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Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial.
Ann Rheum Dis. 2014 Sep; 73(9):1665-72.AR

Abstract

OBJECTIVES

Tanezumab, a monoclonal antibody, inhibits nerve growth factor and reduces chronic pain. This randomised, double-blind, controlled multicentre study was conducted to evaluate the efficacy and safety of tanezumab added to oral diclofenac sustained release (DSR) in patients with hip or knee osteoarthritis (OA) pain.

METHODS

Patients (N=604) with moderate to severe knee or hip OA tolerating stable DSR were randomised and treated with DSR 75 mg twice daily combined with intravenous tanezumab 10, 5 or 2.5 mg or placebo at weeks 0, 8 and 16. Co-primary efficacy endpoints (Western Ontario and McMaster Universities OA Index (WOMAC) Pain and Physical Function subscales and patient's global assessment of OA) were assessed at week 16.

RESULTS

All co-primary endpoints were significantly improved for all tanezumab+DSR groups versus placebo+DSR (p≤0.039). The incidence of adverse events of abnormal peripheral sensation was lower than in previous tanezumab trials. No new safety signals emerged. Overall incidence of adverse events was higher with tanezumab+DSR (45.2%-49.7%) than with placebo+DSR (34.9%); serious adverse event rates were similar across treatments (5.3%-7.6%). Osteonecrosis was reported in six of 452 patients with tanezumab+DSR (1.3%), but an external adjudication committee did not confirm osteonecrosis in any patient.

CONCLUSIONS

Addition of tanezumab to DSR resulted in significant improvements in pain, function and global assessments in patients with OA. Although no new safety signals were observed, the higher incidence of adverse events in the tanezumab+diclofenac group suggests that combination therapy is unfavourable. Further investigations of tanezumab monotherapy for OA pain treatment are required.

CLINICAL TRIAL REGISTRATION NUMBER

NCT00864097.

Authors+Show Affiliations

Department of Internal Medicine and Rheumatology, Sf. Maria Hospital, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.Department of Rheumatology and Clinical Immunology, Charité-Universitaetsmedizin, Berlin, Germany.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Groton, Connecticut, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23852695

Citation

Balanescu, Andra Rodica, et al. "Efficacy and Safety of Tanezumab Added On to Diclofenac Sustained Release in Patients With Knee or Hip Osteoarthritis: a Double-blind, Placebo-controlled, Parallel-group, Multicentre Phase III Randomised Clinical Trial." Annals of the Rheumatic Diseases, vol. 73, no. 9, 2014, pp. 1665-72.
Balanescu AR, Feist E, Wolfram G, et al. Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. Ann Rheum Dis. 2014;73(9):1665-72.
Balanescu, A. R., Feist, E., Wolfram, G., Davignon, I., Smith, M. D., Brown, M. T., & West, C. R. (2014). Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. Annals of the Rheumatic Diseases, 73(9), 1665-72. https://doi.org/10.1136/annrheumdis-2012-203164
Balanescu AR, et al. Efficacy and Safety of Tanezumab Added On to Diclofenac Sustained Release in Patients With Knee or Hip Osteoarthritis: a Double-blind, Placebo-controlled, Parallel-group, Multicentre Phase III Randomised Clinical Trial. Ann Rheum Dis. 2014;73(9):1665-72. PubMed PMID: 23852695.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. AU - Balanescu,Andra Rodica, AU - Feist,Eugen, AU - Wolfram,Gernot, AU - Davignon,Isabelle, AU - Smith,Michael D, AU - Brown,Mark T, AU - West,Christine R, Y1 - 2013/07/12/ PY - 2013/7/16/entrez PY - 2013/7/16/pubmed PY - 2014/10/17/medline KW - Arthritis KW - Knee Osteoarthritis KW - Osteoarthritis SP - 1665 EP - 72 JF - Annals of the rheumatic diseases JO - Ann Rheum Dis VL - 73 IS - 9 N2 - OBJECTIVES: Tanezumab, a monoclonal antibody, inhibits nerve growth factor and reduces chronic pain. This randomised, double-blind, controlled multicentre study was conducted to evaluate the efficacy and safety of tanezumab added to oral diclofenac sustained release (DSR) in patients with hip or knee osteoarthritis (OA) pain. METHODS: Patients (N=604) with moderate to severe knee or hip OA tolerating stable DSR were randomised and treated with DSR 75 mg twice daily combined with intravenous tanezumab 10, 5 or 2.5 mg or placebo at weeks 0, 8 and 16. Co-primary efficacy endpoints (Western Ontario and McMaster Universities OA Index (WOMAC) Pain and Physical Function subscales and patient's global assessment of OA) were assessed at week 16. RESULTS: All co-primary endpoints were significantly improved for all tanezumab+DSR groups versus placebo+DSR (p≤0.039). The incidence of adverse events of abnormal peripheral sensation was lower than in previous tanezumab trials. No new safety signals emerged. Overall incidence of adverse events was higher with tanezumab+DSR (45.2%-49.7%) than with placebo+DSR (34.9%); serious adverse event rates were similar across treatments (5.3%-7.6%). Osteonecrosis was reported in six of 452 patients with tanezumab+DSR (1.3%), but an external adjudication committee did not confirm osteonecrosis in any patient. CONCLUSIONS: Addition of tanezumab to DSR resulted in significant improvements in pain, function and global assessments in patients with OA. Although no new safety signals were observed, the higher incidence of adverse events in the tanezumab+diclofenac group suggests that combination therapy is unfavourable. Further investigations of tanezumab monotherapy for OA pain treatment are required. CLINICAL TRIAL REGISTRATION NUMBER: NCT00864097. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/23852695/Efficacy_and_safety_of_tanezumab_added_on_to_diclofenac_sustained_release_in_patients_with_knee_or_hip_osteoarthritis:_a_double_blind_placebo_controlled_parallel_group_multicentre_phase_III_randomised_clinical_trial_ L2 - https://ard.bmj.com/lookup/pmidlookup?view=long&pmid=23852695 DB - PRIME DP - Unbound Medicine ER -