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CHAPTER study: collecting real-world data on the itch associated with a rare liver disease



Primary biliary cholangitis (PBC) is a rare, long-term, potentially debilitating, autoimmune liver disease. The major symptoms of PBC are cholestatic pruritus, which is more commonly known as itch, and fatigue.1,2 Up to 81% of PBC patients are estimated to experience itch at some time during their disease, with about half of PBC patients affected at any given point in time.3,6


Itch in PBC

Although PBC itself is often treated, for example with ursodeoxycholic acid (UDCA) or obeticholic acid (OCA), these treatments have not been shown to improve itch, and may even make it worse.4,5

Despite several treatment options being suggested in guidelines, many patients aren’t receiving treatment for their itch. This could be for a variety of reasons, including being difficult to take, causing side effects or not working very well.6

The itch that PBC patients experience can have a significant impact on quality of life and everyday tasks. It can negatively impact on patients physically, leading to sleep disturbance and fatigue, as well as limiting social activities. In addition, the itch can be hard to cope with emotionally, leading to depression, and even suicidality in some cases.6,7

Aside from those who personally experience this type of itch, its full severity and impact may not be appreciated, even amongst the healthcare professionals who manage patients with PBC pruritis.8


The Chapter Study

The CHAPTER study is planned to improve researchers’ understanding of what living with the itch associated with PBC is like for patients, and their experience of current treatments.

The information generated will be used to support awareness and greater understanding of the impact that this type of itch can have for patients, amongst healthcare providers and medicine regulators. The intent is to support the development of future treatment options to improve the quality of life for people with PBC.

It is hoped that the data collected can be used to inform better management of this type of itch in future, helping medical researchers and physicians improve treatments and outcomes for PBC patients. The ultimate aim is to improve the lives of those suffering from the itching associated with PBC, by enabling the development of future treatment options.

Participating patients with recently diagnosed PBC and experiencing itch, or who have recently started or are about to start an itch medication, and their clinicians, will complete online surveys over a period of 9 months. CHAPTER will gather scientific information from patients and clinicians in the US and Germany.

The information captured will include demographics, medical and treatment history and quality of life measures. It will also gather data on patient experiences of itching, including its severity and impact on daily life, as well as patient experiences of existing treatments for itch.

The CHAPTER study is being funded by GSK and being run in partnership with Pulse Infoframe and QualityMetric. All data will be held securely and only de-identified / anonymised data, that has been grouped together with data from other study participants, will be used for research.

For more information about the CHAPTER real-world patient study please click here.


[1] Hirschfield GM, Beuers U, Corpechot C, Invernizzi P, Jones D, Marzioni M, Schramm C. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. Journal of hepatology. 2017 Jul 1;67(1):145-72.

[2] Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019 Jan;69(1):394-419.

[3] Hegade VS, Mells GF, Fisher H, Kendrick S, DiBello J, Gilchrist K, Alexander GJ, Hirschfield GM, Sandford RN, Jones DE, UK-PBC Consortium. Pruritus is common and undertreated in patients with primary biliary cholangitis in the United Kingdom. Clinical Gastroenterology and Hepatology. 2019 Jun 1;17(7):1379-87.

[4] Düll MM, Kremer AE. Newer approaches to the management of pruritus in cholestatic liver disease. Curr Hepatol Rep. 2020;19:86-95.

[5] Ocaliva (obeticholic acid) tablets US Prescribing Information. New York: Intercept Pharmaceuticals; 2020. LABEL (

[6] Mayo MJ, Carey E, Smith HT, et al. Impact of pruritus on quality of life and current treatment patterns in patients with primary biliary cholangitis. Digestive Diseases and Sciences. 2023; 68:995-1005.

[7] Bergasa NV. Pruritus and fatigue in primary biliary cirrhosis. Clin Liver Dis. 2003 Nov;7(4):879-900. doi: 10.1016/s1089-3261(03)00105-3. PMID: 14594135.

[8] Carey EJ, Levy C, Mayo MJ, Bowlus CL, Deane K, Sandefur RA, Laliberte PH, Zink RC, Kim WR. Patient-Reported Indicators of Health and Symptoms in US Patients with Primary Biliary Cholangitis (PBC). In HEPATOLOGY 2018 Oct 1 (Vol. 68, pp. 1107A-1108A).



Disclaimer: Any medical information included in this article is not intended to form medical advice. It must NOT be used as a tool to help understand or assess potential options around diagnosis and treatment. Patients must consult a doctor to receive medical advice, diagnosis and treatment that is appropriate to their specific and unique circumstances. The article does not include all information about the condition, treatments, medications, side effects or risks that may apply to a specific patient. Patients must speak with a health care provider for further information about these. This information does not endorse any treatments or medications as safe, effective or approved for treating any specific patient.


Financial support: This digital spotlight, produced in collaboration with Pulse Infoframe, has been made possible with financial support from GSK. This article was written by GSK. The other articles were independently created by RARE Revolution Magazine. All opinions are those of the contributors. RARE Revolution Magazine and GSK are not responsible for the content of any external sites linked to or referred to within this article. RARE Revolution Magazine retains all copyright.


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