Despite patients being treated early and frequently with immunomodulators and biological therapy in Western Europe, 5-year outcomes including surgery and phenotype progression in this cohort were comparable across Western and Eastern Europe. Differences in treatment strategies between Western and Eastern European centres did not affect the disease course. Treatment with immunomodulators reduced the risk of surgery and hospitalisation.
Background and aims: Few population-based cohort studies have assessed the disease course of ulcerative colitis (UC) in the era of biological therapy and widespread use of immunomodulators. The aim of this study was to assess the five-year outcome and disease course of patients with UC in the Epi-IBD cohort. Methods: In a prospective, population-based inception cohort of unselected patients with UC patients were followed-up from the time of their diagnosis, which included the collection of their clinical data, demographics, disease activity, medical therapy, and rates of surgery, cancers and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis. Results: A total of 717 patients were included in the study. During follow-up, 43 (6%) patients underwent a colectomy, while 163 (23%) patients were hospitalized. Of patients with limited colitis (distal to the left flexure), 90 (21%) progressed to extensive colitis. In addition, 92 (27%) patients with extensive colitis experienced a regression in disease extent, which was associated with a reduced risk of hospitalization (HR: 0.5 CI95% 0.3-0.8). Overall, patients were treated similarly in both geographical regions and 80 (11%) patients needed biological therapy while 210 (29%) patients received immunomodulators. Treatment with immunomodulators was found to reduce the risk of hospitalization (HR: 0.5 CI95% 0.3-0.8). Conclusions: While patients in this population-based cohort were treated more aggressively with immunomodulators and biological therapy than in cohorts from the previous two decades, their disease outcomes including colectomy rates were no different. However, treatment with immunomodulators was found to reduce the risk of hospitalization.
Summary
Background
Ustekinumab is effective in Crohn's disease. However, a substantial proportion of patients will not respond or lose response to ustekinumab. The current evidence to support the effectiveness of dose‐optimisation for ustekinumab nonresponse is limited.
Aim
To assess the effectiveness of dose escalation of ustekinumab.
Methods
This was a multicentre retrospective cohort study. We included active Crohn's disease patients who received a standard‐dose intravenous induction and at least one subcutaneous ustekinumab 90 mg dose. All enrolled patients received dose escalation by either shortening the interval between the doses to every 4 or 6 weeks, intravenous reinduction or a combination of strategies. The primary outcome of the study was clinical response at week 16 after dose escalation.
Results
A total of 142 patients (22 centres/14 countries) were included. The patients were dose‐escalated after a median treatment duration of 30 weeks. At week 16 from escalation, 73/142 (51.4%) responded to treatment, including 55/142 (38.7%) in clinical remission. Corticosteroid‐free remission was achieved in 6/34 (17.6%) patients on corticosteroids at the time of escalation; 118/142 (83%) continued treatment beyond week 16. Follow‐up data beyond week 16 were available for 74/118 (62.7%) patients. On the last follow‐up, 51/98 (52%) patients with available data responded to treatment, including 41/98 (42%) in clinical remission.
Conclusions
Intensification of ustekinumab maintenance dosage was effective in over 50% of the patients. This strategy should be considered in patients who are nonresponsive to every 8 weeks ustekinumab maintenance dosing.
Patients 50 to 75 yrs of age receiving a DO2 of > or =600 mL/min/m2 demonstrated a statistically significant (p=.01) improved survival rate over patients in the control group. Patients >75 yrs of age demonstrated no benefit from attempts to increase DO2 to >600 mL/min/m2, and they may have been overtreated as reflected by the lower O2ER values in this age group. Treating to an O2ER that reflects a balance between oxygen consumption and DO2 may be an alternative goal that allows individual titration.
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