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 Psoriatic Arthritis Patients Treated with Golimumab: Results From the GO-REVEAL Trial

Raju1,  A., Hammond2,  G., Parasuraman,  S., Buchanan,  J., Gathany3,  T.

Lincoln, RI
Qualitymetric Inc., Lincoln, RI
Johnson and Johnson Pharmaceutical Services. LLC, Malvern, PA

Purpose:

Assess the burden of active psoriatic arthritis (PsA) on health-related quality of life (HRQOL) as measured by SF-36. Contrast proportions of individuals meeting or exceeding the age and gender adjusted pop norms.

Methods:

Adult patients (n=405) were randomized to golimumab (GLM) 50 mg (tx 1), GLM 100 mg (tx 2), or placebo (tx 3). Inclusion criteria: diagnosis with PsA (for min. of 6 months), exhibition of at least 3 swollen and tender joints. A t-test was used to assess equivalence in continuous SF-36 scores between wk 24 trial and norm, disease means. Separate c2 tests were used to compare proportions of individuals meeting and exceeding pop norms at wk 24.

Results:

At baseline and wk 24, despite improvement, GO-REVEAL means were significantly lower than age and gender-adjusted US population (pop) norms for all SF-36 domain scores, indicating marked health impairment (Table). At baseline, both disease specific norms means were significantly higher than trial means on 3 SF-36 physical scale scores (PF, RP, BP) and PCS summary scores (all ps<.05). Trial means were significantly higher than the depression specific norms on mental health scale and summary measures (VT, SF, RE, MH, and MCS) at wk 24, but were comparable on 3 of the physical health scales (RP, BP, GH) (Table). At wk 24, trial means were comparable to rheumatoid arthritis norms on all SF-36 domain scores (Table). At wk 24, 30.2% (tx 1) and 28.5% (tx 2) of individuals exceeded the pop. norms for PCS, relative to 7.6% for tx 3 (c2: 16.7 and 18.7, GLM 100, 50, vs. placebo, ps<.01). No difference was observed in the proportion of individuals meeting/exceeding the pop norms for MCS across treatments (c2: 2.6 and 2.5, GLM 100, 50, vs. placebo, ps>.10), although all mental health scales showed significant differences (VT, SF, RE, and MH, all ps<.05).

 GO-REVEALNormsComparisons
 Baseline (n=403)wk 24 (n=388)U.S. Pop. (n=2031)Depression (n=257)Rheumatoid (n=136)U.S. Pop. (Baseline)U.S. Pop. (wk 24)Depression (wk 24)Rheumatoid (wk 24)
 DomainMeanMeanMeanMeanMeanMean Diff. (Comparator-Trial)
PF36.040.450.643.643.014.6*10.2*3.2*2.6
RP36.642.150.642.843.414*8.5*0.71.3
BP36.043.350.043.241.114*6.8*-0.1-2.2
GH39.042.250.240.441.211.2*7.9*-1.8-0.9
VT42.547.150.640.945.78.1*3.5*-6.3*-1.4
SF39.944.450.639.142.810.7*6.2*-5.3*-1.6
RE42.045.850.639.244.58.6*4.7*-6.7*-1.23
MH43.245.550.337.145.47.1*4.8*-8.4*-0.1
PCS35.140.850.344.941.615.2*9.5*4.1*0.7
MCS45.247.850.437.145.95.2*2.7*-10.6*-1.9
*: p<.01

Conclusion:

Trial means improved relative to the US pop norms, but all domain scores were still significantly below pop. norms at wk 24. SF-36 domain scores were comparable to those of the RA specific norms. Both GLM doses showed significant and meaningful improvement in both PCS and all 4 mental scales relative to placebo at wk 24, indicating an improvement in both mental and physical health scores.

To cite this abstract, please use the following information:
Raju, A., Hammond, G., Parasuraman, S., Buchanan, J., Gathany, T.; Assessing HRQoL Burden of Disease and Comparison to the U.S. Population in Psoriatic Arthritis Patients Treated with Golimumab: Results From the GO-REVEAL Trial [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1401
DOI: 10.1002/art.26475

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