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Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE).

Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R - Arthritis Res. Ther. (2015)

Bottom Line: Post hoc analyses were performed from the 12-month, double-blind period of the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE) in patients with early RA (≤2 years) and poor prognostic factors, comparing abatacept plus MTX (n = 210) versus MTX alone (n = 209).Remission was associated with long-term functional benefit; dissociation was seen between clinical and structural outcomes for abatacept.These findings highlight the impact of reaching stringent remission targets early, on physical function and structural damage, in MTX-naïve biologic-treated patients.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Waehringer Guertel 18-20, Vienna, A-1090, Austria. josef.smolen@wienkav.at.

ABSTRACT

Introduction: This study evaluated various remission criteria in abatacept plus methotrexate (MTX)-treated patients with early rheumatoid arthritis (RA). We aimed to investigate the time to, and sustainability of, remission, and to evaluate the relationship between remission, function and structure.

Methods: Post hoc analyses were performed from the 12-month, double-blind period of the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE) in patients with early RA (≤2 years) and poor prognostic factors, comparing abatacept plus MTX (n = 210) versus MTX alone (n = 209).

Results: At month 12, Disease Activity Score 28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index and Boolean remission rates were, for abatacept plus MTX versus MTX alone: 47.6 % versus 27.3 %, 33.3 % versus 12.4 %, 34.3 % versus 16.3 %, and 23.8 % versus 5.7 %, respectively. Cumulative probability demonstrated higher proportions achieving first remission and first sustained remission for abatacept plus MTX versus MTX alone (e.g., 23.3 % [95 % confidence interval (CI): 17.6, 29.1] vs 12.9 % [8.4, 17.5] for first SDAI remission over 0-6 months). For patients in SDAI remission at month 3, mean Health Assessment Questionnaire-Disability Index at month 12 was 0.20 versus 0.50 for abatacept plus MTX versus MTX alone. Mean changes in radiographic score from baseline to month 12 were minimal for patients in SDAI remission at month 3 in both groups, while less structural damage progression was seen, 0.75 versus 1.35, respectively, for abatacept plus MTX versus MTX alone for patients with moderate/high disease activity at month 3 (adjusted mean treatment difference: -0.60 [95 % CI: -1.11, -0.09; P < 0.05]).

Conclusions: High proportions of abatacept plus MTX-treated patients achieved stringent remission criteria. Remission was associated with long-term functional benefit; dissociation was seen between clinical and structural outcomes for abatacept. These findings highlight the impact of reaching stringent remission targets early, on physical function and structural damage, in MTX-naïve biologic-treated patients.

Trial registration: ClinicalTrials.gov identifier NCT00122382. Registered 19 July 2005.

No MeSH data available.


Related in: MedlinePlus

Functional and structural outcomes at month 12 according to disease activity status. Functional (a–c) and structural (d–f) outcomes at month 12 according to disease activity status at months 3 and 12, based on patients with data available at baseline, month 6 and month 12. *P <0.05; †Non-significant. Disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: Disease Activity Score using 28-joint counts (DAS28) remission = DAS28 <2.6; DAS28 low disease activity (LDA) = DAS28 2.6–3.2; DAS28 moderate disease activity (MDA)/high disease activity (HDA) = DAS28 >3.2; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; SDAI LDA = SDAI >3.3–11; SDAI MDA/HDA = SDAI >11; Clinical Disease Activity Index (CDAI) remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA/HDA = CDAI >10. ANCOVA analysis of covariance, MTX methotrexate
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Fig4: Functional and structural outcomes at month 12 according to disease activity status. Functional (a–c) and structural (d–f) outcomes at month 12 according to disease activity status at months 3 and 12, based on patients with data available at baseline, month 6 and month 12. *P <0.05; †Non-significant. Disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: Disease Activity Score using 28-joint counts (DAS28) remission = DAS28 <2.6; DAS28 low disease activity (LDA) = DAS28 2.6–3.2; DAS28 moderate disease activity (MDA)/high disease activity (HDA) = DAS28 >3.2; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; SDAI LDA = SDAI >3.3–11; SDAI MDA/HDA = SDAI >11; Clinical Disease Activity Index (CDAI) remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA/HDA = CDAI >10. ANCOVA analysis of covariance, MTX methotrexate

Mentions: Patients receiving abatacept plus MTX who achieved remission or LDA according to DAS28, SDAI or CDAI at month 3 achieved greater improvements in HAQ-DI scores at month 12 vs patients with MDA or HDA (Fig. 4a–c). Similar trends were seen for MTX alone, with greater improvements in HAQ-DI scores at month 12 for patients in remission or LDA at month 3 vs patients in MDA or HDA. Similar data were reported at different time points. At all time points, in line with their more stringent nature, mean HAQ-DI scores were numerically lower for patients in SDAI and CDAI remission (with mean HAQ-DI score of ≤0.5 with MTX alone and ≤0.25 with abatacept plus MTX) versus DAS28 remission (see Additional file 7: Table S4).Fig. 4


Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE).

Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R - Arthritis Res. Ther. (2015)

Functional and structural outcomes at month 12 according to disease activity status. Functional (a–c) and structural (d–f) outcomes at month 12 according to disease activity status at months 3 and 12, based on patients with data available at baseline, month 6 and month 12. *P <0.05; †Non-significant. Disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: Disease Activity Score using 28-joint counts (DAS28) remission = DAS28 <2.6; DAS28 low disease activity (LDA) = DAS28 2.6–3.2; DAS28 moderate disease activity (MDA)/high disease activity (HDA) = DAS28 >3.2; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; SDAI LDA = SDAI >3.3–11; SDAI MDA/HDA = SDAI >11; Clinical Disease Activity Index (CDAI) remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA/HDA = CDAI >10. ANCOVA analysis of covariance, MTX methotrexate
© Copyright Policy - open-access
Related In: Results  -  Collection

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Fig4: Functional and structural outcomes at month 12 according to disease activity status. Functional (a–c) and structural (d–f) outcomes at month 12 according to disease activity status at months 3 and 12, based on patients with data available at baseline, month 6 and month 12. *P <0.05; †Non-significant. Disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: Disease Activity Score using 28-joint counts (DAS28) remission = DAS28 <2.6; DAS28 low disease activity (LDA) = DAS28 2.6–3.2; DAS28 moderate disease activity (MDA)/high disease activity (HDA) = DAS28 >3.2; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; SDAI LDA = SDAI >3.3–11; SDAI MDA/HDA = SDAI >11; Clinical Disease Activity Index (CDAI) remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA/HDA = CDAI >10. ANCOVA analysis of covariance, MTX methotrexate
Mentions: Patients receiving abatacept plus MTX who achieved remission or LDA according to DAS28, SDAI or CDAI at month 3 achieved greater improvements in HAQ-DI scores at month 12 vs patients with MDA or HDA (Fig. 4a–c). Similar trends were seen for MTX alone, with greater improvements in HAQ-DI scores at month 12 for patients in remission or LDA at month 3 vs patients in MDA or HDA. Similar data were reported at different time points. At all time points, in line with their more stringent nature, mean HAQ-DI scores were numerically lower for patients in SDAI and CDAI remission (with mean HAQ-DI score of ≤0.5 with MTX alone and ≤0.25 with abatacept plus MTX) versus DAS28 remission (see Additional file 7: Table S4).Fig. 4

Bottom Line: Post hoc analyses were performed from the 12-month, double-blind period of the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE) in patients with early RA (≤2 years) and poor prognostic factors, comparing abatacept plus MTX (n = 210) versus MTX alone (n = 209).Remission was associated with long-term functional benefit; dissociation was seen between clinical and structural outcomes for abatacept.These findings highlight the impact of reaching stringent remission targets early, on physical function and structural damage, in MTX-naïve biologic-treated patients.

View Article: PubMed Central - PubMed

Affiliation: Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Waehringer Guertel 18-20, Vienna, A-1090, Austria. josef.smolen@wienkav.at.

ABSTRACT

Introduction: This study evaluated various remission criteria in abatacept plus methotrexate (MTX)-treated patients with early rheumatoid arthritis (RA). We aimed to investigate the time to, and sustainability of, remission, and to evaluate the relationship between remission, function and structure.

Methods: Post hoc analyses were performed from the 12-month, double-blind period of the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE) in patients with early RA (≤2 years) and poor prognostic factors, comparing abatacept plus MTX (n = 210) versus MTX alone (n = 209).

Results: At month 12, Disease Activity Score 28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index and Boolean remission rates were, for abatacept plus MTX versus MTX alone: 47.6 % versus 27.3 %, 33.3 % versus 12.4 %, 34.3 % versus 16.3 %, and 23.8 % versus 5.7 %, respectively. Cumulative probability demonstrated higher proportions achieving first remission and first sustained remission for abatacept plus MTX versus MTX alone (e.g., 23.3 % [95 % confidence interval (CI): 17.6, 29.1] vs 12.9 % [8.4, 17.5] for first SDAI remission over 0-6 months). For patients in SDAI remission at month 3, mean Health Assessment Questionnaire-Disability Index at month 12 was 0.20 versus 0.50 for abatacept plus MTX versus MTX alone. Mean changes in radiographic score from baseline to month 12 were minimal for patients in SDAI remission at month 3 in both groups, while less structural damage progression was seen, 0.75 versus 1.35, respectively, for abatacept plus MTX versus MTX alone for patients with moderate/high disease activity at month 3 (adjusted mean treatment difference: -0.60 [95 % CI: -1.11, -0.09; P < 0.05]).

Conclusions: High proportions of abatacept plus MTX-treated patients achieved stringent remission criteria. Remission was associated with long-term functional benefit; dissociation was seen between clinical and structural outcomes for abatacept. These findings highlight the impact of reaching stringent remission targets early, on physical function and structural damage, in MTX-naïve biologic-treated patients.

Trial registration: ClinicalTrials.gov identifier NCT00122382. Registered 19 July 2005.

No MeSH data available.


Related in: MedlinePlus