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AboutAlopecia AreataBurden of Alopecia AreataMOAEfficacySafety ProfileOverviewSALT score ≤10SALT score ≤20PGI-CEyebrow and Eyelash ResponsesBefore and After Patient ImagesSafety ProfileSafety ProfileContraindications, Special Warnings and PrecautionsAdverse ReactionsPatient ProfilesGetting Started
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Click here for ▼LITFULO (ritlecitinib) Prescribing Information

Overview

SALT score ≤10

Eyebrow and Eyelash Responses

Before and After Patient images

PRIMARY OUTCOME: Proportion of patients who achieved SALT score ≤10 at week 24 vs placebo1,2

With Litfulo (ritlecitnib), significantly more patients achieved SALT score ≤10 versus placebo at Week 241,2,4

At Week 24, significantly more patients treated with Litfulo 50mg once a day achieved response based on SALT score ≤10 vs placebo;
estimated response rate 13.4% (n=17) vs 1.5% (n=2) respectively (difference between groups was 11.9% [95% CI: 5.4–18.3]; p=0.0003).1,2,4
 Adapted from Litfulo Summary of Product Characteristics1, King B, et al. Lancet. 2023. 401(10387):1518–1529 and Data on File.3,4

Placebo (N=131); Placebo groups from the study were combined for analysis. n=participants with SALT score ≤10 response (before imputation); N=N1+N2+N3, N=total number of participants in the full analysis set categorised under:
N1= participants with non-missing SALT score; N2= participants with missing SALT score due to COVID-19 assumed to be MAR; N3= participants with missing SALT score due to reasons unrelated to COVID-19 considered as non-responders.

Data limitations:

Multiple imputation methods were based on generalised linear mixed model for longitudinal binary data up to Week 24, with an assumption of MAR 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 method2

SECONDARY OUTCOME: Proportion of patients with SALT score ≤10 to week 482,6

Extension period: Increased scalp hair response (SALT score ≤10) was observed to Week 48 (not placebo-controlled)1,5,6

Up to Week 48 of the extension period, an increase in the proportion of patients on Litfulo 50mg once a day with SALT score ≤10 response was observed (31.2% [39/125]; 95% CI: 23.08-39.32, not placebo-controlled period.2,5,6At Week 24, significantly more patients treated with Litfulo 50mg once a day achieved response based on SALT score ≤10 vs placebo;
estimated response rate 13.4% (n=17) vs 1.5% (n=2) respectively (difference between groups was 11.9% [95% CI: 5.4–18.3]; p=0.0003).1,2,4
N: Number of participants in the full analysis set population. n/N1(%): Number of participants with SALT score ≤10 (percentage based on N1) / Number of participants with valid data at the analysis visit (Non-response for missing due to reasons unrelated to COVID-19; excludes missing due to COVID-19).5

Data limitations:

Cases with missing data at that timepoint due to COVID-related reasons are excluded from n and N1. Cases with missing data at that timepoint due to reasons unrelated to COVID-19 are considered as non-response5

SALT score ≤10 = Severity of Alopecia Tool score of ≤10 (90% or more scalp hair coverage).
SALT scores range from 0 to 100 with 0 = no scalp hair loss and 100 = total scalp hair loss.1
*CI is calculated based on normal approximation.

CI=confidence interval; COVID=coronavirus disease; MAR=missing at random; SALT=Severity of Alopecia ToolSALT Evaluation >>LoadingSALT Example >>     Loading
SALT Score <20
References

1. Litfulo (ritlecitinib) Summary of Product Characteristics
2. King B, Zhang X, Harcha WG, et al. Lancet. 2023 May 6;401(10387):1518–1529 
3. Pfizer Ltd. Data on File: REF-LGF0060. Litfulo (ritlecitinib) scalp hair response based on SALT score ≤10 before Week 24 
4. Pfizer Ltd. Data on File: REF-LGF0155. Litfulo (ritlecitinib) scalp hair response based on SALT score ≤10 at Week 24
5. Pfizer Ltd. Data on File: REF-LGF0040. Litfulo (ritlecitinib) scalp hair response based on SALT score ≤10 at Week 48 
6. King B, Zhang X, Harcha WG, et al. Lancet. 2023. May 6;401(10387):1518-1529, supplementary appendix
 
PP-LGF-GBR-0311. July 2025

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