FOR ADULTS WITH ACTIVE AS
REDUCTION IN SYMPTOMS OF ACTIVE DISEASE
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
BASDAI50* response at Week 16 vs placebo†:
Nearly 3x more patients achieved BASDAI50 response with SIMPONI ARIA® than placebo
*BASDAI=Bath Ankylosing Spondylitis Disease Active Index. BASDAI is a summary of 6 self-assessments, using a visual analog scale where subjects rate (0-10) (A) fatigue, (B) spinal pain, (C) joint paint, (D) enthesitis, (E) equality of morning stiffness, and (F) quantitative morning stiffness. The BASDAI score is calculated as 0.2 (A + B + C + D + 0.5 [E+F]). BASDAI50 is defined as at least a 50% improvement from baseline.
†At least a 50% improvement from baseline in BASDAI was based on imputed data using treatment failure, and last observation carried forward (LOCF) for missing 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.