{"id":6859,"date":"2025-09-18T13:51:09","date_gmt":"2025-09-18T11:51:09","guid":{"rendered":"https:\/\/alpha1-deutschland.org\/?p=6859"},"modified":"2025-09-19T14:49:34","modified_gmt":"2025-09-19T12:49:34","slug":"lebererkrankung-blick-ueber-den-tellerrand","status":"publish","type":"post","link":"https:\/\/alpha1-deutschland.org\/en\/lebererkrankung-blick-ueber-den-tellerrand","title":{"rendered":"Liver disease \u2013 thinking outside the box"},"content":{"rendered":"
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Presentation by Dr. Malin Fromme, summarized by Gabi Niethammer | As published in Alpha1 Journal 1\/2025<\/a>.<\/strong><\/p>\n<\/div>\n\n\n\n

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The speaker first explains the origin of alpha-1 antitrypsin deficiency and its effects on the liver and lungs.<\/p>\n

It is now known that AATM does not only affect these two organs, but in rare cases can also affect other parts of the body, such as:<\/p>\n

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  • Panniculitis (inflammation of subcutaneous fat tissue)<\/li>\n
  • ANCA Vasculitis (inflammation of blood vessels)<\/li>\n
  • Low risk of embolisms<\/li>\n
  • Low risk of leukemia<\/li>\n<\/ul>\n

    Normally, the liver is soft and elastic. Due to AATD and the associated accumulation of alpha-1 antitrypsin in the liver, an increase in connective tissue, known as liver fibrosis, can occur over time. With further scarring, this can develop into cirrhosis. A distinction is then made between compensated and decompensated cirrhosis. Compensated cirrhosis causes no problems, whereas decompensated cirrhosis is associated with ascites (fluid accumulation in the abdomen), kidney damage, varicose veins (dilated veins), and an increased risk of liver cancer. It is important to note that this process develops over many years and is not a sudden event.<\/p>\n

    At the University Hospital Aachen, the liver is examined using FibroScan, a non-invasive method for measuring liver stiffness, as well as a comprehensive blood test. Key indicators can be calculated from certain blood parameters that correlate well with liver damage; the APRI value, calculated by dividing the AST value by the platelet count, provides valuable information about liver health (see also our website at https:\/\/alpha1-deutschland.org\/alpha-1-und-die-leber). In addition, MR elastography, an MRI imaging technique, can be used, but it is very expensive and available at only a few locations. In indicated cases, a liver biopsy is performed, in which a small sample is taken from the liver.<\/p>\n

    In patients with Pi*ZZ, liver involvement progresses in two peaks:<\/p>\n

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    • Newborns\/Infants: AATD often manifests as prolonged neonatal jaundice and failure to thrive. In 90\u201398% of children with %, liver function tests normalize during childhood and adolescence; only a few develop severe liver disease at such a young age.<\/li>\n
    • From about age 40: The increase in liver enzyme levels becomes higher, and at 20\u201335 % levels, a noticeable liver change (fibrosis) is found.<\/li>\n<\/ul>\n

      In Great Britain, there is a biobank in which half a million people have been genotyped. This shows that while Pi*ZZ individuals have the highest liver enzyme levels, only 10-15 of them actually have elevated % levels. Therefore, if someone has abnormal liver enzyme levels, a hepatopathy screening should be performed to rule out other liver diseases.<\/p>\n

      Over the past five years, Aachen University Hospital, together with its cooperation partners, has enrolled 730 patients in the liver study and now has a 3.5-year follow-up period. Analysis of numerous FibroScan examinations shows that liver stiffness is higher in patients with Pi*ZZ than in healthy subjects. Combined with data from the British Biobank, this suggests that Pi*ZZ patients have an approximately 20-fold increased risk of developing liver disease. For Pi*SZ, the risk is 3-fold increased, and for Pi*MZ, it is still 1.7-fold increased. Furthermore, it was shown that Pi*ZZ patients who subsequently develop complications of liver disease already had higher FibroScan and APRI values at the initial examination than participants who did not develop complications.<\/p>\n

      It has been shown that the liver tests used, both FibroScan and APRI, have excellent predictive powers for liver complications. Recently, liver experts from around the world issued the following recommendation:<\/p>\n

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      • A Fibroscan score below 8 is considered normal.<\/li>\n
      • A FibroScan score between 8 and 13 describes the yellow zone, where further, non-invasive tests are used for clarification and a follow-up examination is performed in one to two years.<\/li>\n
      • A FibroScan score above 13 indicates advanced scarring and is therefore in the red zone; in this case, liver cirrhosis management must be continued.<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n\t\t\t<\/div> \n\t\t<\/div>\n\t<\/div> \n<\/div><\/div>\n\t\t
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        \n \"Grafik:\n <\/div>\n <\/div>\n \n <\/div>\n <\/div>\n\t\t\t<\/div> \n\t\t<\/div>\n\t<\/div> \n<\/div><\/div>\n\t\t
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        Another large study with 1,700 Pi*ZZ patients revealed that the progression of the disease accelerates noticeably when the body is subjected to additional stress. If the ZZ patient is severely overweight (BMI over 30) or has diabetes, the risk of elevated liver enzymes increases so significantly that it leads to earlier scarring of the liver. This must be avoided at all costs!<\/p>\n

        As mentioned previously, heterozygous affected individuals (Pi*MZ) have a 1.7-fold increased risk of developing liver disease due to AATD. Again, if the liver is further stressed (a "second hit"), for example, through excessive alcohol consumption or fatty liver disease, the risk rises to 6-7. The liver is therefore not quite as resilient as in people without AATD, and it is important to avoid these risk factors to maintain liver health. Furthermore, it has also been found that there is a minimal risk of developing gallstones in carriers.<\/p>\n

