Impact of Concomitant Methotrexate Administration on the Risk of Infections Among Rheumatoid Arthritis Patients Treated with Anti-TNF in Real-World

John Kelsall¹, Anna Jaroszynska², Louis Bessette³, Raman Joshi⁴, Isabelle Fortin⁵, Jacqueline Stewart⁶, Keltie Anderson⁷, Emmanouil Rampakakis⁸, Eliofotisti Psaradellis⁹, Francois Nantel¹⁰, Karina Maslova¹¹, Brendan Osborne¹², Cathy Tkaczyk¹² and Allen J Lehman¹¹, ¹Rheumatology, University of British Columbia, Vancouver, BC, Canada, ²Private practice, Burlington, ON, Canada, ³Rheumatology, CHUL de Quebec, Quebec, QC, Canada, ⁴William Osler Health Centre-Brampton Civic Hospital, Brampton, ON, Canada, ⁵Centre de Rhumatologie De l’Est du Quebec, Rimouski, QC, Canada, ⁶Penticton Regional Hospital, Penticton, BC, Canada, ⁷University of Saskatchewan, Saskatoon, SK, Canada, ⁸JSS Medical Research, St-Laurent, QC, Canada, ⁹JSS Medical Research, Montreal, QC, Canada, ¹⁰19 Green belt Dr, Janssen Inc., Toronto, ON, Canada, ¹¹Janssen Inc., Toronto, ON, Canada, ¹²Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords: Biologic agents, Infection, methotrexate (MTX), registry and rheumatoid arthritis (RA)

Session Information

Date: Tuesday, November 15, 2016

Title: Rheumatoid Arthritis – Clinical Aspects - Poster III: Treatment – Monitoring, Outcomes, Adverse Events

Session Type: ACR Poster Session C

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

Background/Purpose: Methotrexate (MTX) is routinely used among rheumatoid arthritis (RA) patients treated with anti-TNF agents to enhance treatment efficacy and minimize the dose of biologic therapy. The aim of this analysis was to evaluate the risk of infections among patients treated with infliximab (IFX) or golimumab (GLM) in combination with MTX in the first 12 months following the start of biologic therapy.

Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment with infliximab or GLM for RA, ankylosing spondylitis, or psoriatic arthritis (PsA), or with ustekinumab for PsA. Eligible participants for this analysis included RA patients treated with IFX or GLM enrolled since 2002 and 2010, respectively, in combination or in monotherapy with MTX. Patients were excluded from the analysis if concomitant corticosteroids were used during any time point from baseline to 12 months of treatment. Serious and non-serious infections were assessed with the incidence density rate (IDR) as events /100 patient-years (PY). Poisson regression was used to compare the IDRs of infections between treatments while controlling for baseline disease activity and length of exposure to biologic treatment.

Results: A total of 526 RA patients were included in the analysis. At baseline, 71 (13.5%) were on anti-TNF monotherapy, while 109 (20.7%) were on combination therapy with MTX ≤15mg (low-moderate dose), and 346 (65.8%) with MTX>15mg (high dose). The vast majority (93.3%) of patients were bio-naïve, 73.4% were female, mean (SD) age was 55.7 (13.4) years and disease duration since diagnosis was 7.5 (8.3) years. A total of 163 (37.4 events/100 PY) infections were reported by 104 (19.8%) patients and a total of 10 (2.8 events/100 PY) serious infections. Specifically, the mean (95% CI) adjusted IDR was 23.9 (14.4-39.8) events/100 PY for monotherapy, 30.2 (21.4-42.7) events/100 PY for MTX low-moderate dose, and 30.5 (24.9-37.4) events/100 PY for MTX high dose. Furthermore, among patients treated with MTX, no association between use of other concomitant DMARDs in the treatment regimen and risk of infection was observed while adjusting for MTX dose with mean (95% CI) IDR of 33.6 (25.6-44.1) events/100 PY for DMARDs vs. 33.8 (25.2-45.3) events/100 PY for no DMARDs.

Conclusion: The results of this real-world observational study have shown that, overall, a low incidence of serious infections is observed with anti-TNF treatment. Concomitant use of anti-TNFs and MTX, with or without other DMARDs, is not associated with a higher incidence of total infections.

Disclosure: J. Kelsall, Janssen Inc., 5; A. Jaroszynska, None; L. Bessette, Janssen Inc., 5; R. Joshi, Janssen Inc., 5; I. Fortin, None; J. Stewart, Janssen Inc., 5; K. Anderson, Janssen Pharmaceutica Product, L.P., 5; E. Rampakakis, employee of JSS Medical Research, 3; E. Psaradellis, employee of JSS Medical Research, 3; F. Nantel, Employee of Janssen Inc., 3; K. Maslova, Employee of Janssen Inc., 3; B. Osborne, Employee of Janssen Inc., 3; C. Tkaczyk, Employee of Janssen Inc., 3; A. J. Lehman, Employee of Janssen Inc., 3.

To cite this abstract in AMA style:

Kelsall J, Jaroszynska A, Bessette L, Joshi R, Fortin I, Stewart J, Anderson K, Rampakakis E, Psaradellis E, Nantel F, Maslova K, Osborne B, Tkaczyk C, Lehman AJ. Impact of Concomitant Methotrexate Administration on the Risk of Infections Among Rheumatoid Arthritis Patients Treated with Anti-TNF in Real-World [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/impact-of-concomitant-methotrexate-administration-on-the-risk-of-infections-among-rheumatoid-arthritis-patients-treated-with-anti-tnf-in-real-world/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-concomitant-methotrexate-administration-on-the-risk-of-infections-among-rheumatoid-arthritis-patients-treated-with-anti-tnf-in-real-world/