Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Assessing HRQoL Burden of Disease and Comparison to the U.S. Population in RA Patients Treated with Golimumab: Results From the GO-FORWARD Trial

Hammond1,  G., Raju,  A., Parasuraman,  S., Buchanan,  J., Gathany2,  T.

Lincoln, RI
Johnson and Johnson Pharmaceutical Services, LLC, Malvern, PA
Johnson and Johnson Pharmaceutical Services, LLC, Malvern, PA

Purpose:

Assess the disease burden of RA relative to the U.S. population using SF-36 scale, summary measures. To contrast the percentage of individuals meeting or exceeding the age, gender adjusted population means.

Methods:

A prospective, multisite, randomized control study of 444 patients with active rheumatoid arthritis despite methotrexate therapy was assessed at baseline, wk 14, and wk 24. Eligible patients were 18 or older with a confirmed diagnosis of active rheumatoid arthritis (RA) despite MTX therapy. Patients were randomized 3:3:2:2 to receive one of four treatments: 1) MTX plus placebo (tx 1), 2) GLM 100mg plus placebo (tx 2), 3) GLM 50mg plus MTX (tx 3), or 4) GLM 100mg plus MTX (tx 4). Comparisons to population and disease specific norms (heart disease and rheumatoid arthritis norms) in continuous SF-36 scores were made at baseline, wk 14 and wk 24 (not displayed) using multiple t-tests. Separate c2 tests were used to compare proportions of individuals meeting and exceeding pop norms at wks 14, 24.

Results:

At baseline all 8 scale and 2 summary SF-36 measures were significantly lower than age and gender adjusted U.S. and disease specific norms, indicating significant impairment. At wk 14 (Table), scores improved, but remained significantly lower than general population norms. Scores were comparable to the heart disease sample with the exception of PF, RP, and RE. The wk 14 trial sample showed increased PF, GH, MH and PCS impairment relative to the rheumatoid sample. At wk 14, 17.4% (tx 4), 17.1% (tx 2), and 25.6%* (tx 3) of individuals exceeded the population average value for PCS, relative to 10.9% for tx 1. At wk 24, 18.4% (tx 4) 28.3%* (tx 2) 27.4%* (tx 3) and 14.0% (tx 1) exceeded norm values (*c2 versus tx 1, p<.05).

 GO-FORWARDNormsSignificance Testing
 Baseline (n=442)Wk 14 (n=429)U.S. Pop. (n=2031)Heart Disease (n=188)Rheumatoid (n=136)U.S. Pop.Heart DiseaseRheumatoid
ScalesMeanMeanMeanMeanMeanMean Diff. (Comparator-Trial)  
PF32.536.848.740.342.211.9**3.5*5.5**
RP34.840.549.543.643.29.0**3.1*2.8
BP35.641.549.241.941.67.7**0.50.1
GH37.339.749.839.942.510.1**0.22.8*
VT41.646.250.244.346.14.0**-1.9-0.1
SF38.242.449.944.244.77.5**1.82.3
RE39.042.350.245.545.57.9**3.2*3.2
MH40.543.749.944.346.66.2**0.62.9*
PCS33.538.649.040.741.310.4**2.12.7*
MCS43.045.950.546.547.64.6**0.61.7
**: p<.01, *: p<.05

Conclusion:

Significant differences were still observed between trial and general population means, despite marked improvement with treatment. Disease specific populations were comparable. Regarding percentage return to normal functioning, results corroborate existing clinical findings that additional improvements are achieved by using GLM in combination with MTX. 50 mg Golimumab + MTX showed best overall profile of improvement, with a significant proportion of patients exceeding norm values relative to MTX plus placebo.

To cite this abstract, please use the following information:
Hammond, G., Raju, A., Parasuraman, S., Buchanan, J., Gathany, T.; Assessing HRQoL Burden of Disease and Comparison to the U.S. Population in RA Patients Treated with Golimumab: Results From the GO-FORWARD Trial [abstract]. Arthritis Rheum 2009;60 Suppl 10 :731
DOI: 10.1002/art.25811

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