GO-ALIVE
GO-ALIVE was a Phase 3 clinical trial examining the safety and the efficacy of Simponi Aria in ankylosing spondylitis (AS). Simponi was first approved by the FDA in 2009. Simponi Aria is another formulation of Simponi which requires fewer doses. This formulation was just recently granted approval.
Simponi is a monoclonal antibody which works to prevent TNF-mediated inflammation in AS. Inflammation is a major characteristic of AS. Patients deal with back pain, spinal stiffness, and a loss of physical function among other debilitating symptoms. The disease is progressive and patients slowly lose mobility.
Efficacy in this study was measured by improvement of a minimum of 20% in 3/4 of the domains outlined by the Assessment of SpondyloArthritis International Society and a worsening of no greater than 20% in the last domain. This was assessed at week 16 of treatment.
The trial included 208 total patients all diagnosed with active AS. The patients were randomized to determine which treatment they would receive. The treatment group received intravenous infusions of Simponi Aria in 2mg/kg increments at week 0 and week 4. They then received the treatment every 8 weeks until they reached the one year mark. The placebo crossover group received placebo once every four weeks for a 12 week period. Following 12 weeks, they also began receiving Simponi Aria until the one year mark.
Results
Treatment group (105 patients)
- 73.3% achieved the primary efficacy endpoint
- 82.7% had an improved Ankylosing Spondylitis Disease Activity Score (ASDAS)
Placebo crossover group (103 patients)
- 26.2% achieved the primary efficacy endpoint
- 22.55% had an improved ASDAS (improvement increased after they switched to the treatment)
It is important to note that ASDAS was very similar between the two groups by the 28 week mark (76.9% compared to 71.6%). At one year these numbers were 76.0% and 71.6% respectively.
The results from this study was published in The Journal of Rheumatology.
Conclusions
Ultimately, Go-ALIVE indicated that not only is Simponi Aria efficacious, but that its response was able to maintained throughout a full year. While there were some adverse events (AEs) documented, most were not severe. Eight severe events were documented in total but six of these were determined to be unrelated to the therapy. The most common AEs were nasopharyngitis and upper respiratory tract infection.
These results are extremely promising and bring hope to this patient population.
You can read more about this trial here.
