Tanezumab for Chronic low Back Pain: A Long-Term, Randomized, Celecoxib-Controlled Japanese Phase III Safety Study
Shin‐ichi Konno, Takuya Nikaido, John D. Markman, Makoto Ohta, Toshiya Machida, Naoki Isogawa, Hiroki Yoshimatsu, Lars Viktrup, M. Brown, Christine R. West, Kenneth M. Verburg
Abstract
Aim & methods: This trial investigated long-term (56-week treatment/24-week follow-up) use of subcutaneous tanezumab (5 or 10 mg every 8 weeks) or oral celecoxib (200 mg/day) in Japanese patients with chronic low back pain. Results & conclusion: Tanezumab safety was consistent with previous studies, except overall adverse events (tanezumab 5 mg = 63.0%, tanezumab 10 mg = 54.8%, celecoxib = 67.4%) and events of abnormal peripheral sensation (tanezumab 5 mg = 9.8%, tanezumab 10 mg = 4.3%, celecoxib = 4.3%) were more frequent with 5 mg than 10 mg tanezumab. Joint safety event rates were 1.1% for tanezumab 5 mg, 2.2% for tanezumab 10 mg and 0% for celecoxib. All treatments improved pain and function throughout the treatment period. Clinical trial registration number: NCT02725411