TOPLINE: 

Golimumab with methotrexate and corticosteroids showed no significant difference in disease control compared with methotrexate and corticosteroids alone in treatment-naive patients with early psoriatic arthritis (PsA). Both treatments led to improved disease activity at week 24, with no serious adverse events reported by week 52.

METHODOLOGY:

• Researchers conducted a randomized, single-center phase 3b trial in the UK to assess the effect of golimumab plus methotrexate and corticosteroids vs methotrexate and corticosteroids on disease activity in PsA.
• A total of 84 adult participants with early PsA (mean age, 42.5 years; 55% men; 73% White individuals) who were naive to disease-modifying antirheumatic drugs (DMARDs) or other treatments were enrolled between November 2015 and January 2022.
• Participants were randomly assigned to receive either golimumab and methotrexate (n = 43) or placebo and methotrexate (n = 41), with stratification by joint involvement.
• Golimumab (50 mg or 100 mg) or placebo was administered subcutaneously every 4 weeks with oral methotrexate (increased from 15 to 25 mg weekly within 28 days) for up to 24 weeks, with follow-up for 52 weeks. All participants received an initial dose of 120 mg methylprednisolone.
• The primary outcome was the Psoriatic Arthritis Disease Activity Score (PASDAS) at week 24, with secondary outcomes such as enthesitis, dactylitis, and American College of Rheumatology (ACR) response criteria assessed at 12, 24, 36, and 52 weeks.

TAKEAWAY:

• At week 24, no significant difference in PASDAS was observed between the golimumab and methotrexate group and the placebo and methotrexate group.
• More participants in the placebo and methotrexate group vs the golimumab and methotrexate group received additional corticosteroids by week 24 (49% vs 21%).
• By week 24, over 50% of participants in both groups achieved minimal disease activity, and more than 60% had an ACR20 response; at week 52, 26% in the golimumab and methotrexate group and 22% in the placebo and methotrexate group had an ACR70 response.
• Adverse events occurred at similar rates in both groups, with 95% of participants in the golimumab and methotrexate group and 93% in the placebo and methotrexate group experiencing at least one event; no serious adverse events were reported.

IN PRACTICE:

"These data arguably point to the role of corticosteroids as a pragmatic first-line approach to achieve rapid suppression of inflammation in newly diagnosed psoriatic arthritis. This might be of particular interest to healthcare providers who operate in contexts where biological DMARD access is restricted or to clinicians working in other medical specialties beyond rheumatology who utilize corticosteroids," the authors wrote. 

SOURCE:

The study was led by Gabriele De Marco, PhD, National Institute for Health and Care Research Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK. It was published online on September 3, 2025, in The Lancet Rheumatology.

LIMITATIONS: 

The study's single-center design may limit the generalizability of its findings. The trial did not assess higher methotrexate doses or alternative DMARDs such as sulfasalazine. Treatment with golimumab was not included as a single therapy.

DISCLOSURES:

This study was supported by grants from Janssen Biologics BV. Some authors reported receiving research grants, speaking fees, consulting fees, lecture fees, and/or honoraria from multiple pharmaceutical companies, including AbbVie, Janssen, Lilly, Novartis, and others.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.