Mostrar el registro sencillo del ítem

dc.contributor.authorBerenbaum, Francis
dc.contributor.authorBLANCO GARCIA, FRANCISCO JAVIER 
dc.contributor.authorGuermazi, Ali
dc.contributor.authorMiki, Kenji
dc.contributor.authorYamabe, Takaharu
dc.contributor.authorViktrup, Lars
dc.contributor.authorJunor, Rod
dc.contributor.authorCarey, William
dc.contributor.authorBrown, Mark T
dc.contributor.authorWest, Christine R
dc.contributor.authorVerburg, Kenneth M
dc.date.accessioned2022-03-04T07:45:47Z
dc.date.available2022-03-04T07:45:47Z
dc.date.issued2020
dc.identifier.issn0003-4967
dc.identifier.otherhttps://www.ncbi.nlm.nih.gov/pubmed/32234715es
dc.identifier.urihttp://hdl.handle.net/20.500.11940/16147
dc.description.abstractOBJECTIVE: 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.isoenes
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subject.meshInjections *
dc.subject.meshAdult*
dc.subject.meshMiddle Aged *
dc.subject.meshFollow-Up Studies *
dc.subject.meshPain Measurement *
dc.subject.meshParesthesia *
dc.subject.meshOsteoarthritis *
dc.subject.meshArthroplasty *
dc.subject.meshDouble-Blind Method *
dc.subject.meshAntibodies *
dc.subject.meshHumans *
dc.subject.meshAnalgesics *
dc.subject.meshMusculoskeletal Pain *
dc.subject.meshDisease Progression *
dc.subject.meshAged *
dc.subject.meshHypesthesia *
dc.titleSubcutaneous 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 perioden
dc.typeJournal Articlees
dc.authorsophosBerenbaum, 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.doi10.1136/annrheumdis-2019-216296
dc.identifier.pmid32234715
dc.identifier.sophos35543
dc.issue.number6es
dc.journal.titleAnnals of the rheumatic diseaseses
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de A Coruña - Complexo Hospitalario Universitario de A Coruña::Reumatoloxía
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::Instituto de Investigación Biomédica da Coruña (INIBIC)
dc.relation.publisherversionhttps://ard.bmj.com/content/annrheumdis/79/6/800.full.pdfes
dc.rights.accessRightsopenAccess
dc.subject.decsmedida del dolor *
dc.subject.decsartroplastia *
dc.subject.decsestudios de seguimiento *
dc.subject.decsmediana edad *
dc.subject.decsinyecciones *
dc.subject.decsanticuerpos *
dc.subject.decsadulto *
dc.subject.decsparestesia *
dc.subject.decsprogresión de la enfermedad *
dc.subject.decsmétodo con doble ocultación *
dc.subject.decsdolor musculoesquelético *
dc.subject.decsanciano *
dc.subject.decshipoestesia *
dc.subject.decsanalgésicos *
dc.subject.decshumanos *
dc.subject.decsosteoartritis *
dc.subject.keywordCHUACes
dc.subject.keywordINIBIC
dc.typefidesArtículo Originales
dc.typesophosArtículo Originales
dc.volume.number79es


Ficheros en el ítem

Este ítem aparece en la(s) siguiente(s) colección(ones)

Mostrar el registro sencillo del ítem

Attribution-NonCommercial-NoDerivatives 4.0 International
Excepto si se señala otra cosa, la licencia del ítem se describe como Attribution-NonCommercial-NoDerivatives 4.0 International