Real-world efficacy of Qutenza confirms Phase III trial results
New data from two large observational studies have pointed to the efficacy of Astellas Pharma's Qutenza 8% capsaicin patch in managing peripheral neuropathic pain (PNP) in a real-world setting, improving quality of life and reducing healthcare resource use, according to studies presented at the World Congress on Pain in Milan, Italy.
A Swedish observational study showed the efficacy and tolerability of Qutenza in 211 non-diabetic patients with different PNP conditions, including partial peripheral nerve injury, which can be caused by trauma or as the result of surgery. The study found that average pain intensity using the Numeric Pain Rating Scale (NPRS) over 24 hours at baseline had a mean of 6.3 (SD 1.8). The mean change from baseline to 14 to 90 days post-treatment (maximum pain reduction at any time point during this period) was -1.77 (SD 2.36), (95 per cent CI. (-2.10 - -1.44)), p<0.001. In addition, 29 per cent of patients in the study found that they felt their pain had decreased by 50 per cent or more and 37 per cent recorded a 30 per cent or more reduction in pain, while 51 per cent of patients found some improvement in their overall status following treatment with Qutenza, using the Patient Global Impression of Change (PGIC) scale. Furthermore, 59 per cent of patients asked for re-treatment with Qutenza and 14 per cent of all patients did not seek re-treatment due to unsatisfactory pain relief.
Neuropathic pain is a complex and difficult to treat disorder that can have a detrimental effect on a patient's quality of life. It is estimated that only around none-third of patients receiving treatment for the condition achieve adequate pain relief. A series of three posters presented at the World Congress on Pain showed that Qutenza could provide adequate pain relief with reduced need for other pain medications, and lead to improvements in quality of life for patients. The data were drawn from a prospective observational study of 258 patients with PNP who received treatment in the Czech Republic.
Qutenza was shown to lead to statistically significant improvements in quality of life for patients who had previously been treated for their neuropathic pain. The mean values for quality of life among the patients in the study before treatment with Qutenza was 0.51 (SD 0.19) using the EQ-5D questionnaire and 51.0 (SD 16.7), according to the visual analogue scale. Three months after a single treatment with Qutenza, mean values for quality of life had significantly increased to 0.63 (SD 0.17, p<0.001) and 61.5 (SD 18.2, p<0.001), respectively.
Use of Qutenza enables patients to reduce use of concomitant medications and lead to reduced hospital stay, potentially resulting in cost offset or savings. It was observed that 17.8 per cent of patients who were already receiving treatment for their neuropathic pain were able to stop these medications after treatment with the capsaicin 8% patch. In the previous 12 months, 96.9 per cent of patients in the study had been on treatment for neuropathic pain. Three months after a single treatment with Qutenza, the percentage of patients on other medication had decreased to 79.7 per cent. There was a 54.5 per cent decrease in the probability of neuralgia-associated hospitalisation, and a 65.6 per cent decrease in the duration of any stay in hospital (from 13.1 to 4.5 days).
The Qutenza 8% capsaicin patch uses a synthetic form of capsaicin, the substance found in chilli peppers that gives them their 'heat', to change the way the pain-sensing nerves work in the area of skin affected. The efficacy and safety of the patch have been investigated in a comprehensive clinical trial programme involving 1,327 patients who received at least one application. Pain relief following application of Qutenza can take up to two weeks to take full effect and can last for up to 12 weeks following a single application. Significant reductions in pain have been achieved with the patch when used alone or in combination with other treatments for pain.
Qutenza is approved by the European Medicines Agency for the treatment of PNP in non-diabetic adults either alone or in combination with other medicinal products for pain. It is currently available in 22 countries across Europe. Phase III studies in painful diabetic neuropathy and long-term safety studies are ongoing.