Guselkumab plus golimumab may benefit certain patients with TNFi-refractory PsA

In patients with psoriatic arthritis (PsA) inadequately controlled by a tumour necrosis factor inhibitor (TNFi), combination treatment with guselkumab plus golimumab appears to yield clinically meaningful benefits only in those with elevated C-reactive protein levels, as shown in a study.

The study included 91 adults with active PsA (three or more tender/swollen joints) and inadequate response to a TNFi. At baseline, the median number of tender and swollen joints was 13 and eight, respectively, and psoriatic body surface area was 3 percent. Dactylitis present in 23 percent of patients.

The patients were randomized assigned to receive treatment with guselkumab 100 mg plus golimumab 50 mg (combination group, n=59) or guselkumab monotherapy (monotherapy group, n=32). Treatment was administered subcutaneously every 4 weeks through week 20.

The primary endpoint was minimal disease activity (MDA) at week 24. Additional endpoints included ≥20-percent/50-percent/70-percent improvement in American College of Rheumatology response criteria (ACR20/50/70); changes in patient-reported physical function, and impact of screening C-reactive protein (CRP) on MDA/ACR50 response.

At week 24, the proportion of patients who achieved MDA was 29 percent in the combination group vs 22 percent in the monotherapy group. The primary endpoint was not achieved (odds ratio [OR], 1.4, 90 percent confidence interval, 0.6–3.3; p=0.557). ACR50 response rates were 44 percent in the combination group vs 22 percent in the monotherapy group (p=0.034).

Notably, in the subset of patients with CRP levels ≥0.3mg/dL had 12-fold greater odds of achieving MDA with combination therapy vs monotherapy (32 percent vs 5 percent; OR, 12.3; p=0.025), as well as ninefold greater odds of achieving ACR50 response (55 percent vs 14 percent; OR, 9.6; p=0.003) at week 24.

Compared with monotherapy, combination therapy was associated with higher rates of ACR20 (66 percent vs 44 percent) and ACR70 (27 percent vs 16 percent) responses and greater physical function improvements. Improvements in psoriasis, dactylitis, and enthesitis did not significantly differ between the two treatment groups.

There were no new safety signals and tuberculosis/opportunistic infections documented through week 36.