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Abstract Number: 383

How Low Is Low Disease Activity? an Analysis from a Prospective, Observational Registry

Edward C. Keystone1, Boulos Haraoui2, John Kelsall3, Carter Thorne4, Philip Baer5, William Bensen6, Denis Choquette7, Regan Arendse8, Dalton Sholter9, Niall Jones10, Algis Jovaisas11, Emmanouil Rampakakis12, John S. Sampalis12, Francois Nantel13, May Shawi13, Allen J Lehman14 and Susan Otawa14, 1Medicine, University of Toronto, Toronto, ON, Canada, 2University of Montreal Hospital Centre, Montreal, QC, Canada, 3The Mary Pack Arthritis Centre, Vancouver, BC, Canada, 4Southlake Regional Health Centre, Newmarket, ON, Canada, 5Private Practice, Scarborough, ON, Canada, 6St Josephs Hospital and McMaster University, Hamilton, ON, Canada, 7Rheumatology, Institut de rhumatologie de Montréal (IRM), Montréal, QC, Canada, 8University of Saskatchewan, Saskatoon, SK, Canada, 9University of Alberta, Edmonton, AB, Canada, 10Dept of Rheumatology, University of Alberta, Edmonton, AB, Canada, 11194 Main Street, University of Ottawa, Ottawa, ON, Canada, 12JSS Medical Research, Montreal, QC, Canada, 13Janssen Inc., Toronto, ON, Canada, 14Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Disease Activity, Outcome measures, outcomes and registry

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Session Information

Title: Rheumatoid Arthritis - Clinical Aspects: Novel Biomarkers and Other Measurements of Disease Activity

Session Type: Abstract Submissions (ACR)

Background/Purpose: Composite measures of disease activity can facilitate clinical decision-making to achieve treatment goals, and treating-to-target has been shown to improve outcomes. Both CRA and ACR/EULAR recommend that treatment target should be remission or, when not possible, low disease activity (LDA). Low levels of acute phase reactants, patient-reported disease activity (PtGA), or tender joints included in such measures may result in meeting LDA criteria while having significant residual disease activity. This analysis examined the levels of individual components of composite measures in RA patients with LDA.

Methods: BioTRAC is an ongoing, prospective registry of RA, AS, or PsA patients initiating treatment with infliximab or golimumab as first biologics or after having been treated with a biologic for <6 months. In this analysis, data from RA patients treated with infliximab for 6-18 months who were enrolled between 2002-2012 were used. LDA was defined using the DAS28-ESR (2.6-3.2), CDAI (2.8-10.0), and SDAI (3.3-11.0) criteria.

Results: 321 RA patients with mean age of 57.1 years and mean duration since diagnosis of 10.5 years were included, providing information from 488 instances of LDA. Among patients with DAS28 LDA, mean (min,max) TJC28 was 1.3 (0,9), SJC28 was 1.2 (0,7), PtGA was 2.1 (0.0,10.0), and ESR was 21.0 (1.0,75.0). Similarly, disease parameters in patients with CDAI and SDAI LDA were, respectively: TJC28 [1.4 (0,6); 1.5 (0,8)], SJC28 [1.1 (0,7); 1.0 (0,6)], PtGA [2.3 (0.0,8.5); 2.3 (0.0,9.6)], MDGA [1.7 (0.0,9.0); 1.6 (0.0,9.0)], and CRP [6.7 (0.0, 68.0)]. More than two swollen joints were present in 18.2%/14.1%/14.5% of DAS28 / CDAI / SDAI instances, respectively, and MDGA was >2 in 24.0%% / 18.6% / 18.2% of instances. With respect to HAQ-DI, patients with DAS28, CDAI and SDAI LDA had a mean (min,max) score of 0.96 (0.00,2.88), 1.00 (0.00,2.88), and 0.96 (0.00,2.88), respectively; with 8.5%, 11.3%, and 9.8% of cases having HAQ-DI≥2.0 indicating severe to very severe disability. 

Conclusion: Despite meeting the LDA criteria, significant residual disease may exist as indicated by the number of swollen joints and MDGA. Furthermore, a significant proportion of patients in LDA may have severe to very severe disability, although this may be due to long disease duration and irreversible damage. Altogether, although targeting LDA results in improved outcomes, it may not be an appropriate target for a significant portion of patients. Furthermore, treatment decisions should not be based solely on composite measures, but also take into consideration the global patient picture.


Disclosure:

E. C. Keystone,

Abbott Laboratories,

2,

Amgen Canada,

2,

Astrazeneca Pharmaceuticals LP,

2,

Bristo-Myers Squibb,

2,

F. Hoffman La-Roche Inc.,

2,

Janssen Pharmaceutica Product, L.P.,

2,

Eli Lilly and Company,

2,

Novartis Pharmaceutical Corporation,

2,

Pfizer Inc,

2,

Sanofi-Aventis Pharmaceutical,

2,

Abbott Laboratories,

5,

AstraZeneca,

5,

Biotest,

5,

Bristol-Myers Squibb,

5,

F. Hoffman-La Roche Inc.,

5,

Genentech and Biogen IDEC Inc.,

5,

Janssen Pharmaceutica Product, L.P.,

5,

Eli Lilly and Company,

5,

Merck Pharmaceuticals,

5,

Pfizer Inc,

5,

Abbott Laboratories,

8,

AstraZeneca,

8,

Bristol-Myers Squibb,

8,

F. Hoffman La-Roche Inc.,

8,

Janssen Pharmaceutica Product, L.P.,

8,

Pfizer Inc,

8,

UCB,

8,

Amgen,

8;

B. Haraoui,

AbbVie,

2,

AbbVie,

5,

Amgen,

2,

Amgen,

5,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5,

Janssen Pharmaceutica Product, L.P.,

2,

Janssen Pharmaceutica Product, L.P.,

5,

Pfizer Inc,

2,

Pfizer Inc,

5,

Roche Pharmaceuticals,

2,

Roche Pharmaceuticals,

5,

UCB,

2,

UCB,

5;

J. Kelsall,

Janssen Inc.,

5;

C. Thorne,

Janssen Inc.,

5;

P. Baer,

Janssen Inc.,

5;

W. Bensen,

Janssen Inc,

5;

D. Choquette,
None;

R. Arendse,

Janssen Inc.,

5;

D. Sholter,

Janssen Inc.,

5;

N. Jones,
None;

A. Jovaisas,

Janssen Inc.,

5;

E. Rampakakis,
None;

J. S. Sampalis,
None;

F. Nantel,

Janssen Inc.,

3;

M. Shawi,

Janssen Inc.,

3;

A. J. Lehman,

Janssen Inc.,

3;

S. Otawa,

Janssen Inc.,

3.

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