{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T14:10:46Z","timestamp":1760710246330,"version":"build-2065373602"},"reference-count":18,"publisher":"MDPI AG","issue":"20","license":[{"start":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:00:00Z","timestamp":1760659200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: The efficacy and safety of the anti-TNF inhibitor golimumab in ulcerative colitis (UC) have been demonstrated in pivotal randomized controlled trials (RCTs). However, real-world data are needed to assess its effectiveness and safety in routine clinical practice, where patient populations and treatment settings are more heterogeneous. Methods: This pooled, retrospective\u2013prospective cohort analysis draws on primary data from four IBD registries that contribute UC data to the UMBRELLA-IBD data warehouse: BioColitis, RUN-UC, TARGET-IBD, and VEDO-IBD. Data for each registry were collected across multiple centers under routine clinical care conditions in Germany. Eligible patients had a confirmed diagnosis of UC according to DGVS\/ECCO criteria, were \u226518 years of age, and had newly initiated treatment with golimumab between 2017 and 2023. In total, 222 patients met these criteria and were included in the analysis. Statistical analyses included descriptive summaries, group comparisons, and Kaplan\u2013Meier analysis of treatment persistence. Adverse events (AEs) and serious adverse events (SAEs) were also assessed and compared to other anti-TNF therapies from UMBRELLA-IBD. Results: Of the 222 patients who newly initiated golimumab, 134 had a documented month 12 visit with a documented pMayo score and were included in the modified intention-to-treat (mITT) analysis. A high proportion of the patients in the study had previously received treatment with at least two biologics (81%). In this mITT population, clinical remission was achieved in 38.1% and steroid-free clinical remission (SFCR) in 36.6% at 12 months. In the full cohort, treatment persistence at 12 months was 67.2%. Safety data on adverse events (AEs) and serious adverse events (SAEs) were reported in 14.8% and 5.8% of cases, respectively, with no significant differences compared with other anti-TNF therapies. Conclusions: In addition to the positive findings from the pivotal RCTs, these real-world data further support the clinical effectiveness and safety of golimumab in routine care for UC.<\/jats:p>","DOI":"10.3390\/jcm14207347","type":"journal-article","created":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T13:07:22Z","timestamp":1760706442000},"page":"7347","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Effectiveness of Golimumab in Ulcerative Colitis: A Pooled Analysis from the Prospective UMBRELLA-IBD Registry in Germany"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4238-751X","authenticated-orcid":false,"given":"Arne","family":"Bokemeyer","sequence":"first","affiliation":[{"name":"Department for Gastroenterology, Diabetology and Palliative Care, Bonifatius Hospital Lingen, 49808 Lingen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Wenske","sequence":"additional","affiliation":[{"name":"Competence Network IBD, 24103 Kiel, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1945-4198","authenticated-orcid":false,"given":"Sandra","family":"Plachta-Danielzik","sequence":"additional","affiliation":[{"name":"Competence Network IBD, 24103 Kiel, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2016-6991","authenticated-orcid":false,"given":"Bernd","family":"Bokemeyer","sequence":"additional","affiliation":[{"name":"Competence Network IBD, 24103 Kiel, Germany"},{"name":"Interdisciplinary Crohn Colitis Center, 32429 Minden, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1053\/j.gastro.2013.05.048","article-title":"Subcutaneous Golimumab Induces Clinical Response and Remission in Patients with Moderate-to-Severe Ulcerative Colitis","volume":"146","author":"Sandborn","year":"2014","journal-title":"Gastroenterology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1053\/j.gastro.2013.06.010","article-title":"Subcutaneous Golimumab Maintains Clinical Response in Patients with Moderate-to-Severe Ulcerative Colitis","volume":"146","author":"Sandborn","year":"2014","journal-title":"Gastroenterology"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2852","DOI":"10.3748\/wjg.v26.i21.2852","article-title":"Golimumab in Real-World Practice in Patients with Ulcerative Colitis: Twelve-Month Results","volume":"26","author":"Teich","year":"2020","journal-title":"World J. Gastroenterol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"764","DOI":"10.5009\/gnl210335","article-title":"Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study","volume":"16","author":"Yu","year":"2022","journal-title":"Gut Liver"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1016\/j.dld.2018.11.002","article-title":"Effectiveness of Golimumab in Ulcerative Colitis: A Review of the Real World Evidence","volume":"51","author":"Olivera","year":"2019","journal-title":"Dig. Liver Dis."