- Design
- Open-label, assessor-blinded single-arm feasibility study with historic placebo control
- Population
- 20 adults with moderate-to-severe palmoplantar pustulosis, UK
- Primary outcome
- Feasibility (recruitment, adherence, acceptability); PP-PASI change at week 8
- Effect
- PP-PASI −12.3 (95% CI −15.8 to −8.9) vs historic placebo; PP-PASI75 65% vs 3.2%
A UK specialist centre treated 20 adults with moderate-to-severe palmoplantar pustulosis with upadacitinib 30 mg daily (15 mg for higher-risk patients) for eight weeks. The study was designed to test whether a definitive trial is feasible, and its procedures matched an earlier randomised trial so results could be set against that trial's placebo arm.
All feasibility targets were met: 95% adherence and 95% acceptability. PP-PASI fell from 20.3 to 4.6, against 18.0 to 15.4 with historic placebo — an adjusted difference of −12.3 points (95% CI −15.8 to −8.9). All patients reached PP-PASI50 and 65% PP-PASI75. Headache, acne and upper respiratory infections were the common adverse events.
The comparison is with historic controls, not concurrent randomisation, so the effect size is exploratory. Palmoplantar pustulosis has few effective options, which makes this worth watching; the group now plans a multicentre active-comparator trial.
- Treat upadacitinib for palmoplantar pustulosis as off-label and supported only by early data.
- Ask about and address smoking, which is closely linked to palmoplantar pustulosis.
- Screen for infection, thrombosis and cardiovascular risk before any JAK inhibitor.
- Warn patients that acne is a common side effect.
Why it matters
It is a rare signal of substantial benefit in a disease where most treatments disappoint.
Don't overread it
Comparison with historic placebo cannot give a reliable effect size.
The statistics, in plain English
Historic controls come from a different group of patients treated at a different time, so differences in expectation and care can inflate the apparent effect. The tight confidence interval reflects the model, not freedom from that bias.
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