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Janssen Research & Development, LLC (Janssen) announced new findings from a pivotal Phase 3 study showing the efficacy and safety profile of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA® (golimumab) in the treatment of active ankylosing spondylitis (AS).
Data from the GO-ALIVE study showed that 73.3 percent of patients with active ankylosing spondylitis receiving SIMPONI ARIA® 2 mg/kg achieved the study's primary endpoint of at least a 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16, compared with 26.2 percent of patients receiving placebo (P ≤ 0.001). Data from GO-ALIVE, which will be part of an upcoming submission to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® for the treatment of active ankylosing spondylitis, are being presented for the first time at the 2016 ACR/ARHP Annual Meeting. In July 2013, SIMPONI ARIA® received U.S. FDA approval as a 30-minute infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.
"Anti-TNF therapy remains the mainstay in the treatment of ankylosing spondylitis, a complex chronic inflammatory disease involving the spine, peripheral joints and multiple other organ systems," said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and lead study author.* "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."
Additional assessments in GO-ALIVE were ASAS partial remission, change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI), change in baseline measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36), and Ankylosing Spondylitis Quality of Life (ASQoL) patient-reported outcomes. Each of these demonstrated statistically significant superiority of SIMPONI ARIA® compared with placebo.
Through week 16, 32.4 percent of patients receiving SIMPONI ARIA® and 23.3 percent of patients receiving placebo had one or more adverse events (AEs). The most common type of AE was infection, 11.4 percent reported in the SIMPONI ARIA® group and 7.8 percent reported in the placebo group. At week 16, patients initially treated with placebo began to receive SIMPONI ARIA®. Through week 28, 34.8 percent of SIMPONI ARIA®-treated patients experienced one or more AEs, and nasopharyngitis was the most common AE reported (5.4 percent) and serious AEs reported in the SIMPONI ARIA® group included one case of pancreatitis and one case of pneumonia. There were no opportunistic infections, malignancies, or deaths through week 28. Infusion reactions were low (1.5 percent) among SIMPONI ARIA®-treated patients, with three patients reporting four reactions, none of which was serious or severe.
GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of IV golimumab (SIMPONI ARIA®) in adult patients with active ankylosing spondylitis. Patients had a diagnosis of definite AS per modified New York criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater than or equal to four, total back pain visual analogue scale greater than or equal to four, and C-reactive protein greater than or equal to 0.3 mg/dL. Up to 20 percent of patients could have had prior anti-TNF-alpha treatment with agents other than SIMPONI® (golimumab) and up to 10 percent of patients could have complete ankylosis of the spine. Patients (n=208) were randomized one-to-one to receive SIMPONI ARIA® 2 mg/kg at weeks 0, 4, and every 8 weeks or placebo at week 0, 4, and 12, with crossover to SIMPONI ARIA® at week 16. The study will continue through 52 weeks.
