Golimumab With or Without Methotrexate in Rheumatoid Arthritis

By Patrick Daly - Last Updated: March 29, 2023

In the phase 4 AWARE study, researchers compared golimumab and infliximab in patients with rheumatoid arthritis. After around 40% of AWARE participants reported no concurrent use of methotrexate, researchers conducted a post hoc analysis to evaluate golimumab with or without methotrexate for rheumatoid arthritis. Data were presented in BMC Rheumatology.

The analysis’s lead author, Aaron Broadwell, reported that the efficacy of golimumab either with or without methotrexate was generally similar over 1 year, regardless of prior biologic treatment history. The report noted that real-world adverse event outcomes with golimumab were consistent with the previously described safety profile.

Golimumab Performs Similarly With or Without Methotrexate

The real-world, prospective, noninterventional AWARE study included 685 patients treated with golimumab, of which 420 (61%) were on concomitant methotrexate and 265 (39%) were not; authors added that 63% and 72% of the groups, respectively, discontinued the study.

The efficacy of golimumab was evaluated based on mean change in Clinical Disease Activity Index (CDAI) at months 6 and 12 and safety was evaluated based on adverse events over 1 year of follow-up.

Authors found patients in the golimumab with methotrexate group had a shorter mean disease duration compared with patients in the golimumab without methotrexate group, at 8.7 years versus 10.0 years. Additionally, 60% of patients in the combination group had received prior biologic treatments compared with 72% in the monotherapy group.

The mean changes in CDAI scores were similar between the two groups, however, at -10.2 ± 14.2 and -10.8 ± 13.8 at months 6 and 12, respectively, in the methotrexate group, versus -9.6 ± 12.9 and -9.9 ± 13.1 in the non-methotrexate group.

The overall incidence of adverse events per 100 patient-years was 155.6 (95% CI, 145.6-166.1) in the golimumab with methotrexate group and 191.2 (95% CI, 176.2-207.1) in the golimumab without methotrexate group. Researchers noted infections were the most common type of event.

Ultimately, Broadwell and colleagues suggested that their results “indicate that improvements in CDAI scores were similar for golimumab-treated patients, regardless of concomitant [methotrexate] use.”

Related: JAK Inhibitors With or Without Methotrexate in Rheumatoid Arthritis

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