Rheumatologic disorders

PREVENT Trial: Monoclonal Antibody Improves Nonradiographic AxSpA Symptoms

In patients with nonradiographic axial spondyloarthritis (nr-axSpA), secukinumab, 150 mg, with loading and without loading, provides significant improvement in the signs and symptoms of the condition through 16 weeks of treatment, according to findings from a late-breaking abstract presented at the 2019 American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting. The findings include efficacy results to 16 weeks and safety results to 20 weeks.

To reach this conclusion, Atul Deodhar, MD, MRCP, from the Oregon Health & Science University, and colleagues randomly assigned 555 participants to either subcutaneous secukinumab, 150 mg, loading (n=185); secukinumab, 150 mg, nonloading (n=184); or placebo (n=186). Patients in the secukinumab-loading group received 150 mg at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks through 52 weeks. Patients in the secukinumab-nonloading group received 150 mg at baseline and placebo at 1, 2, and 3 weeks, then secukinumab, 150 mg, every 4 weeks starting at week 4. Patients in the placebo group received placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks.


IF YOU LIKE THIS, READ MORE...

Researchers Identify Factors Associated With Complete Spinal Fusion in Ankylosing Spondylitis

Can Alcohol Consumption Predict Progression of Spinal Damage in AxSpA?


All patients had met the Assessment of Spondyloarthritis international Society (ASAS) classification criteria for diagnosis of axSpA, plus had an abnormal C-reactive protein level and/or abnormal magnetic resonance imaging findings, with no radiographic changes in the sacroiliac joints.

The primary endpoint was an ASAS40 response with secukinumab, 150 mg, loading, in anti-TNF-naïve patients at 16 weeks. Secondary endpoints included ASAS40 response rates, ASAS partial remission, and other outcomes based on a number of validated diagnostic tools, in the overall population.

In all, 94.6% of patients in the secukinumab-loading group, 96.2% of patients in the secukinumab-nonloading group, and 94.1% of patients in the placebo group completed 24 weeks of treatment.

All primary and all secondary endpoints were met.

At 16 weeks, the ASAS40 response in anti-TNF-naïve patients was significantly higher in the secukinumab-loading group than the placebo group. Secukinumab, 150 mg, loading and nonloading, also showed significant improvement compared with placebo in all secondary endpoints.

No cases of esophageal candidiasis, major adverse cardiovascular events, malignancy, or death were reported on any secukinumab dose up to week 20. Three cases of serious infections/infestations (0.8%) and one case of Crohn disease (0.3%) were reported among patients who received secukinumab.

“PREVENT is the first randomized controlled trial evaluating the efficacy and safety of [secukinumab] in [patients] with nr-axSpA,” the researchers concluded. “[Secukinumab, 150 mg, loaded and unloaded,] provided significant improvement in signs and symptoms of nr-axSpA through [week] 16.”

—Melinda Stevens

Reference:

Deodhar A, Blanco R, Dokoupilova E, et al. Secukinumab 150 mg significantly improved signs and symptoms of non-radiographic axial spondyloarthritis: results from a phase 3 double-blind, randomized, placebo-controlled study [abstract L21]. Arthritis Rheumatol. 2019;71(suppl 10). Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. https://acrabstracts.org/abstract/secukinumab-150-mg-significantly-improved-signs-and-symptoms-of-non-radiographic-axial-spondyloarthritis-results-from-a-phase-3-double-blind-randomized-placebo-controlled-study/. Accessed November 8, 2019.