{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T23:51:42Z","timestamp":1792281102398,"version":"4.4.0"},"reference-count":35,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,6,7]],"date-time":"2021-06-07T00:00:00Z","timestamp":1623024000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the long\u2010term safety and 16\u2010week efficacy of subcutaneous tanezumab in patients with hip or knee osteoarthritis (OA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a phase III randomized, double\u2010blind, active treatment\u2013controlled (using nonsteroidal antiinflammatory\u00a0drugs [NSAIDs] as the active treatment control) safety trial of tanezumab (56\u2010week treatment\/24\u2010week posttreatment follow\u2010up) in adults who were receiving stable\u2010dose NSAID therapy at the time of screening and who had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores of \u22655; patient global assessment (PtGA) of OA of fair, poor, or very poor; history of inadequate pain relief with standard analgesics; and no history or radiographic evidence of prespecified bone\/joint conditions beyond OA. Patients received oral naproxen, celecoxib, or diclofenac twice daily (NSAID group; n = 996) or tanezumab 2.5 mg (n = 1,002) or 5 mg (n = 998) subcutaneously every 8 weeks. Coprimary efficacy end points at week 16 were changes in WOMAC pain and physical function scores and changes in PtGA. The primary joint safety end point over 80 weeks comprised adjudicated rapidly progressive OA type 1 or 2, primary osteonecrosis, subchondral insufficiency fracture, or pathologic fracture. Mean values, least squares mean values, and least squares mean differences between groups (with 95% confidence intervals [95% CIs]) were calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 3,021 randomized patients, 2,996 received \u22651 treatment dose. Adverse events (AEs) were similar between patients treated with tanezumab 2.5 mg and those treated with NSAIDs, and were more prevalent in those treated with tanezumab 5 mg. Composite joint safety events were significantly more prevalent with tanezumab 2.5 mg and tanezumab 5 mg than with NSAIDs (observation time\u2013adjusted rate\/1,000 patient\u2010years 38.3 [95% CI 28.0, 52.5] and 71.5 [95% CI 56.7, 90.2], respectively, versus 14.8 [95% CI 8.9, 24.6]; <jats:italic>P<\/jats:italic> = 0.001 for tanezumab 2.5 mg versus NSAIDs; <jats:italic>P<\/jats:italic> &lt; 0.001 for tanezumab 5 mg versus NSAIDs). Tanezumab 5 mg significantly improved pain and physical function but did not improve PtGA at week 16 when compared to NSAIDs; corresponding differences between the tanezumab 2.5 mg and NSAID groups were not statistically significant.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In patients previously receiving a stable dose of NSAIDs, tanezumab administered subcutaneously resulted in more joint safety events than continued NSAIDs, with differences being dose dependent. Pain and physical function improved with both doses of tanezumab compared to NSAIDs, reaching statistical significance with tanezumab 5 mg at 16 weeks.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41674","type":"journal-article","created":{"date-parts":[[2021,2,5]],"date-time":"2021-02-05T22:04:42Z","timestamp":1612562682000},"page":"1167-1177","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":85,"title":["Long\u2010Term Safety and Efficacy of Subcutaneous Tanezumab Versus Nonsteroidal Antiinflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial"],"prefix":"10.1002","volume":"73","author":[{"given":"Marc C.","family":"Hochberg","sequence":"first","affiliation":[{"name":"University of Maryland School of Medicine  Baltimore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A.","family":"Carrino","sequence":"additional","affiliation":[{"name":"Hospital for Special Surgery  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas J.","family":"Schnitzer","sequence":"additional","affiliation":[{"name":"Northwestern University Feinberg School of Medicine  Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Guermazi","sequence":"additional","affiliation":[{"name":"Boston University School of Medicine  Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Walsh","sequence":"additional","affiliation":[{"name":"Arthritis Research UK Pain Centre NIHR Nottingham Biomedical Research Centre, and University of Nottingham  Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"White","sequence":"additional","affiliation":[{"name":"Progressive Medical Research  Port Orange Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Nakajo","sequence":"additional","affiliation":[{"name":"Nakajo Orthopaedic Clinic  Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Fountaine","sequence":"additional","affiliation":[{"name":"Pfizer, Inc.  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