Efficacy of NGX-4010 (QUTENZA®), an 8% capsaicin patch, in patients with HIV-associated distal sensory polyneuropathy: results of integrated analyses
G. Moyle1, D.M. Simpson2, D. Clifford3, S. Brown4, B. Brew5, B. Conway6, J. Tobias7, G. Vanhove8
1Chelsea and Westminster Hospital, HIV, London, United Kingdom, 2Mount Sinai Medical Center, Neurology, New York, United States, 3Washington University School of Medicine, Neurology, St Louis, United States, 4AIDS Research Alliance, Los Angeles, United States, 5St Vincent's Hospital Sydney Ltd, Neurology, Sydney, Australia, 6University of British Colombia Infectious Diseases Clinic, Vancouver, Canada, 7NeurogesX, Inc., San Mateo, United States, 8NeurogesX, Inc., Clinical Development, San Mateo, United States
Background: HIV-associated distal sensory polyneuropathy (HIV-DSP) is a serious morbidity of HIV infection. NGX-4010 (QUTENZA®) is an 8% capsaicin patch, approved in the EU for peripheral neuropathic pain in non-diabetic adults. The recommended treatment duration is 30 minutes for the feet and 60 minutes for other locations. Integrated analyses evaluated the efficacy of a 30-minute application to the feet in patients with HIV-DSP.
Methods: Integrated analyses from two randomised, double-blind, 12-week controlled HIV-DSP trials included 239 patients receiving a single 30-minute treatment with NGX-4010 and 100 patients receiving a 0.04% capsaicin control patch. Patients recorded their 'average pain for the past 24 hours' daily using the Neuropathic Pain Rating Scale (NPRS) and completed the subject-rated Patient Global Impression of Change (PGIC) at study conclusion. The percentage change in average NPRS score from baseline to Weeks 2-12 was compared between treatment groups using a gender-stratified ANCOVA model with baseline pain score as the covariate. The percentage of patients with ≥30% reduction in NPRS score or a decrease of ≥2 units from baseline to Weeks 2-12 was compared using logistic regression with baseline pain and gender as covariates. The PGIC was compared using a Cochran-Mantel-Haenszel test. Safety was monitored by adverse events (AEs).
Results: During Weeks 2-12, NGX-4010 reduced the NPRS score 27.0% versus 15.7% for control (p=0.0020); 39% of NGX-4010 patients experienced a ≥30% reduction in NPRS score (23% in control, p=0.0051); 37% of NGX-4010 patients had a decrease of ≥2 units (24% in control, p=0.0284); 36% of NGX-4010 patients reported being much or very much improved on the PGIC (22% in control, p< 0.0001). Mild-to-moderate, transient application site pain and erythema were the most common AEs.
Conclusions: A single 30-minute NGX-4010 application reduces neuropathic pain associated with HIV-DSP for 12 weeks and is well tolerated.
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