Efficacy and safety of ruxolitinib cream combined with narrow-band UVB phototherapy for treatment of vitiligo

Abstract

Ruxolitinib cream and narrow-band UVB (NB-UVB) phototherapy independently promote repigmentation in patients with vitiligo. This exploratory phase 2 study evaluated the efficacy and safety of adding NB-UVB to ruxolitinib cream therapy. Patients (aged ≥12 years) with nonsegmental vitiligo and depigmented areas ≤10% total body surface area applied 1.5% ruxolitinib cream monotherapy twice daily to depigmented areas. At week 12, patients achieving <25% improvement from baseline in total Vitiligo Area Scoring Index (T-VASI) (denoted as <T-VASI25) were eligible to add NB-UVB through week 48; patients achieving T-VASI25 or unable to initiate NB-UVB continued ruxolitinib cream monotherapy. Primary endpoint was T-VASI change from baseline at week 48; secondary endpoints included additional efficacy, pharmacokinetic, and safety assessments. This study enrolled 55 patients. At week 12, 35 of 55 (63.6%) patients had <T-VASI25 and added NB-UVB; mean percentage change from baseline in T-VASI improved from -7.9% at week 12 (n = 35) to -50.4% at week 48 (n = 26). T-VASI50 and T-VASI75 increased from 0% at week 12 to 57.7% (15 of 26) and 19.2% (5 of 26), respectively, at week 48. Ruxolitinib cream was well tolerated with or without NB-UVB. Patients with <T-VASI25 at week 12 experienced meaningful improvements in repigmentation with NB-UVB plus ruxolitinib cream combination therapy through week 48, with no new safety concerns.

Keywords: Combination therapy; JAK inhibitor; NB-UVB; Repigmentation; Safety.