Golimumab in real-world practice in patients with ulcerative colitis:Twelve-month results  

作　　者：Niels Teich Harald Grümmer Eric Jorgensen Thomas Liceni Frank Holtkamp-Endemann Tim Fischer Susanne Hohenberger 

机构地区：[1]Internistische Gemeinschaftspraxis für Verdauungs-und Stoffwechselkrankheiten Leipzig und Schkeuditz,Leipzig 04105,Germany [2]Praxis für Innere Medizin/Gastroenterologie,Potsdam 14471,Germany [3]Magen-Darm-Zentrum Remscheid,Remscheid 42859,Germany [4]MVZ für Gastroenterologie am Bayerischen Platz,Berlin 10825,Germany [5]Gastroenterologische Gemeinschaftspraxis am Germania-Campus,Münster 48159,Germany [6]Medical Affairs,MSD Sharp and Dohme GmbH,Haar 85540,Germany

出　　处：《World Journal of Gastroenterology》2020年第21期2852-2863,共12页世界胃肠病学杂志（英文版）

基　　金：Supported by MSD Sharp and Dohme GmbH,Haar,Germany。

摘　　要：BACKGROUND The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease,ulcerative colitis(UC),with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole.In Germany,there are no prospective data>3 mo that assess the work productivity,daily activities and quality of life(QoL)of patients with moderate-to-severe UC treated with golimumab.AIM To assess change in work productivity,capacity for daily activities and QoL in UC patients treated with golimumab in Germany.METHODS The validated Work Productivity Activity Impairment(WPAI)Questionnaire was used to analyze the change in work productivity,the capacity for daily activities after three months(primary endpoint)and disease specific and health related QoL(HRQoL)up to 1 year(secondary endpoints).The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline.Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire(SF-12).RESULTS This prospective non-interventional study included 287 patients.The analysis population was comprised of 282 patients who had completed at least two visits.At baseline,61%of patients had moderate UC and 18%had severe UC.Furthermore,75%of patients worked full-time or part-time at baseline.A total of 212 patients who were employed at the start of the study(employed population)were evaluated for the primary endpoint.Golimumab significantly reduced all WPAI sub-scores compared to baseline after three,six,nine and twelve months after the start of treatment(P<0.0001).In addition,disease-specific QoL and HRQoL,as measured by the SF-12 questionnaire,improved significantly with golimumab at all evaluation times(P<0.0001 in each case vs baseline).CONCLUSION Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient�

关 键 词：Ulcerative colitis Quality of life Work productivity Non-interventional study GOLIMUMAB Work Productivity Activity Impairment(WPAI)Questionnaire 

分 类 号：R574.62[医药卫生—消化系统]