Biologic works against axial psoriatic arthritis
Secukinumab, at both 300 and 150 mg, scores high in the management of psoriatic arthritis (PsA) patients with axial manifestations and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs), as shown in the results of the phase III MAXIMISE trial.
Patients treated with either secukinumab dose demonstrated significant improvements across all primary, key secondary, and secondary endpoints at week 12, according to the investigators, and these favourable changes persisted through week 52.
Meanwhile, those initially on placebo and switched to either secukinumab dose at week 12 improved rapidly and considerably. What is more, magnetic resonance imaging (MRI) assessments indicated that inflammation largely declined in both the spine and the sacroiliac joints (SIJ) of patients treated with the biologic drug.
The analysis included 498 patients (average age 47 years, 49.4 percent male) randomized to receive secukinumab 300 (n=167) or 150 mg (n=165) or placebo (n=166) weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo-treated patients were rerandomized to secukinumab 300/150 mg.
All patients had spinal pain Visual Analogue Score (VAS) ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two NSAIDs. The primary endpoint of ASAS20 (Assessment of SpondyloArthritis international Society) response at week 12 occurred with significantly greater frequency in the secukinumab arms than in the placebo arm (63 percent with 300 mg and 66 percent with 150 mg vs 31 percent). [Ann Rheum Dis 2020;doi:10.1136/annrheumdis-2020-218808]
In multivariable logistic regression models, the odds of achieving the primary endpoint were about fourfold higher for patients treated with secukinumab 300 and 150 mg than for those on placebo (odds ratios, 3.8, 95 percent confidence interval [CI], 2.4–6.1 and 4.4, 95 percent CI, 2.7–7.0, respectively; p<0.0001).
MAXIMISE also met the key secondary endpoint of an ASAS20 response with secukinumab 150 mg (after having established the superiority of the 300-mg dose). Finally, both doses of the biologic drug showed superiority over placebo in terms of ASAS40, BASDAI50, and ACR20 (American College of Rheumatology) responses, mean change in spinal pain VAS, Health Assessment Questionnaire Disability Index (HAQ-DI) score, Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue scale, and ASAS Health Index.
Secukinumab had a safety profile that was consistent with those published in previous reports. The types and incidence of adverse events (AEs) were similar in the active treatment and placebo arms, with no apparent relation to dose. Nasopharyngitis, upper respiratory tract infection, and diarrhoea were the most common AEs.
Despite the presence of limitations, “the study provides evidence for the efficacy of interleukin-17A inhibition with secukinumab for the treatment of axial disease in patients with PsA,” and should be considered a boon, according to the investigators.
Axial involvement represents an unmet clinical need in determining the treatment strategy across all PsA manifestations. “Additionally, patients with PsA tend to under-report axial symptoms and consequently the burden of disease might be underestimated for axial disease,” they pointed out.
“The results … will help inform treatment decision-making and deepen the clinical understanding of axial PsA,” the investigators said. [Clin Rheumatol 2018;37:3443-3448; Joint Bone Spine 2019;86:803-805]