Unmet Needs in Real-World Advanced Therapy-Naïve and -Experienced Patients with Moderately to Severely Active Ulcerative Colitis in the United States.

Publication date: Jul 17, 2023

Despite availability of advanced therapies (ATs) for ulcerative colitis (UC), many patients fail to respond to treatment. This study examined real-world clinical and humanistic outcomes associated with current treatments in patients with UC. This cross-sectional study used US data from the Adelphi Real World Disease Specific Programme for inflammatory bowel disease from before (2017-2018) and during the COVID-19 pandemic (2020-2021). Physicians (gastroenterologists) seeing > 5 patients/month reported patients’ disease characteristics, current symptoms and treatments, and reasons for treatment choices for their next seven consecutive patients aged ≥ 18 years with moderately to severely active UC before current treatment. Patients were asked to complete the EQ-5D-5L health-related quality of life (HRQoL) measure. ATs included tumor necrosis factor inhibitors (TNFis), integrin receptor antagonists, interleukin-12/23 antagonists, and Janus kinase inhibitors. Patients were classified as AT-nacEFve or AT-experienced based on current treatment received for ≥ 8 weeks and further classified as responders or non-responders based on symptoms, disease flare status, and remission. Descriptive analyses are presented. The 2017-2018 cohort included 92 physicians and 539 patients (208 [38. 6%] AT-experienced). The 2020-2021 cohort included 73 physicians and 448 patients (349 [77. 9%] AT-experienced). TNFis were the most common ATs. In 2017-2018, 195 (58. 9%) AT-nacEFve and 113 (54. 3%) AT-experienced patients were non-responders; in 2020-2021 this was 57 (57. 6%) and 182 (52. 1%). Efficacy and induction of remission were physicians’ most common reasons for AT choice. Dislike of injections/infusions was the most common reason for eligible patients not receiving biologic therapy. Numerically, non-responders (both AT-nacEFve and AT-experienced) had more symptoms, overall pain and fatigue, and lower HRQoL scores than responders. Before (2017-2018) and during the pandemic (2020-2021), over half of patients with UC did not respond to AT. Non-responders carried a high burden of disease. Alternative therapies are urgently needed to treat UC.

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Concepts Keywords
5d Advanced therapy
Gastroenterologists Janus kinase inhibitor
Humanistic Quality of life
Necrosis Treatment
Ulcerative colitis
Unmet needs

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