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Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older¹

Study design

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 universalis.^1,2 The study treatment period consisted of a placebo‑controlled 24‑week period and a 24‑week extension period (not placebo-controlled)^.1,2The study included 130 patients in the Litfulo 50mg group and 131 patients in the placebo group.¹

Primary outcome:¹

Proportion of patients who achieved a SALT (Severity of Alopecia Tool) score of ≤10 (90% or more scalp hair coverage) at Week 24 versus placebo

Key secondary outcome:¹

Patient’s Global Impression of Change (PGI-C) response at Week 24 versus placebo

Secondary outcomes:¹

SALT score ≤20 at Week 24 versus placebo
Improvements in regrowth of eyebrows at Week 24 versus placebo
Improvements in regrowth of eyelashes at Week 24 versus placebo

Primary outcome: Proportion of patients with SALT score ≤10 (90% or more scalp hair coverage) at Week 24 vs placebo¹
Key secondary outcome: Proportion of PGI-C responders with a score of "moderately improved" or "greatly improved" at Week 24 vs placebo^1,2
Secondary outcomes: Proportion of patients with SALT score ≤20 (80% or more scalp hair coverage) at Week 24 vs placebo; proportion of patients with eyebrow response at Week 24 vs placebo; proportion of patients with eyelash response at Week 24 vs placebo¹

Key Inclusion/Exclusion Criteria

Key inclusion criteria³

Male or Female, aged ≥12 years
- <18 years if permitted by the sponsor, local competent authority and IRB/IEC
- Within EU VHP countries: aged 18–74 years (inclusive)
- ~40% had AT/AU and ~15% were adolescents
Meet reproductive criteria, including relevant contraceptive methods (women of childbearing potential)
- Non-pregnant or breastfeeding females
Meet the following AA criteria:
- Clinical diagnosis of AA with no other aetiology of hair loss.
- ≥50% hair loss of the scalp, including AT and AU, without evidence of terminal hair regrowth within 6 months at both Screening and BL visits
- Current episode of hair loss ≤10 years

Key exclusion criteria³

Other types of alopecia, scalp disease, active systemic disease that could impact AA assessment
Any psychiatric condition, including recent or active suicidal ideation or behaviour that meets any of the listed protocol criteria (including clinically significant depression indicated as a PHQ-8 total score ≥15)
Auditory conditions considered acute, fluctuating, or progressive
Known immunodeficiency disorder, including positive serology for HIV at Screening or first-degree relative with hereditary immunodeficiency
Present/past malignancies, except for adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
Past/present lymphoproliferative disorder, lymphoma, leukaemia
History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or recurrent (more than one episode of) localised, dermatomal herpes zoster
Current/recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic, or neurologic disease
Age 12 to <18 y without a documented history of VZV vaccination or presence of VZV IgG Ab
History of systemic infection, active acute or chronic infection, or infection with HBV or HCV
Received any of the treatment regimens in the specified time frames
- At any time: previous use of any JAK inhibitor in any disease indication or any non-B-cell selective lymphocyte-depleting agent (eg, alefacept, alemtuzumab)*
- Within 6 months of first dose of study drug or five half-lives (if known), or until lymphocyte count returns to normal, whichever is longer: any B-cell-depleting agents, including but not limited to rituximab
- Within 12 weeks of first dose of study drug or five half-lives (if known), whichever is longer: other immunomodulatory biologic agents
- Within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer: other systemic treatments that could affect AA

*Four participants had JAK inhibitors listed as prior pharmacologic treatments for AA that was not deemed to meet ineligibility criteria due to topical, short, and inconsistent duration of application.
AA, alopecia areata; Ab, antibody; AT, areata totalis; AU, areata universalis; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IgG, immunoglobulin G; AK, Janus kinase; PHQ-8, Patient Health Questionnaire – 8 items; TB, tuberculosis; VZV, varicella-zoster virus; EU VHP, European Union Voluntary Harmonisation Procedure.

