A FUTURE 5 trial and MAXIMIZE trial demonstrate that Cosentyx frequently stops radiographic progression and lessens axial manifestations, respectively.
Secukinumab (Cosentyx) can stop radiographic progression of psoriatic arthritis (PsA) in almost 90% of patients and lessen axial manifestations, according to a new pair of studies.
PsA affects an estimated 50 million people worldwide alongside other inflammatory diseases (such as spondyloarthritis) that are in the same family. It can start at any age, but usually presents itself between ages 30-50, approximately a decade after psoriasis begins. Currently, while symptoms of inflammation in the joints can be treated, there is no cure.
Novartis funded the FUTURE 5 trial and MAXIMIZE trial, of which the results are being presented at the 2019 Annual European Congress of Rheumatology. Philip J. Mease, MD,—Clinical Professor at University of Washington School of Medicine and Director of Rheumatology Research at Swedish Medical Center/Providence St. Joseph Health—led the investigation.
Cosentyx is currently the only fully-human biologic that directly inhibits interleukin-17A (IL-17A), a key cytokine in PsA development and inflammation. It was first recommended for approval for treating plaque psoriasis by the US Food and Drug Administration (FDA) in 2014, then officially approved along those lines in 2015.
In 2016, it was also approved for use in ankylosing spondylitis and psoriatic arthritis. Having undergone a trio of 5-year phase 3 extension studies, Cosentyx has since treated over 200,000 patients globally since its launch.
"This is the first time we've seen the efficacy of a biologic in the axial manifestations of psoriatic arthritis at 12 weeks," said Dr. Antonio Mera Varela, Head of Rheumatology, Santiago Clinic Hospital in Compostela, Spain, in a statement. "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."
The FUTURE 5 and MAXIMIZE trials of Cosentyx were both phase 3, randomized, double-blind, and placebo-controlled. The former, which took place over 2 years, tested Cosentyx’s ability to control signs and symptoms while preventing radiographic progression of PsA; the latter, which took place over 52 weeks, tested Cosentyx’s ability to control axial manifestations of PsA.
Cosentyx inhibited radiographic progression for the majority of patients in the FUTURE 5 trial: 89.5% at 300 mg, 82.3% at 150 mg, and 81.1% at 150mg with no loading dose. Radiographic damage is characterized by joint inflammation, erosion, and joint space narrowing, especially in hands and feet.
In the MAXIMIZE trial, 63.1% of patients receiving 300 mg and 66.3% of patients receiving 150 mg achieved ASAS20 at week 12 (as opposed to 31.3% for placebo). ASAS20 is defined as an improvement of at least 20% on a 0-100 scale in at least 3 of the following: patient global assessment, pain assessment, function (Bath Ankylosing Spondylitis Functional Index,) and inflammation.
This defines the MAXIMIZE trial as a landmark confirmation of Cosentyx’s effectiveness for PsA patients.
Regarding the MAXIMIZE study, Laura Coates, PhD, NIHR Clinician Scientist and Senior Clinical Research Fellow at Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK, said in a statement that this study provides clinicians with the evidence to help them "choose a comprehensive treatment for psoriatic arthritis that addresses diverse patient phenotypes."
The findings were presented at 2019’s annual European Congress of Rheumatology (EULAR).