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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

Overall remission rates at months 6 and 12 based on as-observed analyses for patients with data available at baseline, month 6 and month 12. Disease Activity Score 28 (DAS28) remission = DAS28 (C-reactive protein (CRP)) <2.6; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; Clinical Disease Activity Index (CDAI) remission = ≤2.8. MTX methotrexate
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Fig1: Overall remission rates at months 6 and 12 based on as-observed analyses for patients with data available at baseline, month 6 and month 12. Disease Activity Score 28 (DAS28) remission = DAS28 (C-reactive protein (CRP)) <2.6; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; Clinical Disease Activity Index (CDAI) remission = ≤2.8. MTX methotrexate

Mentions: At month 12, remission was achieved in 27.3 % (95 % CI 21.2, 33.3) of patients receiving MTX alone compared with 47.6 % (95 % CI 40.9, 54.4) of patients receiving abatacept plus MTX by DAS28 criteria, by 12.4 % (95 % CI 8.0, 16.9) and 33.3 % (95 % CI 27.0, 39.7) by SDAI criteria, by 16.3 % (95 % CI 11.3, 21.3) and 34.3 % (95 % CI 27.9, 40.7) by CDAI criteria, and by 5.7 % (95 % CI 2.6, 8.9) and 23.8 % (95 % CI 18.0, 29.6) by Boolean criteria (the 95 % CI did not overlap) (Fig. 1). Thus, a large proportion of patients achieved remission according to the stringent SDAI, CDAI and Boolean criteria, although, as expected, fewer than by DAS28 (CRP) criteria. Indeed, one out of three patients achieved SDAI remission and almost 25 % of patients achieved Boolean-defined remission (28-joint count with laboratory measures) at month 12. Similar respective rates were seen for CDAI remission and for Boolean remission evaluated without CRP using 66/68-joint counts (see Additional file 4: Figure S1A). Also, large proportions of patients achieved LDA at month 12 with abatacept plus MTX and MTX alone, but – in contrast to the remission criteria – proportions were comparable regardless of the index used, although numerically higher with the combination (see Additional file 4: Figure S1B).Fig. 1


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)

Overall remission rates at months 6 and 12 based on as-observed analyses for patients with data available at baseline, month 6 and month 12. Disease Activity Score 28 (DAS28) remission = DAS28 (C-reactive protein (CRP)) <2.6; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; Clinical Disease Activity Index (CDAI) remission = ≤2.8. MTX methotrexate
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig1: Overall remission rates at months 6 and 12 based on as-observed analyses for patients with data available at baseline, month 6 and month 12. Disease Activity Score 28 (DAS28) remission = DAS28 (C-reactive protein (CRP)) <2.6; Simplified Disease Activity Index (SDAI) remission = SDAI ≤3.3; Clinical Disease Activity Index (CDAI) remission = ≤2.8. MTX methotrexate
Mentions: At month 12, remission was achieved in 27.3 % (95 % CI 21.2, 33.3) of patients receiving MTX alone compared with 47.6 % (95 % CI 40.9, 54.4) of patients receiving abatacept plus MTX by DAS28 criteria, by 12.4 % (95 % CI 8.0, 16.9) and 33.3 % (95 % CI 27.0, 39.7) by SDAI criteria, by 16.3 % (95 % CI 11.3, 21.3) and 34.3 % (95 % CI 27.9, 40.7) by CDAI criteria, and by 5.7 % (95 % CI 2.6, 8.9) and 23.8 % (95 % CI 18.0, 29.6) by Boolean criteria (the 95 % CI did not overlap) (Fig. 1). Thus, a large proportion of patients achieved remission according to the stringent SDAI, CDAI and Boolean criteria, although, as expected, fewer than by DAS28 (CRP) criteria. Indeed, one out of three patients achieved SDAI remission and almost 25 % of patients achieved Boolean-defined remission (28-joint count with laboratory measures) at month 12. Similar respective rates were seen for CDAI remission and for Boolean remission evaluated without CRP using 66/68-joint counts (see Additional file 4: Figure S1A). Also, large proportions of patients achieved LDA at month 12 with abatacept plus MTX and MTX alone, but – in contrast to the remission criteria – proportions were comparable regardless of the index used, although numerically higher with the combination (see Additional file 4: Figure S1B).Fig. 1

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