Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
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Background/Aims: Golimumab has been used for patients with ulcerative colitis (UC) since 2013. However, there is limited data on the effectiveness and safety of the real-world use of golimumab in Asian patients. Methods: This was a multicenter, prospective, observational study. We enrolled patients with moderate-to-severe UC who were administered subcutaneous golimumab at 46 medical centers between May 2014 and November 2019. The primary outcome was the effectiveness and safety of golimumab at week 22. Clinical outcomes and adverse events were assessed according to partial Mayo score at weeks 0, 2, 6, 14, and 22. Results: A total of 130 patients were included (mean age: 45.7±16.0 years). The clinical response/ remission rates at weeks 2, 6, 14, and 22 were 40.4%/22.9%, 56.0%/35.8%, 70.6%/49.5%, and 67.9%/48.6%, respectively. Based on full Mayo score at week 14, clinical response and remission rates were 84.2% and 39.5%, respectively. Mucosal healing rate was 65.8%. In multivariate analysis with logistic regression, longer disease duration was significantly associated with a higher clinical response rate (adjusted odds ratio [aOR], 1.136; 95% confidence interval [CI], 1.006 to 1.282; p=0.040 at week 6; aOR, 1.256; 95% CI, 1.049 to 1.503; p=0.013 at week 22). A higher baseline Mayo endoscopic subscore was significantly associated with a lower clinical response rate at week 6 (aOR, 0.248; 95% CI, 0.089 to 0.692; p=0.008). The incidence of adverse drug reactions was 4.6% (6/130, nine events). No serious unexpected adverse drug reactions or deaths were reported. Conclusions: Golimumab was effective and safe as an induction and maintenance treatment for Korean patients with moderate-to-severe UC.
Abstract
Background/Aims: Golimumab has been used for patients with ulcerative colitis (UC) since 2013. However, there is limited data on the effectiveness and safety of the real-world use of golimumab in Asian patients. Methods: This was a multicenter, prospective, observational study. We enrolled patients with moderate-to-severe UC who were administered subcutaneous golimumab at 46 medical centers between May 2014 and November 2019. The primary outcome was the effectiveness and safety of golimumab at week 22. Clinical outcomes and adverse events were assessed according to partial Mayo score at weeks 0, 2, 6, 14, and 22. Results: A total of 130 patients were included (mean age: 45.7±16.0 years). The clinical response/ remission rates at weeks 2, 6, 14, and 22 were 40.4%/22.9%, 56.0%/35.8%, 70.6%/49.5%, and 67.9%/48.6%, respectively. Based on full Mayo score at week 14, clinical response and remission rates were 84.2% and 39.5%, respectively. Mucosal healing rate was 65.8%. In multivariate analysis with logistic regression, longer disease duration was significantly associated with a higher clinical response rate (adjusted odds ratio [aOR], 1.136; 95% confidence interval [CI], 1.006 to 1.282; p=0.040 at week 6; aOR, 1.256; 95% CI, 1.049 to 1.503; p=0.013 at week 22). A higher baseline Mayo endoscopic subscore was significantly associated with a lower clinical response rate at week 6 (aOR, 0.248; 95% CI, 0.089 to 0.692; p=0.008). The incidence of adverse drug reactions was 4.6% (6/130, nine events). No serious unexpected adverse drug reactions or deaths were reported. Conclusions: Golimumab was effective and safe as an induction and maintenance treatment for Korean patients with moderate-to-severe UC.
참고문헌 (40)
- Sands BE, "From symptom to diagnosis : clinical distinctions among various forms of intestinal inflammation", Gastroenterology, 126, pp.1518~1532 (2004)
- Jess T, "Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades : a population-based study from Copenhagen, Denmark", Inflamm Bowel Dis, 13, pp.481~489 (2007)
- da Silva BC, "Epidemiology, demographic characteristics and prognostic predictors of ulcerative colitis", World J Gastroenterol, 20, pp.9458~9467 (2014)
- Meucci G, "Prognostic significance of endoscopic remission in patients with active ulcerative colitis treated with oral and topical mesalazine : a prospective, multicenter study", Inflamm Bowel Dis, 18, pp.1006~1010 (2012)
- Triantafillidis JK, "Current and emerging drugs for the treatment of inflammatory bowel disease", Drug Des Devel Ther, 5, pp.185~210 (2011)
- Colombel JF, "Outcomes and strategies to support a treat-to-target approach in inflammatory bowel disease : a systematic review", J Crohns Colitis, 14, pp.254~266 (2020)
- Choon Jin Ooi, "Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia", Intestinal research, 17(3), pp.285~310 (2019), 대한장연구학회[DOI]
- Arshdeep Singh, "Use of thiopurines in inflammatory bowel disease: an update", Intestinal research, 20(1), pp.11~30 (2022), 대한장연구학회[DOI]
- 오신주, "Long-term outcomes of infliximab in a real-world multicenter cohort of patients with acute severe ulcerative colitis", Intestinal research, 19(3), pp.323~331 (2021), 대한장연구학회[DOI]
