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HomeAboutAboutAlopecia AreataLITFULO MOASALT EvaluationEfficacyEfficacyStudy OverviewScalp Hair ResponseBefore & After ImagesSafetySafetyBOXED WARNING SummaryPooled Safety DataSpecific Adverse ReactionsAdditional ConsiderationsDosing & MonitoringDosing & MonitoringDosingScreening & MonitoringSupport for PatientsSupport for PatientsSavings & Support OptionsSpecialty Pharmacy NetworkDownloadable Copay Savings CardRequest a RepEventsMaterialsVideos
Full Prescribing Information, including BOXED WARNINGMedication GuideIndication Patient Site
ALLEGRO-2b/3 Study Overview

ALLEGRO-2b/3 Study Overview

Study Design

Baseline Characteristics

The efficacy and safety of LITFULO were evaluated in patients with severe alopecia areata as young as 121,2

The efficacy and safety of LITFULO were evaluated in patients with severe alopecia areata as young as 121,2

ALLEGRO-2b/3 was a pivotal Phase 2b/3, double-blind, placebo-controlled study in patients (N=718) with alopecia areata and 50% or more scalp hair loss, including alopecia totalis and alopecia universalis.

Patients were randomized to receive LITFULO for 48 weeks or placebo for 24 weeks. At Week 24, all patients received LITFULO and there was no placebo control.*

  • The primary endpoint was the proportion of patients with SALT score ≤20 at Week 242
  • Efficacy results include patients who received LITFULO 50 mg (the recommended daily dose) and placebo at Week 241
  • Safety was monitored throughout the study1
This study was a dose-ranging study. LITFULO doses included 30 mg and 50 mg with or without a 200 mg loading dose (once a day for 4 weeks). LITFULO 10 mg was included for pharmacokinetic, dose-response, and safety assessments only, and was not included in statistical comparisons vs placebo.1,2The sample size for this study accounted for multiplicity using a closed testing procedure to ensure strong control of Type I error for all comparisons between active treatment groups and placebo (except LITFULO 10 mg).2What is SALT?

The Severity of Alopecia Tool (SALT) helps visually assess the extent of scalp hair loss.3,4

The SALT score equals the sum of the proportions of scalp hair loss per quadrant3

The SALT score measures hair loss on a scale of 0 (no scalp hair loss) to 100 (complete scalp hair loss). For example, SALT 20 can be defined as 20% scalp hair loss and/or 80% scalp hair coverage1,3

Selected baseline characteristics2

Selected baseline characteristics2

Scroll left to view table
  LITFULO 50 mg
(n=130)
Placebo 
(n=131)
Age, n (%)    
— 12 to 17 years 18 (14) 19 (15)
— ≥18 years 112 (86) 112 (86)
Female, n (%) 71 (55) 86 (66)
Race, n (%)    
— White 79 (61) 94 (72)
— Asian 43 (33) 31 (24)
— Black or African American 5 (4) 4 (3)
Alopecia totalis/universalis,   n (%) 60 (46) 60 (46)
Mean SALT score 90.3 93
Median duration since diagnosis, years (SD) 8.7 (8.7) 11 (11.8)
Mean duration of current episode, years (SD) 3.2 (2.7) 3.2 (2.7)
Key Inclusion Criteria2
  • Male or female patients, 12 years of age or older
  • Clinical diagnosis of alopecia areata
  • 50% or more scalp hair loss, including alopecia totalis and alopecia universalis
  • No evidence of terminal hair regrowth within 6 months, assessed at both the screening and baseline visits
  • Current episode of scalp hair loss ≤10 years

Key Exclusion Criteria2

  • Other types of alopecia
  • Previous use of any Janus kinase (JAK) inhibitor
  • Clinically significant depression
  • Auditory conditions considered acute, fluctuating, or progressive
  • History of disseminated herpes zoster, disseminated herpes simplex, or recurrent localized, dermatomal herpes zoster
  • Patients aged 12 to 17 years without a documented history of varicella-zoster virus vaccination or presence of varicella-zoster virus IgG antibodies
IgG=immunoglobulin G; SD=standard deviation.
What is SALT?

The Severity of Alopecia Tool (SALT) helps visually assess the extent of scalp hair loss.3,4

The SALT score equals the sum of the proportions of scalp hair loss per quadrant3

The SALT score measures hair loss on a scale of 0 (no scalp hair loss) to 100 (complete scalp hair loss). For example, SALT 20 can be defined as 20% scalp hair loss and/or 80% scalp hair coverage1,3

See how LITFULO helped patients with severe alopecia areata1 Scalp Hair Response LoadingSALT=Severity of Alopecia Tool.References:

1. LITFULO. Prescribing Information. Pfizer; 2023. 2. King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2 3. Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines—part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004;51(3):440-447. doi:10.1016/j.jaad.2003.09.032 4. Olsen EA, Canfield D. SALT II: A new take on the severity of alopecia tool (SALT) for determining percentage scalp hair loss. J Am Acad Dermatol. 2016;75(6):1268-1270. doi:10.1016/j.jaad.2016.08.042
Efficacy See how LITFULO helped patients with severe alopecia areata1 Efficacy Loading Explore safety data​​​​​​​ Safety Loading

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PP-RIL-USA-0715
INDICATIONLITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Important Safety Information WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS

SERIOUS INFECTIONS
Patients treated with LITFULO are at increased risk of serious bacterial, fungal, viral and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB).
The most frequent serious infections reported with LITFULO have been appendicitis, COVID-19 infection (including pneumonia), and sepsis. Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO.

Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients:
• with chronic or recurrent infection
• who have been exposed to tuberculosis (TB)
• with a history of serious infection or an opportunistic infection
• who have resided or traveled in areas of endemic TB or mycoses, or
• with underlying conditions that may predispose them to infection

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LITFULO. Interrupt treatment if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with LITFULO should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored. LITFULO may be resumed once the infection is controlled.

Tuberculosis
LITFULO should not be given to patients with active TB. Screen patients for TB before starting and monitor during therapy. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk and consider screening patients at high risk for TB during treatment with LITFULO.

Viral Reactivation
Viral reactivation, including cases of herpes virus reactivation (eg, herpes zoster), was reported in clinical trials. If a patient develops herpes zoster, consider interrupting treatment until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with LITFULO. Patients with evidence of HIV infection or hepatitis B or C infection were excluded from clinical trials.

MORTALITY
In a large, randomized, postmarketing safety study of another Janus kinase (JAK) inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in RA patients treated with the JAK inhibitor compared with tumor necrosis factor (TNF) blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO. LITFULO is not approved for use in RA patients.

MALIGNANCIES AND LYMPHOPROLIFERATIVE DISORDERS
Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials of LITFULO.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
In this study, current or past smokers had an additional increased risk of overall malignancies.

The risks and benefits of ritlecitinib treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than successfully treated NMSC or cervical cancer.

Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of MACE (defined as cardiovascular death, non-fatal myocardial infarction [MI], and non-fatal stroke) was observed with the JAK inhibitor compared to those treated with TNF blockers.
Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue LITFULO in patients that have experienced an MI or stroke.

THROMBOEMBOLIC EVENTS
Thrombosis has occurred in patients treated with LITFULO.
An event of pulmonary embolism (PE) was reported in a patient receiving LITFULO. In a ritlecitinib higher dosing group, 1 patient reported an event of retinal artery occlusion.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, deep vein thrombosis, arterial thrombosis and PE were observed with the JAK inhibitor compared to those treated with TNF blockers.

Avoid LITFULO in patients who may be at increased risk of thrombosis. If symptoms of thrombosis or embolism occur, patients should interrupt LITFULO and be evaluated promptly and treated appropriately.

CONTRAINDICATION
LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.

HYPERSENSITIVITY
Serious reactions, including anaphylactic reactions, urticaria, and rash have been observed in patients receiving LITFULO in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue LITFULO and institute appropriate therapy.

LABORATORY ABNORMALITIES
Treatment with LITFULO was associated with decreases in lymphocytes and platelets. Prior to LITFULO initiation, perform absolute lymphocyte count (ALC) and platelet count. After initiating treatment with LITFULO, treatment interruption or discontinuation is recommended based on ALC and platelet count abnormalities.

Liver Enzyme Elevations: Treatment with LITFULO was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) and aspartate aminotransferase (AST) ≥5 times the upper limit of normal were observed in patients in LITFULO clinical trials. Evaluate at baseline and thereafter according to routine patient management. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO until this diagnosis is excluded.

Creatine Phosphokinase (CPK) Elevations: Treatment with LITFULO was associated with increased incidence of CPK elevation compared to placebo.

VACCINATIONS
No data are available on the response to vaccination in patients receiving LITFULO. Use of live attenuated vaccines should be avoided during or shortly prior to initiating treatment. Prior to initiating LITFULO, it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.

HEPATIC IMPAIRMENT
LITFULO is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS
Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis.

DRUG INTERACTIONS
LITFULO can increase plasma concentrations of CYP3A and CYP1A2 substrates. Consider additional monitoring and dose adjustment of CYP3A and CYP1A2 substrates where small concentration changes may lead to serious adverse reactions when used with LITFULO.

Coadministration with strong inducers of CYP3A is not recommended.

USE IN PREGNANCY
Available clinical trial data on LITFULO use in pregnant women are insufficient to identify a drug-associated risk from major birth defects, miscarriage or other adverse maternal or fetal outcomes. Advise pregnant females and females of reproductive potential to inform their healthcare providers if they are pregnant or intend to become pregnant during treatment with LITFULO.

If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940.

LACTATION
Advise women not to breastfeed during treatment with LITFULO and for 14 hours after the last dose.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
IndicationLITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.