Simponi Aria Effective for Treating Ankylosing Spondylitis

According to a press release, positive findings from a pivotal phase 3 study showed that Simponi Aria (golimumab; Janssen), an intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy, was safe and effective for the treatment of active ankylosing spondylitis.

“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,” Atul Deodhar, MD, lead study author and a professor of medicine at the Oregon Health & Science University, said in a press release. “The results reported from the 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 GO-ALIVE study was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that aimed to evaluate the efficacy and safety of Simponi Aria in adults with active ankylosing spondylitis. The study’s primary endpoint was to achieve at least 20% improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16. The major secondary endpoints evaluated at week 16 were ASAS40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) score, an indicator of a major clinical response, and change in Bath Ankylosing Spondylitis Functional Index score, which measures improvements in physical function. 

Researchers found that 73.3% of patients who received Simponi Aria 2 mg achieved the primary endpoints at week 16 compared with 26.2% of patients receiving the placebo (P ≤ .001). Additionally, all statistically controlled secondary endpoints in the study were met in comparisons of Simponi Aria vs placebo at week 16 (P < .05).

Study results also showed that 47.6% of patients receiving Simponi Aria achieved an ASAS40 response compared with 8.7% of patients receiving placebo
(P < .001). Additionally, 41.0% of Simponi Aria patients achieved a BASDAI 50 response compared with 14.6% of placebo patients (P < .001).

According to the findings, at week 16, 32.4% of patients receiving Simponi Aria, and 23.3% who were receiving placebo had one or more adverse event. The reported adverse events included infection, nasopharyngitis, pancreatitis, and pneumonia. There were no opportunistic infections, malignancies, or deaths through week 28.

According to the press release, Janssen intends to pursue an expanded indication for the treatment of ankylosing spondylitis.

“With the data from the GO-ALIVE Phase 3 study, we look forward to pursuing FDA approval of Simponi Aria for the treatment of active ankylosing spondylitis,” Newman Yeilding, MD, head of immunology development at Janssen Research and Development, said in a press release. —Julie Mazurkiewicz