دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | Berenbaum, Francis, Blanco, Francisco, J, Guermazi, Ali, Miki, Kenji, Yamabe, Takaharu, Viktrup, Lars, Junor, Rod, Carey, William, Brown, Mark, West, Christine, R, Verburg, Kenneth, M |
| المساهمون: | CHU Saint-Antoine AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Boston University School of Medicine (BUSM), Boston University Boston (BU), Eli Lilly and Company Indianapolis |
| المصدر: | ISSN: 0003-4967. |
| بيانات النشر: | HAL CCSD BMJ Publishing Group |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | analgesics, knee osteoarthritis, osteoarthritis, [SDV]Life Sciences [q-bio] |
| الوصف: | International audience ; 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/32234715; hal-02932100; https://hal.sorbonne-universite.fr/hal-02932100Test; https://hal.sorbonne-universite.fr/hal-02932100/documentTest; https://hal.sorbonne-universite.fr/hal-02932100/file/800.full.pdfTest; PUBMED: 32234715; PUBMEDCENTRAL: PMC7286052 |
| DOI: | 10.1136/annrheumdis-2019-216296 |
| الإتاحة: | https://doi.org/10.1136/annrheumdis-2019-216296Test https://hal.sorbonne-universite.fr/hal-02932100Test https://hal.sorbonne-universite.fr/hal-02932100/documentTest https://hal.sorbonne-universite.fr/hal-02932100/file/800.full.pdfTest |
| حقوق: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.C36AF724 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/annrheumdis-2019-216296 |
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