Resmetirom w leczeniu stłuszczeniowego zapalenia wątroby związanego z zaburzeniami metabolicznymi (MASH) - bezpieczeństwo i skuteczność kliniczna

Brouwers, B., Rao, G., Tang, Y., Rodríguez, Á., Glass, L.C., Hartman, M.L.: Incretin-based investigational therapies for the treatment of MASLD/MASH. Diabetes Res Clin Pract. 211, 111675 (2024). https://doi.org/10.1016/j.diabres.2024.111675

Musso, G., Saba, F., Cassader, M., Gambino, R.: Lipidomics in pathogenesis, progression and treatment of nonalcoholic steatohepatitis (NASH): Recent advances. Prog Lipid Res. 91, 101238 (2023). https://doi.org/10.1016/j.plipres.2023.101238

Wang, X., Zhang, L., Dong, B.: Molecular mechanisms in MASLD/MASH-related HCC. Hepatology. (2024). https://doi.org/10.1097/HEP.0000000000000786

Wang, S., Friedman, S.L.: Found in translation—Fibrosis in metabolic dysfunction–associated steatohepatitis (MASH). Sci Transl Med. 15, (2023). https://doi.org/10.1126/scitranslmed.adi0759

Harrison, S.A., Bashir, M.R., Guy, C.D., Zhou, R., Moylan, C.A., Frias, J.P., Alkhouri, N., Bansal, M.B., Baum, S., Neuschwander-Tetri, B.A., Taub, R., Moussa, S.E.: Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet. 394, 2012–2024 (2019). https://doi.org/10.1016/S0140-6736(19)32517-6

Younossi, Z.M., Kalligeros, M., Henry, L.: Epidemiology of Metabolic Dysfunction Associated Steatotic Liver Disease. Clin Mol Hepatol. (2024). https://doi.org/10.3350/cmh.2024.0431

Adams, L.A., Anstee, Q.M., Tilg, H., Targher, G.: Non-alcoholic fatty liver disease and its relationship with cardiovascular disease and other extrahepatic diseases. Gut. 66, 1138–1153 (2017). https://doi.org/10.1136/gutjnl-2017-313884

Chan, W.-K., Chuah, K.-H., Rajaram, R.B., Lim, L.-L., Ratnasingam, J., Vethakkan, S.R.: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 32, 197–213 (2023). https://doi.org/10.7570/jomes23052

Zhang, S., Mak, L.-Y., Yuen, M.-F., Seto, W.-K.: Screening strategy for non-alcoholic fatty liver disease. Clin Mol Hepatol. 29, S103–S122 (2023). https://doi.org/10.3350/cmh.2022.0336

Njei, B., Ameyaw, P., Al-Ajlouni, Y., Njei, L.-P., Boateng, S.: Diagnosis and Management of Lean Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Systematic Review. Cureus. (2024). https://doi.org/10.7759/cureus.71451

Targher, G., Byrne, C.D., Tilg, H.: MASLD: a systemic metabolic disorder with cardiovascular and malignant complications. Gut. gutjnl-2023-330595 (2024). https://doi.org/10.1136/gutjnl-2023-330595

Bittla, P., Paidimarri, S.P., Ayuthu, S., Chauhan, Y.D., Saad, M.Z., Mirza, A.A., Khan, S.: Resmetirom: A Systematic Review of the Revolutionizing Approach to Non-alcoholic Steatohepatitis Treatment Focusing on Efficacy, Safety, Cost-Effectiveness, and Impact on Quality of Life. Cureus. (2024). https://doi.org/10.7759/cureus.69919

Harrison, S.A., Bashir, M., Moussa, S.E., McCarty, K., Pablo Frias, J., Taub, R., Alkhouri, N.: Effects of Resmetirom on Noninvasive Endpoints in a 36‐Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 5, 573–588 (2021). https://doi.org/10.1002/hep4.1657

Harrison, S.A., Taub, R., Neff, G.W., Lucas, K.J., Labriola, D., Moussa, S.E., Alkhouri, N., Bashir, M.R.: Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 29, 2919–2928 (2023). https://doi.org/10.1038/s41591-023-02603-1

Chen, V.L., Morgan, T.R., Rotman, Y., Patton, H.M., Cusi, K., Kanwal, F., Kim, W.R.: Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 81, 312–320 (2025). https://doi.org/10.1097/HEP.0000000000001112

