In patients with active rheumatoid arthritis (RA), intravenous (IV) golimumab has a similar efficacy rate in patients aged <65 and ≥65 years, according to results published in Arthritis Research & Therapy.
The study included patients with active RA from the GO-FURTHER trial (n=592). Patients were randomly assigned to receive IV golimumab 2 mg/kg plus methotrexate (MTX) or placebo plus MTX at weeks 0 and 4 and every 8 weeks thereafter. Patients had crossover to golimumab at week 16 (early escape) or week 24 (per-protocol). Patients received their final golimumab infusion at week 100.
The researchers assessed patients using American College of Rheumatology (ACR) 20/50/70 response criteria. They monitored efficacy and adverse events (AEs) through 2 years.
Of 592 patients, 197 were randomly assigned to receive placebo and 395 to receive golimumab. A total of 515 patients were aged <65 years and 77 were ≥65 years.
At week 24, the results indicated that in patients <65 years, golimumab plus MTX patients had higher ACR20 response rates compared with placebo plus MTX (61.6% vs. 31.3%; P <.001). This was also true in patients ≥65 years, with ACR20 response rates of 69.5% for golimumab plus MTX compared with 33.3% for placebo plus MTX (P <.01).
During 112 weeks of follow-up, infections were the most common AE, occurring in 51.6% of patients <65 years and 55.3% of patients aged ≥65 years. In patients <65 years and ≥65 years, upper respiratory infections were the most common infection (13.2% and 11.8%, respectively).
Serious AEs occurred in 17.7% of patients aged <65 years and in 25.0% of patients aged ≥65 years, including malignancies, pneumonia, fractures, acute pancreatitis, cellulitis, and bacterial arthritis.
The researchers noted that the relatively small number of patients in the older age groups limits their analysis. In addition, the effect of immunosenescence presents a possible confounder.
“Although this analysis did not demonstrate a stronger signal for serious infections, these results do advise cautious patient selection for risk and monitoring for serious infection for older patients receiving golimumab,” the researchers wrote.
Disclosure: This clinical trial was supported by Janssen Research & Development, LLC. Please see the original reference for a full list of authors’ disclosures.
Tesser J, Kafka S, DeHoratius RJ, et al. Efficacy and safety of intravenous golimumab plus methotrexate in patients with rheumatoid arthritis aged <65 years and those ≥65 years of age [published online August 20, 2019]. Arthritis Res Ther. doi:10.1186/s13075-019-1968-x