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SIMPONI ARIA® (golimumab) RA Clinical Trial: Sharp (vdH-S) Scores | HCP
  1. Efficacy
  2. RA - Efficacy - INHIBITION

FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX

INHIBITION OF RADIOGRAPHIC PROGRESSION

ACR20 response at Week 14 (primary endpoint): 59% of patients receiving SIMPONI ARIA® + MTX achieved ACR20 response vs 25% of patients receiving placebo + MTX (P<0.001)1,2

At Week 24: The mean change from baseline in total Sharp (vdH-S*) score was†

0.03
for patients receiving SIMPONI ARIA® + MTX (n=395) (P<0.001)

VS

1.09
for patients receiving placebo + MTX (n=197)1,3

Calculated difference shows

97%

Inhibition of the progression of structural damage vs control group1‡

*vdH-S=van der Heijde Modified Sharp score. The total modified vdH-S score (0-448) is a composite score of structural damage that measures the number and size of joint erosions and the degree of joint space narrowing in the hands and feet.

†Missing data (linear extrapolation) rules were applied. For patients who early escaped, linear extrapolation was performed on the Week 16 data to the Week 24 endpoint.

‡Percentage is the difference in mean total vdH-S scores divided by the placebo + MTX value.

WEEK 24 CROSSOVER†‡

At Week 52§: The mean change from baseline in total Sharp score was

0.13
for patients receiving SIMPONI ARIA® + MTX (n=395)

VS

1.22
for patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (n=197)3
OPEN-LABEL EXTENSION

At Week 100§#: The mean change from baseline in total Sharp score was

0.74
for patients receiving SIMPONI ARIA® + MTX (n=395)

VS

2.10
for patients receiving placebo who crossed over to SIMPONI ARIA® + MTX at Week 24 (n=197)4

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

ǁMissing data (linear extrapolation) rules were applied. For patients who early escaped, linear extrapolation was performed on the Week 16 data to the Week 24 endpoint.

At Week 24, all remaining patients in the placebo + MTX group began receiving SIMPONI ARIA® + MTX in a blinded manner.

#At Week 52, all sponsor personnel were unblinded to subject-level data.

Study design: GO-FURTHER™ was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), RF positive and/or anti-CCP antibody positive, and CRP ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8 weeks through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8 weeks in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8 weeks in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.

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