Brepocitinib doses hold promise in treatment of psoriatic arthritis
Treatment with brepocitinib at 30 and 60 mg daily outperforms placebo at relieving signs and symptoms of psoriatic arthritis (PsA), with a safety profile consistent with that seen in other brepocitinib trials, according to data from a phase IIb study.
A total of 218 participants (mean age 47.6 years, 46.8 percent men) with PsA were randomly assigned to receive 10 mg once daily (QD), 30 mg QD, 60 mg QD, or placebo for 16 weeks. At week 16, participants in the brepocitinib 30 mg and 60 mg groups maintained the same dosage, whereas those in the brepocitinib 10 mg and placebo groups were given either brepocitinib 30 mg or 60 mg QD.
The primary endpoint was American College of Rheumatology (ACR)20 response rate at week 16. Secondary endpoints were response rates of ACR50/70, 75-percent and 90-percent improvement in Psoriasis Area and Severity Index (PASI75/90), and Minimal Disease Activity (MDA) at weeks 16 and 52. Adverse events (AEs) were monitored throughout the study.
ACR20 response rates at week 16 were significantly greater in the brepocitinib 30 and 60 mg QD groups than in the placebo groups (66.7 percent and 74.6 percent, respectively, vs 43.3 percent; p=0.0197 and p=0.0006, respectively).
Likewise, the brepocitinib 30 and 60 mg QD groups had significantly higher ACR50/70, PASI75/90, and MDA response rates compared with the placebo group. Response rates either improved or remained stable through week 52.
In terms of safety, AEs were mostly mild to moderate in severity. Serious AEs were documented in 12 (5.5 percent) participants, including infections in six (2.8 percent) in the brepocitinib 30 and 60 mg QD groups. None of the participants experienced major adverse cardiovascular events or died.