Brepocitinib in Active Psoriatic Arthritis Save
Brepocitinib is a novel tyrosine kinase 2/Janus kinase 1 inhibitor and has been studied in patients with moderately-to-severely active psoriatic arthritis (PsA), showing impressive efficacy at both 16 weeks and 52 weeks.
Brepocitinib is an oral, selective Tyk2/JAK1 inhibitor with both immunomodulatory and anti-inflammatory activities and is being studied in dermatomyositis, SLE and PsA.
This is a 52 week, placebo-controlled, dose-ranging, phase IIb study where active PsA patients were randomized to receive either brepocitinib 10 mg once daily (QD), 30 mg QD, 60 mg QD, or placebo (advancing to brepocitinib 30 or 60 mg QD at week 16). The primary endpoint was the ACR20 response at week 16.
A total of 218 patients were enrolled and treated. The week 16 ACR 20 responses favored brepocitinib 30 mg (67%) and brepocitinib 60 mg (75%) over placebo ( 43%; P = 0.0006]. Similarly, brepocitinib showed significantly higher ACR50, ACR70, PASI75, PASI90, PASDAS and MDA response rates. These clinical response rates were sustained through week 52.
Most adverse events (AEs) were mild/moderate. Serious AEs (15) were seen in 12 (5.5%) patients. Four patients developed serious infections, H. Zoster or malignancy on brepocitinib 30 or 60 mg QD. No major adverse cardiovascular events or deaths occurred.
Brepocitinib appears to be effective and safe in patients with active PsA. Further phase III trials are needed to confirm these findings.