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.