ARGO phase II: Sonelokimab for psoriatic arthritis

Results from the phase II ARGO trial (NCT05640245) investigating sonelokimab, a dual inhibitor of interleukin (IL)-17A and IL-17F, in patients with active psoriatic arthritis (PsA) were recently published by McInnes et al. in Nature Medicine. Overall, 207 patients were randomized to receive sonelokimab 120 mg (n = 43) or 60 mg (n = 41) every 4 weeks (Q4W) with induction (WI), or to receive 60 mg Q4W with no induction (n = 41), placebo (n = 40), or adalimumab (reference arm; n = 42). The primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 50 response at Week 12.

Key data: At Week 12, a higher proportion of patients in the sonelokimab 60 mg (46.3%; p < 0.05) and 120 mg WI (46.5%; p < 0.01) groups achieved ACR50 vs those in the placebo group (20.0%). ACR20 was achieved by 78.0% (60 mg WI, p < 0.001) and 72.1% (120 mg WI, p = 0.002) vs placebo (37.5%). Psoriasis Area and Severity Index (PASI) 90 was achieved by 76.9% (60 mg WI, p < 0.001) and 59.3% (120 mg WI, p = 0.003) vs placebo (15.4%) at Week 12. The most common treatment-emergent adverse events (TEAEs) through Week 24 were nasopharyngitis (6.1% and 5.2%), upper respiratory tract infection (6.1% and 4.1%), injection-site erythema (3.7% and 3.1%), and headache (2.4% and 4.1%) in the sonelokimab 60 mg- and 120 mg-exposed groups, respectively. 

Key learning: Sonelokimab demonstrated substantial improvements across multiple domains in patients with active PsA. Further trials are required to establish the potential of sonelokimab as a treatment option for PsA.