Introduction
Severe fatigue, which has a large negative impact on quality of life, is often present in Crohn’s disease (CD) and ulcerative colitis (UC), even in remission.1 The Communicating Needs and Features of Inflammatory bowel disease (IBD) Experiences (CONFIDE) study explored patient and healthcare professional perspectives on the experiences and impact of CD/UC-related symptoms on patients in Europe (France, Germany, Italy, Spain, and UK), the United States (US), and Japan. These analyses focus on the experience and impact of fatigue among European and US patients with moderate-to-severe CD/UC.
Aims & Methods
Online, quantitative, cross-sectional surveys were conducted among patients with moderate-to-severe CD/UC, defined using criteria based on previous treatment, steroid use, and/or hospitalization. Fatigue over the past seven days was assessed using the 13-item Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–F) scale2 (range: 0–52, higher scores indicate less fatigue; mean score in general population: 43/523; scores <30/52 indicate severe fatigue4). The Manitoba IBD Index5 assesses disease activity based on patient-reported symptom persistence in the last six months (6-level scale:
1=constantly active,
2=often active,
3=sometimes active,
4=occasionally active,
5=rarely active, and
6=remission/absence of symptoms).
Disease was considered active if symptoms were experienced constantly to occasionally (responses 1–4), and inactive when infrequent/absent (responses 5/6). Patient-reported impact of CD/UC on energy levels was reported on a scale of 1–7, where 1=no impact and 7=high impact. Data are presented as descriptive statistics.
Results
A total of 547 European (55.4% male, mean age: 38.0 years) and 215 US (54.9% male, 40.9 years) patients with CD and 556 European (57.4% male, 38.9 years) and 200 US (61.5% male, 40.4 years) patients with UC completed the surveys.
Overall, 34.2% European and 35.8% US patients with CD, and 20.9% European and 27.5% US patients with UC reported currently (in the last month) experiencing fatigue. More than 80% of all patients indicated that CD/UC negatively impacted their energy levels (scores 4–7): CD, Europe: 80.1%, US: 84.2%; UC, Europe: 81.1%, US: 88.0%. Mean (SD) FACIT-F scores were 27.4 (11.3) and 26.8 (10.8) for European and US patients with CD, and 29.4 (10.0) and 26.2 (11.3) for European and US patients with UC, respectively.
Among patients currently experiencing fatigue, FACIT-F scores were 24.3 (10.8) and 26.1 (10.9) for European and US patients with CD, and 26.0 (10.6) and 24.5 (11.5) for European and US patients with UC. Among those currently experiencing fatigue, most patients with CD described their disease as active (Europe: 92.5%, US: 93.5%). Similar results were observed among patients with UC (Europe: 92.2%, US: 98.1%). Among patients reporting ever experiencing fatigue (CD, Europe: 45.2%, US: 45.6%; UC, Europe: 30.6%, US: 40.0%), most reported experiencing fatigue at least once a week (CD, Europe: 67.5%, US: 79.6%; UC, Europe: 66.4%, US: 70.0%).
Conclusion
European and US patients with CD/UC reported severe fatigue (FACIT-F scores <30)4,indicating a major burden of fatigue, which is also clearly associated with patient-reported active disease. Both CD and UC negatively impact energy levels for the majority of patients. The findings of this study underscore the importance of active fatigue management in CD/UC to improve patients’ overall quality of life.
References
- Uhlir, V et al. (2023) BMC Gastroenterol. 23(1):288.
- Yellen et al. (1997) J Pain Symptom Manage. 13(2):63–74.
- Eek, D et al. (2021) J Patient Rep Outcomes. 5(1):27.
- Saraiva, S et al. (2019) Scand J Gastroenterol. 54(4):465–70.
- Clara, I et al. (2009) Am J Gastroenterol. 104(7):1754–63.
