Tanezumab reduces osteoarthritic hip pain: Results of a randomized, double-blind, placebo-controlled phase III trial

Arthritis and Rheumatism

Volumn 65, Issue 7, 2013, Pages 1795-1803

  Brown, Mark T ^a   Murphy, Frederick T ^b,c   Radin, David M ^d   Davignon, Isabelle ^a   Smith, Michael D ^a   West, Christine R ^a  

^a PFIZER INC   (United States)

^b Altoona Center for Clinical Research   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d Stamford Therapeutics Consortium   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TANEZUMAB;

ADULT; AGED; ARTHRALGIA; ARTICLE; CARPAL TUNNEL SYNDROME; CLINICAL ASSESSMENT; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEMOROACETABULAR IMPINGEMENT; HEADACHE; HIP DYSPLASIA; HIP OSTEOARTHRITIS; HIP PAIN; HUMAN; HYPESTHESIA; JOINT PROSTHESIS; MALE; MEDICAL HISTORY; PAIN; PARALLEL DESIGN; PARESTHESIA; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; POLYNEUROPATHY; PRIORITY JOURNAL; RADICULOPATHY; RANDOMIZED CONTROLLED TRIAL; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX;

ADULT; AGED; AGED, 80 AND OVER; ANALGESICS; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRALGIA; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; OSTEOARTHRITIS, HIP; PAIN MEASUREMENT; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84878809061     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.37950     Document Type: Article

References (28)

1. Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al, for the National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: part II. Arthritis Rheum 2008; 58: 26-35.
2. Hoaglund FT, Steinbach LS,. Primary osteoarthritis of the hip: etiology and epidemiology. J Am Acad Orthop Surg 2001; 9: 320-7.
3. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008; 16: 137-62.
4. Johnsen SP, Larsson H, Tarone RE, McLaughlin JK, Norgard B, Friis S, et al. Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch Intern Med 2005; 165: 978-84.
5. Whelton A,. Renal and related cardiovascular effects of conventional and COX-2-specific NSAIDs and non-NSAID analgesics. Am J Ther 2000; 7: 63-74.
6. Hawker GA,. Who, when, and why total joint replacement surgery? The patient's perspective. Curr Opin Rheumatol 2006; 18: 526-30.
7. Woolf CJ, Safieh-Garabedian B, Ma QP, Crilly P, Winter J,. Nerve growth factor contributes to the generation of inflammatory sensory hypersensitivity. Neuroscience 1994; 62: 327-31.
8. Hefti F, Mokhtarani M, Gray M, Zhao C, Chan C,. RN624 (anti-NGF) reduces pain and improves function in subjects with moderate to severe pain from osteoarthritis of the knee [abstract]. J Pain 2006; 7: S45.
9. Abdiche YN, Malashock DS, Pons J,. Probing the binding mechanism and affinity of tanezumab, a recombinant humanized anti-NGF monoclonal antibody, using a repertoire of biosensors. Protein Sci 2008; 17: 1326-35.
10. McMahon SB,. NGF as a mediator of inflammatory pain. Philos Trans R Soc Lond B Biol Sci 1996; 351: 431-40.
11. Skaper SD,. The biology of neurotrophins, signalling pathways, and functional peptide mimetics of neurotrophins and their receptors. CNS Neurol Disord Drug Targets 2008; 7: 46-62.
12. Petruska JC, Mendell LM,. The many functions of nerve growth factor: multiple actions on nociceptors. Neurosci Lett 2004; 361: 168-71.
13. Barker PA, Murphy RA,. The nerve growth factor receptor: a multicomponent system that mediates the actions of the neurotrophin family of proteins. Mol Cell Biochem 1992; 110: 1-15.
14. Frade JM, Barde YA,. Nerve growth factor: two receptors, multiple functions. Bioessays 1998; 20: 137-45.
15. Nicol GD, Vasko MR,. Unraveling the story of NGF-mediated sensitization of nociceptive sensory neurons: ON or OFF the Trks? Mol Interv 2007; 7: 26-41.
16. Hefti FF, Rosenthal A, Walicke PA, Wyatt S, Vergara G, Shelton DL, et al. Novel class of pain drugs based on antagonism of NGF. Trends Pharmacol Sci 2006; 27: 85-91.
17. Mantyh P, Tive L, Shelton D,. Tanezumab, a humanized anti-nerve growth factor antibody for the treatment of pain [abstract]. J Pain 2009; 10: S44.
18. Cattaneo A,. Tanezumab, a recombinant humanized mAb against nerve growth factor for the treatment of acute and chronic pain. Curr Opin Mol Ther 2010; 12: 94-106.
19. Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, et al. Tanezumab for the treatment of pain from osteoarthritis of the knee. N Engl J Med 2010; 363: 1521-31.
20. Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR,. Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled phase III trial. J Pain 2012; 13: 790-8.
21. Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum 1991; 34: 505-14.
22. Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al. OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 2004; 12: 389-99.
23. Hochberg MC, Wohlreich M, Gaynor P, Hanna S, Risser R,. Clinically relevant outcomes based on analysis of pooled data from 2 trials of duloxetine in patients with knee osteoarthritis. J Rheumatol 2012; 39: 352-8.
24. Deeks JJ, Smith LA, Bradley MD,. Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. BMJ 2002; 325: 619.
25. Quintana JM, Arostegui I, Escobar A, Azkarate J, Goenaga JI, Lafuente I,. Prevalence of knee and hip osteoarthritis and the appropriateness of joint replacement in an older population. Arch Intern Med 2008; 168: 1576-84.
26. Pfizer. Tanezumab Arthritis Advisory Committee briefing document. February 2, 2012. URL: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/UCM295205.pdf.
27. Rappaport BA, US Food and Drug Administration. Regulatory issues in reviewing and approving opioid analgesics. February 10, 2009. URL: www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163692.pdf.
28. US Food and Drug Administration. Addendum to the background package for the March 12, 2012, AAC meeting, regarding the agency adjudication of cases of joint replacements occurring in clinical trials of anti-NGF agents. March 2, 2012. URL: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/UCM295203.pdf.