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

Anita Afzali; Rina Lukanova; Fritha Hennessy; Sumie Kakehi; Hannah Knight; Gary Milligan; Komal Gupte-Singh

doi:10.1007/s12325-023-02605-y

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

Adv Ther. 2023 Oct;40(10):4321-4338. doi: 10.1007/s12325-023-02605-y. Epub 2023 Jul 17.

Authors

Anita Afzali¹, Rina Lukanova², Fritha Hennessy², Sumie Kakehi³, Hannah Knight², Gary Milligan², Komal Gupte-Singh³

Affiliations

¹ Division of Digestive Diseases, Department of Internal Medicine, University of Cincinnati, College of Medicine, 231 Albert Sabin Way, ML 0551, Room 6065, Cincinnati, OH, 45267, USA. afzaliaa@ucmail.uc.edu.
² Adelphi Real World, Bollington, UK.
³ Bristol Myers Squibb, Princeton, NJ, USA.

Abstract

Introduction: 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.

Methods: 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-naïve 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.

Results: 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-naïve 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-naïve and AT-experienced) had more symptoms, overall pain and fatigue, and lower HRQoL scores than responders.

Conclusions: 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.

Keywords: Advanced therapy; Janus kinase inhibitor; Quality of life; Treatment; Tumor necrosis factor inhibitor; Ulcerative colitis; Unmet needs.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

COVID-19*
Colitis, Ulcerative* / diagnosis
Colitis, Ulcerative* / drug therapy
Cross-Sectional Studies
Humans
Pandemics
Quality of Life
United States / epidemiology