Novartis' Cosentyx Demonstrates Durable Efficacy in nr-axSpA with Positive 52-Week Phase III PREVENT Data, Challenging Lilly's Taltz

Compiled by Keke

On June 4, Novartis announced positive results from the 52-week Phase 3 PREVENT clinical trial, demonstrating substantial and sustained benefits of Cosentyx (secukinumab) in patients with axial spondyloarthritis (axSpA).

The PREVENT study is a randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of Cosentyx in the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA). The study enrolled 555 adult patients with active nr-axSpA [onset before age 45, spinal pain score ≥40/100 on the Visual Analog Scale (VAS), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4], who had received at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at maximum dosage within the 4 weeks prior to the start of the study. Patients may have previously received no more than one TNF inhibitor but had an inadequate response. Among the 555 patients, 501 were biologic-naïve. Patients were divided into three groups receiving: Cosentyx 150 mg with a loading dose (induction: 150 mg subcutaneous injection once weekly for 4 weeks; maintenance: 150 mg subcutaneous injection once monthly), Cosentyx 150 mg without a loading dose (150 mg subcutaneous injection once monthly), or placebo (induction: subcutaneous injection once weekly for 4 weeks; maintenance: subcutaneous injection once monthly). The primary endpoint was the proportion of TNF-inhibitor-naïve patients achieving Assessment of SpondyloArthritis international Society 40% improvement criteria (ASAS40) at Week 16 and Week 52. ASAS40 represents a 40% improvement in disease signs and symptoms, such as pain, inflammation, and function. Secondary endpoints included changes in BASDAI over time and changes in the Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP).

Studies have found that patients treated with Cosentyx showed significant and sustained improvement in the symptoms and signs of nr-axSpA at 52 weeks. In terms of the primary endpoint, approximately 40% of patients in the Cosentyx loading dose group achieved ASAS40 response at both Week 16 and Week 52 compared to placebo (Week 16: 41.5% vs. 29.2%, P<0.05; Week 52: 35.4% vs. 19.9%, P<0.05). In trials prior to 52 weeks, the loading dose group also met secondary endpoints for improvements in pain, disease activity, and health-related quality of life.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory back pain, encompassing ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). In AS, joint damage is typically visible on X-rays, whereas it is not in nr-axSpA. Nevertheless, both conditions share a similar symptom burden, including nocturnal pain, morning stiffness, fatigue, and functional impairment, which can significantly impact quality of life if left untreated. There are approximately 1.7 million patients with nr-axSpA across the five largest European Union countries and the United States. However, due to underdiagnosis, the average diagnostic delay for this condition exceeds seven years or more.

Cosentyx is the world’s first and only fully human monoclonal antibody that specifically targets and inhibits interleukin-17A (IL-17A). Approved by the U.S. Food and Drug Administration (FDA) in 2015, it is currently marketed in more than 80 countries and regions, including the European Union and the United States, for indications such as psoriatic arthritis (PsA), plaque psoriasis (PsO), and ankylosing spondylitis (AS). Since its launch, over 300,000 patients worldwide have received treatment with Cosentyx. In April 2020, Cosentyx received European Union approval for the treatment of adult patients with non-radiographic axial spondyloarthritis (nr-axSpA).(See details:Fourth Indication! Novartis’ Cosentyx Approved by the EU for Axial Spondyloarthritis）. Novartis has submitted the application for this indication to regulatory authorities in the United States and Japan for review.

The latest data released by Novartis will enable Cosentyx to maintain its competitive edge against Eli Lilly’s Taltz. Although Taltz gained a first-mover advantage by receiving U.S. FDA approval on June 2 for the treatment of patients with active non-radiographic axial spondyloarthritis (nr-axSpA), Novartis has placed greater emphasis on the long-term data for Cosentyx during the FDA review process. Meanwhile, Cosentyx appears to outperform Taltz in terms of the primary endpoint of ASAS40 response rates. Taltz was approved based on the Phase 3 COAST-X trial, which demonstrated that at Week 16, the ASAS40 response rate was 35% in the Taltz group versus 19% in the placebo group (p<0.01); at Week 52, the ASAS40 response rate was 30% in the Taltz group versus 13% in the placebo group (p=0.0045).

In March this year, UCB’s anti-TNF antibody Cimzia received FDA approval for the treatment of nr-axSpA; however, the drug carries a safety warning indicating an increased risk of serious infections. This has positioned Eli Lilly and Novartis as the primary contenders in this therapeutic area.

References:

1、Novartis PREVENT data show Cosentyx® helps patients realize early and lasting relief in axial spondyloarthritis

2、Novartis' Cosentyx chases Lilly's just-approved Taltz with long-term data in spondyloarthritis