Rodrigo Galhardi Gasparini, Carlos Taxonera, Antônio José Tibúrcio Alves Júnior, Bianca Loyo Pona Schiavetti, Francisco Guilherme Cancela E Penna, Richard Borba Magalhães, Sandro da Costa Ferreira, Renata de Sá Brito Fróes, Carlos Henrique Marques Dos Santos, Cristina Flores, Bruno César da Silva, Rogério Serafim Parra, Alexandre Venâncio, Hélio Rzetelna, Carlos Frederico Pereira Porto Alegre Rosa, Adriana Ribas Andrade
{"title":"将组织学愈合与生活质量联系起来:对溃疡性结肠炎戈利姆单抗治疗的真实世界见解。","authors":"Rodrigo Galhardi Gasparini, Carlos Taxonera, Antônio José Tibúrcio Alves Júnior, Bianca Loyo Pona Schiavetti, Francisco Guilherme Cancela E Penna, Richard Borba Magalhães, Sandro da Costa Ferreira, Renata de Sá Brito Fróes, Carlos Henrique Marques Dos Santos, Cristina Flores, Bruno César da Silva, Rogério Serafim Parra, Alexandre Venâncio, Hélio Rzetelna, Carlos Frederico Pereira Porto Alegre Rosa, Adriana Ribas Andrade","doi":"10.1080/03007995.2025.2535454","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC) significantly impacts patients' quality of life (QoL). Therapeutic strategies have increasingly focused on achieving histological and endoscopic remission in addition to clinical outcomes and patient-reported measures. Real-world data on the effectiveness of golimumab to achieve histologic remission is scarce.</p><p><strong>Methods: </strong>This was a multicenter, cohort study including 73 patients with moderate-to-severe UC treated with golimumab across Brazilian centers. Outcomes were assessed at weeks 24 and 54 and included histological remission (Nancy histological index [NHI]), endoscopic remission (Mayo endoscopic subscore [MES]), inflammatory biomarkers (CRP and fecal calprotectin), and QoL (IBDQ-36). Correlations between histological scores with endoscopic outcomes and QoL were analyzed using Spearman test.</p><p><strong>Results: </strong>At week 24, 32.4% of patients achieved complete histological remission (NHI grade 0), and 80.8% achieved endoscopic remission (MES 0 or 1). At week 54, 55.2% of patients had histological remission and 84.4% of patients achieved endoscopic remission. Mean CRP levels decreased from 13.16 mg/dL at baseline to 1.35 mg/dL at week 54 (<i>p</i> < 0.001), and mean calprotectin decreased from 2113.2 to 106.9 mcg/g (<i>p</i> < 0.001). QoL significantly improved, with IBDQ-36 scores increasing from 121.5 at baseline to 182.1 at week 24 and 194.2 at week 54 (<i>p</i> = 0.002). Significant correlations were observed between NHI with MES and IBDQ-36 at week 24.</p><p><strong>Conclusion: </strong>Golimumab has achieved sustained efficacy in the induction of histological and endoscopic remission and improvement in QoL in patients with moderate-to-severe UC in a real-world setting. These results support the use of golimumab as an effective, patient-centered therapeutic option, particularly when multidimensional disease control is the goal.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1219-1226"},"PeriodicalIF":2.2000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Linking histological healing to quality of life: real-world insights into golimumab therapy in ulcerative colitis.\",\"authors\":\"Rodrigo Galhardi Gasparini, Carlos Taxonera, Antônio José Tibúrcio Alves Júnior, Bianca Loyo Pona Schiavetti, Francisco Guilherme Cancela E Penna, Richard Borba Magalhães, Sandro da Costa Ferreira, Renata de Sá Brito Fróes, Carlos Henrique Marques Dos Santos, Cristina Flores, Bruno César da Silva, Rogério Serafim Parra, Alexandre Venâncio, Hélio Rzetelna, Carlos Frederico Pereira Porto Alegre Rosa, Adriana Ribas Andrade\",\"doi\":\"10.1080/03007995.2025.2535454\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Ulcerative colitis (UC) significantly impacts patients' quality of life (QoL). Therapeutic strategies have increasingly focused on achieving histological and endoscopic remission in addition to clinical outcomes and patient-reported measures. Real-world data on the effectiveness of golimumab to achieve histologic remission is scarce.