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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

Cumulative probability plot for time to achieve first low disease activity (LDA)/remission or sustained LDA/remission. Cumulative probability plot to achieve (a) first Simplified Disease Activity Index (SDAI) LDA, (b) first sustained SDAI LDA, (c) first SDAI remission, and (d) first sustained SDAI remission over 12 months (Kaplan–Meier estimation), based on patients with data available at baseline, month 6 and month 12. Cumulative probability and corresponding 95 % CI were computed using Kaplan–Meier limit-product estimators. Patients who lost first LDA or remission status were censored at the time of remission loss. SDAI LDA = SDAI ≤11; SDAI remission = SDAI ≤3.3; sustained remission was defined as maintained first LDA or remission at all subsequent visits up to 12 months. Median time to achieve outcome corresponds to the time point when 50 % of patients achieved the outcome. Median time was therefore not calculated if <50 % of patients achieved the outcome over the 12-month period. Median times (95 % CI) to first SDAI LDA and first SDAI remission for the abatacept plus methotrexate (MTX) arm were 140.0 and 371.0 days, respectively. Median time (95 % CI) to first SDAI LDA for the MTX arm was 197 days. Median time to achieve first SDAI remission cannot be defined in the MTX arm
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Fig2: Cumulative probability plot for time to achieve first low disease activity (LDA)/remission or sustained LDA/remission. Cumulative probability plot to achieve (a) first Simplified Disease Activity Index (SDAI) LDA, (b) first sustained SDAI LDA, (c) first SDAI remission, and (d) first sustained SDAI remission over 12 months (Kaplan–Meier estimation), based on patients with data available at baseline, month 6 and month 12. Cumulative probability and corresponding 95 % CI were computed using Kaplan–Meier limit-product estimators. Patients who lost first LDA or remission status were censored at the time of remission loss. SDAI LDA = SDAI ≤11; SDAI remission = SDAI ≤3.3; sustained remission was defined as maintained first LDA or remission at all subsequent visits up to 12 months. Median time to achieve outcome corresponds to the time point when 50 % of patients achieved the outcome. Median time was therefore not calculated if <50 % of patients achieved the outcome over the 12-month period. Median times (95 % CI) to first SDAI LDA and first SDAI remission for the abatacept plus methotrexate (MTX) arm were 140.0 and 371.0 days, respectively. Median time (95 % CI) to first SDAI LDA for the MTX arm was 197 days. Median time to achieve first SDAI remission cannot be defined in the MTX arm

Mentions: Cumulative probability plots to first SDAI LDA and remission and sustained first SDAI LDA and remission over 12 months are shown in Fig. 2 (Kaplan–Meier estimation). Cumulative probability of achieving DAS28 and CDAI remission and LDA within the first 6 months and looking at 12-month outcomes are shown in Table 1. Patients receiving abatacept plus MTX were more likely to achieve first remission or LDA than patients receiving MTX alone, for all criteria. For LDA, all indices gave similar probability of reaching LDA and time to achieve first or sustained LDA. For remission, cumulative probabilities of achieving SDAI or CDAI remission were lower than DAS28, as expected. Although very stringent, regarding the definition of sustained remission, these analyses highlight that a higher proportion of patients receiving abatacept plus MTX attained sustained LDA or remission than patients receiving MTX alone. The median time to achieve first remission was also longer for SDAI and CDAI than for DAS28 (data not shown), indicating greater stringency.Fig. 2


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)

Cumulative probability plot for time to achieve first low disease activity (LDA)/remission or sustained LDA/remission. Cumulative probability plot to achieve (a) first Simplified Disease Activity Index (SDAI) LDA, (b) first sustained SDAI LDA, (c) first SDAI remission, and (d) first sustained SDAI remission over 12 months (Kaplan–Meier estimation), based on patients with data available at baseline, month 6 and month 12. Cumulative probability and corresponding 95 % CI were computed using Kaplan–Meier limit-product estimators. Patients who lost first LDA or remission status were censored at the time of remission loss. SDAI LDA = SDAI ≤11; SDAI remission = SDAI ≤3.3; sustained remission was defined as maintained first LDA or remission at all subsequent visits up to 12 months. Median time to achieve outcome corresponds to the time point when 50 % of patients achieved the outcome. Median time was therefore not calculated if <50 % of patients achieved the outcome over the 12-month period. Median times (95 % CI) to first SDAI LDA and first SDAI remission for the abatacept plus methotrexate (MTX) arm were 140.0 and 371.0 days, respectively. Median time (95 % CI) to first SDAI LDA for the MTX arm was 197 days. Median time to achieve first SDAI remission cannot be defined in the MTX arm
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig2: Cumulative probability plot for time to achieve first low disease activity (LDA)/remission or sustained LDA/remission. Cumulative probability plot to achieve (a) first Simplified Disease Activity Index (SDAI) LDA, (b) first sustained SDAI LDA, (c) first SDAI remission, and (d) first sustained SDAI remission over 12 months (Kaplan–Meier estimation), based on patients with data available at baseline, month 6 and month 12. Cumulative probability and corresponding 95 % CI were computed using Kaplan–Meier limit-product estimators. Patients who lost first LDA or remission status were censored at the time of remission loss. SDAI LDA = SDAI ≤11; SDAI remission = SDAI ≤3.3; sustained remission was defined as maintained first LDA or remission at all subsequent visits up to 12 months. Median time to achieve outcome corresponds to the time point when 50 % of patients achieved the outcome. Median time was therefore not calculated if <50 % of patients achieved the outcome over the 12-month period. Median times (95 % CI) to first SDAI LDA and first SDAI remission for the abatacept plus methotrexate (MTX) arm were 140.0 and 371.0 days, respectively. Median time (95 % CI) to first SDAI LDA for the MTX arm was 197 days. Median time to achieve first SDAI remission cannot be defined in the MTX arm
Mentions: Cumulative probability plots to first SDAI LDA and remission and sustained first SDAI LDA and remission over 12 months are shown in Fig. 2 (Kaplan–Meier estimation). Cumulative probability of achieving DAS28 and CDAI remission and LDA within the first 6 months and looking at 12-month outcomes are shown in Table 1. Patients receiving abatacept plus MTX were more likely to achieve first remission or LDA than patients receiving MTX alone, for all criteria. For LDA, all indices gave similar probability of reaching LDA and time to achieve first or sustained LDA. For remission, cumulative probabilities of achieving SDAI or CDAI remission were lower than DAS28, as expected. Although very stringent, regarding the definition of sustained remission, these analyses highlight that a higher proportion of patients receiving abatacept plus MTX attained sustained LDA or remission than patients receiving MTX alone. The median time to achieve first remission was also longer for SDAI and CDAI than for DAS28 (data not shown), indicating greater stringency.Fig. 2

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