Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study
Colette Mankowski, Chris D Poole, Etienne Ernault, Roger Thomas, Ellen Berni, Craig J Currie, Cecil Treadwell, José I Calvo, Christina Plastira, Eirini Zafeiropoulou, Isaac Odeyemi, Colette Mankowski, Chris D Poole, Etienne Ernault, Roger Thomas, Ellen Berni, Craig J Currie, Cecil Treadwell, José I Calvo, Christina Plastira, Eirini Zafeiropoulou, Isaac Odeyemi
Abstract
Background: In randomised studies, the capsaicin 8% patch has demonstrated effective pain relief in patients with peripheral neuropathic pain (PNP) arising from different aetiologies.
Methods: ASCEND was an open-label, non-interventional study of patients with non-diabetes-related PNP who received capsaicin 8% patch treatment, according to usual clinical practice, and were followed for ≤52 weeks. Co-primary endpoints were percentage change in the mean numeric pain rating scale (NPRS) 'average daily pain' score from baseline to the average of Weeks 2 and 8 following first treatment; and median time from first to second treatment. The primary analysis was intended to assess analgesic equivalence between post-herpetic neuralgia (PHN) and other PNP aetiologies. Health-related quality of life (HRQoL, using EQ-5D), Patient Global Impression of Change (PGIC) and tolerability were also assessed.
Results: Following first application, patients experienced a 26.6% (95% CI: 23.6, 29.62; n = 412) reduction in mean NPRS score from baseline to Weeks 2 and 8. Equivalence was demonstrated between PHN and the neuropathic back pain, post-operative and post-traumatic neuropathic pain and 'other' PNP aetiology subgroups. The median time from first to second treatment was 191 days (95% CI: 147, 235; n = 181). Forty-four percent of all patients were responders (≥30% reduction in NPRS score from baseline to Weeks 2 and 8) following first treatment, and 86.9% (n = 159/183) remained so at Week 12. A sustained pain response was observed until Week 52, with a 37.0% (95% CI: 31.3, 42.7; n = 176) reduction in mean NPRS score from baseline. Patients with the shortest duration of pain (0-0.72 years) experienced the highest pain response from baseline to Weeks 2 and 8. Mean EQ-5D index score improved by 0.199 utils (responders: 0.292 utils) from baseline to Week 2 and was maintained until Week 52. Most patients reported improvements in PGIC at Week 2 and at all follow-up assessments regardless of number of treatments received. Adverse events were primarily mild or moderate reversible application site reactions.
Conclusion: In European clinical practice, the capsaicin 8% patch provided effective and sustained pain relief, substantially improved HRQoL, improved overall health status and was generally well tolerated in a heterogeneous PNP population.
Trial registration: NCT01737294 Date of registration - October 22, 2012.
Keywords: Capsaicin 8% patch; Health-related quality of life; Neuropathy; Numeric pain rating scale; Pain management; Peripheral neuropathic pain; Topical analgesic.
Figures
References
- Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, et al. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008;70(18):1630–5. doi: 10.1212/01.wnl.0000282763.29778.59.
- Marchettini P, Lacerenza M, Mauri E, Marangoni C. Painful peripheral neuropathies. Curr Neuropharmacol. 2006;4(3):175–81. doi: 10.2174/157015906778019536.
- Torrance N, Smith BH, Bennett MI, Lee AJ. The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006;7(4):281–9. doi: 10.1016/j.jpain.2005.11.008.
- Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008;136(3):380–7. doi: 10.1016/j.pain.2007.08.013.
- Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain. 2010;149(2):338–44. doi: 10.1016/j.pain.2010.02.034.
- Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162–73. doi: 10.1016/S1474-4422(14)70251-0.
- Haanpää M, Treede RD. Neuropathic Pain. In Lynch ME, Craig KD & Peng PWH (eds). Clinical pain management: a practical guide. Oxford: Wiley-Blackwell; 2010: 281-9.
- Wallace JM. Update on pharmacotherapy guidelines for treatment of neuropathic pain. Curr Pain Headache Rep. 2007;11(3):208–14. doi: 10.1007/s11916-007-0192-6.
