Successful GO ALIVE trial for intravenous Simponi Aria (golimumab) to treat ankylosing spondylitis. Janssen Biotech

Almost half of patients with ankylosing spondylitis receiving intravenous golimumab (Simponi Aria) had a 40% improvement after 4 months of treatment in a phase III trial known as GO-ALIVE , a researcher reported . At week 16, 47.6% of patients given intravenous golimumab, 2 mg/kg every 8 weeks, achieved a 40% response on the criteria of the Assessment in Ankylosing Spondylitis (ASAS) International Working Group compared with 8.7% of those receiving placebo, according to Atul Deodhar, MD, of Oregon Health & Science University in Portland.

Also at that time point, a 20% improvement on the ASAS response criteria was seen in 73.3% of patients randomized to golimumab compared with 26.2% of those given placebo (P<0.001). The difference was "quite dramatic."

The study included 208 patients who had a diagnosis of definite ankylosing spondylitis, with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or greater, total back pain visual analog scale of at least 4, and C-reactive protein (CRP) of 0.3 mg/dL or higher. The regimen included a loading dose in which intravenous golimumab was given as 2 mg/kg at baseline and week 4, and then every 8 weeks through week 16, at which time all patients began receiving the active treatment. The primary endpoint was ASAS20 at week 16. More than three-quarters of the patients were men, and mean age was 39. Mean duration of disease was 5.5 years, 6% had complete ankylosis of the spine, and 90% were HLA-B27 positive. A total of 14.4% had previously been treated with an anti-TNF agent.Mean baseline BASDAI was 7.1, Bath Ankylosing Spondylitis Functional Index (BASFI) averaged 6.2, mean Bath Ankylosing Spondylitis Metrology Index (BASMI) was 5, and mean Baseline Ankylosing Spondylitis Disease Activity Score was 4.2,"which is very active disease".

As early as week 2, the ASAS20 response rate was significantly higher in the golimumab group (37.1% versus 19.4%, P=0.05), and at all time points through week 16 remained significantly different from the placebo group (P=0.001). After those in the placebo group switched to the active treatment at week 16, their ASAS20 response rates improved and were maintained through week 28. Mean changes in BASFI from baseline were -2.39 in the golimumab group at week 16 compared with -0.47 in the placebo group (P<0.001), while changes on BASMI were -0.38 versus -0.10 (P=0.001).

At week 16, a significantly greater proportion of patients in the golimumab group had achieved ASAS partial remission (16.2% versus 3.9%, P=0.003) and inactive disease, with a score below 1.3 on the ASDAI (27.6 versus 2.9, P<0.001).

Safety was similar to what has been seen with other anti-TNF therapies, including subcutaneous golimumab. During the 16 weeks, 32.4% of patients receiving golimumab had one or more adverse event, as did 23.3% of those given placebo. A total of 11.4% of patients in the active treatment group had one or more infections, as did 7.8% of those in the placebo group. There was only serious infection, which was a case of pneumonia in a patient in the golimumab group. There were no opportunistic infections, malignancies, or deaths. Infusion reactions, which occurred in three patients, were very minor, with no anaphylaxis. During the extended follow-up through week 28, there were no further infusion reactions.