Golimumab With and Without Concomitant MTX in RA Comparable in Safety and Efficacy

Real-world data show the comparable safety and efficacy of golimumab with and without concomitant methotrexate for the treatment of RA.

Improvements in disease activity were found to be comparable among patients with rheumatoid arthritis (RA) who received treatment with golimumab with and without concomitant use of methotrexate (MTX), according to study findings published in BMC Rheumatology.

In an observational, prospective, noninterventional, real-world study (AWARE; ClinicalTrials.gov Identifier: NCT02728934), researchers aimed to evaluate the safety and efficacy of intravenous (IV) golimumab in combination with MTX compared with IV golimumab alone among biologic-naive and biologic-experienced patients with RA.

Effectiveness was measured by the mean change in Clinical Disease Activity Index (CDAI) scores at 6 and 12 months; safety was observed for approximately 1 year. Patients included in the study had a mean baseline CDAI score of greater 22, which is indicative of increased disease activity.

Primary endpoint was the percentage of patients with an infusion reaction and secondary endpoint included mean change in CDAI.

The study population included 685 patients, 420 (61%) received IV golimumab and MTX during the study and 265 (39%) received IV golimumab alone after enrollment. A total of 63% of patients receiving golimumab and MTX and 72% of those receiving golimumab alone discontinued participation in the study.

The real-world data presented here may assist healthcare providers and patients with RA in making informed treatment decisions.

With regard to dosing, concomitant MTX use was defined as the administration of MTX at any time during or after week 0. Dosing for golimumab was 2 mg/kg infused over a period of 30 minutes at weeks 0 and 4, and every 8 weeks thereafter with concomitant MTX.

Patients receiving treatment with golimumab plus MTX vs golimumab alone had a shorter mean disease duration (8.7 vs 10.0 years).

Overall, the baseline CDAI scores with golimumab plus MTX and golimumab without MTX were comparable (30.8±15.1 and 32.6±15.4). In addition, the changes from baseline CDAI scores at both 6 and 12 months were also similar between the 2 groups. The group receiving golimumab plus MTX experiencing a change of -10.2±14.2 and -10.8±13.8, respectively. The group receiving golimumab alone experienced a change of -9.6±12.9 and -9.9±13.1 at 6 and 12 months, respectively.

Golimumab plus MTX was associated with a lower incidence of infusion reactions (2.1 per 100/patient-years [PY]; 95% CI, 1.1-3.6 per 100/PY) than that of golimumab alone (5.1 PY; 95% CI, 2.9-8.3 PY).

Infections were the most commonly reported adverse event (AEs), with the most common reasons for treatment discontinuation being AEs (9.3% for golimumab plus MTX and 12.5% for golimumab alone) and lack of efficacy (27.1% for golimumab plus MTX and 32.1% for golimumab alone).

The AWARE study had limitations, including the open-label design, the post hoc analyses being exploratory, and the inability to compare the safety and effectiveness of golimumab with and without MTX. Another major limitation of the study was the high treatment discontinuation rates seen among both groups.

The study authors concluded, “The real-world data presented here may assist healthcare providers and patients with RA in making informed treatment decisions.”

Disclosure: This research was supported by Janssen Scientific Affairs, LLC. Multiple study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Broadwell A, Schechtman J, Conaway D, et al. Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study. BMC Rheumatol. Published online March 27, 2023. doi:10.1186/s41927-023-00329-8