A systematic review of the efficacy and general safety of antibodies to NGF in the treatment of OA of the hip or knee

Osteoarthritis and Cartilage

Volumn 23, Issue , 2015, Pages S8-S17

  Schnitzer, T J ^a   Marks, J A ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Antibodies to NGF; NGF; OA; Pain

Indexed keywords

FASINUMAB; FULRANUMAB; MONOCLONAL ANTIBODY; NERVE GROWTH FACTOR; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PLACEBO; TANEZUMAB;

AUTONOMIC NEUROPATHY; CONFIDENCE INTERVAL; DOSE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSESTHESIA; EFFECT SIZE; HIP OSTEOARTHRITIS; HUMAN; KNEE OSTEOARTHRITIS; LOW DRUG DOSE; META ANALYSIS; MONOTHERAPY; PAIN; PAIN ASSESSMENT; PARESTHESIA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK; SENSORY DYSFUNCTION; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREATMENT RESPONSE; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; ANTAGONISTS AND INHIBITORS; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE;

ANTIBODIES, MONOCLONAL; HUMANS; NERVE GROWTH FACTOR; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; TREATMENT OUTCOME;

EID: 84922616655     PISSN: 10634584     EISSN: 15229653     Source Type: Journal    
DOI: 10.1016/j.joca.2014.10.003     Document Type: Review

References (38)

