The three-year data were reported in a study, titled “Secukinumab 150/300 mg Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis: 3‐Year Results from the Phase 3 MEASURE 3 Study,” published in the journal ACR Open Rheumatology.
Cosentyx, developed and marketed by Novartis, is a biologic therapy approved for the treatment of AS in Europe and in the U.S. The medication works by blocking the activity of a pro-inflammatory molecule called interleukin-17A, reducing inflammation and easing AS symptoms.
A Novartis-sponsored Phase 3 trial called MEASURE 3 (NCT02008916) investigated the safety, tolerability, and efficacy of Cosentyx in 226 patients with active AS who had either never received anti-TNF (tumor necrosis factor) therapies, or had an inadequate response/intolerance to such treatments. Excess levels of TNF drive inflammation, and contribute to pain and swelling in the joints of the spine.
Once enrolled in the study, participants were randomly assigned to receive intravenous infusions (directly into the bloodstream) of Cosentyx at a dose of 10 mg/kg or a placebo. Treatment was given at the start of the trial and at week two and week four.
Following that, those assigned to Cosentyx continued receiving under-the-skin (subcutaneous) injections of the medication at a dose of 150 mg or 300 mg, every four weeks, until the end of the study. Participants in the placebo group received subcutaneous injections at weeks 8 and 12, and at week 16 were switched to every-four-week treatment with either 150 mg or 300 mg of Cosentyx.
The study’s main goal was to evaluate the proportion of patients who met the Assessment in SpondyloArthritis International Society (ASAS 20) response. This is defined as having an improvement of at least 20% in a minimum of three of four domains — patient global assessment of disease, pain, function, and inflammation — with no more than 20% worsening in the remaining domains.
Additional goals included assessing the proportion of participants who met the ASAS 40 response rate — improvement/reduction of at least 40% — and ASAS partial remission. Partial remission is scoring not more than 2.0 units in each of the four main ASAS domains, on a scale of 0-10.
Previous findings from MEASURE 3 showed that both doses of Cosentyx increased the percentage of patients achieving ASAS 20 at week 16 compared with placebo. These improvements were particularly noticeable among those who had never been treated with anti-TNF therapies.
In addition, improvements lasting up to week 52 — one year — were reported for most secondary outcomes assessed in the trial.
The new three-year findings — from patients initially assigned to Cosentyx as well those who switched from placebo at week 16 — showed that over half of those given 150 mg (68.2%) or 300 mg (75.0%) of Cosentyx achieved ASAS 20.
Approximately half of the patients treated with Cosentyx at a dose of 150 mg (47.7%) or 300 mg (56.5%) also achieved ASAS 40 at three years.
Improvements in secondary outcomes assessing more stringent clinical responses, such as ASAS partial remission, were higher among people receiving the highest dose of Cosentyx, particularly those who responded inadequately to anti-TNF therapies.
Cosentyx’s safety profile was consistent with findings from previous studies. No new safety concerns were identified and no deaths were reported in the course of the trial.
Altogether, these findings demonstrated that both dosing regimens of Cosentyx led to “sustained improvements in the signs and symptoms of active AS with a favorable and consistent safety profile through 3 years of treatment,” the researchers said.
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