Novartis Announces Updated Analysis from Phase III NATALEE Trial

Updated results show Cosentyx significantly improved signs and symptoms of axial spondyloarthritis

Data presented at the Annual European Congress of Rheumatology (EULAR 2023)

Basel, June 23, 2023 – Novartis today announced updated results from the Phase III NATALEE trial, which evaluated the efficacy and safety of Cosentyx® (secukinumab) in patients with active axial spondyloarthritis (axSpA) who had an inadequate response or were intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

The updated results, presented at the Annual European Congress of Rheumatology (EULAR 2023), showed that Cosentyx significantly improved signs and symptoms of axSpA, including pain, stiffness, and function. Cosentyx also significantly reduced inflammation in the spine and sacroiliac joints, as measured by magnetic resonance imaging (MRI). The safety profile of Cosentyx was consistent with previous studies.

"These updated results from the NATALEE trial provide further evidence of the efficacy and safety of Cosentyx in patients with axSpA," said John Tsai, MD, Global Head of Medical Affairs, Immunology, Hepatology and Dermatology at Novartis. "Cosentyx is a targeted biologic therapy that has been shown to significantly improve signs and symptoms of axSpA, including pain, stiffness, and function. We are committed to continuing to research Cosentyx to further understand its potential benefits for patients with axSpA."

AxSpA is a chronic inflammatory disease that affects the spine and sacroiliac joints. It can cause pain, stiffness, and difficulty with movement. AxSpA is a type of spondyloarthritis, which is a group of related conditions that affect the joints, tendons, and ligaments.

Cosentyx is a fully human monoclonal antibody that inhibits interleukin-17A (IL-17A), a cytokine that plays a key role in the inflammatory process. Cosentyx is approved for the treatment of axSpA in the United States, the European Union, and other countries.

The NATALEE trial is a Phase III, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of Cosentyx in patients with active axSpA who had an inadequate response or were intolerant to NSAIDs. The trial enrolled 422 patients who were randomized to receive Cosentyx 300 mg or placebo every four weeks for 16 weeks. The primary endpoint of the trial was the proportion of patients who achieved an Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 16. ASAS40 is a measure of improvement in signs and symptoms of axSpA.

The updated results from the NATALEE trial showed that Cosentyx significantly improved signs and symptoms of axSpA, including pain, stiffness, and function. Cosentyx also significantly reduced inflammation in the spine and sacroiliac joints, as measured by MRI. The safety profile of Cosentyx was consistent with previous studies.

The updated results from the NATALEE trial provide further evidence of the efficacy and safety of Cosentyx in patients with axSpA. Cosentyx is a targeted biologic therapy that has been shown to significantly improve signs and symptoms of axSpA, including pain, stiffness, and function. Novartis is committed to continuing to research Cosentyx to further understand its potential benefits for patients with axSpA.