Anti-Nerve Growth Factor in the Treatment of Low Back Pain and Radiculopathy: A Systematic Review and a Meta-Analysis

Imagem de Miniatura
Arquivos
art_LEITE_AntiNerve_Growth_Factor_in_the_Treatment_of_Low_2014.PDF (629.88 KB)
Citações na Scopus
44
Tipo de produção
article
Data de publicação
2014
Scopus
Web of Science
Título da Revista
ISSN da Revista
Título do Volume
Editora
AM SOC INTERVENTIONAL PAIN PHYSICIANS
Autores
ABD, Omar El
BENYAMIN, Ramsin M.
MAZLOOMDOOST, Danesh
Citação
PAIN PHYSICIAN, v.17, n.1, p.E45-E60, 2014
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Background: Low back pain with or without radiculopathy is an important cause of disability and economic expenditure. However, many patients are not meeting optimal pain control through existing treatments. Recent studies have linked nerve growth factor (NGF) and the pathophysiology of persistent pain. Anti-NGF could be an alternative drug treatment for low back pain. Objective: Systematically review the efficacy and safety of anti-NGF in the treatment of low back pain. Methods: A systematic review of the literature with no language, date or publication status restriction, using Medline, EMBASE, Cochrane Library, and the clinicaltrials. gov database. Additional literature was retrieved by conferring with experts in the field or reviewing bibliographies and annals of meetings and congresses. Search terms included ""monoclonal antibodies,"" "" nerve growth factor,"" ""anti-ngf,"" ""fulranumab,"" ""tanezumab,"" "" sciatica,"" "" back pain,"" and ""spine."" Study Design: Inclusion criteria were observational studies with safety as an outcome and randomized or nonrandomized controlled trials studying the efficacy and/or the safety of anti-NGF drugs on low back pain. Exclusion criteria included patients with autoimmune conditions or osteoporosis. Studies were assessed independently by 2 authors regarding inclusion/exclusion criteria, risk of bias, clinical relevance, and quality of evidence (GRADE approach). Results: 1,168 studies were retrieved. After excluding duplicates and applying the inclusion/exclusion criteria, 4 RCTs remained (n = 2,109): 2 for tanezumab, one for REGN475, and one for fulranumab. Only the tanezumab studies showed any significant difference over placebo (n = 1,563) for both pain relief and functional improvement. Conclusions: There is very low evidence that systemically administered anti-NGF therapy has a small positive effect compared to placebo for both pain relief (standarized mean difference [SMD] = -0.29, 95% confidence interval [CI] -0.58 to 0.00) and functional improvement (SMD = -0.21, 95% CI -0.37 to -0.05) of low back pain. There was low evidence of adverse effects (AEs) compared to placebo and low evidence of neurological AEs than placebo (relative risk = 1.93, 95% CI 1.41 to 2.64). Tanezumab, as a specific anti-NGF treatment, showed low evidence of a small to moderate effect for pain relief of low back pain (SMD = -0.44, 95% CI -0.81 to -0.07); and low evidence of a small effect for functional improvement (SMD = -0.26, 95% CI -0.40 to -0.12) with systemic administration, although not clinically significant. Tanezumab and anti-NGFs overall had, respectively, moderate and low evidence of overall AEs and serious AEs and a higher risk of developing neurological AEs when compared with placebo. Although anti-NGF, specifically tanezumab, showed a low-to-moderate effect on pain relief and functional improvement, it cannot be recommended for low back pain treatment. Without more research on the pathophysiology of anti-NGFs and adverse effects, its use is not safe in the overall population. However, as corroborated by the US Food and Drug Administration, this meta-analysis underscores a role for greater insight into anti-NGF therapy for painful conditions that are refractory to current drugs, such as oncologic pain, chronic pancreatitis, and phantom-limb pain. Given the pathophysiology of axial pain involving inflammatory mediators and the adverse effects of systemic anti-NGF use, consideration of local therapies may warrant further exploration.
