Treatment of painful radiculopathies with capsaicin 8% cutaneous patch

Abstract

Background and objective: The treatment of neuropathic pain due to low-back (lumbosacral) radiculopathies, a common source of neuropathic pain, is challenging and often requires a multimodal therapeutic approach. The capsaicin 8% patch is the first topical analgesic licensed for peripheral neuropathic pain. To evaluate this treatment, a subset of patients with painful radiculopathy (lumbar and cervical, including ventral and dorsal rami) enrolled into the multicenter, non-interventional QUEPP study (Qutenza² – safety and effectiveness in peripheral neuropathic pain) was analyzed.

Methods: Of the 1044 study participants, 50 were diagnosed with painful radiculopathy as only peripheral neuropathic pain syndrome and were eligible for evaluation. Patients received a single treatment (visit 1) with follow-up visits 2–5 at weeks 1–2, 4, 8 and 12. Parameters assessed at all visits included pain intensity, neuropathy symptoms and side effects. Quality of life (SF-12) and painDETECT¹ questionnaires were completed at baseline and final visit. Data was analyzed by patch application site and duration of pain.

Results: Topical treatment led to a significant decrease of pain intensity between weeks 1/2 and week 12 versus baseline at the application sites representing dermatomes of ventral (N = 26) and dorsal rami (N = 13) of spinal nerves. A significant decline (p ≤ .001) of numeric pain rating scale scores was observed between weeks 1/2 following patch application and the end of observation (week 12) in the overall radiculopathy group (N = 50), and the groups with either 3 months to 2 years (N = 14) or >2 years (N = 23) duration of pain. Pain relief of at least 30% was observed in 50.0%, 71.4% and 39.1% of patients in the respective groups. Four patients experienced in total seven adverse drug reactions (application site pain or pruritus).

Conclusion: Effective neuropathic pain relief was observed after patch application within the innervation territories of both dorsal and ventral branches of the spinal nerve. Further controlled randomized trials are indicated.

Keywords:

• Painful radiculopathy
• peripheral neuropathic pain
• capsaicin 8% cutaneous patch
• pain duration
• topical treatment
• QUEPP study
• low back pain

Note

Transparency

Declaration of funding

The QUEPP study and this re-analysis were funded by Astellas Pharma GmbH, Munich, Germany.

Declaration of financial/other relationships

R.B. has disclosed that she/he received grants from Pfizer, Genzyme, Grünenthal, and Mundipharma; is a Member of EU Project No. 633491: DOLORisk, member of the German Federal Ministry of Education and Research (BMBF): Member of the ERA_NET NEURON/IM-PAIN Project (01EW1503), German Research Network on Neuropathic Pain (01EM0903), NoPain system biology (0316177C), German Research Foundation (DFG); and has received personal fees as speaker and/or consultant from Pfizer, Genzyme, Grünenthal, Mundipharma, Sanofi Pasteur, Medtronic, Eisai, Lilly, Boehringer Ingelheim, Astellas, Desitin, Teva Pharma, Bayer-Schering, MSD, Allergan, Novartis, Bristol-Myers Squibb, Biogenidec, AstraZeneca, Merck, AbbVie, Daichi Sankyo, Glenmark Pharmaceuticals, Genentech, Seqirus, and Galapagos NV. F.B. has disclosed that he serves as a consultant for Astellas Pharma, Lilly Germany and Pfizer Germany; during the last 2 years, he received speakers’ fees from Pfizer and Desitin. T.C. has disclosed that she/he received personal fees from Mundipharma, Grünenthal, Astellas, and Pharm Allergan GmbH. R.F. has disclosed that she/he has received consultancy and speaker fees in the past 12 months from Astellas, Grünenthal, Eli Lilly and Pfizer. M.L.H. has disclosed that she/he is an employee from the Medical Department of Astellas Pharma GmbH. K.U.K. has disclosed that she/he was consultant or presenter for Astellas, Berlin Chemie, Boehringer Ingelheim, Betapharm, Grünenthal, Hexal, Lilly, MSD, Mundipharma and Reckitt Benckiser; and received a LIIRA Grant support for clinical research from Pfizer 2011. C. Maier has disclosed that she/he received grants from IMI-Europain, German Federal Ministry of Education and Research (BMBF), grants and personal fees from Mundipharma, Grünenthal and Astellas, and personal fees from AstraZeneca and Epionics. C. Maihöfner has disclosed that she/he has received honoraria as consultant for Astellas, Bionorica and Mundipharma and has participated in speakers’ bureaus of Allergan, Astellas, Grunenthal, Janssen, and Pfizer. University Hospital Erlangen received financial support from Astellas to fund the investigation. R.R. has disclosed that she/he has received consultancy and speaker fees in the past 12 months from Astellas, Grünenthal, Eli Lilly, Pfizer, Teva, Takeda and Neuraxpharm. S. Seddigh and S. Ständer have disclosed that they have received honoraria as consultants for Astellas (advisory board). C.S. has disclosed that she/he received personal fees from Pfizer, Air Liquide, and Astellas. R.D.T. has disclosed that she/he received honoraria and non-financial support from Astellas during the conduct of a study, grants from IMI-Europain 115007, DFG, BMBF, grants and personal fees from Astellas, AbbVie, Bayer Corporation and BI, personal fees (advisory boards) from Astellas, Astra-Zeneca, Bauerfeind, Bayer, Boehringer Ingelheim, Galderma, Glaxo Smith Kline, Grünenthal, Lilly, Merz, Merck-Sharpe & Dohme, Pfizer, Sanofi, Schwarz-Pharma/UCB, and personal fees (lectures) from Astellas, AWD, Boehringer Ingelheim, Dr. Kade, Nycomed, Grünenthal, Lilly, Mundipharma, Pfizer, Schwarz-Pharma/UCB, Medichem, Teva, outside the submitted work.

Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgements

Franz Gerstheimer and Detlef von Zabern (both medwiss-extern GmbH & Co. KG, Aachen, Germany) provided medical writing assistance funded by Astellas Pharma GmbH. Statistical analysis was done by factum (Gesellschaft für Statistik, wissenschaftliche Information und Kommunikation GmbH, Offenbach, Germany).

Previous presentation: Günther O, Hildebrandt-Stahlschmidt S, Parthe H, et al. Radikulopathien: Effektivität und Sicherheit von Capsaicin 8% kutanes Pflaster. Subgruppenanalyse der QUEPP-Studie. Poster P15.2, Congress of Deutsche Schmerzgesellschaft, Hamburg, Germany, 23–26 October 2013. Heskamp M-LS, Günther O, Hildebrandt-Stahlschmidt S, et al. P 124-Capsaicin 8% cutaneous patch for treatment of radiculopathy, in: Vleeming A, Fitzgerald C, Kamkar A, et al. (eds) 8th Interdisciplinary World Congress on Low Back & Pelvic Pain. Advances in Multidisciplinary Research for better Spinal/Pelvic Care. Dubai, United Arab Emirates: MERC Ltd., 27–31 October 2013:619-20.

Notes

1. painDETECT is a registered trade name of Pfizer Deutschland GmbH, Berlin, Germany.

2. Qutenza is a registered trade name of Astellas Pharma Europe B.V., Leiden, The Netherlands.