Novartis announced results from the head-to-head CLARITY study showing the prevalence of Cosentyx (secukinumab) compared with Stelara (ustekinumab) in delivering clear skin in adults with moderate to- severe plaque psoriasis at 12 weeks.
The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) achieved both co-primary endpoints PASI 90 and IGA mod 2011 0/1, respectively, compared with 47.9% and 55.4% patients, respectively, treated with Stelara (p < 0.0001). At Week 12, patients receiving Cosentyx had significantly greater clear skin in adults with moderate-to-severe plaque psoriasis at 12 weeks r PASI 100 responses (key secondary objective) compared with those taking Stelara (38.1% versus 20.1%, respectively; p < 0.0001).
The study discoveries, which support previously presented information from the CLEAR study showing the superiority of Cosentyx over Stelara in achieving sustained skin clearance (PASI 90 response rates) at 52 weeks, were presented as an abstract at the Winter Clinical Dermatology Conference in Hawaii.
Response Rates of PASI:
Clear skin is the aim of psoriasis treatment, and a Psoriasis Area and Severity Index (PASI) 75, 90 or 100 response rates are viewed as an important measure of treatment achievement.
In the CLARITY study all key secondary endpoints were met. At Week 4, response rates of PASI 75 were more effective with Cosentyx compared to Stelara (40.2% versus 16.3%; p < 0.0001). At Week 16, Cosentyx showed significantly superior response rates compared to Stelara for PASI 75 (91.7% versus 79.8%; p < 0.0001), PASI 90 (76.6% versus 54.2%; p < 0.0001), PASI 100 (45.3% versus 26.7%; p < 0.0001), and IGA mod 2011 0/1 (78.6% versus 59.1%; p < 0.0001).
What is Cosentyx
Cosentyx is the first and only fully human IL-17A inhibitor approved to treat psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Cosentyx is a targeted treatment that particularly inhibits the IL-17A cytokine which assumes a significant role in the pathogenesis of plaque psoriasis, PsA and AS. Cosentyx is also approved for the most hard-to-treat forms of plaque psoriasis – palmoplantar (psoriasis of the palms of the hands and soles of the feet), nail psoriasis and scalp psoriasis.
Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability, a safety out to 5 years and convenient once-monthly dosing in a patient-friendly autoinjector.
Cosentyx Approved In Different Countries:
Cosentyx is approved in 80 nations for the treatment of moderate-to-severe plaque psoriasis, which includes the European Union nations, Japan, Switzerland, Australia, the US, and Canada.
Additionally, Cosentyx is the first IL-17A inhibitor approved in more than 70 nations for the treatment of active AS and PsA, which includes the European Union nations and the US. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.
The Superiority of Cosentyx:
Clearness (NCT02826603) is a 52-week, multicenter, randomized, double-blind study to show the superiority of Cosentyx (secukinumab) 300 mg versus Stelara (ustekinumab) in moderate-to-severe plaque psoriasis patients.
Co-primary endpoints were at least 90% improvement from Baseline Psoriasis Area and Severity Index (PASI 90) and Investigator’s Global Assessment (IGA) mod 2011 0/1 (clear or almost clear) response rates at Week 12. Key secondary goals included showing the superiority of secukinumab versus ustekinumab as for PASI 75 at Week 4; PASI 75 and 100 at Week 12; PASI 75, 90, 100 and IGA mod 2011 0/1 at Week 16.
As per approved label, missing values were dealt with by multiple imputations. Patients were randomized 1:1 to receive subcutaneous secukinumab 300 mg (n = 550) at Baseline, Weeks 1, 2 and 3, then every 4 weeks to 48, or ustekinumab (n = 552) 45 mg or 90 mg subcutaneously (depending upon body weight at randomization).