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Research ArticleArticle
Open Access

Clinical, Functional, and Radiographic Implications of Time to Treatment Response in Patients With Early Rheumatoid Arthritis: a Posthoc Analysis of the PREMIER Study

Edward C. Keystone, Boulos Haraoui, Benoît Guérette, Neelufar Mozaffarian, Shufang Liu and Arthur Kavanaugh
The Journal of Rheumatology February 2014, 41 (2) 235-243; DOI: https://doi.org/10.3899/jrheum.121468
Edward C. Keystone
From the University of Toronto, Toronto, Ontario; the University of Montreal, Montreal, Quebec, Canada; AbbVie Inc., North Chicago, Illinois; and the University of California San Diego, La Jolla, California, USA.
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  • For correspondence: edkeystone@mtsinai.on.ca
Boulos Haraoui
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Benoît Guérette
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Neelufar Mozaffarian
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Shufang Liu
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Arthur Kavanaugh
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    Figure 1.

    Proportions of MTX or ADA + MTX Month 3 and Month 6 responders. The percentages of MTX-treated or ADA + MTX-treated patients exhibiting (A) ACR responses (ACR20/50/70), (B) improvements in DAS28-CRP (improvements > 1.2/1.8), or (C) DAS28-CRP targets (LDA, DAS28-CRP < 3.2; remission, DAS28-CRP < 2.6) at months 3 and 6 (Month 3 responders) or at Month 6 (Month 6 responders). *, **, and *** significantly different between treatment groups at the p < 0.05, 0.01, and 0.001 levels, respectively. Asterisks above columns reflect differences in responder and nonresponder populations across MTX and ADA + MTX groups. Asterisks within columns reflect differences in Month 3 and Month 6 responders across MTX and ADA + MTX groups. MTX: methotrexate; ADA: adalimumab; ACR: American College of Rheumatology; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; LDA: low disease activity.

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    Figure 2.

    Clinical remission at 1 year in MTX or ADA + MTX Month 3 and Month 6 responders. The percentages of MTX or ADA + MTX-treated patients exhibiting clinical remission (DAS28-CRP < 2.6) at 1 year based on (A–C) ACR responses (ACR20/50/70), (D and E) improvements in DAS28-CRP (> 1.2/1.8), or (F and G) DAS28-CRP targets (LDA, DAS28-CRP < 3.2; remission, DAS28-CRP < 2.6] at months 3 and 6 (Month 3 responders) or at Month 6 (Month 6 responders). A, B, and C indicate outcomes that are significantly different relative to ADA + MTX Month 3 responders, ADA + MTX Month 6 responders, and MTX Month 3 responders, respectively, by OR (95% CI). MTX: methotrexate; ADA: adalimumab; ACR: American College of Rheumatology; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; LDA: low disease activity.

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    Figure 3.

    Normal functionality at 1 year in MTX or ADA + MTX Month 3 and Month 6 responders. The percentages of MTX or ADA + MTX–treated patients exhibiting normal function (HAQ-DI < 0.5) at 1 year based on (A–C) ACR responses (ACR20/50/70), (D–E) improvements in DAS28-CRP (improvements > 1.2/1.8), or (F–G) DAS28–CRP targets (LDA, DAS28-CRP < 3.2; remission, DAS28-CRP < 2.6) at months 3 and 6 (Month 3 responders) or at Month 6 (Month 6 responders). A, B, and C indicate outcomes that are significantly different relative to ADA + MTX Month 3 responders, ADA + MTX Month 6 responders, and MTX Month 3 responders, respectively, by OR (95% CI). MTX: methotrexate; ADA: adalimumab; ACR: American College of Rheumatology; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; LDA: low disease activity; HAQ-DI: Health Assessment Questionnaire-Disability Index.

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    Figure 4.

    Radiographic progression in MTX or ADA + MTX Month 3 and Month 6 responders. Mean change in modified total Sharp score (mTSS) from baseline to 1 year in MTX-treated or ADA + MTX-treated patients exhibiting (A) ACR responses (ACR20/50/70), (B) improvements in DAS28-CRP (improvements > 1.2/1.8), or (C) DAS28-CRP targets (LDA, DAS28-CRP < 3.2; remission, DAS28-CRP < 2.6) at months 3 and 6 (Month 3 responders) or at Month 6 (Month 6 responders). MTX: methotrexate; ADA: adalimumab; ACR: American College of Rheumatology; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein.

