390
Views
9
CrossRef citations to date
0
Altmetric
Orthopedic Medicine

Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies

, , , , , & show all
Pages 2117-2127 | Received 28 Mar 2019, Accepted 02 Aug 2019, Published online: 13 Sep 2019

References

  • Vos T, Allen C, Arora M, et al. Global, regional, and national incidence prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388:1545–1602.
  • Thysen S, Luyten FP, Lories R. Targets, models and challenges in osteoarthritis research. Dis Model Mech. 2015;8:17–30.
  • Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthr Cartilage. 2013;21:1145–1153.
  • McAlindon TE, Bannuru R, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartilage. 2014;22:363–388.
  • American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee. Evidence-based guideline Edition 2. 2013. Adopted by the American Academy of Orthopaedic Surgeons. URL: Available from: https://www.aaos.org/research/guidelines/treatmentofosteoarthritisofthekneeguideline.pdf.
  • Fernandes L, Hagen KB, Bijlsma JW, et al. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013;72:1125–35.
  • Pivec R, Issa K, Naziri Q, et al. Opioid use prior to total hip arthroplasty leads to worse clinical outcomes. Int Orthop. 2014;38:1159–1165.
  • Al-Saeed A. Gastrointestinal and cardiovascular risk of nonsteroidal Anti-inflammatory drugs. Oman Med J. 2011;26:385–391.
  • McNamee KE, Burleigh A, Gompels LL, et al. Treatment of murine osteoarthritis with TrkAd5 reveals a pivotal role for nerve growth factor in non-inflammatory joint pain. Pain. 2010;149:386–392.
  • Shelton DL, Zeller J, Ho WH, et al. Nerve growth factor mediates hyperalgesia and cachexia in auto-immune arthritis. Pain. 2005;116:8–16.
  • Matthews GL, Hunter DJ. Emerging drugs for osteoarthritis. Expert Opin Emerg Drugs. 2011;16:479–491.
  • Sanga P, Katz N, Polverejan E, et al. Long-term safety and efficacy of fulranumab in patients with Moderate-to-severe osteoarthritis pain: a phase II randomized, Double-blind, Placebo-controlled extension study. Arthritis Rheumatol. 2017;69:763–773.
  • Mayorga AJ, Wang S, Kelly KM, et al. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial. Int J Clin Pract. 2016;70:493–505.
  • Sanga P, Katz N, Polverejan E, 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.
  • Schnitzer TJ, Marks JA. A systematic review of the efficacy and general safety of antibodies to NGF in the treatment of OA of the hip or knee. Osteoarthr Cartilage. 2015;23(Suppl 1):S8–S17.
  • Ruit KG, Osborne PA, Schmidt RE, et al. Nerve growth factor regulates sympathetic ganglion cell morphology and survival in the adult mouse. J Neurosci. 1990;10:2412–19.
  • Bannwarth B, Kostine M. Nerve growth factor antagonists: is the future of Monoclonal Antibodies Becoming Clearer? Drugs. 2017;77:1377–1387.
  • Miller RE, Malfait AM, Block JA. Current status of nerve growth factor antibodies for the treatment of osteoarthritis pain. Clin Exp Rheumatol. 2017;107(35 Suppl):85–87.
  • Mullard A. Drug developers reboot anti-NGFs pain programmes. Nat Rev. 2015;14:279–298.
  • Dolgin E. Panel backs pain drug studies with new safety checks. Nat Med. 2012;18:472
  • Janssen Research & Development, LLC. Janssen Announces Discontinuation of Fulranumab Phase 3 Development Program in Osteoarthritis Pain. Titusville, NJ. [cited 2016 March 31]. Available from: https://www.jnj.com/media-center/press-releases/janssen-announces-discontinuation-of-fulranumab-phase-3-development-program-in-osteoarthritis-pain
  • Cornblath DR1, Chaudhry V, Carter K, et al. Total neuropathy score: validation and reliability study. Neurology. 1999;53:1660–1664.
  • Bellamy N. The WOMAC Knee and Hip Osteoarthritis Indices: development, validation, globalization and influence on the development of the AUSCAN Hand Osteoarthritis Indices. Clin Exp Rheumatol. 2005;23:S148–S53.
  • McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001;45:453–461.
  • Ornetti P, Dougados M, Paternotte S, et al. Validation of a numerical rating scale to assess functional impairment in hip and knee osteoarthritis: comparison with the WOMAC function scale. Ann Rheum Dis. 2011;70:740–746.
  • Ehrich EW, Davies GM, Watson DJ, et al. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27:2635–2641.
  • Gentelle‐Bonnassies S, Le Claire P, Mezieres M, et al. Comparison of the responsiveness of symptomatic outcome measures in knee osteoarthritis. Arthritis Care Res. 2000;13:280–285.
  • Martin DP, Engelberg RU, Agel J, et al. Comparison of the musculoskeletal function assessment questionnaire with the short form-36, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Sickness Impact Profile health-status measures. J Bone Joint Surg Am. 1997;79:1323–1325.
  • Conner-Spady BL, Marshall DA, Bohm E, et al. Reliability and validity of the EQ-5D-5L compared to the EQ-5D-3L in patients with osteoarthritis referred for hip and knee replacement. Qual Life Res. 2015;24:1775–1784.
  • Bellamy N, Campbell J, Haraoui B, et al. Clinimetric properties of the AUSCAN Osteoarthritis Hand Index: an evaluation of reliability, validity and responsiveness. Osteoarthritis and Cartilage. 2002;10:863–869.
  • Chang DS, Hsu E, Hottinger DG, et al. Anti-nerve growth factor in pain management: current evidence. J Pain Res. 2016;9:373–383.
  • Wang H, Romano G, Frustaci ME, et al. Fulranumab for treatment of diabetic peripheral neuropathic pain: a randomized controlled trial. Neurology. 2014;83:628–637.
  • Sanga P, Polverejan E, Wang S, et al. Efficacy, safety, and tolerability of fulranumab as an adjunctive therapy in patients with inadequately controlled, moderate-to-severe chronic low back pain: a randomized, double-blind, placebo-controlled, dose-ranging, dose-loading phase II study. Clin Ther. 2016;38:1435–1450.
  • Flemming DJ, Gustas-French CN. Rapidly progressive osteoarthritis: a review of the clinical and radiologic presentation. Curr Rheumatol Rep. 2017;19:42.
  • Dworkin RH, Turk DC, Peirce-Sandner S, et al. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain. 2012;153:1148–1158.
  • Farrar JT, Troxel AB, Haynes K, et al. Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: an ACTTION study. Pain. 2014;55:1622–1631

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.