1. Institute of Medicine Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research 2011, The National Academies Press, Washington, D.C.
2. Goldring M.B. The link between structural damage and pain in a genetic model of osteoarthritis and intervertebral disc degeneration: a joint misadventure. Arthritis Rheum 2009, 60:2550-2552.
3. Centers for disease control and prevention. Osteoarthritis.
4. Centers for Disease Control and Prevention Prevalence of disabilities and associated health conditions among adults-United States, 1999. MMWR Morb Mortal Wkly Rep 2001, 50:120-125.
5. Translational Pain Research: From Mouse to Man 2010, CRC Press, Boca Raton, FL.
6. Levi-Montalcini R. The nerve growth factor 35 years later. Science 1987, 237:1154-1162.
7. Levi-Montalcini R., Skaper S.D., Dal Toso R., Petrelli L., Leon A. Nerve growth factor: from neurotrophin to neurokine. Trends Neurosci 1996, 19:514-520.
8. Apfel S.C. Nerve growth factor for the treatment of diabetic neuropathy: what went wrong, what went right, and what does the future hold?. Int Rev Neurobiol 2002, 50:393-413.
9. Melamed I., Levy J., Parvari R., Gelfand E.W. Anovel lymphocyte signaling defect: trk A mutation in the syndrome of congenital insensitivity to pain and anhidrosis (CIPA). JClin Immunol 2004, 24:441-448.
10. Indo Y. Molecular basis of congenital insensitivity to pain with anhidrosis (CIPA): mutations and polymorphisms in TRKA (NTRK1) gene encoding the receptor tyrosine kinase for nerve growth factor. Hum Mutat 2001, 18:462-471.
11. Eibl J.K., Strasser B.C., Ross G.M. Structural, biological, and pharmacological strategies for the inhibition of nerve growth factor. Neurochem Int 2012, 61:1266-1275.
12. Chao M.V., Rajagopal R., Lee F.S. Neurotrophin signalling in health and disease. Clin Sci (Lond) 2006, 110:167-173.
13. Hefti F.F., Rosenthal A., Walicke P.A., Wyatt S., Vergara G., Shelton D.L., et al. Novel class of pain drugs based on antagonism of NGF. Trends Pharmacol Sci 2006, 27:85-91.
14. Mantyh P.W., Koltzenburg M., Mendell L.M., Tive L., Shelton D.L. Antagonism of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology 2011, 115:189-204.
15. Lane N.E., Webster L., Shiao-ping L., Gray M., Hefti F., Walicke P. RN624 (anti-NGF) improves pain and function in subjects with moderate knee osteoarthritis: a phase I study. Arthritis Rheum 2005, 52:S461.
16. 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. JPain 2006, 7:S45.
17. Lane N.E., Schnitzer T.J., Birbara C.A., Mokhtarani M., Shelton D.L., Smith M.D., et al. Tanezumab for the treatment of pain from osteoarthritis of the knee. NEngl J Med 2010, 363:1521-1531.
18. Sanga P., Katz N., Polverejan E., Wang S., Kelly K.M., Haeussler J., et al. Efficacy, safety, and tolerability of fulranumab, an anti-nerve growth factor antibody, in the treatment of patients with moderate to severe osteoarthritis pain. Pain 2013, 154:1910-1919.
19. Tiseo P.J., Kivitz A.J., Ervin J.E., Ren H., Mellis S.J. Fasinumab (REGN475), an antibody against nerve growth factor for the treatment of pain: results from a double-blind, placebo-controlled exploratory study in osteoarthritis of the knee. Pain 2014, 155:1245-1252.
20. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM307880.pdf.
21. Hochberg M.C. Serious joint-related adverse events in randomized controlled trials of anti-nerve growth factor monoclonal antibodies. Osteoarthritis Cartilage 2014, 23:S18-S21. 10.1016/j.joca.2014.10.005.
22. Jadad A.R., Moore R.A., Carroll D., Jenkinson C., Reynolds D.J., Gavaghan D.J., et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996, 17:1-12.
23. Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
24. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 2011, The Cochrane Collaboration, [updated March 2011]. J. Higgins, S. Green (Eds.).
25. Nagashima H., Suzuki M., Araki S., Yamabe T., Muto C. 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, 19:1405-1412.
26. Balanescu A.R., Feist E., Wolfram G., Davignon I., Smith M.D., Brown M.T., 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 2013, 73:1665-1672.
27. Schnitzer T.J., Ekman E.F., Spierings E.L., Greenberg H.S., Smith M.D., Brown M.T., et al. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis 2014, [Epub ahead of print].
28. Spierings E.L., Fidelholtz J., Wolfram G., Smith M.D., Brown M.T., West C.R. Aphase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain 2013, 154:1603-1612.
29. Ekman E, Gimber JS, Bello AE, Smith MD, Keller DS, Annis KM, etal. Efficacy and safety of intravenous tanezumab in osteoarthritis hip and knee pain: comparison to placebo and naproxen in 2 phase III studies (NCT00830063 & NCT00863304). Poster presented at the American Pain Society (APS) 30th Annual Scientific Meeting, Austin, TX, May 19-21, 2011.
30. Mayorga AJ, Wang S, Wang S, Kelly KM, Thipphawong J. Double-blind, randomized study to evaluate efficacy and safety of fulranumab in patients with moderate to severe, chronic knee pain from Osteoarthritis: Interim analysis results. Poster presented at 32nd Annual Scientific Meeting of the American Pain Society, May 8-11, 2013, Ernest N. Morial Convention Center, New Orleans, Louisiana.
31. Brown M.T., Murphy F.T., Radin D.M., Davignon I., Smith M.D., West C.R. Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled phase III trial. JPain 2012, 13:790-798.
32. Brown M.T., Murphy F.T., Radin D.M., Davignon I., Smith M.D., West C.R. Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial. Arthritis Rheum 2013, 65:1795-1803.
33. Schnitzer T.J., Lane N.E., Birbara C., Smith M.D., Simpson S.L., Brown M.T. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage 2011, 19:639-646.
34. Mayorga. Poster.
35. Evans R.J., Moldwin R.M., Cossons N., Darekar A., Mills I.W., Scholfield D. Proof of concept trial of tanezumab for the treatment of symptoms associated with interstitial cystitis. JUrology 2011, 185:1716-1721.
36. Nickel J.C., Atkinson G., Krieger J.N., Mills I.W., Pontari M., Shoskes D.A., et al. Preliminary assessment of safety and efficacy in proof-of-concept, randomized clinical trial of tanezumab for chronic prostatitis/chronic pelvic pain syndrome. Urology 2012, 80:1105-1110.
37. Katz N., Borenstein D.G., Birbara C., Bramson C., Nemeth M.A., Smith M.D., et al. Efficacy and safety of tanezumab in the treatment of chronic low back pain. Pain 2011, 152:2248-2258.
38. Kivitz A.J., Gimbel J.S., Bramson C., Nemeth M.A., Keller D.S., Brown M.T., et al. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain 2013, 154:1009-1021.