Both secukinumab 300 mg and secukinumab 150 mg significantly improved signs and symptoms of axial disease in patients with psoriatic arthritis (PsA) who had inadequate response to non- steroidal anti-inflammatory drugs.
Findings from a randomized controlled trial (RCT) are making the case for using secukinumab to treat axial disease in certain patients with psoriatic arthritis (PsA). Specifically, the trial found 2 doses of the interleukin (IL)-17A inhibitor yielded significant improvements in disease signs and symptoms.
The MAXIMISE (Managing AXIal Manifestations in psoriatic arthritis with SEcukinumab) trial was the first RCT to test a biological disease modifying anti-rheumatic drug’s ability to improve outcomes in axial manifestations of PsA. All patients previously had inadequate responses to at least 2 non-steroidal anti-inflammatory drugs over a 4-week period.
“The axial involvement represents an unmet clinical need in determining the treatment strategy across all PsA manifestations and ultimately supports informed treatment decision-making,” wrote the researchers. “Additionally, patients with PsA tend to under-report axial symptoms and consequently the burden of disease might be underestimated for axial disease in such patients. As a consequence, the efficacy of a biological treatment in managing axial symptoms in PsA has been investigated only in two observational studies to date, and never in a randomized controlled setting.”
A total of 425 patients completed the 52-week MAXIMISE study and received placebo or either secukinumab 300 mg or secukinumab 150 mg, both of which significantly improved responses compared with placebo after 12 weeks of treatment (63% and 66%, respectively, vs 31%).
Compared with placebo, the odds ratio of having an improved response as determined by the Assessment of SpondyloArthritis International Society (ASAS20)—defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least 3 of the 4 main ASAS domains—was 3.8 for patients receiving secukinumab 300 and 4.4 for patients receiving secukinumab 150 mg.
Responses rates for patients receiving secukinumab 300, secukinumab 150 mg, or switching from placebo to either secukinumab dose were 81%, 80%, and 75%, respectively. The responses were durable, researchers found, with patients sustaining responses through the end of the study.
“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 [sacroiliac joints] for patients treated with secukinumab,” authors wrote.
Researchers observed comparable types and incidences of adverse events between the monoclonal antibody and placebo. No notable differences were seen between the 2 secukinumab doses.
Reference: 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. Ann Rheum Dis. Published online December 17, 2020. doi:10.1136/annrheumdis-2020-218808