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      Effect of Tanezumab on Joint Pain, Physical Function, and Patient Global Assessment of Osteoarthritis Among Patients With Osteoarthritis of the Hip or Knee : A Randomized Clinical Trial

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Patients with osteoarthritis (OA) may remain symptomatic with traditional OA treatments.

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          Most cited references18

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          Nerve growth factor contributes to the generation of inflammatory sensory hypersensitivity.

          C.J. Woolf, B Safieh-Garabedian, Q.-P. Ma … (1994)
          Experimental inflammation produced by an intraplantar injection of complete Freund's adjuvant results in local sensory hypersensitivity and up-regulates the neuropeptides substance P and calcitonin gene related peptide in the primary sensory neurons innervating the inflamed tissue. The inflammation also elevates nerve growth factor levels in the skin. Systemic administration of anti-NGF neutralizing antibodies prevent the behavioral sensitivity, the up-regulation of neuropeptides and the inflammation-induced expression of the immediate early gene c-fos in dorsal horn neurons, without modifying swelling and erythema. Elevation of the neurotrophin NGF in the periphery is a major contributor, therefore, of inflammatory pain.
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            Efficacy and safety of tanezumab in the treatment of chronic low back pain.

            Matthew Brown, C Birbara, M Nemeth … (2011)
            Increased nerve growth factor levels are associated with chronic pain conditions, including chronic low back pain (LBP). This study examined safety and analgesic efficacy of tanezumab, a humanized anti-nerve growth factor antibody, in adults with chronic LBP. Patients received intravenous tanezumab 200 μg/kg plus oral placebo (n=88), intravenous placebo plus oral naproxen 500 mg twice a day (n=88), or intravenous placebo plus oral placebo (n=41). Primary outcome was average LBP intensity (aLBPI) at Week 6. Secondary outcomes were proportion of patients with ≥30% or ≥50% reduction in aLBPI, Roland-Morris Disability Questionnaire and Brief Pain Inventory-short form scores, Patients' Global Assessment of LBP, Patients' Global Evaluation of study medication, and rescue medication use. Mean aLBPI change from baseline to Week 6 was greater with tanezumab vs naproxen (P=0.004) and placebo (P<0.001). Greater proportions of patients reported ≥30% and ≥50% reduction in aLBPI with tanezumab vs naproxen (P≤0.013) and placebo (P<0.001), and greater improvements in Roland-Morris Disability Questionnaire (P<0.001) and other secondary outcomes except rescue medication use. Tanezumab was associated with adverse events (AEs) of abnormal peripheral sensation that were generally mild and resolved before study completion; however, there were no serious AEs. Nine patients (4 of whom were tanezumab-treated) discontinued due to AEs. In conclusion, tanezumab resulted in analgesic efficacy that was clinically and statistically superior to placebo and naproxen in patients with chronic LBP. Tanezumab clinical development is on regulatory hold due to AEs in osteoarthritis patients. Copyright © 2011. Published by Elsevier B.V.
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              Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled phase III trial.

              Mark Brown, Frederick Murphy, David Radin … (2012)
              The objective of this study was to compare the analgesic efficacy of tanezumab versus placebo in patients with osteoarthritis (OA) of the knee. This was a 32-week, randomized, double-blind, placebo-controlled phase III trial (NCT00733902). The patient criteria included diagnosis of OA; Western Ontario and McMaster Universities OA Index (WOMAC) Pain and Physical Function subscale scores of ≥5 and ≥4, respectively; Patient's Global Assessment of Osteoarthritis (PGA) ≥3; and failure of nonopiate pain medications or candidacy for invasive interventions. Patients received 3 intravenous doses of tanezumab (2.5, 5, or 10 mg) or placebo. The co-primary efficacy end points were changes in WOMAC subscales and PGA at week 16. Adverse events were monitored throughout. Overall, 690 patients (61% female) were randomized and treated. Those treated with tanezumab showed significant improvement in the 3 co-primary end points (P ≤ .015 for all). The incidence of adverse events was 55 to 60% for tanezumab-treated patients versus 48% for placebo-treated patients. Joint replacement was reported in 4 patients, 1 in each treatment group; a total of 5 joints were replaced (1 index knee and 4 hips). The tanezumab OA clinical program is currently on clinical hold due to potential adverse reactions leading to joint replacement.
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                Author and article information

                Journal
                Title: JAMA
                Abbreviated Title: JAMA
                Publisher: American Medical Association (AMA)
                ISSN (Print): 0098-7484
                Publication date Created: July 02 2019
                Publication date (Print): July 02 2019
                Volume: 322
                Issue: 1
                Page: 37
                Affiliations
                [1 ]Northwestern University Feinberg School of Medicine, Chicago, Illinois
                [2 ]Michigan Orthopaedic & Spine Surgeons, Rochester Hills
                [3 ]St Joseph Heritage Healthcare, Fullerton, California
                [4 ]Chicago Clinical Research Institute, Chicago, Illinois
                [5 ]Pfizer Inc, Morrisville, North Carolina
                [6 ]Eli Lilly and Company, Indianapolis, Indiana
                [7 ]Pfizer Inc, Groton, Connecticut
                Article
                DOI: 10.1001/jama.2019.8044
                PMC ID: 6613301
                PubMed ID: 31265100
                SO-VID: 4501ab0f-791e-4f7e-a7fe-7d9e1d30b6c2
                Copyright © © 2019
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