Novartis' IL-17A Inhibitor Cosentyx Demonstrates Superior Efficacy and Quality of Life Benefits Over Janssen's IL-12/23 Inhibitor Stelara in Psoriasis

March 08, 2019/Bio ValleyBIOON/--Swiss pharmaceutical giantNovartis(Novartis) recently announced additional results from the head-to-head Phase III clinical trial CLARITY of its novel anti-inflammatory drug Cosentyx (secukinumab) at the 2019 American Academy of Dermatology (AAD) Annual Meeting held in Washington, D.C. The study was conducted in adult patients with moderate-to-severe plaque psoriasis and directly compared Cosentyx with Johnson & Johnson’s anti-inflammatory drug Stelara (ustekinumab). New data presented at the meeting showed that Cosentyx demonstrated advantages over Stelara in certain aspects of quality of life (QoL): a higher proportion of patients in the Cosentyx treatment group reported that their skin disease did not affect their QoL compared to those in the Stelara treatment group.

CLARITY was a 52-week, multicenter, randomized, double-blind study conducted in adult patients with moderate-to-severe plaque psoriasis to evaluate the superiority of Cosentyx versus Stelara. In the study, patients were randomized in a 1:1 ratio: the Cosentyx treatment group (n=550) received 300 mg subcutaneous injections at baseline, Week 1, Week 2, and Week 3, followed by 300 mg subcutaneous injections every 4 weeks from Week 4 to Week 48; the Stelara treatment group (n=552) received 45 mg or 90 mg subcutaneous injections according to the approved product label (based on body weight at randomization).

The newly released data show that the proportion of patients achieving Dermatology Life Quality Index (DLQI) 0/1 remission was higher in the Cosentyx group than in the Stelara group at both Week 12 and Week 16 (Week 12: 64.0% vs 51.7%, p < 0.0001; Week 16: 68.4% vs 55.9%, p < 0.0001).

Data from the CLARITY study, published in 2018, demonstrated that Cosentyx was more effective than Stelara in achieving clear or almost clear skin at Weeks 12 and 16. The safety profile of Cosentyx remained favorable and consistent. Previously published data also confirmed that Cosentyx was superior to Stelara in achieving sustained skin clearance (PASI 90 response rate) at Week 52.

These QoL results reinforce the findings of the SCULPTURE study published in 2018, demonstrating that two-thirds of patients with moderate-to-severe plaque psoriasis experienced no impact of skin disease on their quality of life within 5 years of treatment with Cosentyx (DLQI 0/1 remission rates: 72.7% at Year 1 and 65.5% at Year 5).

Psoriasis is not merely a cosmetic issue; it is a persistent, chronic (long-lasting), and sometimes painful disease that can even affect the smallest aspects of people's daily lives.NovartisImmunologySam Khalil, Global Head of Medical Affairs for Hepatology and Dermatology, stated, “We are proud to have achieved significant improvements in quality-of-life data, which reinforce our confidence in Cosentyx as a comprehensive treatment regimen for patients with psoriasis. More than two-thirds of patients with psoriasis experience persistent manifestations beyond skin plaques, including nail, scalp, palmoplantar psoriasis, and joint involvement. Our goal is to provide therapies that address all these symptoms with proven long-term safety and efficacy, thereby improving the quality of life for patients with psoriasis.”

Cosentyx byNovartisAs the first and only fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A), it can selectively block the activity of circulating IL-17A, reduce immune system activity, and improve disease symptoms. Studies have revealed that IL-17A drives the body in variousAutoimmunityplay an important role in the immune response of inflammatory diseases, including psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).

Cosentyx was approved for marketing in January 2015 and has currently been approved for three indications (PsO, PsA, AS). In 2018, global sales of Cosentyx reached $2.837 billion, representing a 37% increase compared to 2017. According to forecasts by the pharmaceutical market research firm EvaluatePharma, Cosentyx will become a driving forceNovartisAs one of the key products for future growth, Cosentyx’s sales are expected to grow steadily in the coming years with a steady expansion of indications, with global sales projected to reach $5.5 billion in 2024.

Stelara, marketed by Johnson & Johnson, targets and binds to interleukin-12 (IL-12) and interleukin-23 (IL-23). By binding to the p40 subunit shared by IL-12 and IL-23, Stelara prevents their interaction with the IL-12β1 receptor on the cell surface, thereby inhibiting these two pro-inflammatory cytokines. IL-12 and IL-23 are naturally occurring proteins believed to play a key role in immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and systemicLupus Erythematosusetc.

Stelara is Johnson & Johnson's entry intoAutoimmunityAs a core product in the field of immune-mediated diseases, Stelara was launched in 2009. Its currently approved indications include plaque psoriasis, psoriatic arthritis, and Crohn’s disease (CD). In 2018, global sales of Stelara reached $5.156 billion, representing a 28.5% increase from 2017. EvaluatePharma had previously predicted that Stelara’s global sales would reach $6.466 billion in 2024. (Bioon.com)

Original Source:Novartis Cosentyx? shows superior improvements in psoriasis patients' quality of life versus Janssen's IL-23 Stelara?*