The potential of therapy with SORIATANE to induce hepatotoxicity was prospectively evaluated using liver biopsies in an open-label trial of 128 subjects. Pretreatment and posttreatment biopsies were available for 87 subjects. A comparison of liver biopsy findings before and after therapy revealed 49 (58%) subjects showed no change, 21 (25%) improved, and 14 (17%) subjects had a worsening of their liver biopsy status. For 6 subjects, the classification changed from class 0 (no pathology) to class I (normal fatty infiltration; nuclear variability and portal inflammation; both mild); for 7 subjects, the change was from class I to class II (fatty infiltration, nuclear variability, portal inflammation, and focal necrosis; all moderate to severe); and for 1 subject, the change was from class II to class IIIb (fibrosis, moderate to severe). No correlation could be found between liver function test result abnormalities and the change in liver biopsy status, and no cumulative dose relationship was found.
Bruce Katz, MD, Medical advisory board of Bioform.
Rhoda Narins, MD ,Medical board, consultant, and/or investigator for Q-Med, Artes, Bioform, Johnson & Johnson, Ortho-Neutrogena, Colbar, Merz, Medicis, Contura, Mentor, Stiefel, Allergan, Sanofi Aventis Dermik, and Genzyme.
Ellen Marmur, MD, Medical education faculty for Bioform, Sanofi Aventis, and Allergan.
Joel Schlessinger, MD ,Researcher, advisory board, and/or consultant for 3M Pharma, Abbot Pharma, Allergan, Amgen, Barrier Therapeutics, Bioten, Centocor, Clay-Park Labs, Collagenix, Connetics, Dermik, Dow, ESC Medical, Fujisawa, Galderma, Genentech, Glaxo Pharma, Glenmark Pharma, Healthpoint, Immunex, Ipsen, Kythera, Medicis, Mentor, Merz, Novartis, Novum, Nucryst, Ortho Pharma, Penederm Pharma, Perrigo, Pfizer, QLT USA, Regeneratio Pharma AG, Sandox, Shering Plough, Stiefel Labs, UCB/Vitae, Artes, Glaxo, Health and Wellness Council of America, MJD Communications, Obagi, , and Vaseline Petroleum Jelly (National spokesperson 2000-2001). Stockholder of Allergan, Excel Cosmeceuticals, Medicus, Mentor, Obagi, and TKL Graceway.