04 Oct Cosentyx Offers Longer-Term Treatment Option for Patients With Moderate To Severe Plaque Psoriasis
MedicalResearch.com Interview with:
Craig Leonardi, MD
Adjunct Professor of Dermatology
Saint Louis University School of Medicine
Saint Louis, Missouri
MedicalResearch.com: What is the background for this study?
Response: A2304E1 is a multicenter, double-blind and open-label extension study to evaluate the long-term safety and efficacy of Cosentyx in patients with moderate to severe plaque psoriasis. Patients who completed 52 weeks of the core SCULPTURE and STATURE studies and re-consented to treatment were eligible for the extension, and continued the same Cosentyx dose and regimen that they were receiving in their core study. Patients did not have to achieve a PASI 75 response at the end of their core study to enroll.
A total of 642 patients entered the extension study: 168 continued on Cosentyx 300 mg every 4 weeks, 152 continued on Cosentyx 150 mg every 4 weeks, 172 continued on Cosentyx 300 mg retreatment-as-needed, and 150 continued on Cosentyx 150 mg retreatment-as-needed. At the end of Week 156, the study was open-label and patients could continue their assigned dose and regimen or switch to 300 mg every 4 weeks based on the investigator’s judgment.
Results presented at EADV focus on those patients from the SCULPTURE core study who enrolled in the extension study. The primary endpoint of this extension study was overall safety and tolerability. Secondary efficacy measures included the proportion of patients achieving PASI 75, PASI 90 and PASI 100.
MedicalResearch.com: What are the main findings?
Response: In the SCULPTURE extension study, almost clear skin (PASI 90) was achieved by 68.5% of patients at Year 1 (Week 52) and 61.9% of patients at Year 3 (Week 156), and was maintained at Year 4 (Week 208) in 66.4% of patients. In addition, completely clear skin (PASI 100) was achieved by 43.8% of patients at Year 1 and 41.7% of patients at Year 3, and was maintained at Year 4 in 43.5% of patients. The historic standard goal of treatment, PASI 75 skin clearance, was achieved by 88.9% of patients at Year 1 and 78.4% of patients at Year 3, and was maintained by 88.5% of patients at Year 4. All results presented at EADV were for the Cosentyx 300 mg every 4 weeks group.
The most common adverse events (AEs) at Year 4 were nasopharyngitis (12.1%) and upper respiratory tract infection (3.5%) and were similar to those observed at Year 1.
MedicalResearch.com: What should readers take away from your report?
Response: The four-year study, the longest running study for an IL-17A inhibitor, adds to a growing body of evidence that Cosentyx is an important longer-term treatment option for patients with moderate to severe plaque psoriasis.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: It is important that we continue to study newer medicines over the long term to confirm if efficacy is maintained. I look forward to seeing additional Cosentyx data over the coming years including the results from the five year SCULPTURE extension study.
MedicalResearch.com: Is there anything else you would like to add?
Response: Psoriasis is a chronic condition causing itching, scaling and pain and patients need therapies, like Cosentyx, that keep delivering high levels of skin clearance over time.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
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