Secukinumab may provide significant improvement in signs and symptoms of axial disease in patients with psoriatic arthritis (PsA), according to study results published in the Annals of the Rheumatic Diseases.
There are several common clinical features between PsA and ankylosing spondylitis, and the current definition of axial PsA is not clear. Secukinumab — a fully human monoclonal antibody that inhibits interleukin-17A (IL-17A) — has been proven in previous studies to provide significant and sustained improvements in the signs and symptoms of active PsA and ankylosing spondylitis.
In a phase 3b, double-blind, placebo-controlled, multicenter trial (MAXIMISE; ClincialTrials.gov Identifier: NCT02721966), the researchers sought to determine the efficacy and safety of secukinumab 300 mg and 150 mg for axial manifestations in patients with PsA who had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). The study included a 12-week placebo-controlled phase of secukinumab 300 mg or 150 mg, followed by randomly reassigning patients in the placebo group to 1 of the doses of secukinumab through week 52.
The study sample included 498 adults with PsA from 97 centers between 2016 and 2018. All participants had evidence of active spinal disease with a Bath Ankylosing Spondylitis Disease Activity Index score of 4 or greater, spinal pain score of 40 or greater by visual analog score, and inadequate response to 2 or more NSAIDs over a 4-week period.
The primary endpoint was a 20% response on the criteria of the Assessment of Spondyloarthritis International Society (ASAS20) at week 12, defined as an improvement of 20% or greater and at least 1 unit on a scale of 10 in 3 or more of the 4 main ASAS domains. Magnetic resonance imaging (MRI) of the spine and sacroiliac joints was performed at baseline and at weeks 12 and 52 for all patients to assess sacroiliac and spinal inflammation.
At week 12, secukinumab significantly improved ASAS20 response, with 63% and 66% of patients receiving either secukinumab 300 mg or 150 mg meeting this criterion, compared with 31% of patients in the placebo group. The odds ratios for achieving ASAS20 response were 3.8 (95% CI, 2.4-6.1; P <.0001) for secukinumab 300 mg compared with placebo, and 4.4 (95% CI, 2.7-7.0; P < .0001) for secukinumab 150 mg compared with placebo.
At week 52, ASAS20 responses with secukinumab were 81% (n=113/139) for the 300 mg group and 80% (n=113/141) for the 150 mg group. For those who initially received placebo, ASAS20 responses were 75% (n=54/72) for those who had been reassigned to secukinumab 300 mg and 80% (n=59/74) for those reassigned to receive secukinumab 150 mg.
Nonserious adverse events up to week 12 were reported in 39% and 36% of patients treated with secukinumab 300 mg and 150 mg, respectively, compared with 47% in the placebo group. Serious adverse events were recorded in 6% of patients treated with secukinumab over the entire treatment period
The study had several limitations, including the lack of consensus in the clinical and/or imaging criteria to define axial PsA and the lack of specific outcome measures for axial PsA.
“The study provides evidence for the efficacy of IL-17A inhibition with secukinumab for the treatment of axial disease in patients with PsA,” the researchers concluded. “The results provide valuable data that will help inform treatment decision-making and deepen the clinical understanding of axial PsA, one of the disease manifestations lacking universally acceptable definition criteria.”
Disclosure: This clinical trial was supported by Novartis. Please see the original reference for a full list of authors’ disclosures.
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