medwireNews: Patients with ankylosing spondylitis (AS) continue to derive benefits from secukinumab treatment for up to 4 years, suggest study results reported at the 2017 ACR/ARHP Annual Meeting in San Diego, California, USA.
Presenting the results of the MEASURE 1 extension trial, Jürgen Braun (Ruhr University Bochum, Herne, Germany) told delegates that 2 years of treatment with the interleukin-17A inhibitor resulted in improvements in disease activity, function, and mobility relative to placebo in the core trial, the results of which have been published previously.
Patients in the original placebo group who did not have at least a 20% improvement in Assessment of SpondyloArthritis international Society score (ASAS20 response) from baseline were switched to secukinumab 75 mg or 150 mg at week 16, while those who responded to treatment were switched at week 24. Patients were followed up for an additional 2 years in the extension study, and Braun’s presentation focused on the 87 participants who received the approved 150 mg dose of secukinumab.
In the extension study, ASAS20 and ASAS40 response rates observed at the 2-year follow-up were maintained at 4 years, with corresponding rates of 79.7% and 60.8%. These results demonstrated “a sustained clinical response of secukinumab,” said Braun.
Improvements in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores seen with secukinumab treatment were also maintained over the extension study.
Furthermore, approximately 80% of secukinumab-treated patients experienced no radiographic progression over 4 years, as indicated by a change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) of less than 2 points from baseline.
During the 4 year follow-up, 86.9% of secukinumab-treated patients experienced adverse events, and 8.9% discontinued treatment due to adverse events. Braun noted that two deaths occurred during the study, neither of which were considered to be related to the study drug.
“I would like to conclude that we have a clear-cut demonstration of efficacy of the 150 mg approved dose through 4 years,” said Braun.
Commenting on these findings, Liron Caplan (Denver Veterans Affairs Medical Center, Colorado, USA), who was not involved in the study, told medwireNews that the study adds to the “limited long term radiographic data” for AS patients, and “shows that the rate of radiographic progression is low.”
However, he noted that “there are still many salient questions” that remain unanswered. For example, “we cannot address the fundamental issue of how this agent compares to existing biologics or patients not treated with biologics at all,” he said.
Looking to the future, Caplan believes that “patients would benefit from a head-to-head study comparing secukinumab with other active therapies.”
And Braun concluded his presentation by announcing that a head-to-head trial of secukinumab versus adalimumab will soon be recruiting participants, emphasizing that “this will be the study that will answer questions on radiographic progression.”
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