AS is characterized by inflammatory back pain and progressive spinal stiffness. As the disease progresses, patients’ spinal mobility decreases along with their physical function, which contributes to disability.
Current treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and inhibitors of the tumor necrosis factor (TNF), a potent pro-inflammatory cytokine (small protein involved in immune reactions).
Simponi (marketed by Janssen) is a monoclonal antibody against TNF that prevents TNF-mediated inflammation and is thought to improve the management of ankylosing spondylitis. The FDA approved Simponi as an ankylosing spondylitis treatment in 2009. Recently, a new formulation of Simponi that requires fewer doses per year, called Simponi Aria, was approved by the FDA.
Simponi Aria’s efficacy — the trial’s primary objective — was determined by the proportion of patients who met the Assessment of SpondyloArthritis International Society (ASAS 20) response, defined as an improvement of at least 20% in at least three of four main ASAS domains (with no more than 20% worsening in the remaining domains) at week 16.
Participants were randomized to receive intravenous infusions of 2 mg/kg of golimumab — delivered at weeks 0, 4, and every 8 weeks thereafter through week 52 — or a placebo for 12 weeks (delivered every four weeks). Patients in the placebo group crossed over and received golimumab until week 52. Each group included 105 and 103 patients, respectively.
The results showed that 73.3% of patients in the treatment group achieved the trial’s primary efficacy endpoint compared to 26.2% of patients in the placebo group.
Accordingly, 82.7% of the patients treated with Simponi Aria showed improvements in the Ankylosing Spondylitis Disease Activity Score (ASDAS) — which reflects disease activity — compared to 22.5% for the placebo group.
After patients in the placebo group crossed to the treatment group at week 16, both group response rates showed a clinically important improvement in ASDAS scores.
Response rates for patients with a clinically important improvement in ASDAS were similar in the two groups at weeks 28 (Simponi Aria 76.9% vs placebo crossover 71.6%) and after one year (Simponi Aria 76.0% vs placebo crossover 71.6%).
The most commonly observed secondary effect was infection, particularly nasopharyngitis (infections of the pharynx and nasal cavities, 11.8%) and upper respiratory tract infection (7.4%). Eight severe adverse events were observed in Simponi Aria-treated patients; however, the researchers considered that all but two cases of pneumonia and pulmonary tuberculosis were not related to the treatment.
The team also explored Simponi Aria concentrations in the blood during treatment and observed that these were maintained at a steady state for both treatment groups throughout a year. However, patients who developed antibodies to Simponi Aria showed worse improvement rates.
Overall, the results of the GO-ALIVE study show that treatment with Simponi Aria “was effective in reducing the signs and symptoms of AS among adult patients with active disease despite treatment with NSAIDs, with sustained response through 1 year,” the researchers concluded.