Adding Golimumab to Treatment Regimen Reduced Rescue Corticosteroid Use in People With Early PsA

Adding golimumab to a methotrexate and corticosteroid regimen reduced the need for rescue corticosteroids and maintained treatment efficacy in people with early psoriatic arthritis (PsA).1

“Current guidance on first-line treatment recommends a step-up approach with methotrexate or other conventional synthetic DMARDs before consideration of biological or targeted synthetic DMARDs.2 Yet, health inequities remain globally, limiting access to these advanced therapies despite the advent of more cost-effective biosimilars, underscoring the need for pragmatic and effective treatment strategies in psoriatic arthritis. Identifying the best treatment strategy for managing psoriatic arthritis is the top research priority identified by patients and their carer,” lead investigator Gabriele De Marco PhD, National Institute for Health and Care Research Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, United Kingdom, and colleagues wrote.1

De Marco and colleagues conducted a double-blind, randomized, placebo-controlled, parallel-group, single-center study between November 3, 2015, and January 26, 2022, in 84 adults with treatment-naïve active PsA who had not been treated with conventional synthetic, biologic, or targeted synthetic disease-modifying antirheumatic drugs or systemic treatments. The study randomized participants 1:1 to receive either combination therapy of golimumab and methotrexate (n = 43) or placebo and methotrexate (n = 41) and stratified them by the number of involved peripheral joints at baseline. Around half (n = 46; 55%) of participants were male and 38 (45%) were female. They had a mean age of 42.5 years (SD, 12.4); 61 (73%) participants were White and 7 (8%) were other ethnicities.

At baseline, all participants received a single dose of 120 mg intramuscular methylprednisolone administration and then commenced weekly methotrexate increasing to 25 mg within 28 days. They received golimumab or placebo by subcutaneous injections every 4 weeks with the possibility of additional methylprednisolone permitted once by week 24, totaling up to 240 mg exposure.

The study’s primary endpoint was the difference in mean Psoriatic Arthritis Disease Activity Score (PASDAS) at week 24 in the intention-to-treat population, which investigators compared using analysis of covariance via multiple linear regression. The trial design was put together with input from people with lived experience of PsA.

Investigators found that PASDAS did not differ between treatment groups at week 24, with an unadjusted mean of 3.09 (SD, 1.32) in the placebo and methotrexate group and 2.70 (SD, 1.38) in the golimumab and methotrexate group (adjusted difference, –0.55 [95% CI, 1.12-0.03]; P = .064). Notably, more participants in the placebo and methotrexate group received additional corticosteroids before week 24 (20; 49%]) compared to 9 (21%) in the golimumab group (OR, 0.28 [95% CI, 0.11-0.72]; P = .009).1

In terms of safety, there were similar rates of adverse events (AE) in the placebo and methotrexate group (38; 93%) and the golimumab and methotrexate group (41 [95%]; risk difference 0.03 [95% CI, –0·09 to 0·15]), although investigators noted that altered laboratory investigations and infections occurred more frequently in the golimumab and methotrexate group. There were no deaths, serious, or unexpected adverse events.

“Both interventions led to improved disease activity in patients with early, untreated psoriatic arthritis, without a clinically or statistically significant difference in PASDAS between treatment groups at week 24. Participants in the placebo and methotrexate group required more rescue corticosteroids. Sustained results were observed at week 52 in both groups, without serious or unexpected adverse events,” De Marco and colleagues wrote.1

References

1. Marco GD, Hensor EMA, Helliwell PS, et al. Effect of a treatment strategy utilising golimumab, methotrexate and corticosteroids versus methotrexate and corticosteroids in early, untreated psoriatic arthritis (GOLMePsA): a single-centre, double-blind, parallel-group, randomised controlled trial. Lancet Rheumatol. Published online September 1, 2025. doi: 1016/s2665-9913(25)00156-0

2. 1.Coates LC, Tillett W, D’Agostino MA, et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022;4(4):e262-e273. doi: 0.1016/s2665-9913(22)00008-x