- Design
- Phase 2, randomised 2:1, double-blind, placebo-controlled, multicentre in China
- Population
- 33 patients with moderate to severe acute GPP flares
- Primary outcome
- GPPGA pustulation sub-score 0 or 1 at day 8
- Effect
- 86.4% vs 9.1%, difference 77.3% (95% CI 42.5-88.9)
This multicentre, double-blind phase 2 trial in China randomised 33 patients with moderate to severe acute generalised pustular psoriasis (GPP) flares 2:1 to one intravenous 1,050 mg dose of recibokibart or placebo. Non-responders could have open-label drug from day 8.
At day 8, 86.4% on recibokibart reached a GPPGA pustulation sub-score of 0 or 1 against 9.1% on placebo (difference 77.3%, 95% CI 42.5-88.9). Complete pustule clearance was 54.5% vs 0%, and GPPASI fell 59.3% vs 0%. Improvement was seen within 24 hours. The commonest adverse events were hypoproteinaemia, raised triglycerides and pruritus.
GPP flares are life-threatening and have had few targeted options. Recibokibart joins spesolimab as a second IL-36 receptor antibody with controlled evidence, supporting IL-36 blockade as the targeted approach to a flare.
It is a small phase 2 trial in one country, and it is not approved. For now it informs where the field is going rather than what to prescribe.
- Treat an acute GPP flare as a medical emergency: fluids, temperature, albumin, electrolytes and infection screen.
- Check lipids and protein in any patient receiving IL-36 blockade.
- Ask about IL36RN family history and triggers such as steroid withdrawal.
- Refer suitable patients to trials where IL-36 blockade is not accessible.
Why it matters
A second IL-36 receptor antibody with a large placebo-controlled effect strengthens the case that this pathway is the right target in GPP.
Don't overread it
Only 33 patients were randomised, and results after day 8 include open-label treatment, so durability is not shown.
The statistics, in plain English
The difference of 77 percentage points is very large, but with 33 patients the confidence interval spans 42 to 89 points. Even the lower bound is a big effect, so the benefit is unlikely to be chance, but its exact size is uncertain.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for dermatology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free