        Another important finding from observations in recent years is that both Pi*ZZ and Pi*MZ patients with pre-existing liver cirrhosis show a faster progression to complications (such as transplantation or death) than liver cirrhosis patients without AAT\u2082. This could be because the existing liver cirrhosis places ongoing stress on the liver, leading to the continuous production of alpha-1 antitrypsin. The resulting clumping in the liver creates a vicious cycle in which it becomes nearly impossible to stop the production of further AATs. However, the underlying mechanisms require further investigation. The University Hospital Aachen advises people with liver cirrhosis to consult a transplant center early on to explore all options and avoid missing any crucial opportunities.<\/p>\n

        Hope is offered by the fact that alpha-1 antitrypsin deficiency has become a kind of model disease for gene therapy research in recent years, and several pharmaceutical companies are researching ways to find therapy options for the liver.<\/p>\n

        To briefly explain: DNA is our genetic material. In the body, it is used to create mRNA, which is essentially a copy of the DNA, from which the protein alpha-1-antitrypsin is then produced. The exciting thing is that research is being conducted at all three levels.<\/p>\n

        With completed Phase II results, the study of the drug Farzirsiran\u00ae is the most advanced, and initial results have already been published. The drug was administered subcutaneously every twelve weeks, resulting in a significant reduction in misfolded AAT in the liver and a marked improvement in liver function.<\/p>\n

        At the same time, lung function remained stable, which is a very positive result. The great hope is that this will lead to a liver-protective medication in the foreseeable future that, because it binds at the RNA level, can be taken continuously to ensure its effectiveness is not lost.<\/p>\n

        The Farzirsiran\u00ae study is currently in Phase III and is seeking adult patients with Pi*ZZ who have advanced liver fibrosis (2\u20134) and an FEV1 of at least 50 %. The FEV1 threshold was recently lowered from 70 to 50 in Europe, so patients with slightly reduced lung function now also have the opportunity to participate in this study. If you meet the criteria and are interested, please contact the University Hospital Aachen at +49 241 80-36606 or alpha1@ukaachen.de.<\/p>\n

        Two recently published press releases are very exciting, announcing that two companies have, for the first time, succeeded in correcting DNA and RNA, respectively. One study comes from the company "WAVE Life Sciences." Here, the incorrectly mutated base was removed at the mRNA level and replaced with a healthy one; this is called RNA editing.<\/p>\n

        The University Hospital Aachen (UK Aachen) plans to offer the "WAVE study" as a second study in Aachen for adults with Pi*ZZ (a type of diabetic nephropathy). This phase Ib\/IIa study will enroll patients not receiving opioid substitution therapy with a FibroScan score below 10 and an FEV1 of at least 50 mcg\/dL. The goal is to develop a therapy for liver and lung function by modifying the mRNA to produce functional alpha-1-antitrypsin. If you are interested, please contact us using the contact information above.<\/p>\n

        The second company, BEAM Therapeutics, has achieved the first-ever DNA editing in humans, meaning they didn't work on the human RNA copy, but directly exchanged a base pair in the genes. It's remarkable that this world-first intervention at the DNA level was applied specifically to alpha-1 antitrypsin deficiency. This offers hope for further research and, one day, the control of this disease!<\/p>\n<\/div>\n\n\n\n\n\t\t\t<\/div> \n\t\t<\/div>\n\t<\/div> \n<\/div><\/div>\n\t\t

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        \n \"Infografik:\n <\/div>\n <\/div>\n \n <\/div>\n <\/div>\n\t\t\t<\/div> \n\t\t<\/div>\n\t<\/div> \n<\/div><\/div>\n\t\t
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        In summary, the recommendations of the UK Aachen are:<\/p>\n

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        • For all those affected by Pi*ZZ, the recommendation is a healthy lifestyle with a balanced diet and sufficient exercise.<\/li>\n
        • Vaccination against Hepatitis A and B<\/li>\n
        • Have your liver function checked regularly via blood tests; if abnormalities are found, have a general liver check-up.<\/li>\n
        • Fibroscan examination to check liver stiffness using the traffic light principle<\/li>\n
        • Ultrasound every six months in cases of severe liver scarring\/cirrhosis<\/li>\n
        • Possibly participation in one of the presented studies (please contact the University Hospital Aachen for more information)<\/li>\n
        • In cases of liver cirrhosis, cancer screening and a one-time presentation at a transplant center<\/li>\n<\/ul>\n

          One more request: For the drug Farzirsiran\u00ae to eventually be approved, a better understanding of the natural disease progression of AATD (with very high data collection and quality standards) is needed. Therefore, the developing company, Takeda, is asking all Alphas already enrolled in the Aachen Liver Study to release their data from the current study for the Takeda Observational Study 5008. This means allowing the University Hospital Aachen (UK Aachen) to forward the available data to Takeda in pseudonymized form. Participation is, of course, entirely voluntary. An optional part of this 5008 study is to complete an online questionnaire developed by Takeda regarding the well-being of patients with Pi*SZ or Pi*ZZ and a FibroScan above 7.1 kPa. The UK Aachen is specifically contacting Alphas for this purpose. We encourage you to contribute to ensuring that nothing stands in the way of drug approval for Farzirsiran, with its very high quality controls, should the drug prove effective in Phase III. Thank you for your help! Together we can do it!<\/p>\n<\/div>\n\n\n\n\n\t\t\t<\/div> \n\t\t<\/div>\n\t<\/div> \n<\/div><\/div>","protected":false},"excerpt":{"rendered":"Author: Dr. Malin Fromme, Summary by Gabi Niethammer | Published in Alpha1-Journal 1\/2025. 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