Pouwels, S., Sakran, N., Graham, Y., Leal, A., Pintar, T., Yang, W., Kassir, R., Singhal, R., Mahawar, K., Ramnarain, D.: Non-alcoholic fatty liver disease (NAFLD): a review of pathophysiology, clinical management and effects of weight loss. BMC Endocr Disord. 22, 63 (2022). https://doi.org/10.1186/s12902-022-00980-1

Loomba, R., Friedman, S.L., Shulman, G.I.: Mechanisms and disease consequences of nonalcoholic fatty liver disease. Cell. 184, 2537–2564 (2021). https://doi.org/10.1016/j.cell.2021.04.015

Karim, G., Bansal, M.B.: Resmetirom: An Orally Administered, Small-molecule, Liver-directed, β-selective THR Agonist for the Treatment of Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis. Eur Endocrinol. 19, 60 (2023). https://doi.org/10.17925/EE.2023.19.1.60

Nassir, F.: NAFLD: Mechanisms, Treatments, and Biomarkers. Biomolecules. 12, 824 (2022). https://doi.org/10.3390/biom12060824

Targher, G., Corey, K.E., Byrne, C.D., Roden, M.: The complex link between NAFLD and type 2 diabetes mellitus — mechanisms and treatments. Nat Rev Gastroenterol Hepatol. 18, 599–612 (2021). https://doi.org/10.1038/s41575-021-00448-y

Parola, M., Pinzani, M.: Liver fibrosis in NAFLD/NASH: from pathophysiology towards diagnostic and therapeutic strategies. Mol Aspects Med. 95, 101231 (2024). https://doi.org/10.1016/j.mam.2023.101231

Schwärzler, J., Grabherr, F., Grander, C., Adolph, T.E., Tilg, H.: The pathophysiology of MASLD: an immunometabolic perspective. Expert Rev Clin Immunol. 20, 375–386 (2024). https://doi.org/10.1080/1744666X.2023.2294046

Steinberg, G.R., Valvano, C.M., De Nardo, W., Watt, M.J.: Integrative Metabolism in MASLD and MASH: Pathophysiology and Emerging Mechanisms. J Hepatol. (2025). https://doi.org/10.1016/j.jhep.2025.02.033

Cusi, K., Isaacs, S., Barb, D., Basu, R., Caprio, S., Garvey, W.T., Kashyap, S., Mechanick, J.I., Mouzaki, M., Nadolsky, K., Rinella, M.E., Vos, M.B., Younossi, Z.: American Association of Clinical Endocrinology Clinical Practice Guideline for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Primary Care and Endocrinology Clinical Settings. Endocrine Practice. 28, 528–562 (2022). https://doi.org/10.1016/j.eprac.2022.03.010

Giashuddin, S., Alawad, M.: Histopathological Diagnosis of Nonalcoholic Steatohepatitis (NASH). Presented at the (2022)

Malandris, K., Arampidis, D., Mainou, M., Papadopoulos, N., Karagiannis, T., Nayfeh, T., Liakos, A., Sinakos, E., Tsapas, A., Bekiari, E.: FibroScan‐AST score for diagnosing fibrotic MASH: A systematic review and meta‐analysis of diagnostic test accuracy studies. J Gastroenterol Hepatol. 39, 2582–2591 (2024). https://doi.org/10.1111/jgh.16770

Zhou, J.-H., Cai, J.-J., She, Z.-G., Li, H.-L.: Noninvasive evaluation of nonalcoholic fatty liver disease: Current evidence and practice. World J Gastroenterol. 25, 1307–1326 (2019). https://doi.org/10.3748/wjg.v25.i11.1307

Chen, R., Petrazzini, B.O., Nadkarni, G., Rocheleau, G., Bansal, M., Do, R.: Machine Learning Enables Single-Score Assessment of MASLD Presence and Severity, (2023)

