FOR ADULTS WITH ACTIVE AS

IMPROVEMENT IN ASQoL SCORES

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

-5.4

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

-1.8

of patients receiving placebo (n=103)1

*  ASQoL is a self-administered disease-specific HRQoL 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 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; ASQoL=ankylosing spondylitis quality of life; HCQ=hydroxychloroquine; hsCRP=high-sensitivity C-reactive protein; HRQoL=health-related quality of life; IV=intravenous; MTX=methotrexate; NSAID=nonsteroidal anti-inflammatory; q8w=every 8 weeks; SSZ=sulfasalazine; VAS=visual analog scale.

NEXT: SF-36 Scores in AS  »

Reference: 1. Data on file. Johnson & Johnson. 2. SIMPONI ARIA® [Prescribing Information]. Horsham, PA: Johnson & Johnson.