Epratuzumab (humanised anti-CD22 antibody) in primary Sj？grens syndrome an open-label phase III study.docVIP

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Epratuzumab (humanised anti-CD22 antibody) in primary Sj？grens syndrome an open-label phase III study.doc

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Epratuzumab (humanised anti-CD22 antibody) in primary Sj？grens syndrome an open-label phase III study

Available online /content/8/4/R129 Research article Open Access Vol 8 No 4 Epratuzumab (humanised anti-CD22 antibody) in primary Sj?grens 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 1Department of Rheumatology, Erasme University Hospital, 808 Route de Lennik, Brussels 1070, Belgium 2Department 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: /content/8/4/R129 ? 2006 Steinfeld et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 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 Sj?grens 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 (epratuzumab) antibody not associated with clinical manifestations. B-cell levels had mean reductions of 54% and 39% at 6 and 18 weeks, respectively, but T-cell levels, immunoglobulins, and routine safety laboratory tests did not change significantly. Fifty-three percent achieved a clinical respo