Limits...
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

Relationship between Disease Activity Score using 28-joint counts (DAS28) remission and Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) status, based on patients with data available at baseline, month 6 and month 12 and achieving DAS28 remission at month 6 or 12 (DAS28 remission = DAS28 <2.6); CDAI/SDAI disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: SDAI remission = SDAI ≤3.3; SDAI low disease activity (LDA) = SDAI >3.3–11; SDAI moderate disease activity (MDA) = SDAI >11–26; SDAI high disease activity (HDA) = SDAI >26; CDAI remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA = CDAI >10–22; CDAI HDA = CDAI >22. MTX methotrexate
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4494702&req=5

Fig3: Relationship between Disease Activity Score using 28-joint counts (DAS28) remission and Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) status, based on patients with data available at baseline, month 6 and month 12 and achieving DAS28 remission at month 6 or 12 (DAS28 remission = DAS28 <2.6); CDAI/SDAI disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: SDAI remission = SDAI ≤3.3; SDAI low disease activity (LDA) = SDAI >3.3–11; SDAI moderate disease activity (MDA) = SDAI >11–26; SDAI high disease activity (HDA) = SDAI >26; CDAI remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA = CDAI >10–22; CDAI HDA = CDAI >22. MTX methotrexate

Mentions: Among patients receiving abatacept plus MTX who achieved DAS28 remission, nearly all achieved at least LDA according to SDAI or CDAI (Fig. 3); approximately 60 % and approximately 70 % also achieved SDAI or CDAI remission at months 6 and 12, respectively, suggesting some residual disease activity for patients in DAS28 remission not achieving SDAI or CDAI remission. Few patients (1–4 %) in DAS28 remission were in SDAI- or CDAI-defined MDA, with none in HDA. For patients in SDAI or CDAI remission, nearly all patients (91–100 %) also achieved DAS28 remission at both time points in either treatment arm. With MTX alone, fewer patients in DAS28 remission at month 12 achieved SDAI or CDAI remission compared with those receiving abatacept plus MTX. These data suggest that patients in DAS28 remission receiving abatacept plus MTX may have greater improvements in underlying disease components than patients receiving MTX alone.Fig. 3


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)

Relationship between Disease Activity Score using 28-joint counts (DAS28) remission and Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) status, based on patients with data available at baseline, month 6 and month 12 and achieving DAS28 remission at month 6 or 12 (DAS28 remission = DAS28 <2.6); CDAI/SDAI disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: SDAI remission = SDAI ≤3.3; SDAI low disease activity (LDA) = SDAI >3.3–11; SDAI moderate disease activity (MDA) = SDAI >11–26; SDAI high disease activity (HDA) = SDAI >26; CDAI remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA = CDAI >10–22; CDAI HDA = CDAI >22. MTX methotrexate
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4494702&req=5

Fig3: Relationship between Disease Activity Score using 28-joint counts (DAS28) remission and Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) status, based on patients with data available at baseline, month 6 and month 12 and achieving DAS28 remission at month 6 or 12 (DAS28 remission = DAS28 <2.6); CDAI/SDAI disease activity states are mutually exclusive (a patient can be in only one category at any one time) and were defined as: SDAI remission = SDAI ≤3.3; SDAI low disease activity (LDA) = SDAI >3.3–11; SDAI moderate disease activity (MDA) = SDAI >11–26; SDAI high disease activity (HDA) = SDAI >26; CDAI remission = CDAI ≤3.3; CDAI LDA = CDAI >2.8–10; CDAI MDA = CDAI >10–22; CDAI HDA = CDAI >22. MTX methotrexate
Mentions: Among patients receiving abatacept plus MTX who achieved DAS28 remission, nearly all achieved at least LDA according to SDAI or CDAI (Fig. 3); approximately 60 % and approximately 70 % also achieved SDAI or CDAI remission at months 6 and 12, respectively, suggesting some residual disease activity for patients in DAS28 remission not achieving SDAI or CDAI remission. Few patients (1–4 %) in DAS28 remission were in SDAI- or CDAI-defined MDA, with none in HDA. For patients in SDAI or CDAI remission, nearly all patients (91–100 %) also achieved DAS28 remission at both time points in either treatment arm. With MTX alone, fewer patients in DAS28 remission at month 12 achieved SDAI or CDAI remission compared with those receiving abatacept plus MTX. These data suggest that patients in DAS28 remission receiving abatacept plus MTX may have greater improvements in underlying disease components than patients receiving MTX alone.Fig. 3

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