Key clinical trials of Novartis psoriasis drug show positive therapeutic effects
January 17, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Novartis today revealed the results of the CLARITY trial, which showed that Cosentyx (secukinumab) showed skin clearance at 12 weeks in adults with moderate to severe plaque psoriasis compared with Stelara (ustekinumab). And almost cleared the effect.
Psoriasis is a common, non-infectious, autoimmune disease that affects more than 125 million patients worldwide. Plaque psoriasis is the most common form of disease, and skin tissue presents red patches covering white dead skin cells. Psoriasis is not only a cosmetic problem, but it also causes pain in patients for a long time, affecting every aspect of life every day; up to 30% of patients with psoriasis may also develop disease. More seriously, psoriasis can also cause psoriatic arthritis (PsA), which causes pain, stiffness, and irreversible joint damage. The study found that psoriasis is also associated with other serious health conditions such as diabetes, heart disease and depression.
Novartis's fully humanized monoclonal antibody, Cosentyx, was launched in January 2015 and is a targeted therapeutic regimen that specifically inhibits interleukin-17A (IL-17A) cytokines. Studies have shown that IL-17A may play an important role in promoting the inflammatory state of autoimmune reactions in diseases such as psoriasis, psoriatic arthritis and ankylosing spondylitis (AS). Cosentyx has been approved for the treatment of moderate to severe plaque psoriasis in 75 countries, including the United States, Canada, the European Union, Japan, Switzerland and Australia. In the European Union, Cosentyx is approved for first-line systemic treatment in adults with moderate to severe plaque psoriasis. In the United States, Cosentyx is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic or phototherapy regimens. Cosentyx is also the first IL-17A inhibitor approved in more than 70 countries for the treatment of active PsA and AS. In Japan, Cosentyx is also approved for the treatment of PsA and pustular psoriasis.
In clinical studies, Cosentyx has been shown to provide long-lasting skin cleansing, up to 5 years of continuous response and good safety, while being conveniently administered in patient-friendly autoinjectors. Cosentyx has been specifically developed for the treatment of the most difficult form of plaque psoriasis - palmoplantar psoriasis (hand and foot psoriasis), scalp psoriasis and nail psoriasis
CLARITY (NCT02826603) is a 52-week, multicenter, randomized, double-blind study evaluating the efficacy of Cosentyx 300 mg in patients with moderate to severe psoriasis compared with controls. The primary primary endpoint of the study was a 90% improvement in the rate of relief from the baseline psoriasis lesion and severity index at week 12 (PASI 90) and the Investigator Global Assessment (IGA) 2011 0/1 (clear or almost cleared) ). Key secondary endpoints included the advantages of Cosentyx compared to the control drug, 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. .
Skin cleansing is the target of psoriasis treatment, and the psoriasis area and severity index (PASI) 75, 90 or 100 response is considered to be an important indicator of treatment success. The results of the study showed that 66.5% and 72.3% of patients treated with Cosentyx achieved a common primary endpoint of PASI 90 and IGA mod 2011 0/1, respectively, and 47.9% and 55.4% of patients receiving control medication (p < 0.0001). All key secondary endpoints in the CLARITY study were met. At week 4, Cosentyx patients had significantly better PASI 75 than the control drug (40.2% vs. 16.3%; p < 0.0001). At week 12, patients receiving Cosentyx had significantly higher PASI 100 response than patients receiving control drug (38.1% vs 20.1%, P < 0.0001). In the 16th week, Cosentyx also showed superiority, PASI 75 (91.7% vs. 79.8%; P <0.0001), PASI 90 (76.6% vs. 54.2%; P <0.0001), PASI 100 (45.3% vs 26.7%; p <0.0001) and IGA mod 2011 0/1 (78.6% vs. 59.1%; p <0.0001).
â–² Dr. Mark Lebwohl has a high opinion on the efficacy of this drug (Source: Icahn School of Medicine at Mount Sinai)
Dr. Mark Lebwohl, director of the dermatology department at the Icahn School of Medicine at Mount Sinai Hospital in New York, said: "These data add to the strong evidence supporting the use of Cosentyx for the treatment of moderate to severe plaque psoriasis. With these findings, clinicians can Have greater confidence in using Costentyx in their treatment plan."
We congratulate this new psoriasis drug for its positive results, and hope that this new drug will enable more patients with psoriasis to get rid of the disease and improve their quality of life.
Reference materials:
[1] Novartis' Cosentyx Beats Johnson & Johnson's Stelara in Head-to-Head Trial
[2] Novartis new data reinforces superiority of Cosentyx® versus Stelara®* in achieving skin clearance for psoriasis patients
[3] WuXi PharmaTech WeChat public number - Novartis IL-17 inhibitor Cosentyx treatment of severe plaque psoriasis 5 years of large-scale research results announced
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