{"doi":"10.3390/diseases14040149","title":"Predictors of Response to Induction Therapy with Ustekinumab in Patients with Ulcerative Colitis: Results from a National Study in Greece","abstract":"<jats:p>Background/Objectives: Ustekinumab has been approved for the treatment of moderate to severe ulcerative colitis. Real-world data regarding its efficacy and the discovery of predictive factors of response need to be studied further. We aimed to evaluate the efficacy and identify predictors of response to induction treatment with ustekinumab in patients with ulcerative colitis. Methods: This is a multicenter, prospective cohort study. Clinical response (CR) at week 16 was the primary endpoint, and steroid-free clinical remission (SFCRem) and endoscopic response were the secondary endpoints. Baseline histology, mucosal gene expression, and pharmacokinetics were studied for their effect on response to treatment. Results: We included 123 patients (mean age = 50.3 years). CR was recorded in 70.8% (75/106), SFCRem in 48% (59/123), endoscopic improvement in 71.4% (40/56), and mucosal healing in 28.6% (16/56). Higher PRO-stool frequency (OR = 0.49, p = 0.027), concomitant use of 5-ASA (OR = 3.69, p = 0.021), platelet number of ≥284 × 109/L (OR = 6.52, p = 0.001) at baseline, and a drop in the total count of platelets by 108/L (OR = 1.23, p = 0.022) at week 8 were independently associated with CR. Elevated trough levels of ustekinumab at week 16 were associated with a higher probability of endoscopic improvement (median difference = 3784 ng/mL, p = 0.013), with an optimal cut-off value of 3500 ng/mL (AUC = 0.82, 95% CI: 0.66–0.96). Increased mucosal mRNA expression for IL-23 (p = 0.007) and IL-23R (p = 0.031) at baseline was associated with increased probability of CR. Higher continuous Geboes scores at baseline were associated with a lower probability of CR (OR = 0.80, p = 0.045), with an optimal cut-off value of 14 (AUC = 0.75, 95% CI: 0.57–0.93). Conclusions: Clinical, laboratory, and molecular markers may identify patients with ulcerative colitis who are more likely to respond to ustekinumab.</jats:p>","journal":"Diseases","year":2026,"id":644631,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1678003,"name":"Georgios Kokkotis","orcid":"0009-0004-9640-6634","position":1,"is_corresponding":false},{"id":1055048,"name":"Maria Gazouli","orcid":"0000-0002-3295-6811","position":2,"is_corresponding":false},{"id":1678005,"name":"Stratigoula Sakellariou","orcid":null,"position":3,"is_corresponding":false},{"id":569935,"name":"Ioannis Vamvakaris","orcid":"0000-0002-2917-7155","position":4,"is_corresponding":false},{"id":1678008,"name":"Alexandros Chatzidakis","orcid":"0000-0002-6137-4212","position":5,"is_corresponding":false},{"id":1678009,"name":"Gerasimos Gerasimatos","orcid":null,"position":6,"is_corresponding":false},{"id":1678010,"name":"Maria Kalogirou","orcid":"0000-0001-9985-4038","position":7,"is_corresponding":false},{"id":1678011,"name":"Kanellos Koustenis","orcid":null,"position":8,"is_corresponding":false},{"id":1678012,"name":"Dimitra Lazou","orcid":null,"position":9,"is_corresponding":false},{"id":1678013,"name":"Afroditi Orfanidou","orcid":"0000-0002-0434-042X","position":10,"is_corresponding":false},{"id":1678014,"name":"Maria Palatianou","orcid":null,"position":11,"is_corresponding":false},{"id":1678015,"name":"Evgenia Papathanasiou","orcid":"0000-0002-0441-0598","position":12,"is_corresponding":false},{"id":1678016,"name":"Andreas Psistakis","orcid":null,"position":13,"is_corresponding":false},{"id":1678017,"name":"Christos Sotiropoulos","orcid":"0000-0001-9233-8700","position":14,"is_corresponding":false},{"id":1678018,"name":"Evaggelia Anagnostopoulou","orcid":null,"position":15,"is_corresponding":false},{"id":1678020,"name":"Konstantinos Argyriou","orcid":"0000-0002-2026-9678","position":16,"is_corresponding":false},{"id":1678021,"name":"Matina-Lydia Chatzinikolaou","orcid":null,"position":17,"is_corresponding":false},{"id":1678022,"name":"Kalliopi Foteinogiannopoulou","orcid":"0000-0003-0554-5256","position":18,"is_corresponding":false},{"id":1678023,"name":"Olga Giouleme","orcid":"0000-0003-0176-3598","position":19,"is_corresponding":false},{"id":1678024,"name":"Andreas Kapsoritakis","orcid":null,"position":20,"is_corresponding":false},{"id":1678025,"name":"Pantelis Karatzas","orcid":null,"position":21,"is_corresponding":false},{"id":1678026,"name":"Konstantinos Karmiris","orcid":"0000-0003-3552-3074","position":22,"is_corresponding":false},{"id":1678027,"name":"Nikolaos Kiriakos","orcid":"0000-0002-7395-6594","position":23,"is_corresponding":false},{"id":671192,"name":"Ioannis E. Κoutroubakis","orcid":"0000-0002-2773-2709","position":24,"is_corresponding":false},{"id":1678028,"name":"Christos Liatsos","orcid":"0000-0001-8025-0808","position":25,"is_corresponding":false},{"id":1678029,"name":"Aikaterini Mantaka","orcid":"0000-0001-7783-8627","position":26,"is_corresponding":false},{"id":1678030,"name":"Gerasimos Mantzaris","orcid":"0000-0002-5302-5450","position":27,"is_corresponding":false},{"id":1678031,"name":"Panagiotis