Palavras-chave
back pain, anti-ngf, spine, sciatica, nerve growth factor, radiculopathy, treatment
URI
https://observatorio.fm.usp.br/handle/OPI/8648
Referências
  1. Ackermann PW, 2011, PAIN, V152, P2248
  2. Andersson GBJ, 1999, LANCET, V354, P581, DOI 10.1016/S0140-6736(99)01312-4
  3. Andrews J, 2013, J CLIN EPIDEMIOL, V66, P719, DOI 10.1016/j.jclinepi.2012.03.013
  4. Atkins D, 2004, BRIT MED J, V328, P1490
  5. Bae WC, 2011, ORTHOP CLIN N AM, V42, P585, DOI 10.1016/j.ocl.2011.07.004
  6. Benyamin RM, 2012, PAIN PHYSICIAN, V15, pE363
  7. Bhamb B, 2006, CURR MED RES OPIN, V22, P1859, DOI 10.1185/030079906X132398
  8. Brain SD, 2004, PHYSIOL REV, V84, P903, DOI 10.1152/physrev.00037.2003
  9. Campbell P, 2013, J PAIN, V14, P873, DOI 10.1016/j.jpain.2013.03.013
  10. Caporali A, 2009, PHYSIOL REV, V89, P279, DOI 10.1152/physrev.00007.2008
  11. Chen JR, 2004, J NEUROTRAUM, V21, P1640, DOI 10.1089/0897715042441729
  12. Chessell IP, 2012, DRUG DISCOV TODAY, V17, P875, DOI 10.1016/j.drudis.2012.03.005
  13. Chou R, 2007, ANN INTERN MED, V147, P505
  14. Chou R, 2010, JAMA-J AM MED ASSOC, V303, P1295, DOI 10.1001/jama.2010.344
  15. Cohen J, 1988, STAT POWER ANAL BEHA
  16. Costa LDM, 2012, CAN MED ASSOC J, V184, pE613, DOI 10.1503/cmaj.111271
  17. COSTE J, 1994, BRIT MED J, V308, P577
  18. Dagenais S, 2009, SPINE J, V9, P944, DOI 10.1016/j.spinee.2009.07.007
  19. Davies RA, 2008, EUR SPINE J, V17, P1423, DOI 10.1007/s00586-008-0783-x
  20. Evans RJ, 2011, J UROLOGY, V185, P1716, DOI 10.1016/j.juro.2010.12.088
  21. Fischer B, 2012, PAIN PHYSICIAN, V15, pES191
  22. Franklin GM, 2008, SPINE, V33, P199, DOI 10.1097/BRS.0b013e318160455c
  23. Freburger JK, 2009, ARCH INTERN MED, V169, P251, DOI 10.1001/archinternmed.2008.543
  24. Furlan AD, 2009, SPINE, V34, P1929, DOI 10.1097/BRS.0b013e3181b1c99f
  25. Gaskin DJ, 2012, J PAIN, V13, P715, DOI 10.1016/j.jpain.2012.03.009
  26. Gobbi Alberto, 2012, Sports Health, V4, P162
  27. Gore M, 2012, SPINE, V37, pE668, DOI 10.1097/BRS.0b013e318241e5de
  28. Grotle M, 2005, SPINE, V30, P976, DOI 10.1097/01.brs.0000158972.34102.6f
  29. Gwak YS, 2003, NEUROSCI LETT, V336, P117, DOI 10.1016/S0304-3940(02)01251-X
  30. Hagen EM, 2006, SPINE, V31, P1491, DOI 10.1097/01.brs.0000219947.71168.08
  31. Halliday DA, 1998, NEUROCHEM RES, V23, P919, DOI 10.1023/A:1022475432077
  32. Hefti FF, 2006, TRENDS PHARMACOL SCI, V27, P85, DOI 10.1016/j.tips.2005.12.001
  33. Higgins J, 2009, COCHRANE HDB SYSTEMA, P174
  34. Hill, 2011, PAIN, V152, P2200
  35. Hill, 2012, PAIN, V153, P1129
  36. Hill R, 2011, PAIN, V152, P2200, DOI 10.1016/j.pain.2011.06.015
  37. Hunter DJ, 2010, BMC MUSCULOSKEL DIS, V11, DOI 10.1186/1471-2474-11-232
  38. Indrakanti SS, 2012, CLIN ORTHOP RELAT R, V470, P1106, DOI 10.1007/s11999-011-2141-2
  39. Institute of Medicine Report from the Committee on Advancing Pain Research, 2011, REL PAIN AM BLUEPR T
  40. Ivanova JI, 2011, SPINE J, V11, P622, DOI 10.1016/j.spinee.2011.03.017
  41. Jacobs WCH, 2013, SPINE, V38, P24, DOI 10.1097/BRS.0b013e3182741b21
  42. Jacobs WCH, 2012, EUR SPINE J, V21, P2232, DOI 10.1007/s00586-012-2422-9
  43. Jaggar SI, 1999, BRIT J ANAESTH, V83, P442
  44. Johnson & Johnson, DOS RANG STUD SAF EF
  45. Katz JN, 2006, J BONE JOINT SURG AM, V88A, P21, DOI 10.2106/JBJS.E.01273
  46. Katz N, 2011, PAIN, V152, P2248, DOI 10.1016/j.pain.2011.05.003
  47. Katz N, 2011, ARTHRITIS RHEUM, V63, P741
  48. Kawamoto K, 2002, J IMMUNOL, V168, P6412
