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Improvement in ASAS20 (Assessment of SpondyloArthritis international Society) was seen in 63% of participants assigned to secukinumab 300 mg and 66% of those assigned to secukinumab 150 mg, versus 31% of the placebo group.
Secukinumab (Cosentyx, Novartis) improved the signs and symptoms of axial disease in patients with axial psoriatic arthritis with inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs), according to a study published in Annals of the Rheumatic Diseases.1
The prevalence of axial disease in patients with psoriatic arthritis ranges from 5% to 70%, and patients under-report axial symptoms due to the prominence of peripheral pain. Secukinumab, a human interleukin-17A antagonist, is approved for use in patients with psoriatic arthritis, but optimal use recommendations for axial psoriatic arthritis remain challenging, as do the definition criteria for the condition. Moreover, the targeted assessment of secukinumab on axial disease in psoriatic arthritis has never been investigated in a randomized-controlled trial.
In this phase 3b randomized-controlled trial, dubbed MAXIMISE, Xenofon Baraliakos, MD, of Ruhr-University Bochum in Germany, and colleagues evaluated the efficacy and safety of secukinumab 300 mg and 150 mg in managing axial disease in psoriatic arthritis. A total of 498 patients (≥18 years, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥4, spinal pain score ≥40 by Visual Analogue Score [VAS]) with an inadequate response to NSAIDs.
Of the patients, 167 were randomly assigned to secukinumab 300 mg, 165 to secukinumab 150 mg, and 166 to placebo. A total of 425 patients completed the trial through to week 52.
The primary and key secondary endpoints were met. Improvement in ASAS20 (Assessment of SpondyloArthritis international Society) was seen in 63% of participants assigned to secukinumab 300 mg and 66% of those assigned to secukinumab 150 mg, versus 31% of the placebo group. The odds ratio (95% confidence interval) for reaching ASAS20 response comparing secukinumab 300 mg and 150 mg versus placebo was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; P<0.0001). Similar patterns were seen with ASAS40.
“In addition, MRI assessments demonstrated that secukinumab 300 mg and 150 mg significantly improved Berlin MRI scores versus placebo, providing objective evidence of reduced inflammation in both the spine and the SIJ for patients treated with secukinumab,” determined investigators.
Clinical improvements were sustained through week 52 with secukinumab, while patients on placebo who switched to secukinumab at week 12 improved considerably. The types and incidence of adverse events with secukinumab were similar to placebo at week 12.
Investigators concluded, “the results will help inform treatment decision-making and deepen the clinical understanding of axial psoriatic arthritis, one of the disease manifestations lacking universally acceptable definition criteria.”
Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial [published online ahead of print, 2020 Dec 17]. Ann Rheum Dis. 2020;annrheumdis-2020-218808. doi:10.1136/annrheumdis-2020-218808