Olén, Ola
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Halfvarson, Jona ...
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Ludvigsson, Jona ...
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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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Digestive Diseas ...
- By the university
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Örebro University
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Linköping University
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Karolinska Institutet