  49. Kelly GA, 2011, CLIN J PAIN, V27, P169, DOI 10.1097/AJP.0b013e3181f3bdd5
  50. Koes BW, 2010, EUR SPINE J, V19, P2075, DOI 10.1007/s00586-010-1502-y
  51. Koltzenburg M, 1999, EUR J NEUROSCI, V11, P1698, DOI 10.1046/j.1460-9568.1999.00590.x
  52. Kuijpers T, 2011, EUR SPINE J, V20, P40, DOI 10.1007/s00586-010-1541-4
  53. Malmivaara A, 2006, SPINE, V31, P1405, DOI 10.1097/01.brs.0000219868.30427.66
  54. Manchikanti L, 2012, PAIN PHYSICIAN, V15, pE199
  55. Manchikanti L, 2011, PAIN PHYSICIAN, V14, P91
  56. Manchikanti L, 2013, SPINE, V38, P157, DOI 10.1097/BRS.0b013e318267f463
  57. Manchikanti L, 2013, PAIN PHYSICIAN, V16, pE129
  58. Martin BI, 2008, JAMA-J AM MED ASSOC, V299, P656, DOI 10.1001/jama.299.6.656
  59. Meloni M, 2010, CIRC RES, V106, P1275, DOI 10.1161/CIRCRESAHA.109.210088
  60. Moore RA, 2005, ARTHRITIS RES THER, V7, pR1046, DOI 10.1186/ar1782
  61. Nagy I, 2004, EUR J PHARMACOL, V500, P351, DOI 10.1016/j.ejphar.2004.07.037
  62. Obata K, 2002, PAIN, V99, P121, DOI 10.1016/S0304-3959(02)00068-4
  63. Orozco L, 2011, TRANSPLANTATION, V92, P822, DOI 10.1097/TP.0b013e3182298a15
  64. Parr AT, 2012, PAIN PHYSICIAN, V15, pE159
  65. Pergolizzi Joseph, 2008, Pain Pract, V8, P287, DOI 10.1111/j.1533-2500.2008.00204.x
  66. Pezet S, 2006, ANNU REV NEUROSCI, V29, P507, DOI 10.1146/annurev.neuro.29.051605.112929
  67. Pfizer, LONG TERM SAF STUD T
  68. Pfizer, 2013, PFE Q2 2013 PFIZ EAR
  69. Pfizer, STUD TAN AD CHRON LO
  70. Pfizer, RN624 AD PAT CHRON L
  71. Pimentel DC, 2014, PAIN PHYSICIAN, V17, pE27
  72. Pinto RZ, 2012, BRIT MED J, V344, DOI 10.1136/bmj.e497
  73. Pleis JR, 2010, VITAL HLTH STAT, V10, P1
  74. Ramer MS, 1999, EUR J NEUROSCI, V11, P837, DOI 10.1046/j.1460-9568.1999.00491.x
  75. Regeneron, STUD EV SAF EFF SUBC
  76. Ro LS, 1999, PAIN, V79, P265, DOI 10.1016/S0304-3959(98)00164-X
  77. Rukwied R, 2010, PAIN, V148, P407, DOI 10.1016/j.pain.2009.11.022
  78. Sanga P, 2011, J PAIN, V12, P53
  79. Sarchielli Paola, 2004, Expert Rev Neurother, V4, P115, DOI 10.1586/14737175.4.1.115
  80. Schaible Hans-Georg, 2006, Adv Drug Deliv Rev, V58, P323, DOI 10.1016/j.addr.2006.01.011
  81. Schnitzer TJ, 2011, OSTEOARTHR CARTILAGE, V19, P639, DOI 10.1016/j.joca.2011.01.009
  82. Sevcik MA, 2005, PAIN, V115, P128, DOI 10.1016/j.pain.2005.02.022
  83. Skoff AM, 2003, NEUROCHEM RES, V28, P847, DOI 10.1023/A:1023211107073
  84. U. S. Food and Drug Administration Center for Drug Evaluation and Research, 2012, BACKGR PACK ADD AAC
  85. U. S. Food and Drug Administration Center for Drug Evaluation and Research, 2012, BACKGR MAT AAC M MAR
  86. Murray CJL, 2013, JAMA-J AM MED ASSOC, V310, P591, DOI 10.1001/jama.2013.13805
  87. US Department of Health and Human Services. Office of Inspector General ( OIG), 2010, IN MED PAYM TRANSF E
  88. U.S. Food and Drug Administration Center for Drug Evaluation and Research, 2012, ARTHR ADV COMM M MAR
  89. U.S. Food and Drug Administration Center for Drug Evaluation and Research, ARTHR ADV COMM AAC M
  90. U.S. Food and Drug Administration Center for Drug Evaluation and Research, 2012, ARTHR ADV COMM AAC M
  91. Volinn E, 2009, PAIN, V142, P194, DOI 10.1016/j.pain.2008.12.017
  92. Watanabe K, 2010, SPINE
  93. WOOLF CJ, 1994, NEUROSCIENCE, V62, P327, DOI 10.1016/0306-4522(94)90366-2
  94. Woolf CJ, 1996, PHILOS T ROY SOC B, V351, P441, DOI 10.1098/rstb.1996.0040

Coleções
Artigos e Materiais de Revistas Científicas - FM/MPT
Artigos e Materiais de Revistas Científicas - HC/IMREA