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Review ArticleArticle
Open Access

Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER

DÉSIRÉE van der HEIJDE, FERDINAND C. BREEDVELD, ARTHUR KAVANAUGH, EDWARD C. KEYSTONE, ROBERT LANDEWÉ, KAUSHIK PATRA and AILEEN L. PANGAN
The Journal of Rheumatology November 2010, 37 (11) 2237-2246; DOI: https://doi.org/10.3899/jrheum.100208
DÉSIRÉE van der HEIJDE
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FERDINAND C. BREEDVELD
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ARTHUR KAVANAUGH
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EDWARD C. KEYSTONE
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ROBERT LANDEWÉ
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KAUSHIK PATRA
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AILEEN L. PANGAN
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  • For correspondence: aileen.pangan{at}abbott.com
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  • Patient distribution by minimum number of weeks of methotrexate (MTX) therapy received during open-label adalimumab (ADA) treatment.
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    Figure 1.

    Patient distribution by minimum number of weeks of methotrexate (MTX) therapy received during open-label adalimumab (ADA) treatment.

  • Percentages of patients demonstrating 28-joint Disease Activity Score (DAS28) remission (A), 70% improvement in the American College of Rheumatology rating scale response criteria (ACR70) (B), and ACR90 (C) during the open-label period. Includes all patients with nonmissing data at each timepoint.
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    Figure 2.

    Percentages of patients demonstrating 28-joint Disease Activity Score (DAS28) remission (A), 70% improvement in the American College of Rheumatology rating scale response criteria (ACR70) (B), and ACR90 (C) during the open-label period. Includes all patients with nonmissing data at each timepoint.

  • Mean Health Assessment Questionnaire (HAQ) scores during randomized and open-label adalimumab (ADA) treatment. Includes all patients with nonmissing data at each timepoint. MTX: methotrexate; RCT: randomized controlled trial.
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    Figure 3.

    Mean Health Assessment Questionnaire (HAQ) scores during randomized and open-label adalimumab (ADA) treatment. Includes all patients with nonmissing data at each timepoint. MTX: methotrexate; RCT: randomized controlled trial.

  • Radiographic scores from baseline to Year 5. Broken lines represent the full randomized study population. Solid lines represent the 5-year completers cohort. A, B, and C present results for modified total Sharp score (mTSS), joint erosion (JE), and joint space narrowing (JSN), respectively. ADA: adalimumab; MTX: methotrexate; RCT: randomized controlled trial.
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    Figure 4.

    Radiographic scores from baseline to Year 5. Broken lines represent the full randomized study population. Solid lines represent the 5-year completers cohort. A, B, and C present results for modified total Sharp score (mTSS), joint erosion (JE), and joint space narrowing (JSN), respectively. ADA: adalimumab; MTX: methotrexate; RCT: randomized controlled trial.

  • Percentages of patients in the 5-year completers cohort with nonmissing data who met triple criteria for comprehensive disease remission at Year 5. ADA: adalimumab; DAS28: 28-joint Disease Activity Score; HAQ: Health Assessment Questionnaire; mTSS: modified total Sharp score; MTX: methotrexate.
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    Figure 5.

    Percentages of patients in the 5-year completers cohort with nonmissing data who met triple criteria for comprehensive disease remission at Year 5. ADA: adalimumab; DAS28: 28-joint Disease Activity Score; HAQ: Health Assessment Questionnaire; mTSS: modified total Sharp score; MTX: methotrexate.

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    Table 1.

    Baseline disease characteristics in the randomized and 5-year completers cohorts. Statistics are group means except where noted.

    CharacteristicRandomized Cohort*5-Year Completers Cohort by Original Randomization Arm
    ADA+MTX, n = 268ADA, n = 274MTX, n = 257ADA+MTX, n = 124ADA, n = 115MTX, n = 115
    RA duration, yrs0.70.70.80.80.70.8
    SJC (66)21.121.822.121.121.022.9
    TJC (68)30.731.832.330.732.831.6
    DAS286.36.46.36.36.36.2
    HAQ1.51.61.51.41.61.5
    CRP, mg/dl3.94.14.03.93.73.7
    mTSS18.118.821.915.516.819.5
    JE11.011.313.69.49.710.7
    JSN7.17.58.26.17.18.8
    Estimated annual mTSS progression, median†28.529.625.624.023.921.9
    • ↵* Data from Breedveld, et al11 except for “estimated annual mTSS progression.”

    • ↵† Median of the estimated individual patient annual mTSS progression. ADA: adalimumab; DAS28: 28-joint Disease Activity Score; HAQ: Health Assessment Questionnaire; JE: joint erosions; JSN: joint space narrowing; mTSS: modified total Sharp score; MTX: methotrexate; SJC: swollen joint count; TJC: tender joint count.

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The Journal of Rheumatology
Vol. 37, Issue 11
1 Nov 2010
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Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER
DÉSIRÉE van der HEIJDE, FERDINAND C. BREEDVELD, ARTHUR KAVANAUGH, EDWARD C. KEYSTONE, ROBERT LANDEWÉ, KAUSHIK PATRA, AILEEN L. PANGAN
The Journal of Rheumatology Nov 2010, 37 (11) 2237-2246; DOI: 10.3899/jrheum.100208

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Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER
DÉSIRÉE van der HEIJDE, FERDINAND C. BREEDVELD, ARTHUR KAVANAUGH, EDWARD C. KEYSTONE, ROBERT LANDEWÉ, KAUSHIK PATRA, AILEEN L. PANGAN
The Journal of Rheumatology Nov 2010, 37 (11) 2237-2246; DOI: 10.3899/jrheum.100208
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