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^1,3:

41^%

of patients receiving
SIMPONI ARIA® (43/105) achieved BASDAI50 response (P<0.001)

15^%

of patients receiving placebo (15/103)^1-3

Nearly 3x more patients achieved BASDAI50 response at Week 16 with SIMPONI ARIA® than with placebo^1,3

BASDAI50 response at Week 2 was not adjusted for multiplicity. Therefore, statistical significance has not been established.

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 (BASDAI ≥4, VAS for total back pain of ≥4, on scales of 0 to 10 cm [0 to 100 mm], and an 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, HCQ, low dose oral corticosteroids (equivalent 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 16.¹

AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; BASDAI=Bath AS Disease Activity Index; HCQ=hydroxychloroquine; hsCRP=high-sensitivity C-reactive protein; IV=intravenous; MTX=methotrexate; NSAID=nonsteroidal anti-inflammatory; q8w=every 8 weeks; SSZ=sulfasalazine; VAS=visual analog scale.

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