FUTURE 5 supports subcutaneous secukinumab for PsA
medwireNews: Results from the phase III FUTURE 5 trial suggest that subcutaneous secukinumab improves disease activity and inhibits radiographic structural progression relative to placebo among patients with psoriatic arthritis (PsA).
Lead author Philip Mease (Swedish Medical Center and University of Washington, Seattle, USA), who presented the findings in a poster session at the 2017 ACR/ARHP Annual Meeting in San Diego, California, USA, told medwireNews that “this is the largest PsA trial to date.”
He added: “It is the pivotal study demonstrating inhibition of radiographic progression in PsA using the subcutaneous loading dose.”
The FUTURE 5 investigators found that patients who were randomly assigned to receive treatment with the interleukin-17 inhibitor were significantly more likely to achieve at least a 20% improvement in ACR criteria (ACR20) at week 16 than those who were treated with placebo.
Specifically, the ACR20 response rates were 62.6% for the 222 patients who received secukinumab at a dose of 300 mg every 4 weeks following a loading dose (LD) of 300 mg weekly for 4 weeks, 55.5% for the 220 participants given secukinumab 150 mg every 4 weeks following a 150 mg LD, and 59.5% for the 222 patients given secukinumab 150 mg every 4 weeks without a LD. This compared with 27.4% for the 332 patients in the placebo group.
Patients in the three secukinumab arms also experienced significantly reduced radiographic progression at week 24 than those receiving placebo, with modified total Sharp/van der Heijde scores (mTSS) of 0.08, 0.17, and –0.09 points in the secukinumab 300 mg, 150 mg, and 150 mg without LD groups, respectively, versus 0.50 points in the placebo group.
And a greater proportion of participants receiving secukinumab had no radiographic progression – defined as a change in mTSS from baseline of no more than 0.5 points – with corresponding rates of 88%, 80%, and 84% versus 74%.
Moreover, patients in the secukinumab groups experienced significantly greater improvements in skin responses, as measured by the proportion of patients with at least a 75% or 90% reduction in Psoriasis Area and Severity Index scores (PASI 75 and 90 responses, respectively), as well as in measures of disability and inflammation, relative to those in the placebo group.
Adverse events occurred in 63.1% of patients in the 300 mg group, 62.7% of patients in the 150 mg group, 61.3% of participants in the 150 mg with no LD group, and 62.0% of those given placebo. The corresponding rates of serious adverse events were 3.2%, 4.1%, 2.7%, and 3.6%, and no deaths, systemic fungal or tuberculosis infections, or major cardiac events were reported during the study.
These findings “confirm good outcomes observed in previous secukinumab studies, and there were no new safety issues,” said Mease.
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