Castera, L., Garteiser, P., Laouenan, C., Vidal-Trécan, T., Vallet-Pichard, A., Manchon, P., Paradis, V., Czernichow, S., Roulot, D., Larger, E., Pol, S., Bedossa, P., Correas, J.-M., Valla, D., Gautier, J.-F., Van Beers, B.E., Bellili, D., Bessadi, O., Da Silveira, C., Djelouat, F.Z., Girard, B., Legrand, V., Neveux, N., Meziani, M., Roy, L., Sekour, D., Sens, M., Slimani, M., Zatout, O., Bachelet, D., Bhavsar, K., Mullaert, B.B.-B.J., Marcault, E., Si-Mohammed, N., Cosson, E., Miguel Albuquerque, Doblas, S., Hammoutene, A., Gonzalez Montpetit, E., Pagé, G., Béatrice Parfait, Postic, C., Lehuen, A., Toubal, A., Rousseau, C., Fruchet, B., Soulard, P., Gouda, Z., Vidaud, M., Letourneur, F., Renault, G., Scharfmann, R., Ait-Boudaoud, A., Barsamian, C., Carette, C., Rives-Lange, C., Baida, R., Couture, O., Decombas, S., Deffieux, T., Nguyen, T., Tanter, M., Baltauss, T., Balzac, E.-L., Barbier Saint Hilaire, P., Delerive, P., Duvivier, V., Fillon, A., Geronimi, J., Laplume, J., Werner, E., Xuereb, L., Liechti, R., Martin, O., Mehl, F., Pruess, M., Castille, J.-M., Drane, F., Deckmyn, O., Castelli, F., Cousin, B.C.E., Fenaille, F., Guilbaud, L., Lohier, A., Chambellin, F., Laaland, L., Clusel, C., Hauduroy, M., Pautre, P.: Prospective head-to-head comparison of non-invasive scores for diagnosis of fibrotic MASH in patients with type 2 diabetes. J Hepatol. 81, 195–206 (2024). https://doi.org/10.1016/j.jhep.2024.03.023

Jung, J., Loomba, R.R., Imajo, K., Madamba, E., Gandhi, S., Bettencourt, R., Singh, S., Hernandez, C., Valasek, M.A., Behling, C., Richards, L., Fowler, K., Sirlin, C.B., Nakajima, A., Loomba, R.: MRE combined with FIB-4 (MEFIB) index in detection of candidates for pharmacological treatment of NASH-related fibrosis. Gut. 70, 1946–1953 (2021). https://doi.org/10.1136/gutjnl-2020-322976

Caussy, C., Reeder, S.B., Sirlin, C.B., Loomba, R.: Noninvasive, Quantitative Assessment of Liver Fat by MRI‐PDFF as an Endpoint in NASH Trials. Hepatology. 68, 763–772 (2018). https://doi.org/10.1002/hep.29797

Martinou, E., Pericleous, M., Stefanova, I., Kaur, V., Angelidi, A.M.: Diagnostic Modalities of Non-Alcoholic Fatty Liver Disease: From Biochemical Biomarkers to Multi-Omics Non-Invasive Approaches. Diagnostics. 12, 407 (2022). https://doi.org/10.3390/diagnostics12020407

Harrison, S.A., Oliver, D., Arnold, H.L., Gogia, S., Neuschwander-Tetri, B.A.: Development and validation of a simple NAFLD clinical scoring system for identifying patients without advanced disease. Gut. 57, 1441–1447 (2008). https://doi.org/10.1136/gut.2007.146019

Angulo, P., Hui, J.M., Marchesini, G., Bugianesi, E., George, J., Farrell, G.C., Enders, F., Saksena, S., Burt, A.D., Bida, J.P., Lindor, K., Sanderson, S.O., Lenzi, M., Adams, L.A., Kench, J., Therneau, T.M., Day, C.P.: The NAFLD fibrosis score. Hepatology. 45, 846–854 (2007). https://doi.org/10.1002/hep.21496

Vali, Y., Lee, J., Boursier, J., Spijker, R., Verheij, J., Brosnan, M., Anstee, Q., Bossuyt, P., Zafarmand, M.: FibroTest for Evaluating Fibrosis in Non-Alcoholic Fatty Liver Disease Patients: A Systematic Review and Meta-Analysis. J Clin Med. 10, 2415 (2021). https://doi.org/10.3390/jcm10112415

Chandra Kumar, C.V., Skantha, R., Chan, W.-K.: Non-invasive assessment of metabolic dysfunction–associated fatty liver disease. Ther Adv Endocrinol Metab. 13, (2022). https://doi.org/10.1177/20420188221139614

