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


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.


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.


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).

 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)
*: p<.01


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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