Psoriasis

Novartis psoriasis drug shows three-year efficacy

pharmafile | October 12, 2015 | News story | |  Cosentyx, EADV, Novartis, Secukinumab, psoriasis 

Novartis has announced new trial data confirming the efficacy of Cosentyx in patients with moderate-to-severe plaque psoriasis.

The results of the latest (and longest) Phase III Cosentyx trial conducted to date – a four-year extension to the SCULPTURE/STATURE study – in which 320 patients received Cosentyx in a fixed dosing schedule for three years, 69% achieving clear or almost clear skin as measured by the Psoriasis Area Severity Index (PASI) at year one. This response was well maintained after three years, with 64% of patients continuing to have a PASI 90 response. 

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. A PASI 90 score represents clear or almost clear skin.

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. Novartis says that in the latest trial, Cosentyx had a favourable safety profile consistent with that observed in previous Phase III studies.

The results were presented at the 24th Annual Congress of the European Academy of Dermatology and Venereology (EADV) in Copenhagen.

Psoriasis affects up to 3% of the world’s population, or more than 125 million people. Cosentyx (secukinumab) is the first fully human interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-to-severe plaque psoriasis. The treatment works inhibiting the action of the IL-17A protein, found in high concentrations in skin affected by the disease.

The treatment was approved in January 2015 (at a recommended dose of 300 mg in the EU/US) and remains the only first-line biologic approved for the systemic treatment of moderate-to-severe plaque psoriasis in adult patients in Europe.

Commenting on new trial data, Vasant Narasimhan, global head of development at Novartis, says: “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. 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.”

Joel Levy

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