BACKGROUND A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis(UC)patients treated in a real-world setting.The use of patient-reported outcomes(PROs)ha...BACKGROUND A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis(UC)patients treated in a real-world setting.The use of patient-reported outcomes(PROs)has been discussed as a primary endpoint in the context of the FDA PRO Guidance,for labelling purposes.Specifically,the efficacy and safety of adalimumab have been demonstrated in pivotal trials;however,data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients,such as symptoms,health-related quality of life(HRQoL),and disability.AIM To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.METHODS UCanADA was a single arm,prospective,1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed—with psychologic distress/depression symptoms as the primary endpoint—by patients with moderate-to-severe UC.Assessments were performed during patients’routine care visit schedule,which was at the initiation of adalimumab(baseline),after induction(approximately 8 wk),and 52 wk after baseline.Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period.Serious safety events and per-protocol adverse events were collected.RESULTS From 23 Canadian centres,100 patients were enrolled and 48 completed the study.Measured with the Patient Health Questionnaire–9 items at week 52,61.5%(40/65)[95%confidence interval(CI):49.7%-73.4%]of the patients improved in psychologic distress/depression symptoms,which was slightly higher in completers[65.9%(29/44);95%CI:51.9%-79.9%].At week 52,clinical response and clinical remission were achieved respectively by 65.7%(44/73)and 47.8%(32/73)of the patients.The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission(CI:1.42,44.41;P=0.018).Significant changes from baseline to weeks 8 and 52 were observed in disability,HRQoL,and fatigue.Meaningful improvement was reported in work impairment.CONCLUSION At week 52,over 60%of the UCanADA patients had depressive symptoms significantly reduced,as well as HRQoL,fatigue symptoms,and work impairment improved.No new safety signals were detected.展开更多
文摘BACKGROUND A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis(UC)patients treated in a real-world setting.The use of patient-reported outcomes(PROs)has been discussed as a primary endpoint in the context of the FDA PRO Guidance,for labelling purposes.Specifically,the efficacy and safety of adalimumab have been demonstrated in pivotal trials;however,data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients,such as symptoms,health-related quality of life(HRQoL),and disability.AIM To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC.METHODS UCanADA was a single arm,prospective,1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed—with psychologic distress/depression symptoms as the primary endpoint—by patients with moderate-to-severe UC.Assessments were performed during patients’routine care visit schedule,which was at the initiation of adalimumab(baseline),after induction(approximately 8 wk),and 52 wk after baseline.Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period.Serious safety events and per-protocol adverse events were collected.RESULTS From 23 Canadian centres,100 patients were enrolled and 48 completed the study.Measured with the Patient Health Questionnaire–9 items at week 52,61.5%(40/65)[95%confidence interval(CI):49.7%-73.4%]of the patients improved in psychologic distress/depression symptoms,which was slightly higher in completers[65.9%(29/44);95%CI:51.9%-79.9%].At week 52,clinical response and clinical remission were achieved respectively by 65.7%(44/73)and 47.8%(32/73)of the patients.The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission(CI:1.42,44.41;P=0.018).Significant changes from baseline to weeks 8 and 52 were observed in disability,HRQoL,and fatigue.Meaningful improvement was reported in work impairment.CONCLUSION At week 52,over 60%of the UCanADA patients had depressive symptoms significantly reduced,as well as HRQoL,fatigue symptoms,and work impairment improved.No new safety signals were detected.
