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Abstract Number: 545

Incidence of Infusion Reactions to Intravenous Golimumab: Results from a Prospective, Real-World Community Registry

Rafat Faraawi1, Andrew Chow2, Majed M M Khraishi3, Derek Haaland4, Milton F. Baker5, Cathy Tkaczyk6, Allen J Lehman7, Francois Nantel6 and Brendan Osborne6, 1McMaster University, Hamilton, ON, Canada, 2Credit Valley Rheumatology, Mississauga, ON, Canada, 3Faculty of Medicine, Memorial University of Newfoundland, St John's, NF, Canada, 4Rheumatology, Clinical Immunology & Allergy, McMaster University, Barrie, ON, Canada, 5VIHA, Victoria, BC, Canada, 6Medical Affairs, Janssen Inc., Toronto, ON, Canada, 7Janssen Inc., Toronto, ON, Canada

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Biologic agents, infusions, observation, registry and rheumatoid arthritis (RA)

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Session Information

Date: Sunday, November 5, 2017

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules

Session Type: ACR Poster Session A

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

Background/Purpose: Golimumab (GLM) is a monoclonal antibody targeting TNF-alpha, indicated for the treatment of adults with rheumatoid arthritis in combination with methotrexate (MTX).  GLM-IV is recommended to be administered at a dose of 2 mg/kg given as a 30-minute intravenous (IV) infusion at weeks 0, 4 and every 8 weeks thereafter. In two separate trials, GO-LIVE and GO-FURTHER, infusion reactions (IRs) were observed in a relatively small group of GLM-treated patients with 2.2% and 3.3% of patients having documented IRs, respectively. The GO-IV registry was initiated to evaluate the incidence and management of IRs with GLM-IV in a real-world Canadian practice setting.

Methods: GO-IV was a prospective, observational, non-interventional, multicenter study conducted at 11 Canadian sites from 2014-2016. GLM infusions were followed to document IRs and their management, pre-medication uses and adverse events (AE). An IR was defined as any AE occurring during the infusion or within 1 hour post-infusion. Patients had to be at least 18 years of age or older, a confirmed diagnosis of rheumatoid arthritis, provide written consent for data collection, be naïve to GLM (both subcutaneous and intravenous formulations) and be seen by a Canadian rheumatologist.

Results: The study was terminated early due to lack of public listing for the drug. At that time, a total of 79 patients were enrolled and 62 of them were still ongoing. Reasons for premature discontinuation included AEs (7), lack of response (4), geographic issues (3), mis-diagnosis, switch to subcutaneous GLM or withdrawal of consent (one each). A total of 77 patients were included in the primary analysis and 78 in the safety analysis. Only 4 patients (5.1%) documented an IR over 483 infusion visits (0.8%), none of which classified as serious or leading to discontinuation. Three of those IRs occurred at the first infusion and on at infusion number three. Infusion-related AEs included palpitations, nausea, fatigue, infusion site pain, dizziness and headache (one each). The impact of pre-medication could not be established since only four infusions were pre-medicated with diphenhydramine and one with steroids.

A total of 164 AEs were reported in 45 patients (57.7%); 2 patients (2.6%) reported a serious adverse event (acute myocardial infarction; multiple fractures, pneumothorax, concussion, traumatic haematoma and pneumothorax resulting from a fall). There was one incidence of a lipoma and no death. There were 30 infectious AEs reported in 24 patients.

Conclusion: The GO-IV registry shows that, in community-based infusion clinics, IRs to GLM are uncommon and predominantly mild in nature.

Primary Analysis

(n=77)

Age (years), mean (SD)

55.5 (11.58)

Female Gender, n(%)

61 (79.2%)

Weight (Kg), mean (SD)

77.2 (19.55)

Any co-morbidity, n (%)

19 (24.6%)

Concomitant Medication

Any DMARD, n (%)

70 (90.9%)

Corticosteroids, n (%)

32 (41.6%)

MTX, n(%)

58 (75.3%)

Number of infusions

Mean per subject (SD)

6.1 (2.69)

Median per subject

6.0

Mean IV Administration (minutes)

36.03

Safety Analysis (n=78)

No. subjects with at least 1 infusion reaction, n (%)

4 (5.1%)

Subject with ≥1 AE, n (%)

45 (57.7%)

Subject with ≥1 SAE, n (%)

2 (2.6%)


Disclosure: R. Faraawi, None; A. Chow, None; M. M. M. Khraishi, None; D. Haaland, None; M. F. Baker, None; C. Tkaczyk, Janssen Inc, 3; A. J. Lehman, Janssen Inc., 3; F. Nantel, Janssen Inc., 3; B. Osborne, Janssen Inc., 3.

To cite this abstract in AMA style:

Faraawi R, Chow A, Khraishi MMM, Haaland D, Baker MF, Tkaczyk C, Lehman AJ, Nantel F, Osborne B. Incidence of Infusion Reactions to Intravenous Golimumab: Results from a Prospective, Real-World Community Registry [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/incidence-of-infusion-reactions-to-intravenous-golimumab-results-from-a-prospective-real-world-community-registry/. Accessed February 27, 2021.
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