Background Bowel urgency reduces ulcerative colitis patient’s quality of life. Mirikizumab, a p19-directed anti-IL-23 antibody, demonstrates ulcerative colitis efficacy. Mirikizumab efficacy to reduce bowel urgency and bowel urgency association with other endpoints were analyzed in 2 Phase 3 trials. Methods LUCENT-1 (Induction): 1162 patients randomized 3:1 to intravenous 300 mg mirikizumab or placebo every 4 weeks for 12 weeks. LUCENT-2 (Maintenance): 544 mirikizumab responders during induction were re-randomized 2:1 to subcutaneous mirikizumab 200 mg or placebo every 4 weeks for 40 weeks (52 weeks of continuous treatment). Bowel urgency was measured using the Urgency Numeric Rating Scale (0-10); for patients with LUCENT-1 baseline score ≥3, bowel urgency clinically meaningful improvement (≥3-point decrease) and remission (score ≤1) rates in mirikizumab versus placebo groups were compared at Weeks 12 and 52. Associations between bowel urgency and other efficacy endpoints were assessed at Weeks 12 and 52. Results A significantly higher proportion of mirikizumab patients versus placebo achieved clinically meaningful improvement in bowel urgency and remission at Weeks 12 and 52. Significantly higher percentages of patients achieving bowel urgency clinically meaningful improvement or remission, compared with those who did not, also achieved endpoints for: clinical, corticosteroid-free, endoscopic, and symptomatic remission; clinical response; normalized fecal calprotectin and C-reactive protein; and improved quality of life. Conclusions In patients with ulcerative colitis, bowel urgency improvement was associated with better clinical outcomes than patients without improvement during induction and maintenance. A greater proportion of mirikizumab patients achieved sustainable bowel urgency improvement and remission compared to placebo patients.
Background The Communicating Needs and Features of IBD Experiences (CONFIDE) study aims to increase understanding of the impact of symptoms on patients with moderate to severe UC and Crohn’s disease and to investigate gaps in communication with healthcare professionals (HCPs) in the United States (US), Europe (EUR), and Japan. Purpose This report focuses on patients with moderate to severe UC and HCPs from the US and EUR. Method Online, quantitative, cross-sectional surveys of patients with UC and HCPs were conducted in the US and EUR (France, Germany, Italy, Spain, and UK). HCP surveys included physicians and non-physician HCPs responsible for making prescribing decisions. Moderate to severe UC was defined based on treatment, steroid use, and/or hospitalization history. Data collected included perspectives on the experience of patients with UC. Result(s) A total of 200 US (62% male, mean age 40.4 years) and 556 EUR patients (57% male, mean age 38.9 years), and 200 US and 503 EUR HCPs completed the survey. According to US and EUR patients, the top 3 symptoms currently (past month) experienced were diarrhoea (63% and 50%), bowel urgency (47% and 30%) and increased stool frequency (39% and 30%). Blood in stool was reported as currently experienced by 27% and 24% of US and EUR patients, respectively. Among patients currently experiencing bowel urgency, 47% of US and 27% of EUR patients discuss this symptom at every appointment. Among those who do not discuss bowel urgency at every appointment, 74% and 75% of US and EUR patients would like to discuss this symptom more frequently with their HCP. A total of 30% and 43% of US and EUR patients that ever experienced bowel urgency were not comfortable reporting it to their HCP, with 62% and 58% of these US and EUR patients feeling embarrassed talking about this symptom (Table). HCPs in both the US and EUR ranked diarrhoea (74% and 65%), blood in stool (69% and 65%) and increased stool frequency (38% and 34%) as the top 3 symptoms most reported by patients. According to US and EUR HCPs, the top 4 symptoms proactively discussed in routine appointments were blood in stool (93% and 94%), diarrhoea (90% and 91%), increased stool frequency (82% and 82%) and bowel urgency (76% and 82%). Among HCPs who did not proactively discuss bowel urgency, 47% of US and 40% of EUR HCPs expect patients to bring this up if it is an issue. Image Conclusion(s) Communication gaps were similar between US and EUR patients and HCPs. Bowel urgency is the second-most reported symptom by patients with moderate to severe UC. However, this symptom is not among the HCP-perceived top 3 most reported symptoms. Although a substantial proportion of patients reported a desire to discuss bowel urgency more frequently with their HCP, some patients reported feeling embarrassed talking about it. Many HCPs who do not proactively discuss this symptom expect patients to bring this up. A communication gap was identified and highlights the under-appreciation of bowel urgency as an important symptom of UC. Please