Markopoulos","orcid":"0009-0001-7345-5298","position":28,"is_corresponding":false},{"id":1678032,"name":"Georgios Michalopoulos","orcid":"0000-0002-0356-6777","position":29,"is_corresponding":false},{"id":1023869,"name":"Spyridon Michopoulos","orcid":"0000-0001-7371-8601","position":30,"is_corresponding":false},{"id":1678033,"name":"Dimitrios Polymeros","orcid":null,"position":31,"is_corresponding":false},{"id":1678034,"name":"Konstantinos Soufleris","orcid":"0000-0001-8635-6400","position":32,"is_corresponding":false},{"id":1325382,"name":"Georgios Theocharis","orcid":null,"position":33,"is_corresponding":false},{"id":1678036,"name":"Angeliki Theodoropoulou","orcid":null,"position":34,"is_corresponding":false},{"id":1678037,"name":"Eftychia Tsironi","orcid":"0009-0007-7371-285X","position":35,"is_corresponding":false},{"id":1678038,"name":"Maria Tzouvala","orcid":null,"position":36,"is_corresponding":false},{"id":1678039,"name":"Nikos Viazis","orcid":"0000-0002-0918-1587","position":37,"is_corresponding":false},{"id":1678040,"name":"Eirini Zacharopoulou","orcid":"0000-0001-8154-0444","position":38,"is_corresponding":false},{"id":1678041,"name":"Evanthia Zampeli","orcid":null,"position":39,"is_corresponding":false},{"id":370700,"name":"Giorgos Bamias","orcid":"0000-0002-5492-5717","position":40,"is_corresponding":false},{"id":1678002,"name":"Konstantina Chalakatevaki","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Predictors of Response to Induction Therapy with Ustekinumab in Patients with Ulcerative Colitis: Results from a National Study in Greece","abstract":"<jats:p>Background/Objectives: Ustekinumab has been approved for the treatment of moderate to severe ulcerative colitis. Real-world data regarding its efficacy and the discovery of predictive factors of response need to be studied further. We aimed to evaluate the efficacy and identify predictors of response to induction treatment with ustekinumab in patients with ulcerative colitis. Methods: This is a multicenter, prospective cohort study. Clinical response (CR) at week 16 was the primary endpoint, and steroid-free clinical remission (SFCRem) and endoscopic response were the secondary endpoints. Baseline histology, mucosal gene expression, and pharmacokinetics were studied for their effect on response to treatment. Results: We included 123 patients (mean age = 50.3 years). CR was recorded in 70.8% (75/106), SFCRem in 48% (59/123), endoscopic improvement in 71.4% (40/56), and mucosal healing in 28.6% (16/56). Higher PRO-stool frequency (OR = 0.49, p = 0.027), concomitant use of 5-ASA (OR = 3.69, p = 0.021), platelet number of ≥284 × 109/L (OR = 6.52, p = 0.001) at baseline, and a drop in the total count of platelets by 108/L (OR = 1.23, p = 0.022) at week 8 were independently associated with CR. Elevated trough levels of ustekinumab at week 16 were associated with a higher probability of endoscopic improvement (median difference = 3784 ng/mL, p = 0.013), with an optimal cut-off value of 3500 ng/mL (AUC = 0.82, 95% CI: 0.66–0.96). Increased mucosal mRNA expression for IL-23 (p = 0.007) and IL-23R (p = 0.031) at baseline was associated with increased probability of CR. Higher continuous Geboes scores at baseline were associated with a lower probability of CR (OR = 0.80, p = 0.045), with an optimal cut-off value of 14 (AUC = 0.75, 95% CI: 0.57–0.93). Conclusions: Clinical, laboratory, and molecular markers may identify patients with ulcerative colitis who are more likely to respond to ustekinumab.</jats:p>","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"42041641","pmcid":"PMC13115418","openalex_id":"https://openalex.org/W7155010180","authors":[],"funders":[{"funder_name":"Hellenic Group for the study of IBD","grant_id":"2022EOMIFNEmp1","title":null}],"total_grants":1,"fwci":0.0,"citation_percentile":0.4272602,"influential_citations":0,"citation_trend":[],"oa_status":"gold","license":"cc-by","oa_locations":[{"url":"https://www.mdpi.com/2079-9721/14/4/149/pdf?version=1776597560","host_type":"journal"},{"url":"https://www.mdpi.com/2079-9721/14/4/149/pdf?version=1776597560","host_type":"publisher"},{"url":"https://www.mdpi.com/2079-9721/14/4/149/pdf","host_type":"publisher"},{"url":"https://doi.org/10.3390/diseases14040149","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/42041641","host_type":"repository"},{"url":"https://doaj.org/article/b97a5c1c87b447078c851bf9799b7df4","host_type":"repository"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13115418/","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC13115418","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC13115418?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Inflammatory Bowel Disease","Microscopic Colitis","Rheumatoid Arthritis Research and Therapies"],"mesh_terms":[],"keywords":["Ustekinumab","Concomitant","Cohort","Prospective cohort study","Cohort study","Odds ratio","Retrospective cohort study","Biomarkers","efficacy","Mucosal Expression"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-09T01:42:51.282115Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}