Journal of Pain Research (Feb 2022)

Comparison of the Effectiveness and Tolerability of Nabiximols (THC:CBD) Oromucosal Spray versus Oral Dronabinol (THC) as Add-on Treatment for Severe Neuropathic Pain in Real-World Clinical Practice: Retrospective Analysis of the German Pain e-Registry

  • Ueberall MA,
  • Essner U,
  • Vila Silván C,
  • Mueller-Schwefe GHH

Journal volume & issue
Vol. Volume 15
pp. 267 – 286

Abstract

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Michael A Ueberall,1 Ute Essner,2 Carlos Vila Silván,3 Gerhard HH Mueller-Schwefe4 1Center of Excellence in Health Care Research of the German Pain Association, Institute of Neurological Sciences, Nuernberg, Germany; 2Medical Department, O. Meany Consultancy GmbH, Hamburg, Germany; 3Global Medical Affairs, Almirall S.A., Barcelona, Spain; 4Medical Head, Schmerz- und Palliativzentrum Göppingen, Göppingen, GermanyCorrespondence: Michael A UeberallCenter of Excellence in Health Care Research of the German Pain Association, Institute of Neurological Sciences, Nordostpark 51, Nuernberg, 90411, GermanyTel +49 911 21773760Fax +49 911 21773761Email [email protected]: To compare the effectiveness and tolerability of add-on treatment with nabiximols (NBX: delta-9-tetrahydrocannabinol: cannabidiol) oromucosal spray or oral dronabinol (DRO: synthetic tetrahydrocannabinol) in patients with severe neuropathic pain poorly responsive to established treatments.Methods: An analysis was conducted of anonymized, propensity score-matched real-world data from the German Pain e-Registry, using a sequential non-inferiority superiority approach, for adult outpatients with neuropathic pain who had initiated treatment with NBX or DRO between 10 March 2017 and 31 December 2019. The primary effectiveness variable was percent change from baseline in a 9-factor aggregated symptom relief (ASR-9) score, a composite index of nine distinct pain- and health-related parameters assessed using validated patient-reported instruments. Safety was assessed by the incidence of physician-confirmed treatment-related adverse events (TRAEs), and TRAEs leading to discontinuation.Results: Propensity score-matched data were analyzed for 337 patients treated with NBX and 337 patients treated with DRO. Mean (standard deviation) THC dose over the 24-week evaluation period was 16.6 (6.5) mg for NBX and 17.2 (7.6) mg for DRO (p< 0.001). Median (standard error) improvement relative to baseline in the ASR-9 composite score was 55.4% (0.5) for NBX and 40.5% (0.5) for DRO (least squares mean difference, 14.0 (0.7), 95% confidence interval 12.6– 15.4; p< 0.001), and incidences of TRAEs (21.1 vs 35%) and TRAE-related discontinuations (5.9 vs 14.8%) were significantly lower with NBX than DRO (p< 0.001 for both), collectively indicating pre-specified non-inferiority and superiority of NBX. More NBX- than DRO-treated patients discontinued non-cannabinoid background pain medications and rescue analgesics, especially opioid analgesics (p< 0.001 for both).Conclusion: Add-on treatment with cannabinoids is effective for treatment of severe neuropathic pain with inadequate response to established treatments. In daily practice, NBX had superior effectiveness and tolerability compared to DRO. The results emphasize the importance of combining CBD with THC in this patient population.Keywords: nabiximols, oromucosal spray, dronabinol, neuropathic pain, real-world data, German Pain e-Registry

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