acknowledge all funding agencies by checking the applicable boxes below Other Please indicate your source of funding; Eli Lilly and Company Disclosure of Interest S. Travis Grant / Research support from: AbbVie, BUHLMANN Diagnostics, ECCO, Eli Lilly and Company, Ferring Pharmaceuticals, International Organization for the Study of Inflammatory Bowel Disease, Janssen, Merck Sharp & Dohme, Normal Collision Foundation, Pfizer, Procter & Gamble, Schering-Plough, Takeda, UCB Pharma, Vifor Pharma, and Warner Chilcott, A. Bleakman Employee of: Eli Lilly and Company, D. Rubin Grant / Research support from: Takeda, Consultant of: AbbVie, Allergan, AltruBio, American College of Gastroenterology, Arena Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene/Syneos Health, Cornerstones Health (non-profit), Eli Lilly and Company, Galen/Atlantica, Genentech/Roche, Gilead Sciences, GoDuRn, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Iterative Scopes, Janssen, Materia Prima, Pfizer, Prometheus Therapeutics and Diagnostics, Reistone Biopharma, Takeda, and TechLab, M. Dubinsky Shareholder of: Trellus Health, Grant / Research support from: AbbVie, Janssen, Pfizer, and Prometheus Biosciences, Consultant of: AbbVie, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, F. Hoffmann-La Roche, Genentech, Gilead Sciences, Janssen, Pfizer, Prometheus Therapeutics and Diagnostics, Takeda, and UCB Pharma, R. Panaccione Grant / Research support from: AbbVie, Ferring Pharmaceuticals, Janssen, Pfizer, and Takeda, Consultant of: Abbott, AbbVie, Alimentiv, Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cosmo Pharmaceuticals, Eisai, Elan Pharma, Eli Lilly and Company, Ferring Pharmaceuticals, Galapagos NV, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Therapeutics, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Takeda, Theravance Biopharma, and UCB Pharma, T. Hibi Grant / Research support from: AbbVie, Activaid, Alfresa Pharma, Bristol Myers Squibb, Eli Lilly Japan K.K., Ferring Pharmaceuticals, Gilead Sciences, Janssen Pharmaceutical K.K., JMDC, Nippon Kayaku, Mochida Pharmaceutical, Pfizer Japan, and Takeda, Consultant of: AbbVie, Apo Plus Station, Bristol Myers Squibb, Celltrion, EA Pharma, Eli Lilly and Company, Gilead Sciences, Janssen, Kyorin, Mitsubishi Tanabe Pharma, Nichi-Iko Pharmaceutical, Pfizer, Takeda, and Zeria Pharmaceutical, Speakers bureau of: AbbVie, Aspen Japan K.K., Ferring Pharmaceuticals, Gilead Sciences, Janssen, JIMRO, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Pfizer, and Takeda, T. Gibble Employee of: Eli Lilly and Company, C. Kayhan Employee of: Eli Lilly and Company, E. Flynn Employee of: Eli Lilly and Company, C. Sapin Employee of: Eli Lilly and Company, C. Atkinson Consultant of: Eli Lilly and Company in connection with the development of this publication, Employee of: Adelphi Real World, S. Schreiber Grant / Research support from: personal fees and/or travel support from: AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly and Company, Dr. Falk Pharma, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos NV, Gilead Sciences, I-MAB Biopharma, Janssen, Merck Sharp & Dohme, Mylan, Novartis, Pfizer, Protagonist Therapeutics, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Theravance Biopharma, and UCB Pharma, J. Jones: None Declared
Bowel urgency, the sudden or immediate need for a bowel movement, is one of the most common and disruptive symptoms experienced by patients with ulcerative colitis. Distinct from the separate symptom of increased stool frequency, bowel urgency has a substantial negative impact on quality of life and psychosocial functioning. Among patients with ulcerative colitis, bowel urgency is one of the top reasons for treatment dissatisfaction and one of the symptoms patients most want improved. Patients may not discuss bowel urgency often due to embarrassment, and healthcare providers may not address the symptom adequately due to lack of awareness of validated tools and/or knowledge of the importance of assessing bowel urgency. The mechanism of bowel urgency in ulcerative colitis is multifactorial and includes inflammatory changes in the rectum that may be linked to hypersensitivity and reduced compliance of the rectum. Responsive and reliable patient-reported outcome measures of bowel urgency are needed to provide evidence of treatment benefits in clinical trials and facilitate communication in clinical practice. This review discusses the pathophysiology and clinical importance of bowel urgency in ulcerative colitis and its impact on quality of life and psychosocial functioning. Patient-reported outcome measures developed to assess the severity of bowel urgency in ulcerative colitis are discussed alongside overviews of treatment options and clinical guidelines. Implications for the future management of ulcerative colitis from the perspective of bowel urgency are also explored.
