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TOPLINE:

In adults with active psoriatic arthritis (PsA) who had an inadequate response to TNF inhibitors, combination therapy with guselkumab and golimumab showed numerically higher rates of achieving minimal disease activity (MDA) than guselkumab alone at 24 weeks; however, the primary endpoint was not met. Participants with an elevated C-reactive protein (CRP) level at screening who received combination therapy had higher odds of achieving MDA.

METHODOLOGY:

• Researchers conducted a phase 2a randomized, controlled, proof-of-concept study across nine countries between November 2021 and 2023 evaluating guselkumab-golimumab combination therapy vs guselkumab monotherapy in participants with active PsA and an inadequate response to up to two TNF inhibitors.
• A total of 91 adults with active PsA were randomly assigned (2:1) to receive subcutaneous combination therapy with 100 mg guselkumab and 50 mg golimumab (n = 59) or monotherapy with 100 mg guselkumab and placebo (n = 32) every 4 weeks through week 20.
• Participants had active PsA (three or more tender joints and three or more swollen joints) for 6 months or more, met the Classification Criteria for Psoriatic Arthritis at screening, and had active plaque psoriasis with one or more psoriatic plaques at least 2 cm in diameter or nail changes consistent with psoriasis; participants were classified within at least one PsA subset.
• The primary endpoint was MDA response — defined as meeting five or more criteria, which comprised a tender joint count of one or less, a swollen joint count of one or less, a patient pain score ≤ 1.5, a patient global assessment score ≤ 2.0, a Health Assessment Questionnaire-Disability Index (HAQ-DI) score ≤ 0.5, Psoriasis Area and Severity Index score ≤ 1 or psoriatic body surface area ≤ 3%, and Leeds Enthesitis Index score ≤ 1 — assessed at 24 weeks.
• Secondary efficacy endpoints included MDA response at week 16, ≥ 50% improvement in American College of Rheumatology response criteria (ACR50), resolution of enthesitis and dactylitis, and changes in 36-item Short Form Physical Component Summary (SF-36 PCS) and HAQ-DI scores through week 24. Adverse events were also assessed.

TAKEAWAY:

• The primary endpoint was not met; a total of 29% of participants receiving combination therapy achieved MDA at week 24 vs 22% of those receiving monotherapy (odds ratio [OR], 1.4; P = .557).
• ACR50 response at week 24 was achieved by 44% of participants receiving combination therapy compared to 22% of those receiving monotherapy (nominal P = .034). Participants receiving combination therapy reported greater improvements in SF-36 PCS scores from baseline through week 24 than those receiving monotherapy (least-squares mean change, 8.84 vs 3.59; nominal P = .010).
• In a post hoc analysis among participants with CRP levels ≥ 0.3 mg/dL at screening, those on combination therapy vs monotherapy demonstrated greater odds of achieving MDA (32% vs 5%; OR, 12.3; 90% CI, 2.0-77.8; nominal P = .025) and ACR50 response (55% vs 14%; OR, 9.6; 90% CI, 2.7-33.7; nominal P = .003) at week 24.
• Through week 24, adverse events occurred in 66% of participants receiving combination therapy and 56% receiving monotherapy, with the most common events being diarrhea, COVID, and headache in the combination therapy group and nasopharyngitis, upper respiratory tract infection, and influenza in the monotherapy group.

IN PRACTICE:

“These findings suggest that participants with a higher systemic inflammatory burden may derive a greater benefit from the additive effect of guselkumab plus golimumab than those with more modest systemic inflammation. This possibility, along with the potential impact of other markers of inflammation, should be tested in further studies, ideally among a larger cohort of individuals with active PsA,” the authors of the study wrote.

SOURCE:

The study was led by Jose U. Scher, MD, New York University Grossman School of Medicine in New York City. It was published online on March 25, 2026, in Arthritis & Rheumatology.

LIMITATIONS:

The relatively small sample size may limit generalizability of findings and may have affected the statistical power to detect differences in secondary endpoints. Only a subset of participants had psoriasis, enthesitis, and dactylitis involvement at the start of the study.

DISCLOSURES:

This study was supported by Johnson & Johnson. Some authors disclosed serving as a consultant, receiving grants, research support, honoraria, and/or speaker fees, or having other ties with various sources, including Johnson & Johnson. Four authors reported being employees and shareholders of Johnson & Johnson, and one author reported employment of their spouse with AstraZeneca.

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