How Cosentyx works
Cosentyx is a human monoclonal antibody that works by selectively blocking the cytokine interleukin-17A (IL-17A), which is a major driver of inflammation in psoriasis and various arthritic conditions. IL-17A plays a central role in the immune-pathological processes underlying psoriasis and arthritic diseases like psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis. By selectively blocking IL-17A, Cosentyx drug reduces inflammation and associated symptoms of these immune-mediated diseases.
Clinical trials and approvals
Cosentyx was first approved by the FDA in 2015 for the treatment of moderate to severe plaque psoriasis. Its efficacy and safety in treating psoriasis was demonstrated in four Phase III clinical trials involving over 2,500 patients. These studies showed Cosentyx drug achieving significantly higher rates of skin clearance and Psoriasis Area and Severity Index (PASI) 75/90/100 response compared to placebo or comparator biologics like Humira. Based on the positive trial results, Cosentyx received approvals globally for psoriasis.
In 2018, the FDA approved Cosentyx for treatment of psoriatic arthritis based on results from two Phase III clinical studies. Both studies met their primary endpoints showing Cosentyx to be statistically superior to placebo in improvements in the signs and symptoms of psoriatic arthritis at week 24. Cosentyx drug was also found to inhibit progression of structural damage to joints.
Cosentyx further received the FDA approval in 2019 for treatment of adult patients with active ankylosing spondylitis based on positive results from two Phase III studies in over 1,200 patients. Both these trials found Cosentyx to significantly improve symptoms and signs of ankylosing spondylitis compared to placebo.
Blockbuster sales and market share
Cosentyx drug has steadily gained market share in the dermatology and rheumatology biologics segment since approval.
According to IQVIA data, in the US psoriasis market, Cosentyx captured around 27% of new patient market share in 2020, second only to Humira. In the growing psoriatic arthritis market, Cosentyx’s new patient share was even higher at around 33% in 2020, making it the leading biologic treatment. With its expanded approvals, analysts expect Cosentyx drug sales to grow further driven by increased market penetration globally.
Positive long-term efficacy and safety data
Long-term extension studies of Cosentyx’s clinical trials out to 5 years have demonstrated the drug's sustained efficacy and favorable safety profile for psoriasis, psoriatic arthritis and ankylosing spondylitis. Up to 90% of patients with psoriasis and 79-88% of patients with arthritic conditions who completed 2 years of treatment maintained or improved their skin clearance, resolution of joint symptoms and physical function in the extended studies.
The safety profile of Cosentyx also remained consistent with no new safety risks observed over the long-term. The most common adverse reactions reported with Cosentyx treatment in clinical trials were nasopharyngitis, upper respiratory tract infection and diarrhea. Serious adverse reactions were reported in less than 2% of patients through 5 years. Cosentyx offers patients an effective biologic with reassuring long-term efficacy, safety and convenience of monthly dosing.
Patient preference and real-world usage
Surveys have shown that patients value the efficacy, convenience and safety profile offered by Cosentyx. Its monthly subcutaneous self-administration allows patients flexibility compared to intravenous biologics. Real-world evidence from large observational studies also support Cosentyx's effectiveness with over 80% of patients achieving ≥75% skin clearance and low switching rates in the real clinical setting over 12-24 months.
Cosentyx's clinical profile translating to high rates of treatment persistence, adherence and patient satisfaction in the real world has supported its rapid uptake since approval across markets. Its profile as a well-tolerated and highly effective biologic administered monthly by auto-injector or pre-filled syringe has made Cosentyx drug a preferred choice for patients and physicians alike in psoriasis, psoriatic arthritis and ankylosing spondylitis treatment.
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