FOR ADULTS WITH ACTIVE AS

IMPROVEMENT IN PHYSICAL FUNCTION AND RANGE OF MOTION/
SPINAL MOBILITY

» Glossary of AS measures

» Glossary of AS measures

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 decrease (improvement) in BASFI* score from baseline vs placebo at Week 161,2†:

-2.4

of patients receiving SIMPONI ARIA®
(n=105) (P<0.001)
versus icon

-0.5

of patients receiving placebo
(n=103)1,2

*The BASFI is a self-assessment represented as a mean of 10 questions from a visual analog scale, 8 of which relate to the subject’s functional anatomy and 2 of which relate to a subject’s ability to cope with everyday life. An increase in BASFI score indicates a worsening condition.

†The analysis was performed using the mixed-effect model for repeated measure 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 (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; BASFI=Bath AS Functional Index; BASMI=Bath AS Metrology Index; HCQ=hydroxychloroquine; hsCRP=high-sensitivity C-reactive protein; IV=intravenous; MTX=methotrexate; NRI=nonresponder imputation; NSAID=nonsteroidal anti-inflammatory; q8w=every 8 weeks; SSZ=sulfasalazine; VAS=visual analog scale.
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» Glossary of AS measures

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 decrease (improvement) in BASMI* score from baseline vs placebo at Week 161,2†:

-0.4

of patients receiving
SIMPONI ARIA® (n=105)
(P<0.001)
versus icon

-0.10

of patients receiving
placebo (n=103)1,2

*The BASMI is represented as an aggregate score of 5 components (ranging from 0 to 10) and was calculated using the van der Heijde calculation (ie, BASMI-linear score). A negative change from baseline in BASMI is indicative of improvement.

†The analysis was performed using the mixed-effect model for repeated measure 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 (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; BASFI=Bath AS Functional Index; BASMI=Bath AS Metrology 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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References: 1. Data on file. Johnson & Johnson. 2. SIMPONI ARIA® [Prescribing Information]. Horsham, PA: Johnson & Johnson.