메뉴 건너뛰기




Volumn 68, Issue 2, 2016, Pages 382-391

When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT; TANEZUMAB;

EID: 84956739072     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.39492     Document Type: Article
Times cited : (125)

References (51)
  • 2
    • 84873684553 scopus 로고    scopus 로고
    • Neurotrophic factors and nociceptor sensitization
    • Kruger L. Light A.R. editors. Boca Raton (FL): CRC Press;. Chapter 2
    • Jankowski MP, Koerber HR,. Neurotrophic factors and nociceptor sensitization. In:, Kruger L, Light AR, editors. Translational pain research: from mouse to man. Boca Raton (FL): CRC Press; 2010. Chapter 2.
    • (2010) Translational Pain Research: From Mouse to Man
    • Jankowski, M.P.1    Koerber, H.R.2
  • 3
    • 0028023450 scopus 로고
    • Nerve growth factor contributes to the generation of inflammatory sensory hypersensitivity
    • 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.
    • (1994) Neuroscience , vol.62 , pp. 327-331
    • Woolf, C.J.1    Safieh-Garabedian, B.2    Ma, Q.P.3    Crilly, P.4    Winter, J.5
  • 5
    • 42049112538 scopus 로고    scopus 로고
    • The biology of neurotrophins, signalling pathways, and functional peptide mimetics of neurotrophins and their receptors
    • 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.
    • (2008) CNS Neurol Disord Drug Targets , vol.7 , pp. 46-62
    • Skaper, S.D.1
  • 6
    • 2342580754 scopus 로고    scopus 로고
    • The many functions of nerve growth factor: Multiple actions on nociceptors
    • Petruska JC, Mendell LM., The many functions of nerve growth factor: multiple actions on nociceptors. Neurosci Lett 2004; 361: 168-71.
    • (2004) Neurosci Lett , vol.361 , pp. 168-171
    • Petruska, J.C.1    Mendell, L.M.2
  • 7
    • 0026510312 scopus 로고
    • The nerve growth factor receptor: A multicomponent system that mediates the actions of the neurotrophin family of proteins
    • 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.
    • (1992) Mol Cell Biochem , vol.110 , pp. 1-15
    • Barker, P.A.1    Murphy, R.A.2
  • 8
    • 0032006901 scopus 로고    scopus 로고
    • Nerve growth factor: Two receptors, multiple functions
    • Frade JM, Barde YA., Nerve growth factor: two receptors, multiple functions. Bioessays 1998; 20: 137-45.
    • (1998) Bioessays , vol.20 , pp. 137-145
    • Frade, J.M.1    Barde, Y.A.2
  • 9
    • 33847618699 scopus 로고    scopus 로고
    • Unraveling the story of NGF-mediated sensitization of nociceptive sensory neurons: On or off the Trks?
    • 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.
    • (2007) Mol Interv , vol.7 , pp. 26-41
    • Nicol, G.D.1    Vasko, M.R.2
  • 10
    • 84872066342 scopus 로고    scopus 로고
    • Nerve growth factor-mediated regulation of pain signalling and proposed new intervention strategies in clinical pain management
    • McKelvey L, Shorten GD, O'Keeffe GW., Nerve growth factor-mediated regulation of pain signalling and proposed new intervention strategies in clinical pain management. J Neurochem 2013; 124: 276-89.
    • (2013) J Neurochem , vol.124 , pp. 276-289
    • McKelvey, L.1    Shorten, G.D.2    O'Keeffe, G.W.3
  • 12
    • 84869186227 scopus 로고    scopus 로고
    • Control of arthritis pain with anti-nerve-growth factor: Risk and benefit
    • Seidel MF, Lane NE., Control of arthritis pain with anti-nerve-growth factor: risk and benefit. Curr Rheumatol Rep 2012; 14: 583-8.
    • (2012) Curr Rheumatol Rep , vol.14 , pp. 583-588
    • Seidel, M.F.1    Lane, N.E.2
  • 13
    • 84905193109 scopus 로고    scopus 로고
    • 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
    • Balanescu AR, Feist E, Wolfram G, Davignon I, Smith MD, Brown MT, 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: 1665-72.
    • (2014) Ann Rheum Dis , vol.73 , pp. 1665-1672
    • Balanescu, A.R.1    Feist, E.2    Wolfram, G.3    Davignon, I.4    Smith, M.D.5    Brown, M.T.6
  • 14
    • 84881660403 scopus 로고    scopus 로고
    • A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee
    • Spierings EL, Fidelholtz J, Wolfram G, Smith MD, Brown MT, West CR., A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain 2013; 154: 1603-12.
