medwireNews: The PREVENT investigators have reported positive results for the interleukin (IL)-17A inhibitor secukinumab in patients with nonradiographic axial spondyloarthritis (axSpA) at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA.
“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” said presenting author Atul Deodhar, from Oregon Health & Science University in Portland, USA.
In all, 555 participants were randomly assigned to receive secukinumab 150 mg every 4 weeks, with or without a loading dose (LD) of 150 mg/week for the first 4 weeks, or placebo. Deodhar explained that the trial had two different analysis plans due to different regulatory requirements. The EU authorities stipulated a primary endpoint of ASAS40 response rate at week 16 for secukinumab with LD versus placebo, while US registration necessitated a primary endpoint of ASAS40 response rate at week 52 for secukinumab without LD versus placebo.
All participants had active axSpA with inflammatory back pain for at least 6 months, with no radiographic evidence of sacroiliitis; the majority (90.3%) had no prior exposure to biologics, while the remainder had an inadequate response to one tumor necrosis factor (TNF) inhibitor.
Deodhar reported that among TNF inhibitor-naïve patients, those treated with secukinumab with or without LD were significantly more likely than patients given placebo to achieve an ASAS40 response at week 16, at rates of 41.5% and 42.2% versus 29.2%, respectively.
These results were consistent in the overall population, with corresponding ASAS40 response rates of 40.0% and 40.8% versus 28.0%.
Moreover, patients treated with secukinumab experienced significant improvements in physical function, quality of life, and objective signs of inflammation including C-reactive protein levels and joint edema on magnetic resonance imaging at week 16 compared with those in the placebo arm, said Deodhar.
And at the 1-year follow-up, ASAS40 response rates remained significantly greater among TNF inhibitor-naïve patients treated with secukinumab with or without LD versus placebo, at 35.4% and 39.8% versus 19.9%, respectively.
The presenter said that “the safety profile of secukinumab was consistent with previous reports,” with “slightly more infections” among patients treated with secukinumab versus placebo. Exposure-adjusted incidence rates for serious infections or infestations were 1.6 for secukinumab-treated patients and 0.5 for placebo-treated patients, with average durations of exposure of 509.8 and 214.6 days, respectively.
PREVENT is the second phase III trial presented at the meeting to demonstrate that IL-17A inhibition may be a promising treatment strategy for nonradiographic axSpA, with the COAST-X trial suggesting similar benefits for ixekizumab.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
This information is brought to you by medwireNews and is not sponsored by, nor a part of, the American College of Rheumatology
Arthritis Rheumatol 2019; 71 (suppl 10)