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Second-Line Treatment for Patients With Primary Biliary Cholangitis: A Systematic Review With Network Meta-Analysis.
Liver Int
January 2025
Liver Center, Digestive Diseases Section, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Background & Aims: Approximately 40% of patients with Primary Biliary Cholangitis (PBC) show incomplete response to ursodeoxycholic acid, thus needing second-line treatment to prevent disease progression. As no head-to-head comparison study is available, we used a network meta-analysis (NMA) to compare efficacy and safety of available second-line therapies.
Methods: We performed a systematic literature review including randomised, placebo-controlled trials of patients with PBC and incomplete response, or intolerance, to ursodeoxycholic acid, and compared relative risks (RRs) for primary (biochemical response at 52-week) and secondary outcomes [incidence of new-onset pruritus and serious adverse events (SAEs)].
Review of Current and Upcoming Second-Line Treatments for Primary Biliary Cholangitis.
Dig Dis Sci
January 2025
Department of Medicine and Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Background: Treatment for primary biliary cholangitis (PBC) was defined by its singular relationship with ursodeoxycholic acid (UDCA) for decades. However, nearly 40% of patients fail to achieve adequate biochemical response with UDCA, necessitating second-line therapies.
Aims: The aim of our review was to assess the efficacy and safety of second-line therapies for PBC from phase three trials.
Correction to COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.
Am J Gastroenterol
January 2025
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina .
Risk of biliary diseases in patients with type 2 diabetes or obesity treated with tirzepatide: A meta-analysis.
J Diabetes Investig
January 2025
Department of Hepato-Pancreato-Biliary Surgery, People's Hospital of Leshan, Leshan, Sichuan, China.
Article Synopsis
- The study aimed to assess the risk of biliary diseases in patients with type 2 diabetes or obesity who were treated with tirzepatide.
- A total of 12 high-quality randomized controlled trials involving over 12,000 patients were analyzed, showing that tirzepatide increased the risk of gallbladder and biliary diseases, particularly cholelithiasis (gallstones).
- The researchers concluded that while tirzepatide is linked to gallbladder/biliary issues, more extensive post-marketing studies are needed to confirm these findings and enhance safety monitoring.
Inebilizumab for Treatment of IgG4-Related Disease.
N Engl J Med
November 2024
From the Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston (J.H.S., Z.S.W., C.A.P.); the Division of Rheumatology, Emory University School of Medicine, Atlanta (A.K.); the Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, National Clinical Research Center for Dermatologic and Immunologic Diseases, Beijing (W.Z.), and the Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan (L.D.) - both in China; the Unit of Immunology, Rheumatology, Allergy, and Rare Diseases, IRCCS San Raffaele Scientific Institute, Milan (E.D.T., M.L.); the Department of Internal Medicine, Kansai Medical University Kori Hospital, Osaka (K.O.), the First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu (Y.T.), and Nagahama City Hospital, Nagahama (H.U.) - all in Japan; the Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm (J.M.L.); Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Centre National de la Recherche Scientifique, INSERM, Centre d'Immunologie de Marseille-Luminy, Hopital de la Timone, Internal Medicine Department, Marseille (N.S., M.E.), and the Pancreatology and Digestive Oncology Department, Beaujon Hospital, Université Paris Cité, Clichy (V.R.) - both in France; the Department of Gastroenterology, University College London Hospitals, London (G.J.W.), the Hepato-Pancreato-Biliary Unit, Freeman Hospital, Newcastle upon Tyne (M.K.N.), and the Translational Gastroenterology and Liver Unit, John Radcliffe Hospital, and Nuffield Department of Medicine, University of Oxford, Oxford (E.L.C.) - all in the United Kingdom; the Internal Medicine Department, Vall d'Hebron Hospital, Vall d'Hebron Research Institute, Universitat Autònoma de Barcelona, Barcelona (F.M.V.); and Amgen, Thousand Oaks, CA (X.D., Y.W., Q.L., N.R., D.C.).
Article Synopsis
- IgG4-related disease is a chronic immune disorder with no current approved treatment, and inebilizumab, which targets CD19+ B cells, is being tested as a potential therapy.
- In a phase 3 trial, 135 adults with active IgG4-related disease were randomly assigned to receive either inebilizumab or a placebo, and the primary measure was time until the first disease flare.
- Results showed that patients receiving inebilizumab had significantly fewer disease flares (10% vs. 60% in the placebo group), lower annual flare rates, and higher rates of complete remission without treatment compared to those in the placebo group.
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