</p><p><strong>Methods: </strong>This was a multicenter, cohort study including 73 patients with moderate-to-severe UC treated with golimumab across Brazilian centers. Outcomes were assessed at weeks 24 and 54 and included histological remission (Nancy histological index [NHI]), endoscopic remission (Mayo endoscopic subscore [MES]), inflammatory biomarkers (CRP and fecal calprotectin), and QoL (IBDQ-36). Correlations between histological scores with endoscopic outcomes and QoL were analyzed using Spearman test.</p><p><strong>Results: </strong>At week 24, 32.4% of patients achieved complete histological remission (NHI grade 0), and 80.8% achieved endoscopic remission (MES 0 or 1). At week 54, 55.2% of patients had histological remission and 84.4% of patients achieved endoscopic remission. Mean CRP levels decreased from 13.16 mg/dL at baseline to 1.35 mg/dL at week 54 (<i>p</i> < 0.001), and mean calprotectin decreased from 2113.2 to 106.9 mcg/g (<i>p</i> < 0.001). QoL significantly improved, with IBDQ-36 scores increasing from 121.5 at baseline to 182.1 at week 24 and 194.2 at week 54 (<i>p</i> = 0.002). Significant correlations were observed between NHI with MES and IBDQ-36 at week 24.</p><p><strong>Conclusion: </strong>Golimumab has achieved sustained efficacy in the induction of histological and endoscopic remission and improvement in QoL in patients with moderate-to-severe UC in a real-world setting. These results support the use of golimumab as an effective, patient-centered therapeutic option, particularly when multidimensional disease control is the goal.</p>\",\"PeriodicalId\":10814,\"journal\":{\"name\":\"Current Medical Research and Opinion\",\"volume\":\" \",\"pages\":\"1219-1226\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Medical Research and Opinion\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/03007995.2025.2535454\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/26 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Medical Research and Opinion","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/03007995.2025.2535454","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/26 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Linking histological healing to quality of life: real-world insights into golimumab therapy in ulcerative colitis.
Background: Ulcerative colitis (UC) significantly impacts patients' quality of life (QoL). Therapeutic strategies have increasingly focused on achieving histological and endoscopic remission in addition to clinical outcomes and patient-reported measures. Real-world data on the effectiveness of golimumab to achieve histologic remission is scarce.
Methods: This was a multicenter, cohort study including 73 patients with moderate-to-severe UC treated with golimumab across Brazilian centers. Outcomes were assessed at weeks 24 and 54 and included histological remission (Nancy histological index [NHI]), endoscopic remission (Mayo endoscopic subscore [MES]), inflammatory biomarkers (CRP and fecal calprotectin), and QoL (IBDQ-36). Correlations between histological scores with endoscopic outcomes and QoL were analyzed using Spearman test.
Results: At week 24, 32.4% of patients achieved complete histological remission (NHI grade 0), and 80.8% achieved endoscopic remission (MES 0 or 1). At week 54, 55.2% of patients had histological remission and 84.4% of patients achieved endoscopic remission. Mean CRP levels decreased from 13.16 mg/dL at baseline to 1.35 mg/dL at week 54 (p < 0.001), and mean calprotectin decreased from 2113.2 to 106.9 mcg/g (p < 0.001). QoL significantly improved, with IBDQ-36 scores increasing from 121.5 at baseline to 182.1 at week 24 and 194.2 at week 54 (p = 0.002). Significant correlations were observed between NHI with MES and IBDQ-36 at week 24.
Conclusion: Golimumab has achieved sustained efficacy in the induction of histological and endoscopic remission and improvement in QoL in patients with moderate-to-severe UC in a real-world setting. These results support the use of golimumab as an effective, patient-centered therapeutic option, particularly when multidimensional disease control is the goal.
期刊介绍:
Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance