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Baricitinib vs. hydroxychloroquine for cutaneous lichen planus: an assessor-blind randomized controlled trial
Hossein Kargar1, Mohammad Ali Esfandiari1, Mehdi Ghahartars1,2
1Department of Dermatology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Background:
Lichen planus (LP) is a chronic autoimmune inflammatory disorder with limited effective long-term treatment options. Hydroxychloroquine has been widely used as systemic therapy, and although baricitinib, a Janus kinase 1/2 inhibitor, has shown promise in patients with refractory cases, comparative evidence is lacking.
Objectives:
This study aimed to compare the efficacy and safety of baricitinib vs. hydroxychloroquine in patients with cutaneous LP.
Methods:
In this randomized controlled trial, 32 patients with cutaneous LP were randomized to baricitinib 4 mg once daily or hydroxychloroquine 200 mg twice daily for 12 weeks. The primary outcome was the change in Lichen Planus Activity and Damage Index (LiPADI). Secondary outcomes included pruritus severity, patient satisfaction (each assessed using a 0-10 visual analogue scale) and Physician Global Assessment (PGA).
Results:
Both groups showed significant improvement in pruritus severity and LiPADI scores (P < 0.001). Mean LiPADI scores decreased from 14.20 (SD 3.44) to 1.07 (SD 0.99) with baricitinib and from 12.18 (SD 3.28) to 5.27 (SD 2.28) with hydroxychloroquine (P = 0.03), indicating a greater reduction in disease activity with baricitinib. The pruritus visual analogue scale improved from 8.33 (SD 1.67) to 0.21 (SD 0.80) in the baricitinib group and from 8.81 (SD 1.66) to 3.27 (SD 1.01) in the hydroxychloroquine group (P < 0.001). Patient satisfaction increased from 4.46 (SD 0.83) to 8.78 (SD 1.12) and from 4.63 (SD 0.50) to 6.90 (SD 0.94), respectively (P = 0.001). PGA improved in both groups, but the between-group difference was not statistically significant (P = 0.38). No major or life-threatening adverse events were observed in both groups.
Conclusions:
In this assessor-blinded randomized trial, both baricitinib and hydroxychloroquine improved cutaneous LP over 12 weeks. Baricitinib was associated with greater short-term improvement in disease activity and pruritus, along with higher patient satisfaction, without evidence of additional short-term safety concerns. The small sample size, short follow-up and nondouble-blind design warrant cautious interpretation. Large double-blind studies with longer follow-up are needed.
