How Cosentyx works
AS is a chronic inflammatory condition that can cause pain and potentially permanent damage to the joints of the spine. The inflammation is caused by the immune system mistakenly attacking healthy tissues.
It is a type of biological “disease modifying anti-rheumatic drug” (DMARD). These are drugs 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 is designed to interact with a highly specific target. Cosentyx targets interleukin-17A (IL-17A), a naturally occurring cytokine, or immune protein, that is released by certain immune cells. 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 from being passed.
This should result in reduced levels of inflammation, leading to reduced symptoms of AS and reduced potential for permanent damage.
Cosentyx in clinical trials
It has been investigated as an AS therapy 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, MEASURE 1 and 2; results were published in the New England Journal of Medicine. Both trials used the proportion of patients with a 20 percent 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 clinical 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. Patients were assigned randomly to a high (150 mg) or low (75 mg) dose of Cosentyx, or a placebo, administered as an injection under the skin. By week 16, the ASAS20 response rates were 61 and 60 percent, respectively, in patients given a high or low dose of Cosentyx, a significant increase compared to the placebo, where only 29 percent of patients responded.
The randomized, double-blind, placebo-controlled Phase 3 MEASURE 2 clinical trial (NCT01649375) enrolled 219 AS patients. The trial, which is still ongoing, took place at 53 sites in North America, Europe, and Asia. The trial is expected to be completed by October 2018. The results demonstrated that the higher (150 mg) doses of Cosentyx were associated with a significant improvement in the number of patients achieving an ASAS20 or higher response, compared to patients given a placebo. By week 16, the ASAS20 response rates of patients on high doses of Cosentyx were 61 percent, compared to 28 percent in the placebo group.
Further results from this trial, published in the journal Annals of the Rheumatoid Diseases, demonstrated that patients who had not been given prior anti-TNF treatments (another type of biological DMARD) responded well to high doses of Cosentyx. By week 16, 68.2 percent of Cosentyx-treated patients achieved ASAS20 compared to only 31.1 percent of patients given a placebo.
The most common side effects of Cosentyx are fevers, headaches, muscle aches, sore throat, blocked or runny nose, tiredness, and weakness.
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