Baseline patient characteristics²

	LITFULO 50mg once a day (N=130)	Placebo (N=131) (placebo groups from the study were combned for the analysis)
Age, n (%)
12 - 17 years	18 (14)	19 (15)
>18 years	112 (86)	112 (86)
Female, n (%)	71 (55)	86 (66)
Male, n (%)	59 (45)	45 (43)
Race, n (%)
White	79 (61)	94 (72)
Black or African American	5 (4)	4 (3)
Asian	43 (33)	31 (24)
Other	1 (1)	2 (2)
Not specified	2 (2)	0
AT or AU, n (%) (SALT score of 100% at baseline)	60 (46)	60 (46)
Baseline SALT score, n (%)
50 to <75	27 (21)	14 (11)
75 to <100	43 (33)	57 (44)
100	60 (46)	60 (46)
All patients, mean (SD)	90.3 (14.7)	93.0 (11.5)
Patients without normal eyebrow assessment score, n (%)	106 (82)	107 (82)
Patients without normal eyelash assessment score, n (%)	95 (73)	97 (74)
Mean duration of AA since diagnosis, years (SD) diagnosis, years (SD)	8.7 (8.7)	11.0 (11.8)
Mean duration of current AA episode, years (SD)	3.2 (2.7)	3.2 (2.7)

AA=alopecia areata; AT=alopecia totalis; AU=alopecia universalis; SALT=Severity of Alopecia Tool; SD=standard deviation.

Key efficacy outcomes¹

Primary outcome	Proportion of patients with SALT score ≤10 (90% or more scalp hair coverage) at Week 24 versus placebo
Key secondary outcome	Proportion of PGI-C responders with a score of “moderately improved” or “greatly improved” at Week 24 versus placebo
Secondary outcomes	Proportion of patients with SALT score ≤20 (80% or more scalp hair coverage) at Week 24 versus placebo Proportion of patients with eyebrow response at Week 24 versus placebo Proportion of patients with eyelash response at Week 24 versus placebo

EBA=Eyebrow assessment; ELA=eyelash assessment; PGI-C=Patient’s Global Impression of Change;
SALT=Severity of Alopecia Tool

SALT Evaluation: For determining scalp surface area

The Severity of Alopecia Tool (SALT) helps visually assess the extent of scalp hair loss associated with alopecia areata^4,5

To calculate SALT score, the scalp is divided into 4 quadrants (top, left side, right side, and back) to represent 100% of the scalp⁴

The total scalp area delineated by each of the 4 quadrants (top, left side, right side, and back) are 40%, 18%, 18% and 24% respectively⁴

Salt score is determined by visually determining the amount of terminal hair loss in each of the four views of the scalp and adding these together with a maximum score of 100%

SALT scores range from 0 (no scalp hair loss) to 100 (total scalp hair loss).¹ For example, a patient with a SALT score of 10 has 10% scalp hair loss or 90% scalp hair coverage.^1,2,4

Example

Illustration developed by Pfizer Ltd based on SALT score definitions in Olsen EA, et al. J Am Acad Dermatol. 2004;51(3):440–447, King B, et al. Lancet. 2023 May 6;401(10387):1518– 1529 and Litfulo Summary of Product Characteristics.^1,2,4

SALT Evaluation Example

Visually assess and estimate the percentage scalp hair loss in each of the 4 quadrants
Multiply the (visual estimated percent scalp hair loss) by the (relative percent surface areas of that scalp area quadrant)
Sum up the total scores from each of the 4 quadrants to get the overall SALT score

Example SALT score calculation using hypothetical patient data.

PGI-C Evaluation²

The Patient’s Global Impression of Change (PGI-C) is a self-administered questionnaire that asks patients to evaluate their alopecia areata since the start of the study.

PGI-C questionnaire³

Eyebrow assesment (EBA) response defined as

Adapted from King B, Zhang X, Harcha WG, et al. Lancet. 2023 May 6;401(10387):1518–1529, supplementary appendix

PGI-C=Patient’s Global Impression of Change

Eyebrow Assessment (EBA) and Eyelash Assessment (ELA) Scale³

Eyebrow evaluation¹
Eyebrow assessment (EBA) response defined as ≥2-grade improvement from baseline or normal EBA score on a 4-point scale of 0 (none eyebrow), 1 (minimal eyebrow), 2 (moderate eyebrow), 3 (normal eyebrow) in patients with abnormal eyebrows at baseline.¹

Eyelash evaluation¹
Eyelash assessment (ELA) response defined as a ≥2-grade improvement from baseline or normal ELA score on a 4-point scales of 0 (none eyelash), 1 (minimal eyelash), 2 (moderate eyelash), 3 (normal eyelash) in patients with abnormal eyelash at baseline.¹

Adapted from King B, Zhang X, Harcha WG, et al. Lancet. 2023 May 6;401(10387):1518–1529, supplementary appendix

SALT score ≤10

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. King B, Zhang X, Harcha WG, et al. Lancet. 2023 May 6;401(10387):1518–1529, supplementary appendix
4. Olsen EA, et al. J Am Acad Dermatol. 2004;51(3):440–447;
5. Olsen EA, Canfield D. J Am Acad Dermatol. 2016;75(6):1268–1270.

PP-LGF-GBR-0262. June 2025

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Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older1

Study design

Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older¹