Author Interviews, Dermatology / 04.10.2016
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.
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