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About
Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.1
In adolescents, it is the first JAK3 inhibitor indicated for the treatment of severe alopecia areata.1
Example
Litfulo is contraindicated in pregnancy and breast-feeding. Litfulo is not recommended in women of childbearing potential not using contraception. Women of reproductive potential have to use effective contraception during treatment and for 1 month following the final dose of Litfulo. The effect of Litfulo on human fertility has not been evaluated.1
Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In adolescents, it is the first JAK3 inhibitor indicated for the treatment of severe alopecia areata.1
One Strength, One Capsule, Once Daily.1
The recommended dose is 50 mg once daily.1
The efficacy and safety of Litfulo was evaluated in a pivotal, randomised, double blind, placebo-controlled study in alopecia areata patients 12 years of age and older with ≥50% scalp hair loss. In the study group with Litfulo 50 mg (N=130) vs placebo (N=131), at Week 24, significantly more patients treated with Litfulo 50mg once daily achieved SALT score ≤10 (90% or more scalp hair coverage) vs placebo (estimated response rate 13.4% (n=17) vs 1.5% (n=2) respectively; treatment difference 11.9% [95% CI: 5.4–18.3]; p<0·0003) (primary outcome).1,15,16
Also at Week 24, significantly more patients treated with Litfulo 50mg once daily achieved SALT score ≤20 (80% or more scalp hair coverage) versus placebo (estimated response rate 23% (n=29) vs 1.6% (n=2) respectively; treatment difference 21.4% [95% CI: 13.4–29.5]; p<0.000001) (secondary outcome).1,15,17
Overall significance level (α) of 0.01.15
The efficacy and safety of Litfulo was evaluated in a pivotal, randomised, double blind, placebo-controlled study in alopecia areata patients 12 years of age and older with ≥50% scalp hair loss including alopecia totalis and alopecia universali. In the study group with Litfulo 50 mg (N=130) vs placebo (N=131), at Week 24, significantly more patients treated with Litfulo 50mg once daily achieved SALT score ≤10 (90% or more scalp hair coverage) vs placebo (estimated response rate 13.4% (n=17) vs 1.5% (n=2) respectively (primary outcome).
Treatment difference 11.9% [95% CI: 5.4–18.3]; p=0·0003).1,2,3
Also at Week 24, significantly more patients treated with Litfulo 50mg once daily achieved SALT score ≤20 (80% or more scalp hair coverage) versus placebo (estimated response rate 23% (n=29) vs 1.6% (n=2) respectively (secondary outcome)
Treatment difference 21.4% [95% CI: 13.4–29.5]; p<0.000001).1,2,4
| Data Limitations for Increased Scalp Hair Coverage: Multiple imputation methods were based on generalised linear mixed model for longitudinal binary data up to Week 24, with an assumption of missing at random for SALT scores missing at Week 24 due to COVID-19. Patients with SALT scores missing due to other reasons were included in the analysis as non-responders. A single complete imputed data set for Week 24 was analysed using the Miettinen and Nurminen method.2,3,4 |
“I don’t recognise myself in the mirror anymore. I feel self-conscious.”
LITFULO key resources including the Initiation Guide
Download Guide
Discover what alopecia areata is and understand its disease course
About alopecia areata
JAK3 and TEC familiy mediated signalling pathways are both involved in AA pathogenesis1
Discover the LITFULO MOA
COVID= coronavirus disease; CI= confidence interval; JAK= janus kinase; SALT= severity of alopecia tool. SALT scores range from 0 to 100 with 0 = no scalp hair loss and 100 = total scalp hair loss.
References:
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