{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T15:14:49Z","timestamp":1771946089926,"version":"3.50.1"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2020,2,15]],"date-time":"2020-02-15T00:00:00Z","timestamp":1581724800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006680","name":"Takeda Medical Research Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006680","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,9,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and Aims<\/jats:title><jats:p>Vedolizumab was shown to be safe and effective for the treatment of Crohn\u2019s disease [CD] and ulcerative colitis [UC] in the GEMINI Long-Term Safety [LTS] study. The vedolizumab Extended Access Program [XAP] provides patients with continued treatment. This XAP pharmacokinetics [PK] sub-study investigated vedolizumab efficacy, safety, and PK.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Vedolizumab dosing frequency was reduced from every 4 weeks [Q4W] to every 8 weeks [Q8W] at XAP enrolment, and patients were followed for 56 weeks. Outcomes included: efficacy, loss of clinical benefit, and re-escalation to Q4W dosing; and vedolizumab PK, immunogenicity, and adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 167 enrolled patients [CD\u2005=\u200588, UC\u2005=\u200579], 80 [91%] with CD and 73 [92%] with UC completed 56 weeks; 76 [86%] and 71 [90%] with CD and UC, respectively, remained on Q8W dosing for 56 weeks. Clinical remission, corticosteroid-free clinical remission, and C-reactive protein levels were stable among patients remaining on Q8W through Week 56. Four patients with CD and two with UC resumed Q4W dosing [three with CD regained clinical response]. Patients with CD who completed Week 56 on Q8W dosing had median trough vedolizumab concentrations of 43.6 \u00b5g\/mL at enrolment and 10.4 \u00b5g\/mL at Week 56; concentrations were 42.4 \u00b5g\/mL and 13.3 \u00b5g\/mL, respectively, in patients with UC. Treatment-related adverse events were infrequent; no new or serious adverse events related to vedolizumab were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In the XAP-PK sub-study, adherence to Q8W dosing was high, with no loss of efficacy; very few patients required re-escalation to Q4W. There were no new safety signals.<\/jats:p><\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaa027","type":"journal-article","created":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T20:14:46Z","timestamp":1581538486000},"page":"1066-1073","source":"Crossref","is-referenced-by-count":17,"title":["Vedolizumab Efficacy, Safety, and Pharmacokinetics With Reduced Frequency of Dosing From Every 4 Weeks to Every 8 Weeks in Patients With Crohn\u2019s Disease or Ulcerative Colitis"],"prefix":"10.1093","volume":"14","author":[{"given":"S\u00e9verine","family":"Vermeire","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium"}]},{"given":"Milan","family":"Luk\u00e1\u0161","sequence":"additional","affiliation":[{"name":"IBD Clinical and Research Centre, ISCARE Clinical Centre, Prague, Czech 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