    • (2013) Pain , vol.154 , pp. 1603-1612
    • Spierings, E.L.1    Fidelholtz, J.2    Wolfram, G.3    Smith, M.D.4    Brown, M.T.5    West, C.R.6
  • 15
    • 84878781623 scopus 로고    scopus 로고
    • Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain
    • Kivitz AJ, Gimbel JS, Bramson C, Nemeth MA, Keller DS, Brown MT, et al., Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain 2013; 154: 1009-21.
    • (2013) Pain , vol.154 , pp. 1009-1021
    • Kivitz, A.J.1    Gimbel, J.S.2    Bramson, C.3    Nemeth, M.A.4    Keller, D.S.5    Brown, M.T.6
  • 16
    • 84864454394 scopus 로고    scopus 로고
    • Tanezumab reduces osteoarthritic knee pain: Results of a randomized, double-blind, placebo-controlled phase III trial
    • 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.
    • (2012) J Pain , vol.13 , pp. 790-798
    • Brown, M.T.1    Murphy, F.T.2    Radin, D.M.3    Davignon, I.4    Smith, M.D.5    West, C.R.6
  • 17
    • 84878809061 scopus 로고    scopus 로고
    • Tanezumab reduces osteoarthritic hip pain: Results of a randomized, double-blind, placebo-controlled phase III trial
    • Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR., Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial. Arthritis Rheum 2013; 65: 1795-803.
    • (2013) Arthritis Rheum , vol.65 , pp. 1795-1803
    • Brown, M.T.1    Murphy, F.T.2    Radin, D.M.3    Davignon, I.4    Smith, M.D.5    West, C.R.6
  • 18
    • 82955195766 scopus 로고    scopus 로고
    • Preliminary assessment of the safety and efficacy of tanezumab in Japanese patients with moderate to severe osteoarthritis of the knee: A randomized, double-blind, dose-escalation, placebo-controlled study
    • Tanezumab Investigators
    • Nagashima H, Suzuki M, Araki S, Yamabe T, Muto C, Tanezumab Investigators. Preliminary assessment of the safety and efficacy of tanezumab in Japanese patients with moderate to severe osteoarthritis of the knee: a randomized, double-blind, dose-escalation, placebo-controlled study. Osteoarthritis Cartilage 2011; 19: 1405-12.
    • (2011) Osteoarthritis Cartilage , vol.19 , pp. 1405-1412
    • Nagashima, H.1    Suzuki, M.2    Araki, S.3    Yamabe, T.4    Muto, C.5
  • 19
    • 80053194062 scopus 로고    scopus 로고
    • Efficacy and safety of tanezumab in the treatment of chronic low back pain
    • Katz N, Borenstein DG, Birbara C, Bramson C, Nemeth MA, Smith MD, et al., Efficacy and safety of tanezumab in the treatment of chronic low back pain. Pain 2011; 152: 2248-58.
    • (2011) Pain , vol.152 , pp. 2248-2258
    • Katz, N.1    Borenstein, D.G.2    Birbara, C.3    Bramson, C.4    Nemeth, M.A.5    Smith, M.D.6
  • 20
    • 79960581514 scopus 로고    scopus 로고
    • A study to investigate tanezumab in patients with interstitial cystitis/painful bladder syndrome
    • Te AE., A study to investigate tanezumab in patients with interstitial cystitis/painful bladder syndrome. Curr Urol Rep 2011; 12: 245-6.
    • (2011) Curr Urol Rep , vol.12 , pp. 245-246
    • Te, A.E.1
  • 21
    • 84956812159 scopus 로고    scopus 로고
    • Tanezumab Arthritis Advisory Committee Briefing Document. February 8
    • Tanezumab Arthritis Advisory Committee Briefing Document. February 8, 2012. URL: http://www.fda.gov/downloads/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm295205.pdf.
    • (2012)
  • 22
    • 0028969471 scopus 로고
    • Non-traumatic avascular necrosis of the femoral head
    • Mont MA, Hungerford DS., Non-traumatic avascular necrosis of the femoral head. J Bone Joint Surg Am 1995; 77: 459-74.
    • (1995) J Bone Joint Surg Am , vol.77 , pp. 459-474
    • Mont, M.A.1    Hungerford, D.S.2
  • 23
    • 84893701640 scopus 로고    scopus 로고
    • Treatment of femoral head osteonecrosis in the United States: 16-year analysis of the Nationwide Inpatient Sample
    • Johnson AJ, Mont MA, Tsao AK, Jones LC., Treatment of femoral head osteonecrosis in the United States: 16-year analysis of the Nationwide Inpatient Sample. Clin Orthop Relat Res 2014; 472: 617-23.
