{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:52:45Z","timestamp":1777420365353,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2025,1,12]],"date-time":"2025-01-12T00:00:00Z","timestamp":1736640000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To summarize the evidence and pharmacologic profile of guselkumab for moderate to severe ulcerative colitis (UC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources:<\/jats:title>\n                    <jats:p>\n                      A PubMed search from inception to end of October 2024 using keywords\n                      <jats:italic>guselkumab, UC, and interleukin (IL)<\/jats:italic>\n                      was conducted. Additional information was obtained from abstracts and package insert.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study selection and data extraction:<\/jats:title>\n                    <jats:p>Phase 2\/3 studies plus applicable literature on guselkumab pharmacologic and clinical profile were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data synthesis:<\/jats:title>\n                    <jats:p>Approval was based on the QUASAR program, a multicenter, randomized, double-blind, placebo-controlled, phase 2b\/3 trial assessing guselkumab\u2019s efficacy and safety in adults with moderately to severely active UC who had inadequate response or intolerance to conventional therapies, biologics (excluding IL antagonists), or Janus Kinase inhibitors. Results indicated that guselkumab led to higher clinical remission rates at week 12 and 44 compared to placebo, along with improvements in clinical response, symptomatic remission, endoscopic improvement, and histologic normalization. Common adverse effects included respiratory tract infections, injection site reactions, and arthralgia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to patient care and clinical practice in comparison to existing drugs:<\/jats:title>\n                    <jats:p>Guselkumab is the fourth IL antagonist approved for UC, and the first to target CD64 (cells involved in IL-23 production). With its dual mechanism, guselkumab is hypothesized to neutralize IL-23 at production and reduce inflammatory response. The QUASAR findings suggest guselkumab can provide durable clinical remission and histologic normalization, addressing a significant gap in UC treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>As the latest addition to UC therapies, guselkumab presents improved efficacy and dosing flexibility without introducing any new safety concerns compared to existing agents.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280241305441","type":"journal-article","created":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T00:20:16Z","timestamp":1736727616000},"page":"862-867","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Guselkumab: A New Therapeutic Option for the Treatment of Moderately to Severely Active Ulcerative Colitis"],"prefix":"10.1177","volume":"59","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7023-9506","authenticated-orcid":false,"given":"Shubha","family":"Bhat","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Cleveland Clinic Foundation, Cleveland, OH, USA"},{"name":"Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Choi","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,1,12]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00966-2"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.disamonth.2019.02.004"},{"key":"e_1_3_2_4_2","unstructured":"MedlinePlus. Ulcerative Colitis. National Library of Medicine. Published 2023. Accessed October 5 2024. https:\/\/medlineplus.gov\/genetics\/condition\/ulcerative-colitis\/"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.07.042"},{"key":"e_1_3_2_6_2","unstructured":"Levine JS Burakoff R. Extraintestinal manifestations of inflammatory bowel disease. Gastroenterol Hepatol. 2011;7(4):235-241. Accessed November 29 2024. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21857821"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjy114"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjv111"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000000152"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.01.006"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.12.009"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1159\/000496739"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjab185"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1126\/science.1135245"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjac190.0634"},{"key":"e_1_3_2_16_2","unstructured":"Janssen Biotech. Tremfya (Gusulkemab) [package insert]. U.S. Food and Drug Administration. Published September 2024. Accessed October 5 2024. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/761061s021lbl.pdf"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.08.038"},{"key":"e_1_3_2_18_2","unstructured":"The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 QUASAR induction study. Gastroenterol Hepatol. 2023;19(7 suppl 3):9-10. Accessed November 29 2024. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/38445000"},{"key":"e_1_3_2_19_2","unstructured":"The efficacy and safety of guselkumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 QUASAR maintenance study. Gastroenterol Hepatol. 2024;20(7 suppl 6):8-9. Accessed November 29 2024. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/39193118"},{"key":"e_1_3_2_20_2","unstructured":"Tremfya (Guselkumab) Medical Information. Janssen Pharmaceuticals. Published 2024. Accessed October 5 2024. https:\/\/www.janssenscience.com\/products\/tremfya\/medical-content\/tremfya-storage-and-stability-for-100-mgml-prefilled-syringe-and#references-content"},{"key":"e_1_3_2_21_2","unstructured":"Janssen Biotech. Tremfya. Published September 2024. Accessed October 5 2024. https:\/\/www.tremfya.com\/cost-support-gi\/"},{"key":"e_1_3_2_22_2","unstructured":"Janssen Biotech. TremfyaWithMe. Published 2024. Accessed October 5 2024. https:\/\/www.tremfyawithme.com\/healthcare-professionals\/resources"},{"key":"e_1_3_2_23_2","unstructured":"Janssen Biotech. TremfyaWithMe. Published 2024. Accessed October 5 2024. https:\/\/www.janssencarepath.com\/patient\/tremfya\/withme\/cost-support"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.12.031"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2314585"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280241305441","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280241305441","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280241305441","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:13:58Z","timestamp":1777374838000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280241305441"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,12]]},"references-count":24,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1177\/10600280241305441"],"URL":"https:\/\/doi.org\/10.1177\/10600280241305441","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,12]]}}}