FOR ADULTS WITH ACTIVE AS

DEMONSTRATED SYMPTOM CONTROL IN ACTIVE AS

» Glossary of AS measures

» Glossary of AS measures

ASAS20* response at Week 16 (primary endpoint) vs placebo1-3:

73%

Seventy Three Percent
of patients receiving
SIMPONI ARIA®
(77/105) achieved ASAS20 response
(P<0.001)
versus icon

26%

Twenty Six Percent
of patients receiving placebo (27/103)1-3

Rapid ASAS20 response at Week 21-3:

37%

of patients receiving
SIMPONI ARIA®
(39/105) achieved ASAS20 response
versus icon

19%

of patients receiving placebo (20/103)1-3

ASAS20 response at Week 2 was not adjusted for multiplicity. Therefore, statistical significance was not established.

*An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defined as ≥20% worsening and absolute worsening of at least 1 on a 0-to-10 scale) in the potential remaining domain. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the remaining domain.

ASAS 20 response Rate Graph

WEEK 24 CROSSOVER†‡§||

ASAS20 response at Week 28:

71%

of patients receiving
SIMPONI ARIA® (75/105) achieved ASAS20 response
versus icon

62%

of patients who crossed over to receive SIMPONI ARIA® at Week 16 (64/103)1,2

ASAS20 response at Week 52:

70%

of patients receiving
SIMPONI ARIA® (73/105) achieved ASAS20 response
versus icon

65%

of patients who crossed over to receive SIMPONI ARIA® at Week 16 (67/103)1,2
ASAS20 response at Week 2 was not adjusted for multiplicity. Therefore, statistical significance was not established.

†The same patients may not have responded at each time point.

‡ASAS20 response is based on imputed data using treatment failure (only through Week 16), last observation carried forward (LOCF) for partially missing data, and NRI for completely missing data.

§In this intention-to-treat analysis, patients were considered to be nonresponders if they experienced any of the following: initiated new DMARDs, biologics, or systemic immunosuppressives; increased SSZ, MTX, or HCQ above baseline dose; initiated treatment with oral, IV, or IM corticosteroids; increased the dose of oral corticosteroids above baseline dose; or discontinued treatment due to unsatisfactory therapeutic effect. Treatment failure rules were applied only through Week 16. LOCF rules were applied for partially missing data.

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

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; DMARD=disease-modifying antirheumatic drug; HCQ=hydroxychloroquine; hsCRP=high-sensitivity C-reactive protein; IM=intramuscular; IV=intravenous; MTX=methotrexate; NRI=nonresponder imputation; NSAID=nonsteroidal anti-inflammatory; q8w=every 8 weeks; SSZ=sulfasalazine; VAS=visual analog scale.
Back to Top

» Glossary of AS measures

ASAS40* response at Week 16 vs placebo1-3:

48%

Fourty Eight Percent
of patients receiving
SIMPONI ARIA®
(50/105) achieved ASAS40 response
(P<0.001)
versus icon

9%

Nine Percent
of patients receiving placebo (9/103)1,2

Rapid ASAS40 response at Week 2:

14%

of patients receiving
SIMPONI ARIA® (15/105) achieved ASAS40 response
versus icon

4%

of patients receiving placebo (4/103)1,2

ASAS40 response at Week 2 was not adjusted for multiplicity. Therefore, statistical significance was not established.

ASAS 40 response Rate Graph

WEEK 16 CROSSOVER†‡§||

ASAS40 response at Week 28:

45%

of patients receiving
SIMPONI ARIA® (47/105) achieved ASAS40 response
versus icon

43%

of patients who crossed over to receive SIMPONI ARIA® at Week 16 (n=103)1,2

ASAS40 response at Week 52:

56%

of patients receiving
SIMPONI ARIA® (59/105) achieved ASAS40 response
versus icon

52%

of patients who crossed over to receive SIMPONI ARIA® at Week 16 (53/103)1,2
ASAS40 response at Week 2 was not adjusted for multiplicity. Therefore, statistical significance was not established.

*An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defined as ≥20% worsening and absolute worsening of at least 1 on a 0-to-10 scale) in the potential remaining domain. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the potential remaining domain.

†The same patients may not have responded at each time point.

‡In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: initiated new DMARDs, biologics, or systemic immunosuppressives; increased SSZ, MTX, or HCQ above baseline dose; initiated treatment with oral, IV, or IM corticosteroids; increased the dose of oral corticosteroids above baseline dose; or discontinued treatment due to unsatisfactory therapeutic effect. Treatment failure rules were applied only through Week 16.

§Last observation carried forward (LOCF) rules were applied for partially missing data and NRI for completely missing data.

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

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; DMARD=disease-modifying antirheumatic drug; HCQ=hydroxychloroquine; hsCRP=high-sensitivity C-reactive protein; IM=intramuscular; IV=intravenous; MTX=methotrexate; NRI=nonresponder imputation; NSAID=nonsteroidal anti-inflammatory; q8w=every 8 weeks; SSZ=sulfasalazine; VAS=visual analog scale.
NEXT: View BASDAI Scores »

References: 1. Data on file. Johnson & Johnson. 2. SIMPONI ARIA® [Prescribing Information]. Horsham, PA: Johnson & Johnson. 3. 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