Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee XXXX .

@entity1 @entity1183 @entity571 @entity132 @entity809 @entity1897 @entity158 @entity17401
OBJECTIVE: This study was designed to evaluate the long-term safety and effectiveness of repeated doses of the humanized anti-nerve growth factor antibody, tanezumab, during open-label treatment of @entity1 with @entity158 . DESIGN: The current study (clinicaltrials.gov identifier: NCT00399490) was a multicenter, phase II, open-label, multiple-dose extension of an earlier randomized clinical trial. All @entity1 (N=281) received infusions of tanezumab 50 g/kg on Days 1 and 56 with subsequent doses administered at 8-week intervals (up to a total of eight infusions). The primary endpoint of this study was safety. Effectiveness evaluations included overall knee @entity158 , Western Ontario and @entity571 (WOMAC) index subscales, and subject global assessment (SGA) of response to therapy on 0-100 point visual analog scales. RESULTS: Repeated administration of tanezumab resulted in a low incidence of treatment-related adverse events (AEs; 7.5%). The rate of serious AEs was also low (2.8%) with none considered treatment-related. Few @entity1897 were reported; @entity1183 was reported by nine @entity1 (3.2%), @entity809 by seven @entity1 (2.5%), and @entity17401 , @entity1897 , and @entity132 were each reported by one @entity1 (0.4% for each). Most @entity1897 were rated as mild (95%) and the majority (65%) resolved before study completion. At Week 8, overall knee @entity158 and SGA improved from baseline by a mean (   standard error) of -12.8 (  1.78) and 8.0 (  1.66), respectively. Similar improvements occurred for WOMAC subscales. CONCLUSIONS: Repeated injections of tanezumab in @entity1 with moderate to severe knee @entity571 provide continued @entity158 relief and improved function with a low incidence of side effects. Additional studies to define the efficacy and duration of @entity158 reduction and to provide a more complete assessment of long-term safety are warranted.
