FOR ADULTS WITH ACTIVE AS

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SIMPONI ARIA® IS THE FIRST ANTI-TNFα BIOLOGIC WITH IMPROVEMENT IN BOTH PHYSICAL AND MENTAL COMPONENT SUMMARY SCORES OF SF-36 IN THE LABEL1-6

» 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)7,8

SF-36 is a 36-item short-form health survey for patients. This instrument yields an 8-domain profile of functional health and well-being scores, as well as psychometrically based physical component summary (PCS) and
mental component summary (MCS) scores.8

Mean change from baseline for patients receiving SIMPONI ARIA® vs patients receiving placebo7-9

Physical Component Chart
Physical Component Chart

In the GO-ALIVE study, a change from baseline in SF-36 score, including PCS and MCS, of ≥5 points was considered clinically meaningful.

Mean change from baseline for patients receiving SIMPONI ARIA® vs patients receiving placebo7-9

Mental Component Chart
Mental Component Chart

In the GO-ALIVE study, a change from baseline in SF-36 score, including PCS and MCS, of ≥5 points was considered clinically meaningful.

*The SF-36 is a validated questionnaire. The same patients may not have responded at each timepoint.

†Change from baseline in SF-36 is based on imputed data using last observation carried forward for missing data.

§After Week 28, selected sponsor personnel were unblinded to subject-level data, which may have affected results.

The 8 multi-item domains of the SF-36 instrument are8:

Physical health domains

  • Limitations in physical functioning due to health problems
  • Limitations in usual role activities due to physical health problems
  • Bodily pain
  • General health perception

Mental health domains

  • Limitations in social functioning due to physical or mental health problems
  • Limitations in usual role activities due to personal or emotional problems
  • Vitality (energy and fatigue)
  • General mental health (psychological distress and well-being)

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 16.8

AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; HCQ=hydroxychloroquine; hsCRP=high-sensitivity C-reactive protein; IV=intravenous; MCS=mental component summary; MTX=methotrexate; NSAID=nonsteroidal anti-inflammatory; q8w=every 8 weeks; PCS=physical component summary; SF-36=36-item short-form survey; SSZ=sulfasalazine; VAS=visual analog scale.

NEXT: View ASAS Partial Remission Data »
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EFFICIENT INFUSION

SIMPONI ARIA® offers an efficient 30-minute infusion.

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DOSING CALCULATOR

Calculate an adult patient's dose of SIMPONI ARIA® based on weight.

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ACCESS AND AFFORDABILITY

View first-line coverage rates for SIMPONI ARIA®.

References: 1. SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 2. SIMPONI® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 3. REMICADE® (infliximab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 4. Enbrel® (etanercept) [Prescribing Information]. Thousand Oaks, CA: Immunex Corporation. 5. Humira® (adalimumab) [Prescribing Information]. North Chicago, IL: AbbVie Inc. 6. Cimzia® (certolizumab pegol)  [Prescribing Information]. Smyrna, GA: UCB, Inc. 7. Deodhar A, Reveille JD, Harrison DD, et al. Safety and efficacy of golimumab administered intravenously in adults with ankylosing spondylitis: results through Week 28 of the GO-ALIVE study. J Rheumatol. 2018;45:3; doi:10.3899/jrheum.170487. 8. Data on file. Johnson & Johnson. 9. Reveille JD, Deodhar A, Caldron PH, et al. Safety and efficacy of intravenous golimumab in adults with ankylosing spondylitis: results through 1 year of the GO‑ALIVE study. J Rheumatol. 2019;46(10):1277-1283.