Cosentyx (secukinumab) is a therapy developed by Novartis to treat ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). The treatment is approved in both the U.S. and Europe. Doctors also can use it to treat plaque psoriasis and psoriatic arthritis.
How does Cosentyx work?
AS is a chronic inflammatory condition. It can lead to pain and potentially permanent damage to the joints of the spine. In AS, the immune system mistakenly attacks healthy tissues, causing inflammation and damage.
Cosentyx is a type of biological “disease-modifying anti-rheumatic drug” (DMARD). These are treatments that directly act to modify the underlying cause of the condition by preventing, rather than just reducing, the inflammation.
The active component of Cosentyx is the secukinumab antibody, a protein that can interact with a highly specific target. Cosentyx targets interleukin-17A (IL-17A), a naturally occurring cytokine, or immune protein, that certain immune cells release. When IL-17A binds to its receptor IL-17, this triggers the inflammation response in tissues. By binding to IL-17A, Cosentyx prevents it from interacting with the IL-17 receptor and stops the signal for inflammation. This should lower inflammation and subsequently reduce the symptoms of AS and the potential for permanent damage.
Cosentyx in clinical trials
Researchers investigated Cosentyx for AS in 12 clinical trials.
The U.S. Food and Drug Administration (FDA) approved Cosentyx as an AS treatment based on the results of two key clinical trials. These were the MEASURE 1 and MEASURE 2 studies. The results of the trials appeared in the New England Journal of Medicine. Both trials used the proportion of patients with a 20% improvement in the Assessment of Spondyloarthritis International Society response criteria (ASAS20) at week 16 as a measure of effectiveness.
The randomized, double-blind, placebo-controlled Phase 3 MEASURE 1 trial (NCT01358175) enrolled 371 AS patients who were intolerant or were not responding to standard treatments. The trial took place at 67 sites in North America, South America, Europe, and Asia. Researchers assigned patients randomly to a high (150 mg) or low (75 mg) dose of Cosentyx, or a placebo, which they received as an injection under the skin. By week 16, the ASAS20 response rates were 61% and 60% respectively, in patients who received a high or low dose of Cosentyx. This was a significant increase in comparison to the placebo, where the ASA20 response rate was only 29%.
The randomized, double-blind, placebo-controlled Phase 3 MEASURE 2 clinical trial (NCT01649375) enrolled 219 AS patients. The trial took place at 53 sites in North America, Europe, and Asia. The results demonstrated that the higher (150 mg) dose of Cosentyx led to a significant improvement in the number of patients achieving an ASAS20 or higher response, compared to patients who received a placebo. By week 16, the ASAS20 response rates of patients on high doses of Cosentyx were 61%. This was 28% in the placebo group. Additional results from this trial that researchers published in the journal Annals of the Rheumatoid Diseases demonstrated that patients who did not receive prior anti-TNF treatments (another type of biological DMARD) responded well to high doses of Cosentyx. By week 16, 68.2% of Cosentyx-treated patients achieved ASAS20 compared to only 31.1% of patients who received a placebo.
Cosentyx received FDA approval as an AS treatment for patients ages 18 or older in January 2016, following its European marketing approval in November 2015. The FDA extended Cosentyx’s indications to active nr-axSpA in June 2020. The European Union had made a similar decision nearly two months earlier.
The most common side effects of Cosentyx are fevers, headaches, muscle aches, sore throat, blocked or runny nose, tiredness, and weakness.
Last updated: June 19, 2020
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