Unmet Need of an Oral Treatment in Moderate to Severe Ulcerative Colitis: Findings From International Patient and Physician Survey

Introduction: Until recently, oral advanced therapies (AT) for moderate to severe ulcerative colitis (UC) were not available in the EU5 (France, Germany, Spain, Italy, United Kingdom), with patients receiving only subcutaneous injection or intravenous infusion AT until 2018. The unmet need for oral treatment and ease of administration among gastroenterologists (GEs) and patients with moderate to severe UC based on a 2017 survey was assessed. Methods: Data were drawn from the Adelphi Real World Disease Specific Programme (DSP™) for Inflammatory Bowel Disease, a point-in-time survey of GEs and their patients with a history of moderate to severe UC conducted in the EU5 (Sep-Dec 2017). GEs completed physician surveys covering the importance of listed attributes in relation to UC management, such as ‘ease of administration’ (EoA) of biologic medication, rated from 1 (no importance) to 7 (very important). GEs then completed patient record forms (PRF) for their next 7 consulting UC patients, including duration of UC and areas for improvement for the patient’s biologic treatment (from a list of 16); patients were stratified into 2 groups based on the GEs’ identification of EoA as an area for improvement. Patients for whom PRFs had been completed were invited to fill in patient self-completion forms, recording preference for injectable or oral treatment. Responses were compared across areas for improvement using a T-test; p values < 0.05 were considered statistically significant. Results: 280 GEs and 709 UC patients receiving biologic treatment were included in this analysis. Patients’ mean age was 39 years, 57% were male, mean time since diagnosis was 5.0 years. Almost half (47%) of patients stated that they preferred an oral treatment only, while 14% did not have a clear preference between oral and injectable. EoA, as reported by GEs, ranked second highest as an area for improvement for the patients’ biologic treatment; this cohort of patients (24%) had significantly longer disease duration (6.1 years) than those for whom EoA was not considered as an area for improvement (4.6 years, P=0.0064). EoA was also rated as 6 or 7 in terms of importance of UC management by 60% of the GEs (Table). Conclusion: These results suggest a need for oral treatment options for moderate to severe UC. Further investigation is needed to understand if GEs’ and patients’ perceptions and needs have changed over time, as small molecule oral treatments for UC became available in 2018.Table 1.: Treatment administration preference (PSC), areas for improvement for the patient’s biologic treatment (PRF) and importance of ‘ease of administration’ (PS)