Background & Aims

In 79 % of 576 adults with painful diabetic peripheral neuropathy (pDPN) participating in online research in UK, ESP, NL and DE, daily pain was rated moderate or severe.1 First line treatments include anticonvulsants, antidepressants and topicals such as high concentration capsaicin (179 mg) patch (HCCP).2 HCCP may be preferred due to its low burden of therapy.3 The efficacy of HCCP in pDPN has been demonstrated in 2 phase III trials evaluating single and up to 7 treatments. 4,5 There are few reports on the effectiveness of HCCP in pDPN clinical practice. The German Pain e-Registry (web-based pain treatment registry), collects data from chronic pain patients in a standardized way. It includes demographics, medical/treatment history and validated patient reported outcome questionnaires. Our study on a cohort of pDPN patients aimed at evaluating effectiveness and tolerability of first and subsequent treatments with HCCP over a period of 12 months.

Methods

This is a non-interventional, retrospective 12 months cohort study using anonymized routine care data from the German Pain eRegistry. The presented analysis is part of a larger study designed to analyze the impact on repeat treatment with HCCP and to correlate responder rates with baseline characteristics in patients with peripheral neuropathic pain. Patients with a diagnosis of pDPN and exposed to treatment with HCCP at least once and followed up for 12 months after the index treatment, were selected for this cohort analysis. Baseline characteristics are presented. Effectiveness analyses focus on 1) responder rates [proportion of patients with a 30% or 50% decrease from baseline in average 24-hour pain intensity score (0-100 mm)] after each treatment with HCCP over the 12 month observation period, 2) change in pain intensity observed with each successive treatment, 3) change in concomitant peripheral neuropathic pain medication use. Finally tolerability of HCCP is assessed.

Results

Included were 826 pDPN patients; 51% female; mean (SD) age: 66.8 (13.1) years; pain duration: 5 (3.6) years; median 7 medications for peripheral neuropathic pain. Most had pDPN of the feet (60.3%), legs (9.2%); 30.5% pDPN of the hands. All received 1 HCCP treatment; 653, 464, and 279 had 2, 3 and 4 treatments, respectively. The interval between treatments was + 12 weeks. After treatment 1, 2, 3 and 4 a decrease of ?30% in average 24 hour pain intensity score from baseline (BL) was noted in 50.1%, 73.1%, 96.1% and 97.8%. These scores decreased from a BL mean (SD) score of 57.5 ( 18.2) to 42.4 (14.7) 30.9 (13.5) 22.3 (12.7) 16.0 (13.2) after treatment 1, 2, 3 and 4 respectively. Concomitant medications for PNP were reduced from median 4 at BL to 3, 3, 2 and 1 after HCCP treatment 1, 2, 3 and 4. Adverse drug reactions reported by >15% at any time in the 12 month period) were application site reactions (pain, erythema, burning sensation, pruritus, hyperesthesia and oedema/swelling).

Conclusions

In this cohort of pDPN patients, mean BL pain scores were consistent with moderate to severe pain as in the online survey. At BL, patients experienced pDPN for a mean of 5 years and had received 7 different medications for PNP. Pain scores were high at BL and HCCP was used after several treatments had been tried. After 1 HCCP treatment, more than 50% of patients had a clinically meaningful response (i.e. a decrease of ?30% in pain score from baseline) already and this increased with subsequent HCCP treatments. As in literature, pain intensity scores progressively decreased as treatment continued.6 To accommodate for late responders, treatment benefit is best assessed after multiple (e.g. 3) HCCP treatments. The decrease in pain intensity scores was observed against a background of decreasing proportion of patients using concomitant neuropathic pain medications. The HCCP tolerability profile was characterized by application site reactions in line with its well-established risk profile.

References

1.Tesfaye S, Brill S, Eerdekens M, Labrador MM, Petersen G, de Rooij Peek A, Reta A, Ryan D, Schaper N, Tölle T, Truini A, Ziegler D. Diagnosis, management and impact of painful diabetic peripheral neuropathy: A patient survey in four European countries. J Diabetes Complications. 2023 Apr;37(4):108417.
2.Blonde L, Umpierrez GE, Reddy SS, McGill JB, Berga SL, Bush M, Chandrasekaran S, DeFronzo RA, Einhorn D, Galindo RJ, Gardner TW, Garg R, Garvey WT, Hirsch IB, Hurley DL, Izuora K, Kosiborod M, Olson D, Patel SB, Pop-Busui R, Sadhu AR, Samson SL, Stec C, Tamborlane WV Jr, Tuttle KR, Twining C, Vella A, Vellanki P, Weber SL. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. 2022 Oct;28(10):923-1049.
3.Abdulahad AK, Snijder RJ, Panni MK, Riaz FK, Karas AJ. A novel standard to evaluate the impact of therapeutic agents on patient safety – The BURDEN OF THERAPY™©?. Contemp Clin Trials Commun. 2016 Sep 23;4:186-191.
4.Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, Schregardus DS, Long SK, Lambourg B, Katz N. Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study. J Pain. 2017 Jan;18(1):42-53.
5.Vinik AI, Perrot S, Vinik EJ, et al. Repeat treatment with capsaicin 8% patch (179mg capsaicin cutaneous patch): Effects on pain, quality of life, and patient satisfaction in painful diabetic peripheral neuropathy: An open-label, randomized controlled clinical trial. J Curr Med Res Opin 2019;2:388–401

Presenting Author

MA Überall

Poster Authors

Mariëlle Eerdekens

MD

Grünenthal

Lead Author

E-mail

Michael A Überall (MD)

Institute of Neurological Sciences, Nürnberg, Germany.

Lead Author

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Tamara Quandel

Grünenthal GmbH Stolberg Germany

Lead Author

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Sylvia Engelen

Grünenthal GmbH Aachen Germany

Lead Author

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Rita Freitas

Grünenthal S.A., Lisbon Portugal

Lead Author

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Lucia Garcia-Guerra

Grünenthal Pharma SA Madrid Spain

Lead Author

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Yana Mas

Laboratoires Grünenthal SAS Paris France

Lead Author

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Samuel Allen

Averitas Pharma Inc Morristown NY USA

Lead Author

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Topics

  • Evidence, Clinical Trials, Systematic Review, Guidelines, and Implementation Science