Huang, Z., Sung, H.K., Yan, X., He, S., Jin, L., Wang, Q., Wu, X., Hsu, H.H., Pignalosa, A., Crawford, K., Sweeney, G., Xu, A.: The adiponectin‐derived peptide ALY688 protects against the development of metabolic dysfunction‐associated steatohepatitis. Clin Transl Sci. 17, (2024). https://doi.org/10.1111/cts.13760

Sheka, A.C., Adeyi, O., Thompson, J., Hameed, B., Crawford, P.A., Ikramuddin, S.: Nonalcoholic Steatohepatitis. JAMA. 323, 1175 (2020). https://doi.org/10.1001/jama.2020.2298

Paternostro, R., Trauner, M.: Current treatment of non‐alcoholic fatty liver disease. J Intern Med. 292, 190–204 (2022). https://doi.org/10.1111/joim.13531

Vogli, S., Naska, A., Marinos, G., Kasdagli, M.-I., Orfanos, P.: The Effect of Vitamin E Supplementation on Serum Aminotransferases in Non-Alcoholic Fatty Liver Disease (NAFLD): A Systematic Review and Meta-Analysis. Nutrients. 15, 3733 (2023). https://doi.org/10.3390/nu15173733

Lassailly, G., Caiazzo, R., Ntandja-Wandji, L.-C., Gnemmi, V., Baud, G., Verkindt, H., Ningarhari, M., Louvet, A., Leteurtre, E., Raverdy, V., Dharancy, S., Pattou, F., Mathurin, P.: Bariatric Surgery Provides Long-term Resolution of Nonalcoholic Steatohepatitis and Regression of Fibrosis. Gastroenterology. 159, 1290-1301.e5 (2020). https://doi.org/10.1053/j.gastro.2020.06.006

Dutta, D., Kamrul-Hasan, A.B.M., Mondal, E., Nagendra, L., Joshi, A., Bhattacharya, S.: Role of Resmetirom, a Liver-Directed, Thyroid Hormone Receptor Beta-Selective Agonist, in Managing Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis. Endocrine Practice. 30, 631–638 (2024). https://doi.org/10.1016/j.eprac.2024.04.016

Petta, S., Targher, G., Romeo, S., Pajvani, U.B., Zheng, M., Aghemo, A., Valenti, L.V.C.: The first MASH drug therapy on the horizon: Current perspectives of resmetirom. Liver International. 44, 1526–1536 (2024). https://doi.org/10.1111/liv.15930

Sookoian, S., Pirola, C.J.: Resmetirom for treatment of MASH. Cell. 187, 2897-2897.e1 (2024). https://doi.org/10.1016/j.cell.2024.05.009

Feng, G., Hernandez-Gea, V., Zheng, M.-H.: Resmetirom for MASH-related cirrhosis. Lancet Gastroenterol Hepatol. 9, 594 (2024). https://doi.org/10.1016/S2468-1253(24)00124-9

Arvanitakis, K., Koufakis, T., Cholongitas, E., Francque, S., Germanidis, G.: Insights into the results of Resmetirom trials: Can a thyroid hormone receptor agonist be the holy grail of MASH therapy? Pharmacol Ther. 268, 108811 (2025). https://doi.org/10.1016/j.pharmthera.2025.108811

Ezhilarasan, D.: Thyromimetics and MASLD: Unveiling the Novel Molecules Beyond Resmetirom. J Gastroenterol Hepatol. 40, 367–378 (2025). https://doi.org/10.1111/jgh.16874

Levien, T.L., Baker, D.E.: Resmetirom. Hosp Pharm. 60, 12–20 (2025). https://doi.org/10.1177/00185787241278571

Harrison, S.A., Bedossa, P., Guy, C.D., Schattenberg, J.M., Loomba, R., Taub, R., Labriola, D., Moussa, S.E., Neff, G.W., Rinella, M.E., Anstee, Q.M., Abdelmalek, M.F., Younossi, Z., Baum, S.J., Francque, S., Charlton, M.R., Newsome, P.N., Lanthier, N., Schiefke, I., Mangia, A., Pericàs, J.M., Patil, R., Sanyal, A.J., Noureddin, M., Bansal, M.B., Alkhouri, N., Castera, L., Rudraraju, M., Ratziu, V.: A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. New England Journal of Medicine. 390, 497–509 (2024). https://doi.org/10.1056/NEJMoa2309000

