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P464 Steroid dependency in patients with Ulcerative Colitis treated with advanced therapies in a German real-world-setting

Bokemeyer, B.(1);Picker, N.(2);Wilke, T.(3);Rosin, L.(4);Patel, H.(5);

(1)Interdisziplinäres Crohn Colitis Center Minden und Medizinische Klinik I- Universitätsklinik Schleswig-Holstein- Campus Kiel, Gastroenterologische Praxis Minden, Minden, Germany;(2)Ingress Health, HWM GmbH, Wismar, Germany;(3)IPAM, e.V., Wismar, Germany;(4)Galapagos, Biopharma Deutschland GmbH, München, Germany;(5)Galapagos, Nv, Mechelen, Belgium

Background

An important treatment goal in Ulcerative Colitis (UC) is a long-lasting corticosteroid (CS)-free remission. Avoidance of steroid dependency in these patients is essential as chronic CS use is known to be associated with an increased risk for multiple severe adverse events.
This study aimed to identify CS dependency in patients with moderate to severe UC treated with advanced therapies.

Methods

This German claims data analysis includes adult patients with ≥2 outpatient diagnoses and/or one inpatient diagnosis for UC (ICD-10: K51) in whom an advanced therapy (anti-TNF agent, vedolizumab or tofacitinib) was initiated between 01/01/2015-30/06/2019.
CS dependency was indicated by ≥2 prescriptions of systemic CS and/or oral budesonide within a median follow-up of 23.4 months. Prior CS use was evaluated by outpatient prescriptions observed in a 12-months baseline period.
Costs were assessed until the end of the study period or loss to follow-up considering all-cause expenses for inpatient and outpatient visits, and approximated indirect cost related to sick-leave days.
Exceeding the recommended dose in maintenance therapy by more than 150% was rated as an escalation of therapy. Time to the therapy discontinuation, escalation or first UC-related hospitalization from start of index therapy were estimated using Kaplan-Meier analysis.

Results

Of 574 included UC patients with a new advanced therapy, 252 (43.9%) received ≥2 prescriptions of CS while on treatment with advanced agents in the observation period up to 24 months. Altogether, 496 patients (86.4%) had prior experience with CS in the 12-months baseline-period. Among patients with ≥2 CS prescriptions, 47.0% had switched their index therapy to another advanced agent after 24 months (31.2% without CS dependency). Median time to therapy discontinuation was 17.3 months in CS-dependent patients; and 19.3 months in those without CS dependency (p = 0.639). There were no differences between naïve or advanced therapy experienced patients, but with clearly more discontinuations in patients with previously more than 1 advanced therapy (p<0.001). CS-dependent patients were more likely to require dose escalation/UC-related hospitalization within the first two years after treatment start (26.7% vs. 16.1%; p = 0.018/ 44.1% vs. 26.6%; p = 0.048; Figure 1). Total cost per patient-year was significantly higher in patients with than without CS dependency (40,884 € vs. 37,449 €; p < 0.001).



Conclusion

Most UC patients starting new advanced therapies were previously treated with CS, and more than two-fifths continue to be CS dependent even after starting such a therapy. More effective therapies are needed to achieve CS-free remission.

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