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Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period
dc.contributor.author | Berenbaum, Francis | |
dc.contributor.author | BLANCO GARCIA, FRANCISCO JAVIER | |
dc.contributor.author | Guermazi, Ali | |
dc.contributor.author | Miki, Kenji | |
dc.contributor.author | Yamabe, Takaharu | |
dc.contributor.author | Viktrup, Lars | |
dc.contributor.author | Junor, Rod | |
dc.contributor.author | Carey, William | |
dc.contributor.author | Brown, Mark T | |
dc.contributor.author | West, Christine R | |
dc.contributor.author | Verburg, Kenneth M | |
dc.date.accessioned | 2022-03-04T07:45:47Z | |
dc.date.available | 2022-03-04T07:45:47Z | |
dc.date.issued | 2020 | |
dc.identifier.issn | 0003-4967 | |
dc.identifier.other | https://www.ncbi.nlm.nih.gov/pubmed/32234715 | es |
dc.identifier.uri | http://hdl.handle.net/20.500.11940/16147 | |
dc.description.abstract | OBJECTIVE: Tanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up. METHODS: This double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study. RESULTS: From March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference+/-SE -0.62+/-0.18, p=0.0006), WOMAC Physical Function (-0.71+/-0.17, p<0.0001) and PGA-OA (-0.19+/-0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%-7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo. CONCLUSION: Tanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups. TRIAL REGISTRATION NUMBER: NCT02709486. | en |
dc.language.iso | en | es |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.subject.mesh | Injections | * |
dc.subject.mesh | Adult | * |
dc.subject.mesh | Middle Aged | * |
dc.subject.mesh | Follow-Up Studies | * |
dc.subject.mesh | Pain Measurement | * |
dc.subject.mesh | Paresthesia | * |
dc.subject.mesh | Osteoarthritis | * |
dc.subject.mesh | Arthroplasty | * |
dc.subject.mesh | Double-Blind Method | * |
dc.subject.mesh | Antibodies | * |
dc.subject.mesh | Humans | * |
dc.subject.mesh | Analgesics | * |
dc.subject.mesh | Musculoskeletal Pain | * |
dc.subject.mesh | Disease Progression | * |
dc.subject.mesh | Aged | * |
dc.subject.mesh | Hypesthesia | * |
dc.title | Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period | en |
dc.type | Journal Article | es |
dc.authorsophos | Berenbaum, Francis;Blanco, Francisco J;Guermazi, Ali;Miki, Kenji;Yamabe, Takaharu;Viktrup, Lars;Junor, Rod;Carey, William;Brown, Mark T;West, Christine R;Verburg, Kenneth M | |
dc.identifier.doi | 10.1136/annrheumdis-2019-216296 | |
dc.identifier.pmid | 32234715 | |
dc.identifier.sophos | 35543 | |
dc.issue.number | 6 | es |
dc.journal.title | Annals of the rheumatic diseases | es |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de A Coruña - Complexo Hospitalario Universitario de A Coruña::Reumatoloxía | |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::Instituto de Investigación Biomédica da Coruña (INIBIC) | |
dc.relation.publisherversion | https://ard.bmj.com/content/annrheumdis/79/6/800.full.pdf | es |
dc.rights.accessRights | openAccess | |
dc.subject.decs | medida del dolor | * |
dc.subject.decs | artroplastia | * |
dc.subject.decs | estudios de seguimiento | * |
dc.subject.decs | mediana edad | * |
dc.subject.decs | inyecciones | * |
dc.subject.decs | anticuerpos | * |
dc.subject.decs | adulto | * |
dc.subject.decs | parestesia | * |
dc.subject.decs | progresión de la enfermedad | * |
dc.subject.decs | método con doble ocultación | * |
dc.subject.decs | dolor musculoesquelético | * |
dc.subject.decs | anciano | * |
dc.subject.decs | hipoestesia | * |
dc.subject.decs | analgésicos | * |
dc.subject.decs | humanos | * |
dc.subject.decs | osteoartritis | * |
dc.subject.keyword | CHUAC | es |
dc.subject.keyword | INIBIC | |
dc.typefides | Artículo Original | es |
dc.typesophos | Artículo Original | es |
dc.volume.number | 79 | es |