ArticleClinical drug investigation2023
Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis.
Article in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 9 registered trials, which are not on this map. Cited by 5 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 3 randomized, double-blind, placebo-controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the knee
A phase 3 randomized, double-blind, placebo-controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the hip.
A phase 3 randomized, double blind placebo and naproxen controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the knee
A phase 3 randomized, double blind placebo and naproxen controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the hip or knee
A phase 3 randomized, double-blind, placebo-controlled multicenter study of tanezumab on peripheral nerve function in patients with osteoarthritis.
A phase 3 randomized, double-blind, placebo and oxycodone controlled multi-center study of the efficacy and safety of tanezumab in patients with osteoarthritis of the knee or hip
A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the analgesic efficacy and safety of subcutaneous administration of tanezumab in patients with osteoarthritis of the knee.
A phase 3 randomized, double-blind, placebo-controlled, multicenter study of the analgesic efficacy and safety of a dose titration regimen for the subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee
A phase 3 randomized, double-blind, placebo-controlled, multicenter study of the analgesic efficacy and safety of the subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee
Who cites it
5 citing papers in PubMed, 4 citations in OpenAlex.
- The potential role and research progress of the gut microbiota-NGF axis in postmenopausal bone homeostasis imbalance.Frontiers in immunology · 2026Review
- Organ-on-chip technologies: Novel tools with the potential to revolutionize osteoarthritis research and clinical development.Osteoarthritis and cartilage open · 2025Review
- The relationship between circulating and tissue biomarkers and OA-related pain: A systematic literature review.Osteoarthritis and cartilage open · 2025Review
- Antibody and aptamer-based therapies for osteoarthritis: Application of antibodies and promise of aptamers.Molecular therapy. Nucleic acids · 2025Review
- Neurotrophin NGF/TrkA and BDNF/TrkB signaling orchestrates the immune microenvironment in osteosarcoma.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTanezumab, a humanized anti-nerve growth factor antibody, was developed for the treatment of pain associated with osteoarthritis. Due to its mechanism of action, peripheral nerve safety was assessed in all clinical studies.
objectivesTo summarize the neurological safety of intravenous (IV) and subcutaneous (SC) tanezumab versus placebo in patients with osteoarthritis.
methodsData were pooled from 3389 patients across seven studies that investigated IV administration, and from 1840 patients across three studies that investigated SC administration. The treatment period of each study ranged from 16 to 24 weeks, and follow-up periods ranged from 8 to 24 weeks. Neurological safety evaluations focused on adverse events (AEs) of abnormal peripheral sensation (APS), neurologic examinations, and consultations.
resultsAcross datasets, the incidence of AEs of APS was higher in tanezumab groups versus placebo. Paresthesia and hypoesthesia were the most frequently reported AEs in tanezumab-treated patients, compared with placebo. In both datasets, most AEs were of mild severity, resolved, and rarely resulted in discontinuation. In all treatment groups in both IV and SC studies, over 90% of patients had no new or worsened neurological examination abnormalities at the last study visit. Across datasets, mononeuropathy was diagnosed more frequently in tanezumab groups compared with placebo. Polyneuropathy was diagnosed in ≤ 0.9% of patients in tanezumab and placebo groups.
conclusionsTanezumab IV or SC had an increased incidence of AEs of APS, such as paresthesia and hypoesthesia, and diagnoses of mononeuropathy compared with placebo. However, tanezumab was not associated with generalized peripheral neuropathy. CLINICALTRIALS: GOV IDENTIFIERS: NCT00733902, NCT00744471, NCT00830063, NCT00863304, NCT00863772, NCT01089725, NCT00985621, NCT02697773, and NCT02709486.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.