- Gahr M, Freudenmann RW, Hiemke C, Kolle MA, Schonfeldt-Lecuona C. Pregabalin abuse and dependence in Germany: results from a database query. Eur J Clin Pharmacol. 2013;69(6):1335–42. doi: 10.1007/s00228-012-1464-6.
- Anand P, Bley K. Topical capsaicin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. Br J Anaesth. 2011;107(4):490–502. doi: 10.1093/bja/aer260.
- Uceyler N, Sommer C. High-dose capsaicin for the treatment of neuropathic pain: what we know and what we need to know. Pain Ther. 2014;3(2):73–84. doi: 10.1007/s40122-014-0027-1.
- Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan P, Jr, Rauck R, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008;7(12):1106–12. doi: 10.1016/S1474-4422(08)70228-X.
- Clifford DB, Simpson DM, Brown S, Moyle G, Brew BJ, Conway B, et al. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr. 2012;59(2):126–33. doi: 10.1097/QAI.0b013e31823e31f7.
- Irving GA, Backonja MM, Dunteman E, Blonsky ER, Vanhove GF, Lu SP, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med. 2011;12(1):99–109. doi: 10.1111/j.1526-4637.2010.01004.x.
- Maihofner C, Heskamp ML. Prospective, non-interventional study on the tolerability and analgesic effectiveness over 12 weeks after a single application of capsaicin 8% cutaneous patch in 1044 patients with peripheral neuropathic pain: first results of the QUEPP study. Curr Med Res Opin. 2013;29(6):673–83. doi: 10.1185/03007995.2013.792246.
- Simpson DM, Brown S, Tobias J, the NGX-4010 C107 Study Group. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008;70(24):2305–13.
- Stoker M, Katz N, Van J, Snijder R, Jacobs H, Long S, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomised, double-blind, placebo-controlled study. Diabetologia. 2015;58(Suppl. 1):S32.
- Haanpää M, Cruccu G, Nurmikko TJ, McBride WT, Docu Axelarad A, Bosilkov A, et al. Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain. Eur J Pain. 2016;20(2):316–28. doi: 10.1002/ejp.731.
- Maihofner CG, Heskamp ML. Treatment of peripheral neuropathic pain by topical capsaicin: Impact of pre-existing pain in the QUEPP-study. Eur J Pain. 2014;18(5):671–9. doi: 10.1002/j.1532-2149.2013.00415.x.
- European Medicines Agency. Qutenza Product Information. Annex 1: Summary of product characteristics. 2015. Available at: .
- Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–58. doi: 10.1016/S0304-3959(01)00349-9.
- Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43. doi: 10.3109/07853890109002087.
- Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35(11):1095–108. doi: 10.1097/00005650-199711000-00002.
- Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004;27(1):26–35. doi: 10.1016/j.jmpt.2003.11.003.
- Grant MD, Samson D. Special report: measuring and reporting pain outcomes in randomized controlled trials. Technol Eval Cent Assess Program Exec Summ. 2006;21(11):1–2.
- Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523–32. doi: 10.1007/s11136-004-7713-0.
- Anastassiou E, Iatrou CA, Vlaikidis N, Vafiadou M, Stamatiou G, Plesia E, et al. Impact of pregabalin treatment on pain, pain-related sleep interference and general well-being in patients with neuropathic pain: a non-interventional, multicentre, post-marketing study. Clin Drug Investig. 2011;31(6):417–26. doi: 10.2165/11589370-000000000-00000.
- Markley HG, Dunteman ED, Kareht S, Sweeney M. Real-world experience with once-daily gabapentin for the treatment of postherpetic neuralgia (PHN) Clin J Pain. 2015;31(1):58–65. doi: 10.1097/AJP.0000000000000082.
- Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18(1):42–53. doi: 10.1016/j.jpain.2016.09.008.
- Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016;16:251. doi: 10.1186/s12883-016-0752-7.
- Simpson DM, Brown S, Tobias JK, Vanhove GF, the NGX-4010 C107 Study Group. NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study. Clin J Pain. 2014;30(2):134–42.
Source: PubMed