    • (2014) Clin Orthop Relat Res , vol.472 , pp. 617-623
    • Johnson, A.J.1    Mont, M.A.2    Tsao, A.K.3    Jones, L.C.4
  • 24
    • 0031694860 scopus 로고    scopus 로고
    • Rapidly progressive osteoarthrosis of the hip
    • Irwin LR, Roberts JA., Rapidly progressive osteoarthrosis of the hip. J Arthroplasty 1998; 13: 642-6.
    • (1998) J Arthroplasty , vol.13 , pp. 642-646
    • Irwin, L.R.1    Roberts, J.A.2
  • 25
    • 39449095779 scopus 로고    scopus 로고
    • Rapidly destructive osteoarthritis of the hip joint: A case series
    • Batra S, Batra M, McMurtrie A, Sinha AK., Rapidly destructive osteoarthritis of the hip joint: a case series. J Orthop Surg Res 2008; 3: 3.
    • (2008) J Orthop Surg Res , vol.3 , pp. 3
    • Batra, S.1    Batra, M.2    McMurtrie, A.3    Sinha, A.K.4
  • 27
    • 0014854170 scopus 로고
    • Total prosthetic replacement in rapidly destructive arthrosis of the hip joint
    • Postel M, Kerboull M., Total prosthetic replacement in rapidly destructive arthrosis of the hip joint. Clin Orthop Relat Res 1970; 72: 138-44.
    • (1970) Clin Orthop Relat Res , vol.72 , pp. 138-144
    • Postel, M.1    Kerboull, M.2
  • 28
    • 0014703981 scopus 로고
    • A post mortem study of the hip joint: Including the prevalence of the features of the right side
    • Byers PD, Contepomi CA, Farkas TA., A post mortem study of the hip joint: including the prevalence of the features of the right side. Ann Rheum Dis 1970; 29: 15-31.
    • (1970) Ann Rheum Dis , vol.29 , pp. 15-31
    • Byers, P.D.1    Contepomi, C.A.2    Farkas, T.A.3
  • 30
    • 79958219659 scopus 로고    scopus 로고
    • Rapidly progressive osteoarthritis: Biomechanical considerations
    • Walker EA, Davis D, Mosher TJ., Rapidly progressive osteoarthritis: biomechanical considerations. Magn Reson Imaging Clin N Am 2011; 19; 283-94.
    • (2011) Magn Reson Imaging Clin N Am , vol.19 , pp. 283-294
    • Walker, E.A.1    Davis, D.2    Mosher, T.J.3
  • 34
    • 0033763286 scopus 로고    scopus 로고
    • The role of subchondral insufficiency fracture in rapid destruction of the hip joint: A preliminary report
    • Yamamoto T, Bullough PG., The role of subchondral insufficiency fracture in rapid destruction of the hip joint: a preliminary report. Arthritis Rheum 2000; 43: 2423-7.
    • (2000) Arthritis Rheum , vol.43 , pp. 2423-2427
    • Yamamoto, T.1    Bullough, P.G.2
  • 36
    • 0035007673 scopus 로고    scopus 로고
    • Subchondral insufficiency fracture of the femoral head: Histopathologic correlation with MRI
    • Yamamoto T, Schneider R, Bullough PG., Subchondral insufficiency fracture of the femoral head: histopathologic correlation with MRI. Skeletal Radiol 2001; 30: 247-54.
    • (2001) Skeletal Radiol , vol.30 , pp. 247-254
    • Yamamoto, T.1    Schneider, R.2    Bullough, P.G.3
  • 37
    • 84922648191 scopus 로고    scopus 로고
    • Serious joint-related adverse events in randomized controlled trials of anti-nerve growth factor monoclonal antibodies
    • Hochberg MC., Serious joint-related adverse events in randomized controlled trials of anti-nerve growth factor monoclonal antibodies. Osteoarthritis Cartilage 2015; 23 Suppl 1:S18-21.
    • (2015) Osteoarthritis Cartilage , vol.23 , pp. S18-21
    • Hochberg, M.C.1
  • 40
    • 0020614820 scopus 로고
    • Morphologic alterations of the subchondral bone in advanced degenerative arthritis
    • Milgram JW., Morphologic alterations of the subchondral bone in advanced degenerative arthritis. Clin Orthop Relat Res 1983; 173: 293-312.
    • (1983) Clin Orthop Relat Res , vol.173 , pp. 293-312
    • Milgram, J.W.1
  • 41
    • 0014799609 scopus 로고
    • Rapid destructive coxarthrosis
    • In French
    • Lequesne M, Amouroux J., Rapid destructive coxarthrosis. Presse Med 1970; 78: 1435-9. In French.
