Improvements in the Proportion of Patients Achieving DAS, CDAI, and SDAI Remission By Omitting the Patient Global Assessment (PtGA): an Analysis from a Prospective, Observational Registry

Philip Baer¹, WG Bensen², Carter Thorne³, Boulos Haraoui⁴, Denis Choquette⁵, Regan Arendse⁶, John Kelsall⁷, Maqbool Sheriff⁸, John S. Sampalis⁹, Emmanouil Rampakakis⁹, Francois Nantel¹⁰, May Shawi¹⁰, Allen J Lehman¹¹, Susan Otawa¹¹ and Edward Keystone¹², ¹Private Practice, Scarborough, ON, Canada, ²St Josephs Hospital and McMaster University, Hamilton, ON, Canada, ³Southlake Regional Health Centre, Newmarket, ON, Canada, ⁴University of Montreal Hospital Centre, Montreal, QC, Canada, ⁵Rheumatology, Institut de rhumatologie de Montréal (IRM), Montréal, QC, Canada, ⁶University of Saskatchewan, Saskatoon, SK, Canada, ⁷The Mary Pack Arthritis Centre, Vancouver, BC, Canada, ⁸Nanaimo Regional General Hospital, Nanaimo, BC, Canada, ⁹JSS Medical Research, Montreal, QC, Canada, ¹⁰Janssen Inc., Toronto, ON, Canada, ¹¹Medical Affairs, Janssen Inc., Toronto, ON, Canada, ¹²Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Outcomes and remission

Session Information

Title: Rheumatoid Arthritis - Clinical Aspects II: Remission and De-escalation of Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose: PtGA is included in the formula of all disease activity indices despite the fact that it may not accurately reflect RA disease activity, but rather reflect symptoms related to fibromyalgia (FM), low back pain, osteoarthritis, depression or other conditions. A high disease activity score based on FM could mislead the physician to overestimate disease activity of RA patients and thereby to initiate therapy not indicated. (1) We previously assessed the impact of the PtGA on the ability to achieve Boolean ACR/EULAR remission state. (2) The aim of this analysis was to assess the proportion of patients failing to achieve DAS, CDAI and SDAI remission based on a real-world, routine clinical care setting in Canada, and the implications of constructing new disease activity indices omitting the PtGA.

Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM. In this analysis, RA patients treated with infliximab from 2002-2014 or with golimumab from 2010-2014 were included. Modified versions of DAS28 (mDAS28), CDAI (mCDAI), and SDAI (mSDAI) were calculated by omitting PtGA from the formulas. Correlation of the standard and modified versions of each index was assessed with the Pearson’s correlation coefficient. In the absence of validated thresholds for remission and LDA for the modified versions, the standard definitions were considered as the gold standard and ROC curve analysis was used to identify new thresholds for the modified versions. Cross-tabulations with the Chi-square test were used to assess the agreement between the standard and modified definitions of remission and LDA.

Results: One thousand nineteen RA patients with a mean (SD) age of 56.1 years (13.5) and disease duration of 8.5 years (9.1) were included in the analysis.

A strong correlation was observed between the standard and modified versions of DAS28 (r=0.98; P<0.001), CDAI (r=0.99; P<0.001), and SDAI (r=0.99; P<0.001). Based on ROC analysis the new thresholds for remission and LDA were: mDAS28 (remission=2.6, LDA=3.1), mCDAI (remission=2.5, LDA=10.5), mSDAI (remission=3.3, LDA=10.9). Cross-tabulation of the standard and modified thresholds showed that an additional 10.1%, 10.6%, and 17.8% of non-remission cases for DAS28, CDAI and SDAI, respectively, would be classified as remission with the modified definitions. Similarly, an additional 11.5%, 21.2%, and 20.6% of non-LDA cases for DAS28, CDAI and SDAI, respectively, would be classified as LDA.

Conclusion: The results of this analysis have shown that PtGA could account for up to 10% of non-remission cases and up to 20% of non-LDA cases as measured by DAS, CDAI and SDAI. Further analyses are required to identify the determinants of patient global assessment.

References: (1) Lage-Hansen PR, et al. EULAR 2014, Abstract# THU0320; (2) Chow A, et al. J Rheumatol June 2013 40(6):991

Disclosure:

P. Baer,

Janssen Inc.,

W. Bensen,
None;

C. Thorne,

Janssen Inc.,

B. Haraoui,

AbbVie,

Amgen,

Bristol-Myers Squibb,

Janssen Pharmaceutica Product, L.P.,

Pfizer Inc,

Roche Pharmaceuticals,

UCB,

D. Choquette,
None;

R. Arendse,

Janssen Inc.,

J. Kelsall,

Janssen Inc.,

M. Sheriff,

Janssen Inc.,

J. S. Sampalis,
None;

E. Rampakakis,
None;

F. Nantel,

Janssen Inc.,

M. Shawi,

Janssen Inc.,

A. J. Lehman,

Janssen Inc.,

S. Otawa,

Janssen Inc.,

E. Keystone,

Abbott, Amgen, AstraZeneca, BMS, F. Hoffmann-La Roche, Janssen, Lilly, Novartis, Pfizer Sanofi-Aventis, UCB,

Abbott Laboratories, AstraZeneca, Biotest, BMS, F. Hoffmann-La Roche, Genentech, Janssen, Lilly, Merck, Pfizer, UCB,

Abbott, AstraZeneca, BMS Canada, F. Hoffmann-La Roche, Janssen, Pfizer, UCB, Amgen,

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