The Lancet Gastroenterology & Hepatology: Resmetirom for NASH: balancing promise and prudence. Lancet Gastroenterol Hepatol. 9, 273 (2024). https://doi.org/10.1016/S2468-1253(24)00049-9

Noureddin, M., Charlton, M.R., Harrison, S.A., Bansal, M.B., Alkhouri, N., Loomba, R., Sanyal, A.J., Rinella, M.E.: Expert Panel Recommendations: Practical Clinical Applications for Initiating and Monitoring Resmetirom in Patients With MASH/NASH and Moderate to Noncirrhotic Advanced Fibrosis. Clinical Gastroenterology and Hepatology. 22, 2367–2377 (2024). https://doi.org/10.1016/j.cgh.2024.07.003

Wang, X., Wang, L., Geng, L., Tanaka, N., Ye, B.: Resmetirom Ameliorates NASH-Model Mice by Suppressing STAT3 and NF-κB Signaling Pathways in an RGS5-Dependent Manner. Int J Mol Sci. 24, 5843 (2023). https://doi.org/10.3390/ijms24065843

Raja, A., Subhash Sagar, R., Saeed, S., Zia ul haq, A., Khan, O., Dileep Bhimani, P., Raja, S., Deepak, F., Ahmed, M., Ashir Shafique, M., Saqlain Mustafa, M., Sohaib Asghar, M., Sharma, V.: Safety and efficacy of resmetirom in the treatment of patients with non-alcoholic steatohepatitis and liver fibrosis: a systematic review and meta-analysis. Annals of Medicine & Surgery. 86, 4130–4138 (2024). https://doi.org/10.1097/MS9.0000000000002195

Harrison, S.A., Ratziu, V., Anstee, Q.M., Noureddin, M., Sanyal, A.J., Schattenberg, J.M., Bedossa, P., Bashir, M.R., Schneider, D., Taub, R., Bansal, M., Kowdley, K. V., Younossi, Z.M., Loomba, R.: Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 59, 51–63 (2024). https://doi.org/10.1111/apt.17734

Ray, K.: Resmetirom proves positive for NASH with liver fibrosis. Nat Rev Gastroenterol Hepatol. 21, 218–218 (2024). https://doi.org/10.1038/s41575-024-00909-0

Kokkorakis, M., Boutari, C., Hill, M.A., Kotsis, V., Loomba, R., Sanyal, A.J., Mantzoros, C.S.: Resmetirom, the first approved drug for the management of metabolic dysfunction-associated steatohepatitis: Trials, opportunities, and challenges. Metabolism. 154, 155835 (2024). https://doi.org/10.1016/j.metabol.2024.155835

Brennan, P.N., Kopka, C.J., Agirre-Garrido, L., Hansen, C.D., Alkhouri, N., Schattenberg, J.M., Ivancovsky-Wajcman, D., Isaacs, S., Michel, M., Lazarus, J. V.: Reviewing MAESTRO-NASH and the implications for hepatology and health systems in implementation/accessibility of Resmetirom. npj Gut and Liver. 2, 3 (2025). https://doi.org/10.1038/s44355-024-00017-5

Mousa, A.M., Mahmoud, M., AlShuraiaan, G.M.: Resmetirom: The First Disease‐Specific Treatment for MASH. Int J Endocrinol. 2025, (2025). https://doi.org/10.1155/ije/6430023

Borozan, S., Vujosevic, S., Mikhailidis, D.P., Muzurovic, E.: Metabolic Dysfunction-associated Steatohepatitis and Cardiovascular Disease Prevention - Is Resmetirom Useful? Curr Vasc Pharmacol. 23, 4–7 (2025). https://doi.org/10.2174/0115701611340703240809044916

Alshehade, S.A.: Resmetirom’s approval: Highlighting the need for comprehensive approaches in NASH therapeutics. Clin Res Hepatol Gastroenterol. 48, 102377 (2024). https://doi.org/10.1016/j.clinre.2024.102377

Guirguis, E., Dougherty, J., Thornby, K., Grace, Y., Mack, K.: Resmetirom: The First Food and Drug Administration–Approved Medication for Nonalcoholic Steatohepatitis (NASH). Annals of Pharmacotherapy. 59, 162–173 (2025). https://doi.org/10.1177/10600280241259528