ObjectiveTo assess test-retest reliability, construct validity, known groups discrimination, and responsiveness of the Assessment of the SpondyloArthritis international Society Health Index (ASAS HI) to evaluate functioning, disability, and health in patients with radiographic axial spondyloarthritis (r-axSpA).MethodsData were generated from 2 randomized, placebo-controlled, active-controlled phase III ixekizumab studies (COAST-V, N = 341; COAST-W, N = 316). Assessments included the following: test-retest reliability (ie, intraclass correlation coefficients [ICCs] between ASAS HI scores at screening and baseline), construct validity (ie, Spearman correlation with standard r-axSpA outcome measures), known groups discrimination (ie, 1-way ANOVA comparing the ASAS HI with different disease activity categories, measured by the Ankylosing Spondylitis Disease Activity Score [ASDAS]), and responsiveness (ie, Spearman correlation between changes in the ASAS HI and changes in the Bath Ankylosing Spondylitis Functional Index [BASFI], the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], the ASDAS, and the Patient Global Assessment [PtGA] as well as ANOVA comparing changes in the ASAS HI with various responder categories).ResultsThe ICC for test-retest reliability was 0.78 for COAST-V and 0.76 for COAST-W, indicating adequate agreement. Moderate-to-large correlations (r= 0.40-0.61) were observed between the ASAS HI and the BASDAI. Statistically significant differences (allP< 0.001) between mean ASAS HI scores were observed for subgroups based on ASDAS-defined disease activity categories at baseline and week 16. Moderate-to-large correlations existed between changes in the ASAS HI and the BASFI, BASDAI, ASDAS, and PtGA from baseline to week 16. The ASAS HI differentiated statistically (P< 0.001) between ASAS, BASDAI, and ASDAS response groups.ConclusionThe ASAS HI demonstrated reliability, construct validity, known groups discrimination, and responsiveness in adults with r-axSpA in 2 clinical trials.
Background Bowel urgency is the symptom described by patients as having the most impact on quality of life but is missing from most disease activity indices (Carpio et al., 2016). The Communicating Needs and Features of IBD Experiences (CONFIDE) study aims to increase understanding of patients’ experiences and the impact of IBD on their lives in the United States (US), Europe, and Japan. These data focus on US patients with moderately-to-severely active ulcerative colitis (UC). Methods An online, quantitative, cross-sectional survey was conducted with patients with moderately-to-severely active UC in the US in July 2021. Data included patient perspectives on their UC symptoms and the impact on their social life, work/school life, and ability to participate in sports/physical activities. Moderately-to-severely active UC was defined based on treatment, steroid use, and/or hospitalization history. Descriptive statistics (frequencies, percentages) summarise the data. Results 200 (of 756 total contacted) patients (61.5% male, mean age 40.4, mean disease duration 7.9 years) completed the survey in the US, with 77% (n=153) of patients receiving advanced therapies (biologic or novel oral therapy). Patients declined participation in social events due to bowel urgency (43%), fear of urge incontinence (40%), increased stool frequency (29%), and blood in stool (15%) in the last three months (Fig. 1). Patients declined participation in sports/physical exercise due to bowel urgency (38%), fear of urge incontinence (36%), increased stool frequency (24%), and blood in stool (10%) in the last three months (Fig. 2). Patients declined participation in work/school due to bowel urgency (37%), fear of urge incontinence (42%), increased stool frequency (25%), and blood in stool (16%) in the last three months (Fig. 3). Out of 123 patients who have ever suffered from bowel urgency, in the last three months 42% stopped working for the day sooner than planned and 41% worked fewer hours. Notably, 76% of patients reported wearing a diaper/pad/protection at least once in the last three months due to fear of urge incontinence. Bowel urgency had no impact on work/school for 22% (n=27) of patients who had ever experienced bowel urgency (Fig. 4). Conclusion Bowel urgency and fear of urge incontinence are the most reported symptoms leading to patients with UC declining participation in work/school, social events, and sports/physical exercise. Over three quarters of the surveyed patients reported wearing diapers/pads/protection in the past three months due to fear of urge incontinence and only 22% of patients who had ever suffered from bowel urgency reported that it had no impact on work or school.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.