Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain

Pain

Volumn 155, Issue 9, 2014, Pages 1793-1801

  Gimbel, Joseph S ^a   Kivitz, Alan J ^b   Bramson, Candace ^c   Nemeth, Mary Anne ^c   Keller, David S ^c   Brown, Mark T ^c   West, Christine R ^c   Verburg, Kenneth M ^b  

^a Arizona Research Center   (United States)

^b Altoona Center for Clinical Research   (United States)

^c PFIZER INC   (United States)

Author keywords

Effectiveness; Low back pain; Nerve growth factor; Safety; Tanezumab

Indexed keywords

ANALGESIC AGENT; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; TANEZUMAB; MONOCLONAL ANTIBODY;

ADULT; AGED; ALLODYNIA; ARTHRALGIA; ARTICLE; ASSESSMENT OF HUMANS; BONE NECROSIS; BRIEF PAIN INVENTORY; BURNING SENSATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSESTHESIA; FEMALE; FORMICATION; HIP OSTEOARTHRITIS; HUMAN; HYPERESTHESIA; HYPESTHESIA; JOINT PROSTHESIS; LABORATORY TEST; LONG TERM CARE; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; MEDICAL DOCUMENTATION; MIDDLE AGED; MULTICENTER STUDY; NEURALGIA; NEUROLOGIC EXAMINATION; PARENT; PARESTHESIA; PATIENT'S GLOBAL ASSESSMENT; PERIPHERAL NEUROPATHY; PHYSICAL EXAMINATION; POLYNEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; ROLAND MORRIS DISABILITY QUESTIONNAIRE; SENSORIMOTOR NEUROPATHY; TREATMENT DURATION; TREATMENT OUTCOME; VERY ELDERLY; ADOLESCENT; CHRONIC PAIN; CLINICAL TRIAL; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANALGESICS; ANTIBODIES, MONOCLONAL, HUMANIZED; CHRONIC PAIN; FEMALE; HUMANS; LOW BACK PAIN; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84926410091     PISSN: 03043959     EISSN: 18726623     Source Type: Journal    
DOI: 10.1016/j.pain.2014.06.004     Document Type: Article

References (34)

