Study Supports Efficacy of Cosentyx for Patients in China, Other Countries
Cosentyx (secukinumab) is a safe and effective treatment for ankylosing spondylitis (AS), producing similar results in Chinese patients compared to other populations, a Phase 3 study indicates.
The study, “Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis,” was published in the Chinese Medical Journal. It was funded by Novartis, which markets Cosentyx.
AS is characterized by inflammation in the joints of the spine. Cosentyx is designed to work by blocking interleukin-17A, a signaling molecule that promotes inflammation.
In prior clinical trials, the treatment provided sustained improvements in AS symptoms. Cosentyx is approved to treat AS in more than 90 countries, including the U.S. and the European Union.
In the new study, researchers reported results from MEASURE 5 (NCT02896127), a Novartis-sponsored Phase 3 trial designed to further evaluate the efficacy and safety of Cosentyx.
MEASURE 5 enrolled 458 people with AS. Most (71.4%) of the participants were from China. The remainder were from the Czech Republic, Republic of Korea, or U.K.
At study enrollment, demographic and disease characteristics were similar among Chinese and non-Chinese participants — more than 80% of participants were men, and about 20% had been treated with a TNF inhibitor.
Participants were randomly assigned to receive Cosentyx (150 mg, 305 participants) or a placebo (153 patients), given via under-the-skin injection once per week for the first four weeks, then every four weeks. At week 16, participants originally given the placebo were switched to Cosentyx, and the study continued for a total of 52 weeks (one year). A follow-up visit took place 12 weeks after the last dose.
More than 95% of participants completed the first 16 weeks of the study, and over 90% completed the one-year study. The most common reason for study withdrawal was participant decision.
The trial’s main measurement of efficacy was the proportion of patients with a 20% improvement in the Assessment of Spondyloarthritis International Society response criteria (ASAS20) at week 16. ASAS20 is defined as an improvement of at least 20% in a minimum three of four categories: global assessment of disease, pain, function, and inflammation.
Significantly more participants on Cosentyx, relative to the placebo, experienced ASAS20 (58.4% vs. 36.6%). Similar differences were found among Chinese and non-Chinese participants.
Secondary efficacy measurements also showed Cosentyx to be more effective than the placebo. For example, the number of participants with inactive disease — as determined by the Ankylosing Spondylitis Disease Activity Score (ASDAS) combined with the levels of the inflammatory marker C-reactive protein (CRP) — was significantly higher after 16 weeks in the Cosentyx group than in the placebo group (14.8% vs. 3.3%). Again, results were similar for Chinese and non-Chinese participants.
The efficacy seen at 16 weeks was generally maintained or improved after one year of treatment. For instance, more than a quarter of all participants had inactive disease after one year of therapy.
After 16 weeks of treatment, rates of adverse events were similar among participants given Cosentyx (67.8%) or a placebo (59.5%). The most common adverse events in both groups were upper respiratory tract infection, hyperlipidemia (high blood cholesterol levels), and nasopharyngitis, or common cold.
Over the entire study, 80.4% of participants reported at least one adverse event. The most common events at 16 weeks were also the most common in the study as a whole. Serious adverse events were reported by 7.3% of participants, with the most common being infections.
“Secukinumab [Cosentyx] 150 mg demonstrated a rapid and significant improvement in the signs and symptoms of AS in both the overall and Chinese populations,” the researchers wrote. “Secukinumab was well-tolerated with no new or unexpected safety signals identified.”