Guselkumab, an IL-23 Inhibitor, Effective in Psoriatic Arthritis Save
The DISCOVER‐2 trial has shown that guselkumab, an interleukin‐23p19 was shown to be safe and effective in biologic‐naïve psoriatic arthritis (PsA) patients in a one year study.
This was a phase III trial that enrolled biologic‐naïve PsA patients with active disease (≥5 swollen+≥5 tender joints; CRP ≥0.6mg/dL) despite prior ineffective DMARD treatment. Patients were randomized to receive either subcutaneous injections of guselkumab (GUS) 100mg every‐4‐weeks (Q4W); guselkumab 100mg at Week0, Week4, Q8W; or placebo with crossover to guselkumab 100mg Q4W at Week24.
A total of 739 patients were randomized, and 93% completed through Week52. ACR20 response rates at week 24 were:
- GUS q4 wk - 64%
- GUS q8 wk - 64%
- Placebo - 33% (both p<0.0001)
After week 24, placebo patients were crossed over to GUS 100 mg q4wk and ACR20 responses were maintained out to week 52 (71% and 75%, respectively).
Similarly, other secondary endpoint outcomes were significantly improved in GUS treated patients (ACR50/ACR70 and skin responses, minimal or very low disease activity) through Week 52.
Week 52 resolution of dactylitis was seen in 75% of GUS treated patients and 58% had resolution of enthesitis.
There were no deaths or opportunistic infections in the trial. Serious infections occured in 1.2% of GUS treated patients (SIE 1.49/100 PY).
Guselkumab was effective in PsA patients with improvements in multiple domains over a 52 week study.