Disclosure
Stefan Schreiber, Consultancy fees: AbbVie, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Falk, Fresenius, Gilead Sciences, IMAB, Janssen, Eli Lilly and Company, Hikma, MSD, Mylan, Pfizer Inc, Protagonist, Provention Bio, Takeda, Ventyx, and Theravance.
Marla C. Dubinsky, Consultancy fees: AbbVie, Abivax, Astra Zeneca, Boehringer Ingelheim International GmbH, Bristol Myers Squibb, Celgene Corporation, Eli Lilly and Company, F. Hoffman-La Roche Ltd, Genentech Inc., Gilead Sciences, Janssen, LLC, Merck, Pfizer, Prometheus Biosciences, Takeda Pharmaceuticals USA, Inc., and UCB; Stock options: TrellusHealth Inc.; Research support: AbbVie, Janssen, LLC, Pfizer, and Prometheus Labsa; and licensing fees: Takeda.
David Rubin, Grant support: Takeda; Consultant: Abbvie, Altrubio, Apex, Avalo Therapeutics, Bristol-Myers Squibb, Buhlmann Diagnostics Corp, Celgene, Connect BioPharma, Intouch Group, Iterative Health, Janssen Pharmaceuticals, Lilly, Pfizer, Samsung Neurologica, and Takeda. Board of Trustees: Crohn’s & Colitis Foundation; Board of Directors: Cornerstones Health.
Remo Panaccione, Consultant for: Abbott, AbbVie, Abbivax, Alimentiv (formerly Robarts), Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Spyre Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx, UCB; Speaker’s Fees for: AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, Takeda Pharmaceuticals; Advisory Boards for: AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, SandozShire, Sublimity Therapeutics, Takeda Pharmaceuticals, Ventyx.
Toshifumi Hibi, Personal fees: Abbvie GK, EA Pharma, Janssen Pharmaceutical K.K, JIMRO, Mitsubishi-Tanabe, Mochida Pharmaceutical, Pfizer Japan, Sandoz K.K, Takeda Pharmaceutical, Zeria Pharmaceutical, Celltrion Healthcare Japan, Eli Lilly Japan, Gilead Sciences, Miyarisan Pharmaceutical, Alfresa Pharma Corporation, Kyorin Pharmaceutical; Grants: JIMRO, Mochida Pharmaceutical, Zeria Pharmaceutical, Miyarisan Pharmaceutical, Alfresa Pharma Corporation, and Kyorin Pharmaceutical.
Christian Atkinson, Employment: Adelphi Real World.
Simon Travis, Grants: AbbVie, ECCO, Eli Lilly and Company, Helmsley Trust International, International Organization for the Study of Inflammatory Bowel Disease, Norman Collision Foundation, Pfizer, Takeda, UCB Pharma, UKIERI, Vifor Pharma; Honoraria: Ferring Pharmaceuticals, Takeda, Eli Lilly and Company, Bristol Myers Squibb, Janssen, Violicom; Travel grants: AbbVie, Eli Lilly and Company, Janssen, Pfizer, Takeda, Ferring Pharmaceuticals, Amgen, Biogen; Consultancy fees: AbbVie, Allergan, Amgen, Apexian, Bioclinica, Biogen, Bristol Myers Squibb, ChemoCentryx, Cosmo Pharmaceuticals, Endpoint Health, Eli Lilly and Company, Enterome, Equillium, Ferring Pharmaceuticals, Genentech/Roche, GlaxoSmithKline, Immunocore, Immunometabolism, Janssen, Merck, Merck Sharp & Dohme, Mestag Therapeutics, Novartis, Pfizer, Protagonist Therapeutics, Proximagen, Receptos, Roche, Sanofi, Satisfai Health, Sensyne Health, Sorriso Pharmaceuticals, Takeda, UCB Pharma, VHsquared, Vifor Pharma.
Alison Potts Bleakman, Theresa Hunter Gibble, Cem Kayhan, Tommaso Panni, Angelo D. Favia, and Eoin J. Flynn are employees and stockholders of Eli Lilly and Company.
