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FOR ADULTS WITH ACTIVE AS
IMPROVEMENT IN PHYSICAL FUNCTION AND RANGE OF MOTION/SPINAL MOBILITY
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 16†:
-2.4
for patients receiving SIMPONI ARIA® (n=105) (P<0.001)
VS
-0.5
for patients receiving placebo (n=98)1,2
*BASFI=Bath Ankylosing Spondylitis Functional Index. 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 (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.
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 16†:
-0.4
for patients receiving SIMPONI ARIA® (n=100) (P<0.001)
VS
-0.10
for patients receiving placebo (n=96)1,2
*BASMI=Bath Ankylosing Spondylitis Metrology Index. The BASMI is represented as an aggregate score of 5 components (ranging from 0-10) 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 (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.