- Ramit Mahajan, "Maintaining infliximab induced clinical remission with azathioprine and 5-aminosalicylates in acute severe steroid-refractory ulcerative colitis has lower cost and high efficacy (MIRACLE): a multicenter study", Intestinal research, 20(1), pp.64~71 (2022), 대한장연구학회[DOI]
- Haruhiko Ogata, "Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study", Intestinal research, 19(4), pp.419~429 (2021), 대한장연구학회[DOI]
- 신승용, "Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study", Intestinal research, 20(3), pp.350~360 (2022), 대한장연구학회[DOI]
- Taku Kobayashi, "Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis", Intestinal research, 19(4), pp.448~460 (2021), 대한장연구학회[DOI]
- Tadakazu Hisamatsu, "Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)", Intestinal research, 19(4), pp.386~397 (2021), 대한장연구학회[DOI]
- Eun Hye Oh, "Long-term Outcomes of Adalimumab Therapy in Korean Patients with Ulcerative Colitis: A Hospital-Based Cohort Study", Gut and Liver, 14(3), pp.347~356 (2020), 거트앤리버 소화기연관학회협의회[DOI]
- Lee Yong Il, "Comparison of Long-Term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naïve Patients with Ulcerative Colitis", Gut and Liver, 15(2), pp.232~242 (2021), 거트앤리버 소화기연관학회협의회[DOI]
- Brigida Barberio, "Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation", Intestinal research, 20(1), pp.114~123 (2022), 대한장연구학회[DOI]
- Harzallah I, "Golimumab pharmacokinetics in ulcerative colitis : a literature review", Therap Adv Gastroenterol, 10, pp.89~100 (2017)
- Sandborn WJ, "Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis", Gastroenterology, 146, pp.85~95 (2014)
- Sandborn WJ, "Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis", Gastroenterology, 146, pp.96~109 (2014)
- Rutgeerts P, "Randomised clinical trial : a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis", Aliment Pharmacol Ther, 42, pp.504~514 (2015)
- Gibson PR, "Maintenance of efficacy and continuing safety of golimumab for active ulcerative colitis : PURSUIT-SC maintenance study extension through 1 year", Clin Transl Gastroenterol, 7, pp.e168~ (2016)
- Adedokun OJ, "Pharmacokinetics and exposure-response relationship of golimumab in patients with moderately-to-severely active ulcerative colitis : results from phase 2", 3 PURSUIT induction and maintenance studies, 2017, pp.11, 35~46
- Taxonera C, "clinical outcomes of golimumab as first, second or third anti-TNF agent in patients with moderate-to-severe ulcerative colitis", Inflamm Bowel Dis, 23, pp.1394~1402 (2017)
- Bosca-Watts MM, "Short-term effectiveness of golimumab for ulcerative colitis : observational multicenter study", World J Gastroenterol, 22, pp.10432~10439 (2016)
- Hibi T, "Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis : a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study)", J Gastroenterol, 52, pp.1101~1111 (2017)
- Reinisch W, "Long-term benefit of golimumab for patients with moderately to severely active ulcerative colitis : results from the PURSUIT-maintenance extension", J Crohns Colitis, 12, pp.1053~1066 (2018)
- Detrez I, "Variability in golimumab exposure : a 'real-life' observational study in active ulcerative colitis", J Crohns Colitis, 10, pp.575~581 (2016)
- Brown EG, "The medical dictionary for regulatory activities(MedDRA)", Drug Saf, 20, pp.109~117 (1999)
- Toshifumi Hibi, "Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis", Intestinal research, 19(1), pp.53~61 (2021), 대한장연구학회[DOI]
- Tursi A, "Effectiveness of golimumab in inducing remission and clinical response in outpatient ulcerative colitis", Clin Res Hepatol Gastroenterol, 40, pp.e61~e63 (2016)
- Olivera P, "Effectiveness of golimumab in ulcerative colitis : a review of the real world evidence", Dig Liver Dis, 51, pp.327~334 (2019)
- Bossuyt P, "Early mucosal healing predicts favorable outcomes in patients with moderate to severe ulcerative colitis treated with golimumab : data from the Real-life BE-SMART cohort", Inflamm Bowel Dis, 25, pp.156~162 (2019)
- Bossa F, "Real-life effectiveness and safety of golimumab and its predictors of response in patients with ulcerative colitis", Dig Dis Sci, 65, pp.1767~1776 (2020)
- Dulai PS, "Development and validation of clinical scoring tool to predict outcomes of treatment with vedolizumab in patients with ulcerative colitis", Clin Gastroenterol Hepatol, 18, pp.2952~2961 (2020)
- Bressler B, "Real world effectiveness of golimumab therapy in ulcerative colitis regardless of prior TNF exposure", J Can Assoc Gastroenterol, 1, pp.129~134 (2018)
- Gardam MA, "Anti-tumour necrosis factor agents and tuberculosis risk : mechanisms of action and clinical management", Lancet Infect Dis, 3, pp.148~155 (2003)
- Keane J, "TNF-blocking agents and tuberculosis: new drugs illuminate an old topic", Rheumatology(Oxford), 44, pp.714~720 (2005)
- Theis VS, "Review article : minimizing tuberculosis during anti-tumour necrosis factor-alpha treatment of inflammatory bowel disease", Aliment Pharmacol Ther, 27, pp.19~30 (2008)
- Hsia EC, "Comprehensive tuberculosis screening program in patients with inflammatory arthritides treated with golimumab, a human anti-tumor necrosis factor antibody, in Phase III clinical trials", Arthritis Care Res(Hoboken), 65, pp.309~313 (2013)