Unmet Medical Needs in Ulcerative Colitis: An Expert Group Consensus

Abstract

Background: The authors aimed to conduct an extensive literature review and consensus meeting to identify unmet needs in ulcerative colitis (UC) and ways to overcome them. UC is a relapsing and remitting inflammatory bowel disease with varied, and changing, incidence rates worldwide. UC has an unpredictable disease course and is associated with a high health economic burden. During 2016 and 2017, a panel of experts was convened to identify, discuss and address areas of unmet need in UC. Methods: PubMed and Cochrane Library databases were searched for relevant articles describing studies performed in patients with UC. These findings were used to generate a set of statements relating to unmet needs in UC. Consensus on these statements was then sought from a panel of 9 expert gastroenterologists using a modified Delphi review process that consisted of anonymous surveys followed by live meetings. Results: In 2 literature reviews, over 5,000 unique records were identified and a total of 138 articles were fully reviewed. These were used to consider 26 areas of unmet need, which were explored in 2 face-to-face meetings, in which the statements were debated and amended, resulting in consensus on 30 final statements. The unmet needs identified were categorised into 7 areas: impact of UC on patients’ daily life; importance of early diagnosis and treatment; drawbacks of existing treatments; urgent need for new treatments; and disease-, practice- or patient-focused unmet needs. Conclusions: These expert group meetings found a number of areas of unmet needs in UC, which is an important first step in tackling them in the future. Future research and development should be focused in these areas for the management of patients with UC.

Faecal neutrophil elastase-antiprotease balance reflects colitis severity

“…In addition, there is an urgent need for alternative therapies for IBD patients, which do not respond to current first-line treatments. 45 To help meet this clinical gap, we propose the possibility of screening specifically for patients for NE activity and treating this subset with NE inhibitors.…”

Living with Ulcerative Colitis Study (LUCY) in England: a retrospective study evaluating healthcare resource utilisation and direct healthcare costs of postoperative care in ulcerative colitis

“…European guidelines recommend sustained steroid-free remission as the treatment goal. [7][8][9] Despite these options, some patients with UC require a colectomy. 10 The highest colectomy rates are seen during the first few years after diagnosis.…”

Living with ulcerative colitis in Germany: a retrospective analysis of dose escalation, concomitant treatment use and healthcare costs

“…Despite these limitations, this analysis confirmed a continuing unmet need in UC, although a number of biologic treatment options are available. Treatment options other than new biologics might have advantages: the secondary loss of response to biologics is a potential issue, as a discrete-choice study has shown that in UC long-term symptom control is the attribute most valued by both physicians and patients 45 ; biologics require parenteral administration, and there is evidence that oral administration is preferred by patients with UC 7,46 ; and numerous studies have shown biologics to have poor cost-effectiveness , [47][48][49] .…”

“…Treatment options for UC include aminosalicylates (5-ASA), corticosteroids, immunosuppressants, biologics (tumor necrosis factor inhibitors and anti-integrins), calcineurin inhibitors, the JAK inhibitor tofacitinib, and surgery as an option for non-responsive patients 7 . Guidelines recommend that treatments are selected based on disease site, severity and current activity [8][9][10][11][12] .…”