Novartis releases new data on Cosentyx ® (secukinumab) from two trials of psoriatic arthritis (PsA) patients.
PsA is a complex disease with multiple manifestations driving patient symptoms. It is estimated to affect up to 50 million people worldwide and is part of a family of long-term inflammatory diseases (spondyloarthritis) that target the joints. If left untreated, PsA patients can go on to develop irreversible radiographic structural damage. Radiographic damage is defined by joint inflammation, erosion and joint space narrowing, particularly in the hands and feet. PsA with radiographic progression is reported in more than half of patients.
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of PsA, psoriasis (PsO), and ankylosing spondylitis (AS). In October 2018 Novartis updated the label for Cosentyx ® to include psoriatic arthritis.
Cosentyx has shown long-lasting efficacy and a favorable safety profile while addressing psoriatic disease, therefore offering a complete treatment. It has shown sustained safety and long-lasting efficacy in three 5-year Phase III extension studies in PsO, PsA and AS. Today, more than 200,000 patients worldwide have been treated with Cosentyx since launch.
The FUTURE 5 trial
The trial investigated the effect of Cosentyx on the signs and symptoms of PsA, in addition to inhibition of radiographic progression of PsA. These data demonstrate that 89.5% (300mg), 82.3% (150mg) and 81.1% (150mg no loading dose [LD]) of PsA patients treated with Cosentyx found no radiographic progression at 2 years.
Clinical responses, such as American College of Rheumatology criteria (ACR20/50) and Psoriasis Area and Severity Index (PASI 90/100) were also maintained through 2 years, with 77% of Cosentyx 300mg patients achieving ACR20, 51.9% ACR50, 70.1% PASI 90 and 49.5% PASI 100.
Results were also achieved at the lowest dose of Cosentyx 150mg. These data are being presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.
Dr. Philip J. Mease, Director of Rheumatology Research, Swedish Medical Center/Providence St Joseph Health and Clinical Professor, University of Washington School of Medicine, Seattle, WA said,”Half of patients with psoriatic arthritis experience bone erosion within approximately two years. Left untreated, this can lead to irreversible joint damage and disability, having a substantial impact on quality of life. The availability of a treatment that is proven to inhibit progression of psoriatic arthritis through two years gives physicians and patients more choice in the management of this debilitating condition.”
Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. “We are continuing to reimagine psoriatic arthritis therapy to improve patients’ lives and provide a treatment option that addresses multiple manifestations and inhibits disease progression. These data further reinforce Cosentyx as a comprehensive treatment that’s backed by over 100 studies, including five-year data across psoriasis, psoriatic arthritis and ankylosing spondylitis.”
The MAXIMISE trial
Evaluates the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. Rapid onset of relief was seen as early as week four, with the trial demonstrating a favorable safety profile consistent with previous clinical trials.
“Up to two thirds of patients with psoriatic arthritis experience inflammatory back pain, which can limit mobility,” said Dr. Laura Coates, NIHR Clinician Scientist and Senior Clinical Research Fellow at Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK. “This study provides clinicians with the evidence to help them choose a comprehensive treatment for psoriatic arthritis that addresses diverse patient phenotypes.”
Dr. Antonio Mera Varela, Head of Rheumatology, Hospital Clínico Universitario de Santiago de Compostela, Spain said, “This is the first time we’ve seen the efficacy of a biologic in the axial manifestations of psoriatic arthritis at 12 weeks. As a physician, it’s highly important that there is something that can help manage all aspects of my patients’ psoriatic arthritis, including inflammation of the spine, joints, enthesitis, dactylitis and psoriasis of the skin and nails.”
These data, which add to the existing evidence supporting Cosentyx as a treatment across multiple psoriatic disease manifestations, will be presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.