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Abstract Number: 0802

Infection in Rheumatoid Arthritis Patients Treated with Golimumab

Louis Bessette1, Proton Rahman2, John Kelsall3, Jane Purvis4, Emmanouil Rampakakis5, Allen Lehman6, Meagan Rachich6, Francois Nantel7 and Odalis Asin-Milan6, 1Laval University, Québec City, QC, Canada, 2Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 3Providence Health Care, Vancouver, BC, Canada, 4Peterborough Education, Peterborough, ON, Canada, 5JSS Medical Research, Montréal, QC, Canada, 6Janssen Inc., Toronto, ON, Canada, 7., Montreal, ON, Canada

Meeting: ACR Convergence 2021

Keywords: Infection, registry, rheumatoid arthritis

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Session Information

Date: Sunday, November 7, 2021

Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Miscellaneous Aspects of RA (0786–0812)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Biologic use in RA is a well-characterized risk factors for infections. The aim of this analysis was to characterize the incidence of infection in RA patients treated with golimumab in Canadian routine care, as well as assess the impact of oral corticosteroid (CS) and DMARD use on infection.

Methods: This is a post-hoc analysis of the Biologic Treatment Registry Across Canada (BioTRAC). Patients with RA who initiated treatment with subcutaneous golimumab were included in this analysis. The incidence density rates (IDR) of total, serious (SI), and non-serious (NSI) infections were calculated for the overall follow-up period as well as by 6-month interval. Negative binomial and cox regressions were used to assess the impact of CS and DMARD use, as well as CS and methotrexate (MTX) dose levels. Time to first infection and time to treatment discontinuation were assessed with the Kaplan-Meier estimator of the survival function, and the impact of concomitant CS and DMARD use was assessed with the log rank test.

Results: 530 patients were included with a mean (SD) age of 57.7 (13.0) years and disease duration of 8.0 (8.3) years. Of these 74 (14.0%) were treated with ≤15mg/week MTX, 280 (52.8%) with >15mg/week MTX, while 173 (32.6%) were not on MTX. In terms of CS, 72 (13.6%) were treated with ≤5mg/day, 63 (11.9%) with >5mg/day, and 391 (73.8%) were not on CS.

Over a mean follow-up duration of 27.0 months, the IDR for total infections, NSI, and SI was 35.10 events/100 PYs, 32.90 events/100 PYs, and 2.23 events/100 PYs. Median estimated time to first infection was 52.9 months (SI: 84.9 months; NSI: 55.1 months). The incidence of total infections was 44.0, 37.3, 35.1, 29.4, 31.1, 35.7, 19.3, 7.4 and 0.0 events/100 PYs at 0-6 months, 6-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months, 60-72 months, 72-84 months and 84-90 months, respectively. Longer follow-up duration was significantly associated with higher number of NSI (HR [95%CI]: 1.011 [1.006-1.017]) but not SI (1.011 [0.988-1.035]), while neither the use of DMARD, CS nor MTX was found to have an impact.

Conclusion: Higher IDR was observed during the first 6 months of treatment and decreasing thereafter. CS and DMARD treatment did not impact retention of golimumab treatment. These results support the notion that CS should be used concomitantly with anti-TNF for the shortest period possible to achieve remission, and then tapered.


Disclosures: L. Bessette, Amgen, 2, 5, 6, Bristol-Myers Squibb, 2, 5, 6, Janssen, 2, 5, 6, Roche, 2, 5, 6, UCB, 2, 5, 6, AbbVie, 2, 5, 6, Pfizer, 2, 5, 6, Merck, 2, 5, 6, Celgene, 2, 5, 6, Sanofi, 2, 5, 6, Eli Lilly, 2, 5, 6, Novartis, 2, 5, 6, Sandoz, 2, 5, 6, Sandoz, 2, 5, 6, Gilead, 2, 5, 6, Fresenius Kabi, 2, 5, 6, Teva, 2, 5, 6; P. Rahman, Janssen, 2, 5, 6, Novartis, 2, 5, 6, AbbVie, 2, 6, Amgen, 2, 6, Bristol Myers Squibb, 2, 6, Celgene, 2, 6, Eli Lilly, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Merck, 2, 6; J. Kelsall, None; J. Purvis, Pfizer, 1, Celltrion, 1, Sandoz, 1, Merck, 1, Roche, 1, Janssen, 1, Sanofi, 1, Amgen, 1; E. Rampakakis, None; A. Lehman, Janssen Inc., 3; M. Rachich, Janssen, 3, 11; F. Nantel, None; O. Asin-Milan, Janssen, 3.

To cite this abstract in AMA style:

Bessette L, Rahman P, Kelsall J, Purvis J, Rampakakis E, Lehman A, Rachich M, Nantel F, Asin-Milan O. Infection in Rheumatoid Arthritis Patients Treated with Golimumab [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/infection-in-rheumatoid-arthritis-patients-treated-with-golimumab/. Accessed .
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