WASHINGTON, DC—At the 2016 ACR/ARHP Annual Meeting, study authors presented data which showed that the majority of patients with ankylosing spondylitis treated with Simponi Aria (golimumab; Janssen) achieved the study’s primary endpoint of at least 20% improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 16.
Golimumab, an intravenous (IV) anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, was evaluated in the Phase 3 GO-ALIVE Study, a multi-center, randomized, double-blind, placebo-controlled trial designed to assess the safety and efficacy of IV golimumab in adults with active ankylosing spondylitis.
Data showed that 73.3% of patients in the Simponi Aria group obtained at least a 20% improvement in ASAS20 at Week 16 vs. 26.2% of patients in the placebo group (P≤0.001). In addition, all statistically-controlled secondary endpoints were met with statistical significance in the Simponi Aria group vs. placebo at Week 16 (P<0.05).
Major secondary endpoints evaluated at Week 16 were ASAS40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) score, and change in Bath Ankylosing Spondylitis Functional Index (BASFI) score.
More patients in the Simponi Aria group achieved an ASAS40 response (47.6% vs. 8.7%; P<0.001), achieved a BASDAI 50 response (41.0% vs. 14.6%; P<0.001), and had a greater mean change from baseline in BASFI (–2.4 vs. –0.5; P<0.001).
Other assessments included ASAS partial remission, change from baseline in BASFI, change from baseline measures of physical and mental health as reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36), and Ankylosing Spondylitis Quality of Life (ASQoL) patient-reported outcomes. All of these outcomes showed statistically significant superiority in the Simponi Aria cohort vs. placebo.
Adverse events occurred in 32.4% of patients receiving Simponi Aria vs. 23.3% in the placebo group. The most common type of adverse event was infection.
The study’s lead author, Atul Deodhar, MD, MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University said, “The results reported from the GO-ALIVE study demonstrate significant improvement in signs and symptoms and physical function in patients with active ankylosing spondylitis receiving Simponi Aria, and these are important findings for patients living with this progressive, debilitating immune disease.”
The study will continue through 52 weeks. Data from the GO-ALIVE Study will be included in an upcoming submission to the Food and Drug Administration (FDA) for the approval of Simponi Aria to treat active ankylosing spondylitis.