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Baricitinib versus Hydroxychloroquine for Cutaneous Lichen Planus: An Assessor-Blind Randomized Clinical Trial
Hossein Kargar1, Mohammad Ali Esfandiari1,2, Mehdi Ghahartars3
1Student Research Committee, Department 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, while baricitinib, a Janus kinase 1/2 inhibitor, has shown promise in refractory cases, but comparative evidence is lacking.
Objective:
This study aimed to compare the efficacy and safety of baricitinib versus hydroxychloroquine in patients with cutaneous lichen planus.
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, 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 14.2 to 1.1 with baricitinib and from 12.2 to 5.3 with hydroxychloroquine (P=0.029), indicating a greater reduction in disease activity for baricitinib. Pruritus VAS improved from 8.3 to 0.2 in the baricitinib group and from 8.8 to 3.3 with hydroxychloroquine (P<0.001). Patient satisfaction increased from 4.5 to 8.8 and from 4.6 to 6.9, respectively (P = 0.001). Global Physician Assessment improved in both groups, but the between-group difference was not statistically significant (P=0.376). No major or life-threatening adverse events were observed in both groups.
Conclusion:
In this assessor-blinded randomized trial, both baricitinib and hydroxychloroquine improved cutaneous lichen planus over 12 weeks. Baricitinib was associated with greater short-term improvementin 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 non-double-blind design warrant cautious interpretation. Larger double-blind studies with longer follow-up are needed.
