Cosentyx Safe, Effective Through 5 Years of Treatment, Novartis Announces

Five-year treatment with Cosentyx (secukinumab) is safe and effective in easing signs and symptoms of ankylosing spondylitis (AS), according to results of a Phase 3 extension clinical trial.

This new data are scheduled to be presented Oct. 23 at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois.

Cosentyx is a therapy approved by the U.S. Food and Drug Administration for adults with AS, as well as for adults with psoriatic arthritis or plaque psoriasis.

Developed by Novartis, Cosentyx is a human monoclonal antibody that selectively targets and blocks interleukin-17A, a protein produced by the immune system that contributes to the inflammatory process involved in active AS and active psoriatic arthritis.

By clocking this protein, Cosentyx reduces inflammation, easing AS symptoms and reducing the potential for permanent damage.

MEASURE 1 was a two-year, randomized, placebo-controlled Phase 3 clinical study (NCT01358175) that evaluated the safety and effectiveness of two doses (75 mg and 150 mg) of Cosentyx in 371 AS patients who were intolerant of, or not responding to, standard treatments.

The trial’s primary objective was to determine the proportion of patients who met the Assessment of Spondyloarthritis International Society response criteria (ASAS20) — defined as an improvement of at least 20% in at least three of four main ASAS domains — at week 16, as a measure of effectiveness.

By week 16, around 60% of patients receiving either dose met the ASAS20 response criteria, compared to 29% of patients receiving placebo.

Patients in the placebo group were randomized again to receive one of the two doses of Cosentyx based on their ASA20 response, with non-responders being switched to Cosentyx at week 16, and responders at week 24.

From a total of 290 patients who completed the trial, 274 entered a three-year extension study (NCT01863732), where the long-term impact of Cosentyx was evaluated.

The long-term data of Cosentyx will be presented in a scientific poster titled “Long-Term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial.”

Among the 274 patients, 146 of them were receiving the lower dose of Cosentyx and 128 were receiving the higher dose. More than 80% of patients receiving either dose completed the five-year treatment (the two years of the MEASURE 1 study plus the three-years of the extension).

At week 168 (shortly after the beginning of the extension study), 82 patients (56%) on Cosentyx 75 mg were escalated to Cosentyx 150 mg.

After five years of treatment, Cosentyx showed a consistent therapeutic benefit in AS patients, with about 90% of patients receiving either dose achieving an ASAS20 response, and about 70% showing a 40% improvement in the ASAS criteria (ASAS40).

Improvements in other measures of effectiveness also were sustained in both groups through five years of treatment.

A year after switching from 75 mg to 150 mg of Cosentyx, a larger proportion of those patients were found to meet the ASAS20 and ASAS40 criteria, as well other effectiveness measures.

Cosentyx was well-tolerated over long-term use, with a consistent safety profile over the course of the five-year study, and consistent with that previously reported in clinical trials.

“Five-year data is often seen as a benchmark for proving long-term efficacy and safety,” Eric Hughes, Novartis’ global development unit head of immunology, hepatology and dermatology, said in a press release.

“We are reinforcing the robust profile of Cosentyx and reimagining the standard of care for patients who search for a complete treatment for [AS]” he added.

Novartis also will present positive five-year data from the extension part of the Phase 3 FUTURE 1 study (NCT01392326), evaluating the safety and effectiveness of Cosentyx in patients with active psoriatic arthritis.