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Research ArticleArticle

Informing Response Criteria for Psoriatic Arthritis. I: Discrimination Models Based on Data from 3 Anti-Tumor Necrosis Factor Randomized Studies

DAFNA D. GLADMAN, BRIAN D.M. TOM, PHILIP J. MEASE and VERNON T. FAREWELL
The Journal of Rheumatology September 2010, 37 (9) 1892-1897; DOI: https://doi.org/10.3899/jrheum.091172
DAFNA D. GLADMAN
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  • For correspondence: dafna.gladman@utoronto.ca
BRIAN D.M. TOM
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PHILIP J. MEASE
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VERNON T. FAREWELL
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Article Figures & Data

Tables

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    Table 1.

    Summaries for 24-week changes from baseline for the various measures. (D_ denotes differences between current and baseline values).

    Training Difference DataMean (SE)t-valueUnadjustedZ-value forEffect SizeSRMGESGUES
    OROR
    (change from baseline)PlaceboDrugDrug vs PlaceboDrug vs PlaceboDrug vs PlaceboPlaceboDrugPlaceboDrugDrug vs Placebo
    D_TJC68−4.066 (0.824)−10.693 (0.835)−5.640.955−5.19−0.2594−0.7661−0.3390−0.8430−0.5362−0.8914
    D_SJC66−2.854 (0.572)−6.368 (0.548)−4.440.946−4.17−0.2800−0.6793−0.3429−0.7644−0.4220−0.7651
    D_HAQ−0.118 (0.029)−0.477 (0.034)−7.950.183−6.88−0.2178−0.7462−0.2859−0.9162−0.7583−1.1519
    D_CRP−0.043 (0.104)−1.281 (0.158)−6.440.611−5.79−0.0662−0.5263−0.0286−0.5370−0.6155−0.8523
    D_logCRP−0.075 (0.058)−1.393 (0.087)−12.440.315−9.15−0.0992−1.0721−0.0893−1.0652−1.1894−1.6600
    D_MDGDA (Likert)−0.333 (0.065)−1.329 (0.069)−10.370.360−8.37−0.5023−1.8403−0.3546−1.2689−0.9983−1.4138
    D_PtGDA (Likert)−0.081 (0.068)−1.069 (0.077)−9.550.426−7.99−0.1123−1.1643−0.0810−0.9168−0.9090−1.0753
    D_Patient assessment of pain (Likert)−0.109 (0.071)−1.165 (0.081)−9.720.435−8.07−0.1708−1.3199−0.1059−0.9443−0.9255−1.1313
    D_SF-36PCS*1.544 (0.621)9.636 (0.672)8.821.0967.470.15730.96880.17120.96180.84781.0685
    D_SF-36 MCS*0.317 (0.763)2.492 (0.656)2.311.0232.290.09830.22200.03240.25510.22250.2548
    • ↵* Improvement over time is indicated by a positive increase in the score, as compared to the other measures where a decrease indicated improvement. SRM: Standardized response mean; GES: group effect size; GUES: Guyatt’s effect size; TJC: tender joint counts; SJC: swollen joint counts; HAQ: Health Assessment Questionnaire; CRP: C-reactive protein; MDGDA: physician global assessment of disease activity; P+GDA: patient global assessment of disease activity; SF-36 PCS: Medical Outcomes Study Short-Form physical component; SF-36 MCS: SF-36 mental component.

    • View popup
    Table 2.

    Factor analysis results for the differences in terms of the factor loadings.

    Loadings
    Factor 1Factor 2Factor 3Factor 4Factor 5
    D_SJC660.13900.73300
    D_TJC680.2090.2280.6320.1820
    D_CRP0.1830.11500.5200.101
    D_MDGDA0.4900.1290.2490.3670
    D_PtGDA0.8600.1950.2200.1500.169
    D_patient assessment of pain0.7440.2330.1760.2620.127
    D_HAQ0.3130.8680.2250.2140.219
    D_SF-36PCS−0.586−0.528−0.225−0.2200.523
    D_SF-36MCS−0.159−0.133−0.136−0.153−0.407
    Percentage of the variance explained by latent factors23.313.613.37.26.1
    Cumulative percentage23.336.950.257.463.6
    • For abbreviations see Table 1. Bold type indicates significant loading.

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    Table 3.

    Logistic regression results based on domains.

    Domain Model
    EstimateSEz-valuep
    Intercept0.69350.18983.650.0003
    C_TJC68−0.02120.0083−2.550.0108
    D_CRP−0.89360.1791−4.99< 0.0001
    BL_CRP−0.60610.1452−4.17< 0.0001
    MAX.SUBJ.ASSESS−0.96790.1625−5.96< 0.0001
    • C_ denotes current; D_ denotes difference; BL_ denotes baseline; MAX.SUBJ.ASSESS: max (D_MDGDA, D_PtGDA, D_patient assessment of pain, 5/3.D_HAQ). For abbreviations see Table 1.

    • View popup
    Table 4.

    Logistic regression results for percentage change measures.

    Percentage Change Model
    EstimateSEz-valuep
    Intercept−0.89580.1629−5.50< 0.0001
    PC_TJC68−0.52900.2313−2.290.0222
    PC_CRP−0.32980.1430−2.310.0211
    PC_MDGDA−1.63100.4155−3.93< 0.0001
    PC_Patient assessment of change−0.79360.3577−2.220.0265
    PC_HAQ−0.63490.2787−2.280.0227
    • PC_ denotes percentage change. For abbreviations see Table 1.

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1 Sep 2010
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Informing Response Criteria for Psoriatic Arthritis. I: Discrimination Models Based on Data from 3 Anti-Tumor Necrosis Factor Randomized Studies
DAFNA D. GLADMAN, BRIAN D.M. TOM, PHILIP J. MEASE, VERNON T. FAREWELL
The Journal of Rheumatology Sep 2010, 37 (9) 1892-1897; DOI: 10.3899/jrheum.091172

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Informing Response Criteria for Psoriatic Arthritis. I: Discrimination Models Based on Data from 3 Anti-Tumor Necrosis Factor Randomized Studies
DAFNA D. GLADMAN, BRIAN D.M. TOM, PHILIP J. MEASE, VERNON T. FAREWELL
The Journal of Rheumatology Sep 2010, 37 (9) 1892-1897; DOI: 10.3899/jrheum.091172
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