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An estimated 20,000 people in the UK live with Primary Biliary Cholangitis (PBC), a chronic autoimmune liver disease, with a higher incidence in women than in men.
While PBC is rare, it can have a major impact on patients. Some people may experience no symptoms while others suffer from fatigue, itching, bone or joint aches, and dry eyes or mouth. Advanced forms of the disease may lead to jaundice – the yellowing of the skin and whites of the eyes.
Our NIHR Nottingham Clinical Research Facility (CRF) is at the forefront of finding new treatments for fatigue in PBC. It has been conducting an innovative clinical trial - involving in-patient stays – looking at improving the symptoms.
Nottingham’s expertise in experimental medicine, facilitated by the CRF, meant it was an obvious choice for Swedish pharmaceutical company Umecrine Cognition to investigate using a new molecule as a treatment for PBC patients with severe symptoms of fatigue and cognitive impairment. Nottingham has conducted the first study designed to evaluate impact on fatigue and cognitive impairment with a drug specifically targeting these symptoms and the UK is leading the way in terms of research into PBC. The study was comparing the new molecule against placebo.
We talk to two patients who are living with PBC and have contributed to the UCAB clinical research trial on the disease.
Wendy Wheat, aged 53, lives in Nottingham and has two children and a grandson. She works for the NHS as a receptionist and business administrator and took part in the UCAB trial to help advance research to help others.
Wendy, who has started her own support group for PBC patients, was eventually diagnosed with the liver condition after battling exhaustion and other symptoms including itching for almost 10 years.
The symptoms of PBC vary from day to day: “Just feeling tired is not the same as fatigue, it is like walking through treacle,” says Wendy. “PBC is classed as a disability, we are all affected differently.”
Recently, the Research & Innovation team at the Queen’s Medical Centre contacted Wendy to see if she wanted to participate in a clinical trial, which was hosted at the NIHR Nottingham Clinical Research Facility (CRF).
In February 2024, she spent seven days and seven nights in the Clinical Research Facility, taking part in Phase 1b of the UCAB fatigue and cognitive function study.
“It was an incredible experience; I met four ladies taking part in the trial who will be friends for life. The staff in the Clinical Research Facility were wonderful and could not do enough for us,” said Wendy.
This part of the study was investigating a new molecule to treat PBC for patients with severe symptoms of fatigue and cognitive impairment. Participants were asked to undergo regular blood tests, blood pressure monitoring and ECGs.
“This happened throughout the night on one occasion. I packed crafts and puzzle books thinking I would be bored, however the other ladies and the staff were so friendly, so this wasn’t the case at all.”
Wendy was among those who also took part in the second phase of the UCAB study, which completed in June, 2024.
During this second phase of the trial, participants were asked to take sixteen tablets a day, eight in the morning and eight in the evening and attended the QMC for blood tests and follow-ups, this included a cognitive function test.
Wendy added: “We are all excited that there will be a treatment for fatigue in the future. When I was taking the medication, I did feel like I had more energy. PBC is a rare condition this is why research is so important.”
“Research makes all the difference and improves peoples’ lives. We are living longer with less pain and symptoms and improving people’s quality of life. Research is crucial for any condition, not just PBC, I just wanted to give something back and help others not to battle with fatigue as I have had to do.”
Wendy is motivated by helping other patients living with PBC. Since patients often do not display any physical symptoms of the disease, it is hard for other people understand the realities of life with PBC.
After finally receiving her diagnosis after referral to a hepatologists and a liver biopsy, she said: “I remember feeling relieved rather than upset and scared, as I finally had an answer as to why I was itching and fatigued all of the time.”
Over the years, Wendy has been prescribed medications including Ursodeoxycholic Acid, “this is the medication for PBC which slows the progression down, and unfortunately it does not relieve the symptoms or cure it.”
On the group’s 10th anniversary, Wendy took part in a sky dive to raise funds. She has also been featured in local and national media including the Mail on Sunday, Women Magazine, the Good Housekeeping, and ITV News, and has taken part in a project to help newly diagnosed patients cope with PBC, organised by a pharmaceutical company in the USA.
She added: “I have found that I am doing more now than I was before the diagnosis. I refuse to let PBC change my life or get me down and manage to maintain a full-time job with the NHS, but I still have good and bad days.”
Kathleen Rose Heaveron, aged 56, lives in Dungiven in County Derry, Northern Ireland. The fifth child from a family of nine siblings, Kathleen has two children of her own who she raised single-handedly for many years, as well as fostering her nephew from the age of five.
She has worked full time in the clothing manufacturing industry, including for Marks & Spencer’s, and in another career with a Northern Ireland utilities company. Kathleen decided to be part of the UCAB trial “mainly for the good of all PBC patients now and in the future”. She said: “The more we come together to learn as much about this disease and find any cures or beneficial medications, the better.”
Kathleen heard of the UCAB study, which was being conducted in Nottingham, via the PBC Foundation charity.
“There was a number to contact if you wanted to take part and an interview took place by phone to establish if l met the criteria to take part in the trial.”
She said: “I regard clinical trials into PBC as very important as there’s still a lot unknown about this rare disease. It has a huge impact on the quality of people’s lives, both mentally and physically.
“Hopefully, some day in the near future, together we can find a cause for this disease and stop it in its tracks before it develops.”
Kathleen took part in the first phase of the UCAB study, hosted by Nottingham Clinical Research Facility (CRF), which was first study designed to evaluate impact on fatigue and cognitive impairment with a molecule specifically targeting these symptoms. In February 2024, she spent seven days and seven nights staying in the Clinical Research Facility, taking part in Phase 1b of the study.
“We spent a week in the Nottingham Clinical Research Facility whilst being administered with the trial/placebo drug. We constantly had bloods, urine, oxygen level, blood pressure, ECG and weight checked and recorded, with any symptoms, drug related or otherwise recorded,” she recalls.
“We had to be always accompanied by a nurse. There was a great excitement and the staff were all so lovely, they went above and beyond to make sure we were comfortable and had everything we needed. It was a great experience for us on the trial spending time bonding over a disease we all share, with others that totally understand. It’s a time l will always remember fondly.”
The follow-up was taking part in the second phase of the UCAB study, which took place from May - June 2024.
“We got to take the study drug at home, with weekly returns to Nottingham Clinical Research Centre to monitor our health throughout and record any problems that arose,” said Kathleen.
Having first learned she had PBC in 2011 after going to her GP with itchy red spots on the palms of her hands, Kathleen is keen to see better education for clinicians so patients with this debilitating condition receive the full support they need.
In terms of the symptoms of the disease: “I had to give up my work due to fatigue and brain fog,” said Kathleen. “These days, I’m a shell of my former self, unable to keep up with life, just existing is so exhausting, getting out of bed most days to roll onto the couch is exhausting. l feel like l have MS and dementia, I am unable to keep up with my housework anymore…”
Despite having to battle to get the correct dosage of her regular PBC medication and not seeing an improvement in her own health, Kathleen is looking to the future: “Taking part in the trial was about trying to gain a little bit of my life back, but some improvement would have been fantastic.”
She added: “I would like to see better education on PBC rolled out within the medical professions, better care and information, better patient-clinician relations.
“As members of the PBC Foundation with access to professionals working in PBC, we are sometimes better informed than some GPs. This can make us appear condescending.
“I’d like to see more empathy towards people with PBC symptoms, with patients feeling more listened to, so that they feel less isolated and desolate. That patients can feel safe in the knowledge that they are being taken care of, rather than having to be their own advocate for their disease.”