Novartis has announced new late-breaking data demonstrating that Cosentyx (secukinumab) provides high levels of skin clearance and sustained efficacy in patients with moderate-to-severe plaque psoriasis while maintaining a favorable safety profile across three years.
The company say that the results of this study – the longest Phase III Cosentyx trial conducted to-date – were presented at the 24th Annual Congress of the European Academy of Dermatology and Venereology (EADV) in Copenhagen, Denmark. Cosentyx is the first fully human interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-to-severe plaque psoriasis.
In this extension study, 320 patients received Cosentyx in a fixed dosing schedule for three years. 69% achieved clear or almost clear skin (PASI 90) at year one. This response was extremely well maintained after three years with 64% of patients continuing to have a PASI 90 response. In addition, 43% of patients maintained completely clear skin (PASI 100) at year three (from 44% at year one). 83% achieved the standard treatment goal of PASI 75 skin clearance at three years.
“Psoriasis patients want therapies that maintain high levels of skin clearance over the long-term given the impact of the disease on their physical and psychological wellbeing,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “In these new data from our longest Phase III trial to date with Cosentyx, we are pleased to show patients were able to maintain clear or almost clear skin for up to three years.”
The PASI score assesses the reduction from baseline in the redness, scaling and thickness of psoriatic plaques and to what extent it affects each area of the body. PASI 75 has historically been considered the goal for psoriasis treatment. However, with newer treatments with increased efficacy, there is now a focus on PASI 90 (clear or almost clear skin) and PASI 100 (clear skin) as the ultimate goal for treatment, as recommended by clinical guidelines and regulatory authorities, expained the company.
Furthemore, in this study, Cosentyx had a favorable safety profile consistent with that observed in previous Phase III studies.
Novartis About the A2304E1 Extension Study (Cosentyx Extension Study to SCULPTURE and STATURE studies)
A2304E1 is a multicenter, double-blind and open-label, four-year extension to the pivotal Phase III SCULPTURE and STATURE studies. In SCULPTURE 642 patients who completed 52 weeks of treatment continued into the extension. During the core study, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of subcutaneous secukinumab 300 mg or 150 mg, administered either at a four-week fixed-interval (FI) regimen (320 patients) or in a retreatment-as-needed (RAN) regimen (322 patients). At entry into the extension, patients continued with the same blinded maintenance treatment regimen and dose that they had received in the SCULPTURE core study.
The primary objective of the extension study was to assess the long-term safety and tolerability of Cosentyx in patients with moderate-to-severe chronic plaque psoriasis. The secondary objective was to evaluate long-term efficacy of 300 mg and 150 mg Cosentyx administered in retreatment-as-needed versus fixed-interval regimens in patients who were PASI 75 responders at Week 12. Efficacy measures included proportion of patients achieving PASI 75, PASI 90 and PASI 100 as well as IGA mod 2011 0/1 responses.