Ruxolitinib cream cleared or almost cleared half of patients with cutaneous lichen planus

Design

Phase 2, randomised, double-blind, vehicle-controlled, 16 weeks plus open-label extension

Population

64 adults with cutaneous lichen planus, BSA 20% or less

Primary outcome

IGA 0 or 1 with at least 2-grade improvement at week 16

Effect

50.0% vs 21.9%; difference 29.4 pp (95% CI 7.6 to 51.3)

This phase 2, double-blind trial at 19 North American sites randomised 64 adults with predominantly cutaneous lichen planus (moderate or severe, itch score 4 or more, up to 20% body surface area) to ruxolitinib 1.5% cream or vehicle twice daily for 16 weeks, followed by 16 weeks of open-label use. About a quarter of participants were Black.

At 16 weeks, 50.0% on ruxolitinib reached clear or almost clear skin with at least a two-grade improvement, against 21.9% on vehicle (difference 29.4 percentage points, 95% CI 7.6 to 51.3). Itch fell by 4 or more points in 48.4% versus 16.1%. Responses continued to improve to week 32. There were no serious treatment-related adverse events or discontinuations.

Lichen planus has had few trial-tested topical options beyond potent corticosteroids. A steroid-sparing cream with this effect size would matter for chronic, itchy disease, particularly on thin skin. But this is a small phase 2 trial with a wide confidence interval, and ruxolitinib cream is not licensed for lichen planus.

• Potent topical corticosteroids remain first-line for cutaneous lichen planus
• Ruxolitinib cream is an evidence-supported off-label option where steroids fail or cause atrophy
• Limit use to localised disease; the trial capped body surface area at 20%
• Expect results over weeks; improvement continued beyond 16 weeks
• Its licensed status and availability in India are not established; check before prescribing

Why it matters

Lichen planus finally has randomised evidence for a steroid-sparing topical.

Don't overread it

This is a 64-patient phase 2 trial; the true benefit could be as small as 8 percentage points.

The statistics, in plain English

The difference of 29.4 points has a wide interval (7.6 to 51.3) because the trial was small. The benefit is real but its size is uncertain.

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