https://orcid.org/0000-0002-2861-2194
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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
Lay abstract
In this study, researchers looked at the safety of tanezumab (a medication that blocks nerve growth factor) in Japanese people with chronic low back pain (CLBP). Researchers also looked at how well tanezumab improves the symptoms (pain and difficulty doing activities) of CLBP. People in the study were given oral (taken by mouth) celecoxib (a medication commonly used to treat CLBP) or injections of tanezumab (5 or 10 mg doses) under the skin of the belly or upper leg every 8 weeks for a total of 56 weeks. Side effects (something expected or unexpected that people experienced during the study that may or may not be due to the medication they received) occurred in 63.0% of people receiving tanezumab 5 mg, 54.8% of people receiving tanezumab 10 mg and 67.4% of patients receiving celecoxib. More people receiving tanezumab 5 mg (9.8% of people) had a side effect related to abnormal peripheral sensation (tingling, burning, numbness or sensitivity to heat or cold hands or feet) than people receiving tanezumab 10 mg (4.3% of people) or celecoxib (4.3% of people). More people receiving tanezumab (5 mg = 1.1% of people, 10 mg = 2.2% of people) had a problem with one of their joints (knees or hips) during the study than people receiving celecoxib (0% of people). All treatments improved pain and the ability to do activities. Overall, the researchers concluded that tanezumab was well tolerated in most people and may improve the symptoms of CLBP.
Supplementary data
To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2021-0040
Author contributions
S Konno, T Nikaido, JD Markman, M Ohta, T Machida, N Isogawa, H Yoshimatsu, L Viktrup, MT Brown, CR West and KM Verburg were involved in study conception or design and acquisition or analysis of data. All authors were involved in interpretation of data, revising the paper for critically important content, provided final approval for submission and agree to be accountable for all aspects of the work.
Financial & competing interests disclosure
The study was sponsored by Pfizer and Eli Lilly and Company. S Konno has received grants or personal fees from Medtronic Japan Company Ltd, Hoken Kagaku Inc, Asahi KASEI Pharma Corporation, Mochida Pharmaceutical Company Ltd, Daiichi Sankyo Company Ltd, Shionogi & Company Ltd, Hisamitsu Pharmaceutical Company Inc, Taisho Pharmaceutical Company Ltd, Takeda Pharmaceutical Company Ltd, Nippon Shinyaku Company Ltd, Eisai Company Ltd, Chugai Pharmaceutical Company Ltd, Taiho Pharmaceutical Company Ltd, Nippon Zoki Pharmaceutical Company Ltd, Astellas Amgen BioPharma K.K., Ono Pharmaceutical company Ltd, Eli Lilly Japan K.K., Pfizer, Taisho Pharma Company Ltd, Mochida Pharmaceutical Company Ltd, Astellas Pharma Inc, Janssen Pharmaceutical K.K., Johnson & Johnson; and served as Coordinating Investigator for conduct of the reported study. T Nikaido has served as a lecturer for Pfizer Japan Inc, Daiichi Sankyo Company, Eisai Company and Shionogi Company; and served as Principle Investigator for conduct of the reported study at the Fukushima Medical University. JD Markman has served on an advisory board for Clexio Biosciences, Esteve Pharmaceuticals, Flexion Therapeutics, Quark Pharmaceuticals, Quartet Medicine, Collegium Pharmaceutical, Purdue Pharma, Biogen, Novartis, Aptinyx, Nektar, Allergan, Grünenthal, Eli Lilly and Company, Depomed, Janssen Pharmaceuticals, Teva Pharmaceutical Industries, KemPharm, Abbott Laboratories, Plasma Surgical, Chromocell, Convergence Pharmaceuticals, Inspirion, Pfizer, Sanofi, Daiichi Sankyo, SK lifesciences, and Trevena; has served as a consultant to Trigemina, Editas Medicine, and Plasma Surgical; has served on data safety monitoring boards for Novartis, Allergan, and Regenacy; and has served on the board of Flowonix Medical. M Ohta, T Machida, N Isogawa and H Yoshimatsu are employees of Pfizer R&D Japan. L Viktrup is an employee of Eli Lilly & Company. MT Brown, CR West and KM Verburg are employees of, and own stock and/or options in, Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing support was provided by M Soulsby of Engage Scientific Solutions and was funded by Pfizer and Eli Lilly and Company.
Ethical conduct of research
The study was conducted (in compliance with ethical principles of the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guidelines) from May 2016 to June 2019 at 58 sites in Japan. The protocol was approved by Institutional Review Boards or Independent Ethics Committees for each site and all patients provided informed consent.
Data sharing statement
The authors certify that this manuscript reports original clinical trial data, NCT02725411. Upon request, and patient to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer and Lilly will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.