Background & Aims

In a randomized, controlled, open label trial, treatment with high concentration (179 mg) capsaicin patch (HCCP) applied at intervals of ? 8 weeks for 1 year added to standard of care (SoC), was associated with a progressive reduction in pain intensity compared to SOC alone in adults with painful diabetic peripheral neuropathy (pDPN).[1] A post-hoc analysis of the same study showed that some patients may not be responders (defined by a decrease ?30% from baseline pain score) after 1 treatment but may become responders with continued HCCP treatment.[2]
Similar data from clinical practice are lacking. The German Pain e-Registry (web-based pain treatment registry), collects data from chronic pain patients on an ongoing basis in a standardized way. It includes validated patient reported outcome questionnaires.
Our clinical practice study aimed to evaluate effectiveness in a cohort of pDPN patients who received up to four HCCP treatments and were all followed up for 12 months.

Methods

We conducted a non-interventional, retrospective cohort study in patients who had a 12 month follow-up after a first HCCP treatment in the German Pain eRegistry. This analysis is part of a larger study and analyzes cohorts of pDPN patients. Patients were divided into groups based on the number of HCCP treatments received (1, 2, 3 or 4) and were followed for 12 months after the initial treatment. Effectiveness analyses focus on 1) decrease in average 24-hour pain intensity score (VAS), 2) change in sleep measured as part of the modified pain disability index (VAS), 3) change in affective distress assessed by the Depression, Anxiety and Stress Scale (DASS-21, 4), Quality of Life (QoL) as measured by the Veterans RAND-12 (VR-12): a 12 items scale that measures the status of physical [physical component score (PCS)] and mental health [mental component score (MCS)] and, 5) change in concomitant analgesic medication.

Results

In total 173, 189, 185 and 279 pDPN patients received 1, 2, 3 and 4 HCCP treatments, respectively. Relative decrease in pain intensity score was similar across cohorts after 1st HCCP treatment (between -25.6% and-26.7%). Thereafter cohorts diverged: pain intensity scores continued to decrease in cohorts continuing HCCP and increased in cohorts discontinuing HCCP. At month 12, relative changes (%) in average pain intensity scores compared to baseline were -2.0, -39.1, -69.6, -75.8 with 1, 2, 3 and 4 HCCP treatments. Similarly at month 12 relative change (% ) for mPDI sleep were +3.3, -32.1, -60.1, -73.1, for DASS-21 depression: +18.0, -13.9, -40.6, -55.1; for DASS-21 anxiety: +25.4, -13.9, -41.6, -54.3, for DASS-21 stress: +14.5, -14.6, -44.2, -54.6; for VR12-MCS: -26.7, +5.6, +26.8, +30.6 and for VR12-PCS: -28.7, +0.6, +19.9, +30.7. Finally, initially all patients used concomitant analgesic medication; after 12 months, 2.9%, 14.3%, 20% and 28.7% had stopped using this medication.

Conclusions

This cohort analysis of pDPN patients showed that repeated treatment with HCCP generated better treatment outcomes than a single HCCP treatment. As in literature, pain intensity scores and sleep impairment progressively decreased as treatment continued.[2] Additionally, our analysis indicates that as pain intensity decreases, QoL parameters and mood improve. This is evidenced by increases in physical and mental health subscales of the VR-12, and decreases in affective distress, as reflected by lower scores on the DASS-21 depression, anxiety, and stress scales. These improved outcomes are associated with significant decreases in concomitant analgesic medication use. Although it is difficult to disentangle cause and effect in longitudinal cohort studies without comparator group, the differential effect in cohorts treated with 1 vs 2, 3 and 4 treatments suggest a progressive response and that for optimal treatment effect multiple HCCP treatments are needed in patients with pDPN.

References

1.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
2.Freynhagen R, Argoff C, Eerdekens M, Engelen S, Perrot S. Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications. Pain Med. 2021 Oct 8;22(10):2324-2336.

Presenting Author

Mariëlle Eerdekens

Poster Authors

Mariëlle Eerdekens

MD

Grünenthal

Lead Author

E-mail

Michael A Überall (MD)

Institute of Neurological Sciences, Nürnberg, Germany.

Lead Author

E-mail

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

E-mail

tawfik Fajri

Laboratoires Grünenthal S.A.S.

Lead Author

E-mail

Samuel Allen

Averitas Pharma Inc Morristown NY USA

Lead Author

E-mail

Topics

  • Specific Pain Conditions/Pain in Specific Populations: Neuropathic Pain - Peripheral