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Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

Bergqvist, Viktoria (författare)
Lund University,Lunds universitet,Medicin, Lund,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Medicine, Lund,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
Kadivar, Mohammad (författare)
Lund University,Lunds universitet,Adaptivt immunförsvar,Forskargrupper vid Lunds universitet,Adaptive Immunity,Lund University Research Groups
Molin, Daniel (författare)
Lund University,Central Hospital Kristianstad
visa fler...
Angelison, Leif (författare)
Lund University,Lunds universitet,Gastro,Forskargrupper vid Lunds universitet,Lund University Research Groups,Helsingborg Hospital
Hammarlund, Per (författare)
Ängelholm Hospital
Olin, Marie (författare)
Helsingborg Hospital
Torp, Jörgen (författare)
Central Hospital Kristianstad
Grip, Olof (författare)
Lund University,Lunds universitet,Internmedicin - epidemiologi,Forskargrupper vid Lunds universitet,Internal Medicine - Epidemiology,Lund University Research Groups,Skåne University Hospital
Nilson, Stefan (författare)
Central Hospital Kristianstad
Hertervig, Erik (författare)
Lund University,Lunds universitet,Clinical studies af Atrial Fibrillation,Forskargrupper vid Lunds universitet,Lund University Research Groups,Skåne University Hospital
Lillienau, Jan (författare)
Lund University,Lunds universitet,Medicin, Lund,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Medicine, Lund,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
Marsal, Jan (författare)
Lund University,Lunds universitet,Gastro,Forskargrupper vid Lunds universitet,Lund University Research Groups,Skåne University Hospital
visa färre...
 (creator_code:org_t)
SAGE Publications, 2018-10-11
Engelska.
Ingår i: Therapeutic Advances in Gastroenterology. - : SAGE Publications. - 1756-283X. ; 11
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13. Methods: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events. Results: A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events. Conclusions: This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Nyckelord

biosimilar
Crohn’s disease
infliximab
switch
ulcerative colitis

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