Data from Pharmawand - Curated by EPG Health - Date added 13 June 2019
Novartis has announced new data from the FUTURE 5 trial showing no radiographic progression (mTSS <0.5) in almost 90% of psoriatic arthritis (PsA) patients treated with Cosentyx (secukinumab) 300mg over 2 years. "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," said 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. "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."
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 (79.4% ACR20, 52.6% ACR50, 59.2% PASI 90 and 44.2% PASI 100). These data are being presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.
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.
About FUTURE 5 ; FUTURE 5 is a Phase III, randomized, double-blind, placebo-controlled study reporting on the effect of Cosentyx on radiographic progression across 2 years in PsA patients. In the study, 996 adults with active PsA were randomized to receive subcutaneous Cosentyx 300 mg (with LD of 300 mg), 150 mg (LD 150 mg), 150 mg with no LD or placebo at baseline at Weeks 1, 2, 3, 4 and every 4 weeks thereafter. Patients could have the Cosentyx dose escalated from 150 to 300 mg, starting from Week 52, based on physicians' judgement. The primary endpoint was ACR20 at Week 16. Radiographic progression as measured by mean change at Week 24 in van der Heijde-modified total Sharp score and its components erosion and joint space narrowing measured by hand/foot/wrist X-rays was a key secondary endpoint. Other endpoints included ACR50, PASI75/90/100 and resolution of dactylitis and enthesitis.