Variability In Patient Characteristics and Outcomes In Rheumatoid Arthritis Upon Infliximab Treatment Based On The Size Of Biologic Treatment Registry Site

J. Carter Thorne¹, William G. Bensen², Sanjay Dixit³, Rafat Y. Faraawi^3,4, Dalton E. Sholter⁵, Maqbool K. Sheriff⁶, Philip Baer⁷, Denis Choquette⁸, Boulos Haraoui^8,9, Algis Jovaisas¹⁰, Emmanouil Rampakakis^11,12, John S. Sampalis^11,12, May Shawi¹³, Francois Nantel¹⁴, Allen J. Lehman¹⁵ and Susan M. Otawa¹⁵, ¹Southlake Regional Health Centre, Newmarket, ON, Canada, ²Department of Medicine, Division of Rheumatology, Clinical Professor, McMaster University, Hamilton, ON, Canada, ³McMaster University, Hamilton, ON, Canada, ⁴Rheumatologist, KW Musculoskeletal Research Inc., Kitchener, ON, Canada, ⁵Rheumatology Associates, Edmonton, AB, Canada, ⁶Nanaimo Regional General Hospital, Nanaimo, BC, Canada, ⁷Private Practice, Scarborough, ON, Canada, ⁸Rheumatology, Institut de rhumatologie de Montréal (IRM), Montréal, QC, Canada, ⁹Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada, ¹⁰Division of Rheumatology, University of Ottawa, Ottawa, ON, Canada, ¹¹JSS Medical Research, Montreal, QC, Canada, ¹²Jewish General Hospital, McGill University, Montreal, QC, Canada, ¹³Medical Affairs, Janssen Canada Inc, Toronto, ON, Canada, ¹⁴Janssen Inc., Toronto, ON, Canada, ¹⁵Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Effective, Practice and rheumatoid arthritis (RA)

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy III

Session Type: Abstract Submissions (ACR)

Background/Purpose: Efficacy of TNFi agents in the management of rheumatoid arthritis (RA) has been demonstrated in numerous controlled clinical trials. Variations with respect to patient (pt) profile, extent of physician familiarization with TNFi agents, and pt management may affect real-world outcomes. The aim of this analysis is to compare the pt profile and outcomes of RA patients (pts) treated with infliximab under routine clinical practice in biologic treatment registry sites of different sizes.

Methods: BioTRAC is an ongoing, prospective registry of pts initiating treatment for RA with infliximab or golimumab as first biologics or treated with a biologic for <6 mons. Pts with RA treated with infliximab who were enrolled between 2002-2012 were included in the analysis (N=832). The number of pts enrolled in BioTRAC at each site was used as the measure for the size of the registry site, resulting in the classification of 3 sizes of registry sites - Group A: sites enrolling 1-15 pts; Group B: sites enrolling 16-35 pts; Group C: sites enrolling >35 pts. The total number of pts enrolled in each type of rheumatology practice site was; Group A: n=324, Group B: n=239, Group C: n=269.

Results: Mean (SD) age of the cohort was 55.8 (13.4) years with the majority of pts being female (76.0%) and rheumatoid factor (RF) positive (74.2%). No significant differences in demographic characteristics and RF status were observed between the three pt subgroups. Pts seen at larger sites had significantly shorter disease duration (Group A: 11.9 years, Group B: 10.9 years, Group C: 7.5 years; P<0.001) and had been treated with a smaller number of previous DMARDs (2.5, 2.5, 1.6, respectively; P<0.001). Furthermore, a trend towards lower disease activity at infliximab initiation was observed in larger sites as indicated by the decreased physician global assessment (7.0 vs. 6.4 vs. 6.2; P<0.001), DAS28-CRP (5.6 vs. 5.3 vs. 5.3; P=0.023), CDAI (38.1 vs. 34.5 vs. 35.0; P=0.019), and SDAI (40.9 vs. 36.3 vs. 36.9; P=0.009). Significant differences were also observed with respect to pt management with a significantly greater proportion of pts in the larger sites being treated with concomitant DMARD (87.3% vs. 89.5% vs. 95.2%; P=0.004) and lower proportion being treated with a corticosteroid (23.5% vs. 22.6% vs. 15.6%; P=0.044).

Upon adjusting for baseline disease activity, DAS28-CRP remission (P=0.013) and minimal clinically meaningful improvement in HAQ-DI (Δ≥0.25; P=0.025) over 24 mons of treatment was significantly greater among pts seen in larger sites. Achievement of CDAI and SDAI remission was numerically higher without reaching statistically significance.

Conclusion: Consistent with findings from a Canadian early RA registry¹, results of this real-world observational study demonstrate that significant variation in disease characteristics, pt management and outcomes exist within the BioTRAC registry based on the size of the site. A trend towards earlier infliximab initiation and improved outcomes was observed with larger enrolment sites.

Reference: Harris J, et al. Improving outcomes in early RA by determining best practices: Does site size matter or is best treatment early? An analysis of the Canadian ERA cohort. CRA 2013.

Disclosure:

J. C. Thorne,

Amgen,

Pfizer Inc,

Abbott Laboratories,

Bristol-Myers Squibb,

Centocor, Inc.,

Merck Pharmaceuticals,

Roche Pharmaceuticals,

UCB,

W. G. Bensen,
None;

S. Dixit,
None;

R. Y. Faraawi,
None;

D. E. Sholter,
None;

M. K. Sheriff,
None;

P. Baer,

Janssen Pharmaceutica Product, L.P.,

D. Choquette,
None;

B. Haraoui,

Amgen,

Abbott Laboratories,

Bristol-Myers Squibb,

Merck Pharmaceuticals,

Pfizer Inc,

Roche Pharmaceuticals,

UCB,

A. Jovaisas,

Janssen Pharmaceutica Product, L.P ,

E. Rampakakis,
None;

J. S. Sampalis,
None;

M. Shawi,

Janssen Canada,

F. Nantel,
None;

A. J. Lehman,

Janssen Canada,

S. M. Otawa,

Janssen Canada,

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