P389 Indicators for inadequate response to advanced therapy in patients with Ulcerative Colitis: results from a medical chart review in the United Kingdom
Lindsay, J.(1);Picker, N.(2);Kromer, D.(2);Smyth, M.(3);Patel, H.(4);
(1)Barts and the London School of Medicine- Queen Mary University of London, Centre for Immunobiology- Blizard Institute, London, United Kingdom;(2)Ingress Health HWM, GmbH, Wismar, Germany;(3)Galapagos, Uk, Cambridge, United Kingdom;(4)Galapagos, Nv, Mechelen, Belgium;
Background
Patients with Ulcerative Colitis (UC) who commence advanced therapy may experience inadequate response or require therapy modification to achieve remission. Therapeutic modification increases health care costs and is associated with adverse events. This study aimed to examine the rates of inadequate response, therapeutic modification and subsequent remission among UC patients starting advanced therapy in the UK.
Methods
Using a retrospective chart review, patients with UC treated with an advanced therapy (adalimumab, infliximab, golimumab, vedolizumab, and tofacitinib) between 01/2017 and 09/2019 were selected from 8 clinics across the UK. Patients with ≥12 months of data before and after starting an advanced therapy (Index Date) were included. Inadequate response was defined as at least one of the following events: index therapy discontinuation or switch due to lack of response, therapy escalation, augmentation with an additional conventional therapy, corticosteroid (CS) dependency (use for ≥12 weeks), new CS initiation, UC-related hospitalisation, surgery, or emergency department visit. Remission was assessed using components of the Mayo score. Kaplan-Meier analysis was used to examine remission rates over 24 months. Subgroups included patients with prior exposure to biologics, and patients with vs. without remission at 12 months. Factors associated with time to remission were assessed in a multivariate Cox regression model.
Results
Among 238 patients included (female: 46.6%; median age 42 years; median follow-up: 28.8 months), 178 (74.8%) patients were biologic-naïve, and 60 (25.2%) were biologic-experienced. At 12 months, 105 (44.3%) patients had ≥1 indicator for an inadequate response (Figure 1); the median time to first event was 18 months. Among those who discontinued (N=72), 69.4% switched to another advanced therapy. Inadequate response was more frequent in biologic-naïve vs. experienced patients (50.3% vs. 26.7%; p<0.01) and among those without vs. with remission (56.3% vs. 34.4%; p<0.01). At 12 months, 61 patients (46.1%) had not achieved remission (median time to remission: 7.6 months; Figure 2). At 12 months, one third (33.0%) of patients in remission required therapy modification (augmentation, dose escalation, and use of CS). In an adjusted model, chances of remission were halved in biologic-experienced patients vs. naive patients (hazard ratio: 0.49; p<0.05).
Conclusion
More than two-fifths of UC patients had an inadequate response, and nearly half did not achieve remission within one year after therapy start. Even among patients in remission, one third required additional therapy modifications. More effective therapies are needed to achieve better outcomes for patients with UC.