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  • Hirschfield, Gideon M (author)

Ustekinumab for patients with primary biliary cholangitis who have an inadequate response to Ursodeoxycholic Acid: a proof-of-concept study.

  • Article/chapterEnglish2016

Publisher, publication year, extent ...

  • 2016-01-14
  • Ovid Technologies (Wolters Kluwer Health),2016

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/234495
  • https://gup.ub.gu.se/publication/234495URI
  • https://doi.org/10.1002/hep.28359DOI

Supplementary language notes

  • Language:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • The interleukin (IL)-12 signaling cascade has been associated with primary biliary cholangitis (PBC). This multicenter, open-label, proof-of-concept study evaluated the anti-IL12/23 monoclonal antibody ustekinumab (90 mg subcutaneous at weeks 0 and 4, then every 8 weeks through week 20) in adults with PBC and an inadequate response to ursodeoxycholic acid therapy (i.e., alkaline phosphatase [ALP] >1.67x upper limit of normal [ULN] after ≥6 months). ALP response was defined as a >40% decrease from baseline, and ALP remission as ALP normalization (if baseline ALP 1.67x-2.8x ULN) or <1.67x ULN (if baseline ALP >2.8x ULN). Changes in Enhanced Liver Fibrosis (ELF) scores and serum bile acids were also assessed. At baseline, patients had median disease duration of 3.2 years, median ELF score of 9.8, and highly elevated total bile acid concentration (median: 43.3 µmol/L); 13/20 (65%) patients had baseline ALP >3x ULN. Although steady-state serum ustekinumab concentrations were reached by week 12, no patient achieved ALP response or remission. The median percent ALP reduction from baseline to week 28 was 12.1%. The ELF score decreased slightly from baseline to week 28 (median reduction: 0.173), and total serum bile acid concentrations decreased from baseline to week 28 (median reduction: 8.8 µmol/L). No serious infections or discontinuations due to adverse events were reported through week 28. One patient had a serious upper gastrointestinal hemorrhage considered unrelated to test agent by the investigator.

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Gershwin, M Eric (author)
  • Strauss, Richard (author)
  • Mayo, Marlyn J (author)
  • Levy, Cynthia (author)
  • Zou, Bin (author)
  • Johanns, Jewel (author)
  • Nnane, Ivo P (author)
  • Dasgupta, Bidisha (author)
  • Li, Katherine (author)
  • Selmi, Carlo (author)
  • Marschall, Hanns-Ulrich,1954Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine(Swepub:gu)xmarsh (author)
  • Jones, David (author)
  • Lindor, Keith (author)
  • Göteborgs universitetInstitutionen för medicin, avdelningen för molekylär och klinisk medicin (creator_code:org_t)

Related titles

  • In:Hepatology (Baltimore, Md.): Ovid Technologies (Wolters Kluwer Health)64:1, s. 189-1991527-33500270-9139

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