    • (1970) Presse Med , vol.78 , pp. 1435-1439
    • Lequesne, M.1    Amouroux, J.2
  • 42
    • 0034230721 scopus 로고    scopus 로고
    • Rapidly destructive hip disease: A case report and review of the literature
    • Flik K, Vargas JH III., Rapidly destructive hip disease: a case report and review of the literature. Am J Orthop (Belle Mead NJ) 2000; 29: 549-52.
    • (2000) Am J Orthop (Belle Mead NJ) , vol.29 , pp. 549-552
    • Flik, K.1    Vargas, J.H.2
  • 44
    • 62949246527 scopus 로고
    • Radiological assessment of osteo-arthrosis
    • Kellgren JH, Lawrence JS., Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957; 16: 494-502.
    • (1957) Ann Rheum Dis , vol.16 , pp. 494-502
    • Kellgren, J.H.1    Lawrence, J.S.2
  • 45
    • 80052439205 scopus 로고    scopus 로고
    • The Charcot joint: A modern neurologic perspective
    • Chisholm KA, Gilchrist JM., The Charcot joint: a modern neurologic perspective. J Clin Neuromuscul Dis 2011; 13: 1-13.
    • (2011) J Clin Neuromuscul Dis , vol.13 , pp. 1-13
    • Chisholm, K.A.1    Gilchrist, J.M.2
  • 46
    • 0028838390 scopus 로고
    • Effects of antiinflammatory drugs on the progression of osteoarthritis of the knee
    • on behalf of the LINK Study Group
    • Huskisson EC, Berry H, Gishen P, Jubb RW, Whitehead J, on behalf of the LINK Study Group. Effects of antiinflammatory drugs on the progression of osteoarthritis of the knee. J Rheumatol 1995; 22: 1941-6.
    • (1995) J Rheumatol , vol.22 , pp. 1941-1946
    • Huskisson, E.C.1    Berry, H.2    Gishen, P.3    Jubb, R.W.4    Whitehead, J.5
  • 47
    • 0037961062 scopus 로고    scopus 로고
    • The mechanisms of the inhibitory effects of nonsteroidal anti-inflammatory drugs on bone healing: A concise review
    • Harder AT, An YH., The mechanisms of the inhibitory effects of nonsteroidal anti-inflammatory drugs on bone healing: a concise review. J Clin Pharmacol 2003; 43: 807-15.
    • (2003) J Clin Pharmacol , vol.43 , pp. 807-815
    • Harder, A.T.1    An, Y.H.2
  • 48
    • 37349059237 scopus 로고    scopus 로고
    • Non-steroidal anti-inflammatory drugs, cyclooxygenase-2 and the bone healing process
    • Vuolteenaho K, Moilanen T, Moilanen E., Non-steroidal anti-inflammatory drugs, cyclooxygenase-2 and the bone healing process. Basic Clin Pharmacol Toxicol 2008; 102: 10-4.
    • (2008) Basic Clin Pharmacol Toxicol , vol.102 , pp. 10-14
    • Vuolteenaho, K.1    Moilanen, T.2    Moilanen, E.3
  • 49
    • 84874017660 scopus 로고    scopus 로고
    • The effect of nonsteroidal anti-inflammatory drugs on tissue healing
    • Chen MR, Dragoo JL., The effect of nonsteroidal anti-inflammatory drugs on tissue healing. Knee Surg Sports Traumatol Arthrosc 2013; 21: 540-9.
    • (2013) Knee Surg Sports Traumatol Arthrosc , vol.21 , pp. 540-549
    • Chen, M.R.1    Dragoo, J.L.2
  • 50
    • 0142062926 scopus 로고    scopus 로고
    • Microfractures and microcracks in subchondral bone: Are they relevant to osteoarthrosis?
    • Burr DB, Radin EL., Microfractures and microcracks in subchondral bone: are they relevant to osteoarthrosis? Rheum Dis Clin North Am 2003; 29: 675-85.
    • (2003) Rheum Dis Clin North Am , vol.29 , pp. 675-685
    • Burr, D.B.1    Radin, E.L.2
  • 51
    • 0026519562 scopus 로고
    • Synovial, articular cartilage and bone changes in rapidly destructive arthropathy (osteoarthritis) of the hip
    • Mitrovic DR, Riera H., Synovial, articular cartilage and bone changes in rapidly destructive arthropathy (osteoarthritis) of the hip. Rheumatol Int 1992; 12: 17-22.
    • (1992) Rheumatol Int , vol.12 , pp. 17-22
    • Mitrovic, D.R.1    Riera, H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.