{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T21:22:17Z","timestamp":1790889737122,"version":"4.1.0"},"reference-count":43,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>PF-06687234 is a novel, human, single-chain variable fragment cytokine fusion protein comprising the antibody fragment F8 and the immunoregulatory cytokine interleukin-10.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>We evaluated the efficacy and safety of PF-06687234 as an add-on therapy to infliximab in participants with active ulcerative colitis (UC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This phase IIa, double-blind, placebo-controlled, parallel-group, multicenter study randomized (1:1) participants with active UC to subcutaneous PF-06687234 20 mg or placebo once weekly, and participants continued intravenous background infliximab every 6 or 8\u2009weeks, for 12\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The primary endpoint was the proportion of participants who achieved clinical remission determined by the modified total Mayo score at week 12. Safety assessments, including adverse event (AE) reporting and laboratory abnormalities, were also primary endpoints. Secondary endpoints included the proportion of participants achieving endoscopic improvement at week 12, and exploratory endpoints included the concentration of PF-06687234 in colonic mucosal tissue from biopsies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      After 20 participants were randomized and treated, this study was stopped early for futility. There were no statistically significant differences between groups for any efficacy endpoint (all\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&gt;\u20090.05), although numerical trends towards efficacy were observed in some secondary endpoints. PF-06687234 was detected at a low concentration in only one colon tissue sample. There were no differences in AEs between the groups. The most frequently reported AE in the PF-06687234-treated group was injection site reaction.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>PF-06687234 was well tolerated, but when combined with background infliximab, did not meet the primary efficacy endpoint in this cohort of participants with active UC. Efficacious PF-06687234 tissue concentrations may not have been achieved at the dose tested.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trail registration:<\/jats:title>\n                    <jats:p>\n                      Efficacy, safety, and tolerability of PF-06687234 as add-on therapy to infliximab in active UC subjects not in remission.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT03269695\">https:\/\/clinicaltrials.gov\/study\/NCT03269695<\/jats:ext-link>\n                      . NCT03269695.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562848251410784","type":"journal-article","created":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T08:00:36Z","timestamp":1770710436000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of the interleukin-10\u2013fragment F8 fusion protein PF-06687234 as add-on therapy to infliximab in patients with active ulcerative colitis: a randomized, phase IIa clinical trial"],"prefix":"10.1177","volume":"19","author":[{"given":"Stefan","family":"Schreiber","sequence":"first","affiliation":[{"name":"Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Rosalind-Franklin Str. 12 [Haus K1], Kiel 24105, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e9verine","family":"Vermeire","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupert W.","family":"Leong","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Faculty of Medicine and Health Sciences, Macquarie University Hospital, Sydney, NSW, Australia"},{"name":"Department of Gastroenterology, Concord Hospital, Concord, NSW, Australia"},{"name":"Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4590-5383","authenticated-orcid":false,"given":"Vivek","family":"Pradhan","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi Shankar P.","family":"Singh","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dahong","family":"Yu","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean","family":"Messing","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Neubert","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-5958-0810","authenticated-orcid":false,"given":"Joe","family":"Palandra","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Tehlirian","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0906-4890","authenticated-orcid":false,"given":"Jeremy D.","family":"Gale","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,2,10]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60150-0"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa050516"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2014.07.002"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.10.032"},{"key":"e_1_3_3_6_2","article-title":"Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis","volume":"146","author":"Sandborn WJ","year":"2014","unstructured":"Sandborn WJ, Feagan BG, Marano C, et al. 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