A study presented at the American College of Rheumatology (ACR) Convergence 2021 investigated the incidence of infection among patients with rheumatoid arthritis (RA) receiving treatment with golimumab.
“Biologic use in RA is a well-characterized risk factors for infections,” wrote the study authors. “The aim of this analysis was to characterize the incidence of infection in [patients with] RA treated with golimumab in Canadian routine care, as well as assess the impact of oral corticosteroid (CS) and disease-modifying antirheumatic drug (DMARD) use on infection.”
The researchers conducted a post-hoc analysis of the Biologic Treatment Registry Across Canada, comprising 530 patients with RA who initiated treatment with subcutaneous golimumab. They calculated the incidence density rates (IDR) of total, serious, and non-serious infections at six months intervals, and overall.
Patients were an average of almost 58-years-old, with an average disease duration of eight years. Seventy-four patients (14.0%) received ≤15mg/week of methotrexate (MTX), 280 (52.8%) received >15mg/week MTX, and 173 (32.6%) were not on MTX. Seventy-two patients (13.6%) received ≤5mg/day of corticosteroids (CS), 63 (11.9%) received >5mg/day CS, and 391 (73.8%) were not on CS. Mean follow-up was 27 months.
The IDR for total infections over the follow-up period was 35.10 events per 100 person-years. For serious and non-serious infections, the IDRs were 2.23 events/100 person-years and 32.90 events/100 person-years, respectively. The median estimated time to first infection was 52.9 months for overall infections, and 84.9 months and 55.1 months for serious and non-serious infection, respectively.
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 zero to six months, six to 12 months, 12 to 24 months, 24 to 36 months, 36 to 48 months, 48 to 60 months, 60 to 72 months, 72 to 84 months, and 84 to 90 months, respectively.
The researchers noted that longer follow-up duration was significantly associated with higher number of non-serious infections (hazard ratio=1.011, 95% confidence interval 1.006-1.017), but not serious infection (hazard ratio=1.011, 95% confidence interval 0.988-1.035). The use of disease modifying anti-rheumatic drugs (DMARD), CS, and MTX were also not associated with risk of infection.
In conclusion, the authors wrote, “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-tumor necrosis factor [agents] for the shortest period possible to achieve remission, and then tapered.”