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Efficacy of NGX-4010 (QUTENZA), an 8% capsaicin patch, in patients with HIV-associated distal sensory polyneuropathy: results of integrated analyses
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Vienna July 2010 IAC
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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Evaluation of the effect of NGX-4010 (QUTENZA), an 8% capsaicin patch, on neurosensory function in patients with HIV-associated distal sensory polyneuropathy: results of integrated analyses
D. Simpson1, D. Clifford2, S. Brown3, J. Tobias4, G.F. Vanhove4
1Mount Sinai School of Medicine, Neurology, New York, NY, United States, 2Washington University School of Medicine, Neurology, St Louis, United States, 3AIDS Research Alliance, Los Angeles, United States, 4NeurogesX, Inc., San Mateo, United States
Background: HIV-associated distal sensory polyneuropathy (HIV-DSP) is a serious morbidity of HIV infection. It has been reported that HIV-DSP affects >50% of patients with HIV and of those affected, almost 40% present with pain.1 NGX-4010 (QUTENZA) is an 8% capsaicin patch that has been approved in the EU for peripheral neuropathic pain in non-diabetic adults.
Methods: Data were derived from 205 patients treated with NGX-4010 in five HIV-DSP studies, including 180 HIV-DSP patients treated more than once. At screening, Week 12/termination and Week 48/termination (for patients enrolled in open-label re-treatment studies), deep tendon reflexes, sharp, vibration, and warm sensations were evaluated in the treatment area. Change from screening was categorised as decreased, no change, increased or increased above normal (deep tendon reflexes only). A Cochran-Mantel-Haenszel correlation test was used to test for differences in proportions of patients in each change category between NGX-4010 and control and by number of treatments received. In addition, analyses were performed in 38 patients treated with up to eight treatments with a median follow-up duration of 30 months.
Results: Most NGX-4010 patients had no change in neurosensory function from screening to Weeks 12 or 48 and of those patients showing a change, most had an improvement in neurosensory function. There were no trends in change in neurosensory function by number of treatments received. Similarly, longer-term (follow-up range 7-43 months) safety data collected in 38 patients showed no detrimental effects of up to eight exposures on neurosensory function.
Conclusions: Single and repeated treatment with NGX-4010 does not appear to further impair neurosensory function in patients with HIV-DSP.
1. Ellis RJ, et al. Persisting high prevalence of HIV-DSP in the era of combination ART: Correlates in the CHARTER study. Conference on retroviruses and opportunistic infections; 8-11 February 2009; Montreal, Canada.
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