ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2744

What Is the Treatment Durability and Safety Profile of Rheumatoid Arthritis Patients Treated with Infliximab Plus Methotrexate and/or Leflunomide? an Analysis from a Real-World Registry

Rafat Faraawi1, Raman Joshi2, William G Bensen3, Denis Choquette4, Wojciech Olsynzynski5, Regan Arendse5, Maqbool Sheriff6, Proton Rahman7, Emmanouil Rampakakis8, Eliofotisti Psaradellis9, Francois Nantel10, Allen J Lehman11, Susan Otawa11, Cathy Tkaczyk11 and Brendan Osborne11, 1McMaster University, Hamilton, ON, Canada, 2William Osler Health Centre-Brampton Civic Hospital, Brampton, ON, Canada, 3St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 4Rheumatology Department, Institut de Rhumatologie de Montréal and University of Montreal, Montreal, QC, Canada, 5University of Saskatchewan, Saskatoon, ON, Canada, 6Nanaimo Regional General Hospital, Nanaimo, BC, Canada, 7Medicine, Memorial University, St John's, NF, Canada, 8JSS Medical Research, St-Laurent, QC, Canada, 9JSS Medical Research, Montreal, QC, Canada, 10Janssen Inc., Toronto, ON, Canada, 11Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , , ,

Session Information

Date: Tuesday, November 10, 2015

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

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Clinical trials of anti-TNF therapies have shown that concurrent methotrexate (MTX) therapy enhances the efficacy of TNF inhibitors. A scarcity of data exists on the benefits of combination therapy with IFX and MTX vs. leflunomide (LEF) in a real-world setting; therefore the BioTRAC Registry database was used to explore this question. 

Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or golimumab as first biologics or after having been treated with a biologic for <6 months. RA patients treated with IFX who were enrolled between 2002-2014 were included in this analysis. Treatment durability was assessed with the Kaplan Meier (KM) estimator of the survival function and Cox regression. 

Results: 723 RA patients were included; at baseline 516 (71.4%) were on IFX+MTX, 115 (15.9%) on IFX+LEF, and 92 (12.7%) on IFX+MTX+LEF. The mean (SD) age was 55.5 (13.6) years, 76.2% were female and mean (SD) disease duration was 8.7 (9.2) years.  The majority of patients were from Ontario (50.6%), followed by Western Canada (25.8%), and Quebec (20.9%). There were 217 (30.0%) patients who discontinued due to lack/loss of response, disease progression, adverse event (AE) or change in therapy with a KM-based mean (SE) time to discontinuation of 83.9 (3.0) months. Upon adjusting for potential confounders, higher durability was observed for the IFX+MTX group vs. IFX+LEF [hazard ratio -HR- (95% CI): 0.50 (0.25-1.01), P=0.055]. Moreover, factors independently associated with premature treatment termination were earlier enrolment period [HR2006-09 vs. 2002-05 (95% CI): 0.15 (0.02-1.15, P=0.068; HR2010-2014 vs. 2002-05 (95% CI): 0.09 (0.01-0.70), P=0.021],  shorter baseline disease duration [HR (95% CI): 0.97 (0.93-1.00), P=0.054], and increased baseline pain levels [HR (95% CI): 1.14 (1.03-1.26), P=0.013].  2,016 AEs were reported by 343 patients (106.8 events/100 patient-years) and 156 SAEs by 96 patients (8.3 events/100 patient-years). The incidence density ratio (IDR) (95% CI) was higher in the groups IFX+MTX vs. IFX+LEF for both AEs and SAEs with 1.44 (1.25-1.67) and 1.60 (0.94-2.73), respectively, however the latter was not statistically significant. When examining the triple combination therapy (IFX+MTX+LEF), higher durability was observed compared to both IFX+MTX [HR (95% CI): 3.68 (1.14-11.92); P=0.030] and IFX+LEF [HR (95% CI): 6.34 (1.72-23.34); P=0.006].

Conclusion: The results of this real-world observational study have shown that combination therapy with IFX+MTX is associated with significantly higher treatment durability compared to IFX+LEF in RA patients with increased risk for AEs but not for SAEs. 

Disclosure: R. Faraawi, Janssen Inc., 5; R. Joshi, Janssen Inc, 5; W. G. Bensen, Janssen Inc., 5; D. Choquette, None; W. Olsynzynski, Janssen Inc, 5; R. Arendse, Janssen Inc., 5; M. Sheriff, Janssen Inc, 5; P. Rahman, None; E. Rampakakis, JSS, 3; E. Psaradellis, JSS Medical Research, 3; F. Nantel, Janssen Inc., 3; A. J. Lehman, employee of Janssen Inc., 3; S. Otawa, Employee of Janssen Inc., 3; C. Tkaczyk, Janssen Inc., 3; B. Osborne, Janssen Inc., 3.

To cite this abstract in AMA style:

Faraawi R, Joshi R, Bensen WG, Choquette D, Olsynzynski W, Arendse R, Sheriff M, Rahman P, Rampakakis E, Psaradellis E, Nantel F, Lehman AJ, Otawa S, Tkaczyk C, Osborne B. What Is the Treatment Durability and Safety Profile of Rheumatoid Arthritis Patients Treated with Infliximab Plus Methotrexate and/or Leflunomide? an Analysis from a Real-World Registry [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/what-is-the-treatment-durability-and-safety-profile-of-rheumatoid-arthritis-patients-treated-with-infliximab-plus-methotrexate-andor-leflunomide-an-analysis-from-a-real-world-registry/. Accessed .

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