Spondyloarthritis & psoriatic arthritis
Combination Therapy in Participants With Active Psoriatic Arthritis Using Subcutaneous Guselkumab and Golimumab: Week 24 Results From a Phase 2a, Multicenter, Randomized, Double‐Blind, Proof‐of‐Concept Study
Primary result · MDAResult — go to the resultOdds ratio 1.4 90% CI 0.6–3.3Authors' conclusion
Although the primary endpoint was not achieved, secondary endpoints and exploratory analyses suggest that participants with TNFi-IR PsA, particularly those with elevated CRP levels, could derive clinically meaningful benefits with guselkumab + golimumab combination therapy, with no new safety concerns, warranting further investigation.
Study context
- Population
- Adults with active psoriatic arthritis (PsA) (≥3 tender/swollen joints) and inadequate response to TNFi (TNFi-IR)
- Participants
- 59 vs 32
- Comparison
- Guselkumab 100 mg + golimumab 50 mg SC vs guselkumab monotherapy, every 4 weeks through week 20
- Guselkumab + golimumabn = 59
- Guselkumab monotherapyn = 32reference
- Primary endpoint
- Minimal disease activity (MDA) achievement
- Follow-up
- Week 24
Methodological detailsphase 2a, multicentre, double-blind, proof-of-concept, 2:1 randomisation
- Phase 2a
- Multicentre
- Double-blind
- Proof-of-concept
- 2:1 randomisation
Primary result
MDA
Odds ratio
1.4
90% CI 0.6–3.3
P = 0.557
By group
As reported in the abstract
Secondary outcomes
| Outcome | Guselkumab + golimumab | Guselkumab monotherapy | P value |
|---|---|---|---|
| ACR50 · week 24 | 44% | — not stated in the abstract | nominal P = 0.034 |
| ACR20 | — withheld: not confirmed against the abstract | 44% |
— not stated in the abstract
— withheld: the automatic checks could not confirm the value against the abstract
Physical function
- Greater physical function improvements with combination therapy than monotherapy
Psoriasis, dactylitis and enthesitis
- Improvements similar across groups
Safety
Tuberculosis/opportunistic infections · through week 36
- No new safety signals and no tuberculosis/opportunistic infections
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →