FOR ADULTS WITH ACTIVE AS
IMPROVEMENT IN ASQoL SCORES
ASAS20 response at Week 16 (primary endpoint): 73% of patients receiving SIMPONI ARIA® achieved ASAS20 response vs 26% of patients receiving placebo (P<0.001)1,2
Mean improvement (decrease) in ASQoL* score from baseline vs placebo at Week 16†:
*ASQoL=Ankylosing Spondylitis Quality of life. ASQoL is a self-administered disease-specific HRQoL (Health-related Quality of Life) instrument. It consists of 18 items requesting a "Yes" or "No" response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "Yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQoL.
†The analysis was performed using the mixed-effect model for repeated measure (MMRM) based on observed data.
Study design: GO-ALIVE was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 208 adult patients with active AS with an inadequate response or intolerance to NSAIDs. Patients had a diagnosis of definite AS for at least 3 months according to modified New York criteria. Patients had symptoms of active disease [Bath AS Disease Activity Index (BASDAI) ≥4, VAS for total back pain of ≥4, on scales of 0 to 10 cm (0 to 100 mm), and a hsCRP level of ≥0.3 mg/dL (3 mg/L)]. At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Subjects in the placebo group (n=103) were randomized to receive IV placebo infusions at Weeks 0, 4, and 12. At Week 16, these patients were crossed over to SIMPONI ARIA® and received administrations at Weeks 16, 20, and q8w thereafter through Week 52. Patients in the SIMPONI ARIA® group (n=105) were randomized to receive SIMPONI ARIA® 2 mg/kg infusions at Weeks 0, 4, and 12. These patients received a placebo infusion at Week 16 to maintain the treatment blind and continued to receive SIMPONI ARIA® infusions at Week 20 and q8w thereafter through Week 52. Patients were allowed to continue stable doses of concomitant MTX, SSZ, hydroxychloroquine (HCQ), low dose oral corticosteroids (equivalent 25 to ≤10 mg of prednisone per day), and/or NSAIDs during the trial. The primary endpoint was the percentage of patients achieving ASAS20 response at Week 16.
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