First IL-17A inhibitor PBS listed for non-radiographic axial spondyloarthritis

Pharma News: Novartis Australia’s psoriasis drug is now on the Pharmaceutical Benefits Scheme (PBS) for the treatment of adult patients (aged ≥ 18 years) with active non-radiographic axial spondyloarthritis (nr-axSpA).

Eligible patients for Cosentyx (secukinumab), a fully-human monoclonal antibody, must have objective signs of inflammation (OSI) – evidenced by elevated C-reactive protein (CRP) and magnetic resonance imaging (MRI) – and have had an inadequate response to, or are intolerant to, at least two non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a period of three months.

“Until now, we’ve only had access to one class of biologic therapy, to treat patients with nr-axSpA,” said Stephen Hall, Adjunct Professor Monash University. “While current advanced therapies have transformed the management of nr-axSpA; around 30-40% of patients don’t achieve a good clinical response, either failing to respond or tolerate the treatment, only achieving a partial response or seeing the treatment lose efficacy over time.”

“As a chronic, debilitating and lifelong condition, there is a significant unmet need for additional biologic treatments for nr-axSpA which can help to improve the signs and symptoms of the disease and prevent joint damage,” Stephen Hall said.

While the medical community has been treating AS (the radiographic form of axSpA) for some time, increased use of MRIs has led to identification of the disease at an earlier stage, before structural damage of the spine and sacroiliac joints has occurred. It has now widely accepted nr-axSpA and AS are two consecutive stages of the same disease, with earlier diagnosis and management of nr-axSpA critical to limiting spinal damage and improving a patient’s long-term, health-related quality of life (HRQoL).

“As nr-axSPA typically manifests as general back pain, it can often go undiagnosed for long periods of time; leading to disease progression before effective management and treatment can be administered,” said Stephen Hall.

“Many nr-axSpA patients experience a delay in diagnosis of up to eight years, with 50% expected to see their disease progress and develop into AS, causing significant inflammation, pain and structural damage of the spine.”

Richard Tew, Country President, Novartis Australia and New Zealand said “Novartis welcomes the PBS listing of Cosentyx for Australian adults with active non-radiographic axial spondyloarthritis, the 4th indication for Cosentyx.

“Non-radiographic axial spondyloarthritis is an under-recognised disease that has a significant impact on patients’ life. Today’s announcement ensures clinicians and patients have access to a different class of treatment, providing greater choice for the management of nr-axSpA,” he added.

The PBS listing of Cosentyx for nr-axSpA is based on the efficacy and safety outcomes from the PREVENT clinical trial; a Phase III randomised, double-blind, placebo-controlled study of 555 adults patients with active nr-axSpA from 24 countries, including five trial sites in Australia. To date, PREVENT is the largest randomised controlled trial of a biologic therapy in nr-axSpA.

The study met both primary endpoints, achieving a higher ASAS40 response in the Cosentyx loading dose group (41.5%) compared with the placebo group (29.2%) at week 16 (P = 0.0197); and a significantly higher response in the Cosentyx non-loading dose group (39.8%) compared with the placebo group (19.9%) at week 52 (P = 0.0021).