Results from the PHASE2 study NCT05071664 investigating guselkumab and golimumab combination therapy in participants with active psoriatic arthritis were posted on 2026-07-23. The trial reported that 44.1% of participants receiving the combination achieved an ACR 50 response at Week 24, compared to 21.9% for guselkumab monotherapy.

Background

This study evaluated guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) who had an inadequate response to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies. The aim was to compare clinical response with guselkumab monotherapy.

Trial design

The PHASE2 study, identified as NCT05071664, was a completed trial that enrolled 91 participants with active psoriatic arthritis. The study evaluated the efficacy of guselkumab 100 mg q4w plus golimumab 50 mg q4w combination treatment compared to guselkumab 100 mg q4w plus placebo in participants with an inadequate response to prior anti-TNF-alpha therapies. The brief summary indicates the purpose was to assess clinical response, though specific primary outcomes were not detailed in the provided data.

Key results

Key efficacy results at Week 24 included:

  • For Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 24, the combination arm (Guselkumab 100 mg q4w Plus Golimumab 50 mg q4w) reported 44.1% of participants, compared to 21.9% in the monotherapy arm (Guselkumab 100 mg q4w Plus Placebo). A logistic regression analysis showed an Odds Ratio (OR) of 3.0 (90.0% CI: 1.3, 7.0) with a p-value of 0.034.
  • For Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24, the combination arm showed 28.8% of participants, while the monotherapy arm showed 21.9%. The Odds Ratio (OR) was 1.4 (90.0% CI: 0.6, 3.3) with a p-value of 0.557.
  • At Week 16, for Percentage of Participants Who Achieved Minimal Disease Activity (MDA), the combination arm reported 32.2% compared to 12.5% in the monotherapy arm. The Odds Ratio (OR) was 3.3 (90.0% CI: 1.2, 9.2) with a p-value of 0.056.
  • For Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 (among those with >=3% Body Surface Area (BSA) psoriatic involvement and an Investigator Global Assessment (IGA) score of >=2 (Mild) at Baseline), the combination arm achieved 54.5%, versus 38.5% for monotherapy. The Odds Ratio (OR) was 1.8 (90.0% CI: 0.4, 7.5) with a p-value of 0.488.
  • For Percentage of Participants Who Achieved PASI 100 Response at Week 24 (among the participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline), the combination arm showed 31.8%, compared to 30.8% for monotherapy. The Odds Ratio (OR) was 1.1 (90.0% CI: 0.3, 4.4) with a p-value of 0.904.
  • For Percentage of Participants With an IGA-psoriasis Response at Week 24 (among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline), the combination arm reported 54.5%, while the monotherapy arm reported 61.5%. The Odds Ratio (OR) was 0.6 (90.0% CI: 0.1, 2.2) with a p-value of 0.488.

What this means

The results from the PHASE2 study NCT05071664 suggest that the combination of guselkumab and golimumab may offer an improved clinical response compared to guselkumab monotherapy in participants with active psoriatic arthritis who have had an inadequate response to prior anti-TNF-alpha therapies. Specifically, the combination arm demonstrated a statistically significant improvement in ACR 50 response at Week 24, with 44.1% of participants achieving this endpoint compared to 21.9% in the monotherapy arm. While other measures like MDA at Week 16 also showed a numerically higher response in the combination arm, not all endpoints reached statistical significance or favored the combination. The IGA-psoriasis response at Week 24, for instance, was numerically higher in the monotherapy arm.

Source

This information was sourced from ClinicalTrials.gov, documenting the results of trial NCT05071664, which were posted on 2026-07-23. The study details are available on clinicaltrials.gov.