558 - International Experience of Vedolizumab in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease

Williamson, Kate D.; Lytvyak, Ellina; Krijger, Manon de; Trivedi, Palak; Estes, Derek; Yu, Long; Pratt, Daniel S.; Vries, Annemarie C. de; Daretti, L.M.; Liu, Chung Heng; Bowlus, Christopher L.; Marschall, Hanns‐Ulrich; Montaño-Loza, Aldo J.; Chapman, Roger W.; Woude, Christien J. van der; Marzioni, Marco; Keshav, Satish; Ponsioen, Cyriel Y.; Hirschfield, Gideon; Levy, Cynthia

doi:10.1016/s0016-5085(18)33652-7

Cited by 2 publications

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“… Median faecal calprotectin improved from baseline to month 6. Williamson et al [ 47 ] 2018 11 centres in North America and Europe Abstract: Case series Vedolizumab 60 Yes in half Overall rise Overall, non-significant rise in mean ALP from 2.38 × ULN at baseline to 2.59 × ULN day 42 ( p = 0.32) Statistically significant rise to 2.76 × ULN at last follow-up (median 363 days, p = 0.06). 50.9% had an ALP drop compared with baseline at last follow-up (mean drop − 22.6%).…”

Section: Introductionmentioning

confidence: 99%

“…Two of the abstracts involved rather larger cohorts—the French GETAID cohort [ 45 ] analysed 54 patients whilst the International PSC Study Group (IPSCSG) examined 60 patients [ 47 ]. All four abstracts showed an overall rise in mean/median ALP from baseline to a later time point on VDZ, and in 2/4 abstracts, this rise was statistically significant.…”

Section: Introductionmentioning

confidence: 99%

“…There are 5 published case reports/series [23•, 40–42, 43•], and 4 case series in abstract form only [44–47], evaluating the effect of VDZ in PSC/IBD, comprising a total of 211 patients (see Table 2). These studies vary once again with regard to what endpoints they report on.…”

Section: Introductionmentioning

confidence: 99%

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The Use of Biologics in Patients with Inflammatory Bowel Disease and Primary Sclerosing Cholangitis

Lynch

Keshav

Chapman

2019

Curr Hepatology Rep

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Purpose of Review Biologics are well established in the treatment of many immuno-inflammatory diseases including inflammatory bowel disease (IBD). However, although primary sclerosing cholangitis (PSC) is closely associated with IBD, the role of biologics in PSC remains uncertain. Many new biologics are becoming available to treat IBD, and this review aims to use the experience of biologics in PSC so far to guide more effective evaluation of emerging therapies in the future. Recent Findings Antibodies to TNF-α were the first biologics used in IBD, and retrospective analysis suggests that they may have some benefit in PSC, even though an early randomised controlled trial (RCT) showed no effect. Mechanistic studies suggest that TNF-α may have a pathogenic role in PSC. An antibody to integrin α4β7 is effective in IBD, and there are emerging data on its effects in PSC, although no RCT data are available. Mechanistic studies suggest that interrupting the migration of lymphocytes is relevant in PSC. Two biologics, targeting vascular adhesion protein-1 (VAP-1), and lysyl oxidase-like 2 (LOXL2) have been tested in RCTs. The trial of anti-VAP1 is ongoing, whilst the anti-LOXL2 trial was negative. Summary Anti-TNF antibodies may benefit PSC when used to treat concomitant IBD, and this may be a direct effect on the liver in a subgroup of patients, or may be an indirect effect of treating IBD. Similarly, anti-integrin therapy may benefit a subset of patients with IBD and PSC. RCTs could decide the role of emerging biologics in PSC, although future trials should be guided by biomarkers that could predict response to the pathway being targeted.

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