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    Figure 5.

    Rapid radiographic progression at 1 year MTX or ADA + MTX Month 3 and Month 6 responders. The percentages of MTX-treated or ADA + MTX-treated patients exhibiting rapid radiographic progression (ΔmTSS > 3) at 1 year based on (A–C) ACR responses (ACR20/50/70), (D–E) improvements in DAS28-CRP (improvements > 1.2/1.8), or (F–G) DAS28-CRP targets (LDA, DAS28-CRP < 3.2; remission, DAS28-CRP < 2.6) at months 3 and 6 (Month 3 responders) or at Month 6 (Month 6 responders). A, B, and C indicate outcomes that are significantly different relative to ADA + MTX Month 3 responders, ADA + MTX Month 6 responders, and MTX Month 3 responders, respectively, by OR (95% CI). MTX: methotrexate; ADA: adalimumab; ACR: American College of Rheumatology; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; mTSS: modified total Sharp score; LDA: low disease activity.

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    Table 1.

    Baseline demographics and disease characteristics. All values are mean ± SD, unless otherwise indicated.

    CharacteristicMTX, n = 200ADA + MTX, n = 229
    Age, yrs52.8 ± 13.351.9 ± 14.1
    Female, n (%)146 (73.0)160 (69.9)
    Rheumatoid factor-positive, n (%)170 (87.2)186 (83.8)
    Duration of RA, yrs0.8 ± 0.90.7 ± 0.8
    Baseline DMARD use, n (%)59 (29.5)73 (31.7)
    Baseline corticosteroid use, n (%)68 (34.0)81 (35.4)
    DAS28-CRP, range 0–10a6.3 ± 0.86.3 ± 0.9
    DAS28-CRP ≥ 5.1, n (%)a182 (93.8)199 (90.9)
    CRP, mg/dl4.0 ± 4.04.0 ± 4.2
    SJC (0–66 joints)22.4 ± 12.021.3 ± 11.5
    TJC (0–68 joints)32.0 ± 14.030.7 ± 14.6
    HAQ-DI (range 0–3)1.5 ± 0.71.5 ± 0.6
    mTSS (range 0–398)22.7 ± 22.718.6 ± 20.6
    Joint erosion score (0–230)b14.1 ± 13.711.3 ± 12.9
    Joint space narrowing score (0–168)8.6 ± 10.97.3 ± 9.4
    • ↵a 195 and 220 patients from the MTX and ADA + MTX treatment groups, respectively, had DAS28-CRP values available at baseline.

    • ↵b p = 0.03 for differences between MTX and ADA + MTX. MTX: methotrexate; ADA: adalimumab; RA: rheumatoid arthritis; DMARD: (nonbiologic) disease-modifying antirheumatic drug; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; SJC: swollen joint count; TJC: tender joint count; HAQ-DI: Health Assessment Questionnaire-Disability Index; mTSS: modified total Sharp score.

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The Journal of Rheumatology
Vol. 41, Issue 2
1 Feb 2014
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Clinical, Functional, and Radiographic Implications of Time to Treatment Response in Patients With Early Rheumatoid Arthritis: a Posthoc Analysis of the PREMIER Study
Edward C. Keystone, Boulos Haraoui, Benoît Guérette, Neelufar Mozaffarian, Shufang Liu, Arthur Kavanaugh
The Journal of Rheumatology Feb 2014, 41 (2) 235-243; DOI: 10.3899/jrheum.121468

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Clinical, Functional, and Radiographic Implications of Time to Treatment Response in Patients With Early Rheumatoid Arthritis: a Posthoc Analysis of the PREMIER Study
Edward C. Keystone, Boulos Haraoui, Benoît Guérette, Neelufar Mozaffarian, Shufang Liu, Arthur Kavanaugh
The Journal of Rheumatology Feb 2014, 41 (2) 235-243; DOI: 10.3899/jrheum.121468
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Keywords

RHEUMATOID ARTHRITIS
METHOTREXATE
TUMOR NECROSIS FACTOR INHIBITORS
DISEASE ACTIVITY

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