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Báo cáo y học: " Epratuzumab (humanised anti-CD22 antibody) in primary Sjögren's syndrome: an open-label phase I/II study"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Epratuzumab (humanised anti-CD22 antibody) in primary Sjögren's syndrome: an open-label phase I/II study. | Available online http arthritis-research.eom content 8 4 R1 29 Research article Epratuzumab humanised anti-CD22 antibody in primary Sjogren s syndrome an open-label phase I II study Serge D Steinfeld1 Laure Tant1 Gerd R Burmester2 Nick KW Teoh3 William A Wegener3 David M Goldenberg3 and Olivier Pradier4 Department of Rheumatology Erasme University Hospital 808 Route de Lennik Brussels 1070 Belgium department of Rheumatology Charite Hospital Schumannstr 20-21 Berlin D-10098 Germany 3Immunomedics Inc. Morris Plains 300 American Road New Jersey 07950 USA 4Laboratory of Hematology Erasme University Hospital 808 Route de Lennik Brussels 1070 Belgium Corresponding author Serge D Steinfeld ssteinfe@ulb.ac.be Received 9 May 2006 Revisions requested 8 Jun 2006 Revisions received 16 Jun 2006 Accepted 20 Jul 2006 Published 20 Jul 2006 Arthritis Research Therapy 2006 8 R129 doi 10.1186 ar2018 This article is online at http arthritis-research.com content 8 4 R1 29 2006 Steinfeld et al. licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License http creativecommons.org licenses by 2.0 which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Open Access Abstract This open-label phase I II study investigated the safety and efficacy of epratuzumab a humanised anti-CD22 monoclonal antibody in the treatment of patients with active primary Sjogren s syndrome pSS . Sixteen Caucasian patients 14 females 2 males 33-72 years were to receive 4 infusions of 360 mg m2 epratuzumab once every 2 weeks with 6 months of follow-up. A composite endpoint involving the Schirmer-I test unstimulated whole salivary flow fatigue erythrocyte sedimentation rate ESR and immunoglobulin G IgG was devised to provide a clinically meaningful assessment of response defined as a 20 improvement in at least two of the aforementioned parameters with 20 reduction in ESR and or IgG .