1. 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.
2. Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G. Chapter 4 European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 2006;15(Suppl. 2):S192-300.
3. Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal antiinflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ 2004;329:1317.
4. Brown M, Murphy F, Radin D, Davignon I, Smith M, West C. Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled phase 3 trial. J Pain 2012;13:790-8.
5. Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007;147:505-14.
6. Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007;147: 492-504.
7. Chou R, Qaseem A, Snow V, Casey D, Cross Jr JT, Shekelle P, Owens DK. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007;147:478-91.
8. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994;23:129-38.
9. Deyo RA, Weinstein JN. Low back pain. N Engl J Med 2001;344:363-70.
10. Dyck PJ, Litchy WJ, Lehman KA, Hokanson JL, Low PA, O'Brien PC. Variables influencing neuropathic endpoints: the Rochester Diabetic Neuropathy Study of Healthy Subjects. Neurology 1995;45:1115-21.
11. Ekman E, Gimbel J, Bello A, Smith M, Keller D, Annis K, Brown M, West C, Verburg K. Efficacy and safety of intravenous tanezumab in osteoarthritis hip and knee pain: comparison to placebo and naproxen in two Phase III studies (NCT00830063 & NCT00863304). J Pain 2011;12(Suppl.):P55. Available from: http://download.journals.elsevierhealth.com/pdfs/journals/ 1526-5900/PIIS1526590011002707.pdf. [accessed 27.06.14].
12. Evans RJ, Moldwin RM, Cossons N, Darekar A, Mills IW, Scholfield D. Proof of concept trial of tanezumab for the treatment of symptoms associated with interstitial cystitis. J Urol 2011;185:1716-21.
13. Food and Drug Administration Center for Drug Evaluation and Research. Background materials addendum. Available from: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Arthritis DrugsAdvisoryCommittee/UCM295203.pdf. [accessed 27.06.14].
14. Food and Drug Administration Center for Drug Evaluation and Research. Background materials. Meeting of the Arthritis Advisory Committee (AAC). Available from: http://www.fda.gov/downloads/AdvisoryCommittees/ Committees MeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/ UCM295202.pdf. [accessed 27.06.14].
15. Hefti FF, Rosenthal A, Walicke PA, Wyatt S, Vergara G, Shelton DL, Davies AM. Novel class of pain drugs based on antagonism of NGF. Trends Pharmacol Sci 2006;27:85-91.
16. Hochberg MC, Abramson SB, Hungerford DS, McCarthy E, Vignon EP, Smith MD, Tive L, Verburg KM, West CR. Adjudication of reported serious adverse joint events in the tanezumab clinical development program. Arthritis Rheum 2012;64:S113.
17. Katz N, Borenstein DG, Birbara C, Bramson C, Nemeth MA, Smith MD, Brown MT. Efficacy and safety of tanezumab in the treatment of chronic low back pain. PAIN 2011;152:2248-58.
18. Kivitz AJ, Gimbel JS, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. PAIN 2013;154:1009-21.
19. Koewler NJ, Freeman KT, Buus RJ, Herrera MB, Jimenez-Andrade JM, Ghilardi JR, Peters CM, Sullivan LJ, Kuskowski MA, Lewis JL, Mantyh PW. Effects of a monoclonal antibody raised against nerve growth factor on skeletal pain and bone healing after fracture of the C57BL/6J mouse femur. J Bone Miner Res 2007;22:1732-42.
20. Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, Brown MT. Tanezumab for treatment of knee osteoarthritis pain. N Engl J Med 2010;363:1521-31.
21. Mantyh PW, Koltzenburg M, Mendell LM, Tive L, Shelton DL. Antagonism of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology 2011;115:189-204.
22. 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;19:1405-12.
23. Nickel JC, Atkinson G, Krieger JN, Mills IW, Pontari M, Shoskes DA, Crook TJ. Preliminary assessment of safety and efficacy in proof-of-concept, randomized clinical trial of tanezumab for chronic prostatitis/chronic pelvic pain syndrome. Urology 2012;80:1105-10.
24. Pfizer Inc. Tanezumab Arthritis Advisory Committee briefing document. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/Drugs/ArthritisDrugsAdvisoryCommittee/UCM295205.pdf. [accessed 27.06.14].
25. Quebec Task Force on Spinal Disorders. Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976) 1987;12:S1-S59.
26. Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Nonsteroidal antiinflammatory drugs for low back pain: an updated Cochrane review. Spine (Phila Pa 1976) 2008;33:1766-74.
27. Roland M, Morris R. A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976) 1983;8:145-50.
28. Rowbotham MC. What is a ''clinically meaningful'' reduction in pain? PAIN 2001;94:131-2.
29. Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 2004;8:283-91.
30. Schnitzer TJ, Lane NE, Birbara C, Smith MD, Simpson SL, Brown MT. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage 2011;19:639-46.
31. Shelton DL, Zeller J, Ho WH, Pons J, Rosenthal A. Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis. PAIN 2005;116:8-16.
32. Stengaard-Pedersen K, Ekesbo R, Karvonen AL, Lyster M. Celecoxib 200 mg q.d. is efficacious in the management of osteoarthritis of the knee or hip regardless of the time of dosing. Rheumatology 2004;43:592-5.
33. Watson JJ, Allen SJ, Dawbarn D. Targeting nerve growth factor in pain: what is the therapeutic potential? BioDrugs 2008;22:349-59.
34. Zahn PK, Subieta A, Park SS, Brennan TJ. Effect of blockade of nerve growth factor and tumor necrosis factor on pain behaviors after plantar incision. J Pain 2004;5:157-63.