What liver research gap did this study address?
Researchers are following different clues aiming to find a medicine, therapy or combination that could help people with PSC. At the time of writing, July 2026, there is no approved treatment to slow or stop this disease, except a liver transplant.
This study used old patient records to look into how the addition of a group of medicines called fibrates affected PSC in people already taking UDCA. Previous studies have suggested that fibrates may improve bile flow from the liver (cholestasis), itch (pruritus) and they may lower a key marker in the blood used to monitor bile duct function (ALP).
What were the aims of this PSC study?
This study aimed to investigate the effects and safety of fibrates on people with PSC. Most people taking fibrates don’t have any serious side effects. However, doctors can’t assume that this medicine will behave the same in people with PSC. PSC causes changes to the liver and other parts of the body that might react to fibrates differently than to people with other diseases. This needs to be thoroughly studied to ensure that treatment of PSC with fibrates doesn’t cause unexpected effects.
The long-term effects of fibrates in people with PSC were also studied. The effects of a medicine can change after people have taken it for a long time.This study looked into whether fibrates were safe in people after more than six months of daily treatment.
A Phase 3 clinical trial has recently finished studying the effects of one type of fibrate on PSC. This trial’s results have not yet been published. The current study adds a layer of evidence to fibrates' effectiveness in PSC.
How was the research conducted?
This study used old patient records from 34 people who had been treated for PSC. These people were already taking UDCA, fibrates were then added to their treatment. The researchers never met the patients or had them do any tests for this study.
This type of study is much cheaper, faster and easier to perform than a clinical trial. There are drawbacks though. There is a potential for bias in this kind of study, generally in two forms. When patients aren’t assigned a treatment randomly, differences between these patients can influence the results.
Secondly, when the patients, doctors and/or researchers know who is receiving what medicine in a trial, this can influence how the patient reacts to the medicine (placebo effect) or how the researchers interpret the results. They know what the drug should do and what the results should be, so they might not see what the results actually say.
Also, the medicine that is being studied can’t be compared to anything. In a clinical trial the medicine is compared to either another medicine or something that does not affect the body (the control). This means that a change seen in the people that are taking the medicine, and not in the people taking the control, can be said more confidently to be caused by the medicine.
In this study there was no control. How can the researchers say that it was the fibrates that caused any change? Maybe the change was going to happen anyway. The answer is through statistics! The researchers used high-level statistics to show their level of confidence in the results.
What were the main findings of the study?
In the 34 patients with PSC who were given fibrates for longer than 6 months, the results were:
- Itch (pruritis) - after 12 months of taking fibrates, itch scores decreased to a level that the researchers were confident could have been caused by the medicine.
- ALP (marker of bile duct function in the blood) - after six months of fibrates, this also decreased to a level that the researchers were confident in attributing to the medicine.
- Markers of later-stage PSC did not decrease after the patients began fibrate treatment. In those who initially had higher ALP levels:
- Bilirubin and other markers remained high after 12 months of fibrates.
Why are these research results important for PSC?
This study wasn’t groundbreaking, but it gave some interesting results. In a small group of 34 people with PSC taking UDCA + fibrates, they found that those with early-stage PSC had reduced itch and reduced bile-duct-damage marker, ALP, in the blood. The results suggest that those with later-stage PSC did not respond to fibrates.
Reduced ALP is an important finding. Damage to the bile ducts is a hallmark of PSC. ALP levels generally increase with greater damage to bile ducts. The researchers have suggested the decrease in ALP seen in this study, is due to reduced bile duct damage and blockage. They have linked this decrease in ALP to taking fibrates. However, this decrease in ALP alone does not prove that the disease has stopped.
This doesn’t mean that fibrates are the instant next hot thing in PSC, but it does add more clues and evidence that they should be studied further. As written above, this type of study can’t be relied on too heavily alone, because it may introduce bias and does not have a control, especially when in such a small group.
The results from this study are like the appetiser to the Phase 3 clinical trial on the use of fibrates in PSC that finished recently and whose results are yet to be published.
What does this mean for people with PSC?
This study by itself will not change anything for people with PSC directly. It does, however, add more to the growing evidence that fibrates might be a promising treatment for PSC.
This study has suggested that fibrates + UDCA may be effective in early-stage PSC only. To confirm this, we must wait for the results of the upcoming Phase 3 trial, after which, if the results are positive, fibrates may be approved as a treatment for PSC. The timeframe for this could still be some years away.
Many thanks to Geoff Churchill for this summary.