},{"key":"ref_6","first-page":"1012","article-title":"Real-World Evidence Data Warehouse for Pooled Analyses in Patients with Inflammatory Bowel Diseases in Germany: The \u201cUmbrella-IBD Registry\u201d of the Competence Network IBD","volume":"11","author":"Bokemeyer","year":"2023","journal-title":"United Eur. Gastroenterol. J."},{"key":"ref_7","first-page":"S292","article-title":"P386. Anti-TNF Alpha as Induction and Maintenance Therapy in Ulcerative Colitis Patients in the BioColitis Registry in Germany","volume":"10","author":"Bokemeyer","year":"2016","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"jjaf052","DOI":"10.1093\/ecco-jcc\/jjaf052","article-title":"Real-World Effectiveness of Ustekinumab versus Anti-TNF or Vedolizumab in Ulcerative Colitis: Induction and 12-Month Maintenance Results from the Prospective, Observational RUN-UC Study","volume":"19","author":"Bokemeyer","year":"2025","journal-title":"J. Crohn\u2019s Colitis"},{"key":"ref_9","first-page":"KV063","article-title":"TARGET Register: Biologika- und Small Molecules-Register f\u00fcr Patient:innen mit chronisch-entz\u00fcndlichen Darmerkrankungen in Deutschland\u2014Registerdesign und erste Ergebnisse","volume":"Volume 61","author":"Bokemeyer","year":"2023","journal-title":"Zeitschrift f\u00fcr Gastroenterologie"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1111\/apt.17616","article-title":"Real-world Effectiveness of Vedolizumab Compared to ANTI-TNF Agents in Biologic-na\u00efve Patients with Ulcerative Colitis: A Two-year Propensity-score-adjusted Analysis from the Prospective, Observational VEDOIBD-study","volume":"58","author":"Bokemeyer","year":"2023","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Kanters, S., Karim, M.E., Thorlund, K., Anis, A., and Bansback, N. (2021). When Does the Use of Individual Patient Data in Network Meta-Analysis Make a Difference? A Simulation Study. BMC Med. Res. Methodol., 21.","DOI":"10.1186\/s12874-020-01198-2"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1159\/000488586","article-title":"Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival","volume":"234","author":"Costanzo","year":"2018","journal-title":"Dermatology"},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Menditto, E., Cahir, C., Malo, S., Aguilar-Palacio, I., Almada, M., Costa, E., Giardini, A., Gil Peinado, M., Mesquida, M.M., and Mucherino, S. (2021). Persistence as a Robust Indicator of Medication Adherence-Related Quality and Performance. Int. J. Environ. Res. Public Health, 18.","DOI":"10.3390\/ijerph18094872"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1016\/S2468-1253(22)00427-7","article-title":"VEGA Study Group Guselkumab plus Golimumab Combination Therapy versus Guselkumab or Golimumab Monotherapy in Patients with Ulcerative Colitis (VEGA): A Randomised, Double-Blind, Controlled, Phase 2, Proof-of-Concept Trial","volume":"8","author":"Feagan","year":"2023","journal-title":"Lancet Gastroenterol. Hepatol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e000212","DOI":"10.1136\/bmjgast-2018-000212","article-title":"Golimumab Induction and Maintenance for Moderate to Severe Ulcerative Colitis: Results from GO-COLITIS (Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis)","volume":"5","author":"Probert","year":"2018","journal-title":"BMJ Open Gastroenterol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1177\/2050640620974308","article-title":"Two-Year Effectiveness and Safety of Golimumab in Ulcerative Colitis: An IG-IBD Study","volume":"9","author":"Pugliese","year":"2021","journal-title":"United Eur. Gastroenterol. J."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Iborra, M., Garc\u00eda-Morales, N., Rubio, S., Bertoletti, F., Calvo, M., Taxonera, C., Bosc\u00e1-Watts, M.M., Sierra, M., Mancenido, N., and Beltr\u00e1n, B. (2020). Real-Life Experience with 4 Years of Golimumab Persistence in Ulcerative Colitis Patients. Sci. Rep., 10.","DOI":"10.1038\/s41598-020-73577-0"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1290","DOI":"10.1111\/apt.17421","article-title":"Effectiveness of Golimumab Intensification in Ulcerative Colitis: A Multicentric Prospective Study","volume":"57","author":"Fumery","year":"2023","journal-title":"Aliment Pharmacol. Ther."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/20\/7347\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T13:47:07Z","timestamp":1760708827000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/20\/7347"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,17]]},"references-count":18,"journal-issue":{"issue":"20","published-online":{"date-parts":[[2025,10]]}},"alternative-id":["jcm14207347"],"URL":"https:\/\/doi.org\/10.3390\/jcm14207347","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,17]]}}}