Endoscopic remission can be predicted by golimumab concentrations in patients with ulcerative colitis treated with the changed label. Issue 1 (January 2021)

• Record Type: Journal Article
• Authors: Stefanovic, Sebastian; Detrez, Iris; Compernolle, Griet; Brouwers, Els; Sever, Nejc; Stabuc, Borut; Smrekar, Natasa; Kurent, Tina; Novak, Gregor; Kozelj, Matic; Ferrante, Marc; Gils, Ann; Drobne, David
• Is Part Of: European journal of gastroenterology & hepatology. Volume 33:Issue 1(2021)
• Publication Date: 2021-01
• Subjects: anti-TNF-alpha -- biologics -- endoscopic response -- golimumab -- therapeutic drug monitoring -- ulcerative colitis; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Digestive organs -- Diseases; Liver -- Diseases; Periodicals; 616.33
• DOI: 10.1097/MEG.0000000000001843
• Languages: English
• ISSNs: 0954-691X

Abstract

Abstract : Background: In 2018, the European Medicines Agency (EMA) replaced a fixed 50 mg every 4-week maintenance regimen of golimumab for ulcerative colitis (UC) patients weighing <80 kg with new, flexible dosing that allows reactive dose optimization to 100 mg if clinically needed. We analyzed the endoscopic remission rates and pharmacokinetics of this new dosing regimen in real-life settings. Methods: We prospectively recruited 30 consecutive (17 with body weight <80 kg) patients with UC who received golimumab with the new EMA label. The primary endpoint was endoscopic remission (Mayo ⩽1) assessed by centrally-read endoscopy at week 14 and year 1. Golimumab concentrations, measured at nine prespecified timepoints, were correlated with endoscopic remission and identified cut-offs. Results: Endoscopic remission was achieved in 15/30 (50%) and 10/30 (33%) patients at week 14 and year 1, respectively. Reactive dose optimization to 100 mg maintenance was needed in 13/17 (76%) patients. Golimumab concentrations at week 6 predicted week 14 and year 1 endoscopic remission. Week 6 concentrations >10.7 µg/ml were a strong predictor for achievement and maintenance of endoscopic remission during the first year of treatment, while concentrations <5.1 µg/ml identified the opposite. Conclusion: One-third of the patients reached and maintained endoscopic remission during the first year of golimumab treatment, but the need for dose optimization to 100 mg every 4 weeks of maintenance was high in patients weighing <80 kg. Golimumab concentrations <5.1 µg/ml at week 6 identified patients who are unlikely to reach and maintain endoscopic remission with the new, flexible EMA label. Abstract : Supplemental Digital Content is available in the text.