Patients from the parent study (NCT00876187) were eligible for this safety extension study within 12 weeks after last dose of parent study medication or upon discontinuation due to lack of efficacy. Patients received 3 intravenous then 4 subcutaneous administrations of tanezumab 10mg (n=321) or 20mg (n=527) at 8-week intervals. Safety assessments included adverse event documentation, physical and neurological examinations, and laboratory tests.
Efficacy analyses included change from parent study Baseline in Brief Pain Inventory-short form, Roland-Morris Disability Questionnaire, and Patient’s Global Assessment of CLBP. The study discontinued prematurely due to an FDA-imposed clinical hold. Mean extension study treatment duration was 194 and 202 days for tanezumab 10 and 20mg, respectively.
Both tanezumab doses significantly improved all efficacy outcomes from parent study Baseline to Week 32 in this extension study. In conclusion, long-term tanezumab was generally safe and provided durable efficacy in patients with CLBP.
Supported by Pfizer, Inc.