RxCe - Ritlecitinib for Severe Alopecia Areata Materials

RITLECITINIB AS A TREATMENT OPTION FOR SEVERE ALOPECIA AREATA

STEVEN MALEN, PharmD, MBA

Dr. Steven Malen graduated with a dual degree: Doctor of Pharmacy (PharmD) and Master of Business Administration (MBA) from the University of Rhode Island. Over his career, he has worked as a clinical pharmacist in the retail, specialty, and compounding sectors. He specialized and taught on topics from vaccines to veterinary compounding. Dr. Malen has also written a science fiction novel and taught and co- founded the concept of Patient Empowered Blockchain (P.E.B.). Currently, Dr. Malen continues to write, teach, and consult various companies in the healthcare sector.

Topic Overview

Alopecia areata (AA) is a dermatological disease. It is characterized by non- scarring hair loss of the scalp and/or body, with an unpredictable and variable course. Its etiology is not entirely known, although some evidence suggests that environmental, immunological, and genetic factors could be generating the disease. Ritlecitinib is a new, FDA-approved medication for the treatment of severe AA in adults and adolescents aged 12 and older. This course reviews ritlecitinib's mechanism of action, prescribing guidelines, and its potential to restore a patient’s hair and confidence.

Accreditation Statement

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is

Pharmacist 0669-0000-24-005-H01-P

Pharmacy Technician 0669-0000-24-006-H01-T

Credits: 1 contact hour (0.1 CEU) of continuing education credit

Type of Activity: Knowledge

Media: Internet/Home study Fee Information: $4.99

Estimated time to complete activity: 1 contact hour (0.1 CEU), including Course Test and course evaluation

Release Date: January 24, 2024 Expiration Date: January 24, 2027

Target Audience: This educational activity is for pharmacists and pharmacy technicians

How to Earn Credit: From January 24, 2024, through January 24, 2027, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “Educational Activity;” and

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be uploaded to CPE Monitor®.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Recognize the signs and characteristics of alopecia areata

Identify adverse effects associated with ritlecitinib use

Identify special populations who require a cautious approach when prescribing ritlecitinib

Review recommended dosing and monitoring guidelines for ritlecitinib

Disclosures

The following individuals were involved in developing this activity: Steven Malen, PharmD, MBA, and Pamela Sardo, PharmD, BS. Pamela Sardo was an employee of Rhythm Pharmaceuticals until March 2022 and has no conflicts of interest or relationships regarding the subject matter discussed. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.

Educational Activity

Ritlecitinib as a Treatment Option for Severe Alopecia Areata Introduction

Alopecia areata is an autoimmune condition that is characterized by limited, moderate, or severe hair loss in patients. No treatment for patients as young as 12 with moderate to severe alopecia areata had been approved by the Food and Drug Administration prior to its approval of ritlecitinib to treat severe alopecia areata. This course will briefly discuss alopecia areata and its epidemiology, definition, prevalence, and risk factors. In addition, ritlecitinib will be reviewed as an option to treat patients with severe alopecia areata, and counseling and coping tips will be mentioned. This discussion will include a review of the role of pharmacists and pharmacy technicians within an interdisciplinary approach to treating severe alopecia areata.

Etiology of Alopecia Areata

Alopecia areata (AA) is an autoimmune disease that appears as a single patch or multiple patches of recurrent hair loss.1,2 This disease does not leave scarring, and there are no signs of clinical inflammation or other systemic symptom.1 Alopecia areata most often causes hair loss on the scalp; however, it can impact other parts of the body as well.1,2

People afflicted with AA are generally healthy and do not exhibit other symptoms.2 Hair loss in AA usually starts abruptly and appears as a round or oval patch on the scalp. It can lead to hair loss on any part of the body, e.g., men may have hair loss in their beards, or a patient may lose eyebrows or eyelashes.2 These patches often feature short, broken hairs resembling "exclamation point" hairs, which are narrower at their base than their tip.2 Notably, there is usually no evidence of rash, redness, or scarring on the bare patches. Some individuals report sensations like tingling, burning, or itching in affected areas just before hair loss occurs.2 While AA primarily leads to hair loss, in some cases, it can cause nails to change.2 These changes appear as ridges or pits and are more commonly seen in patients with greater hair loss.2

Alopecia areata manifests in the following three main types:2

Patchy Alopecia Areata: This is the most prevalent type, characterized by hair loss in one or more small, coin-sized patches on the scalp or other body area.

Alopecia Totalis: Individuals with this type of AA experience complete or near-complete hair loss on their scalp.

Alopecia Universalis: Although rare, this type of AA entails total or near- total hair loss on the scalp, face, and entire body.

Predicting the course of AA can be challenging when a bare patch develops. Several outcomes are possible:2

Hair may regrow within a few months, initially appearing white or gray but gradually regaining its natural color over time.

Additional bare patches may emerge, sometimes with concurrent regrowth in the initial patch.

Small patches may merge to form larger ones, and in rare cases, complete scalp hair loss or alopecia totalis may occur.

In exceedingly rare instances, the condition may progress to "alopecia universalis," resulting in the complete loss of body hair.

In most instances, hair does tend to regrow on its own, particularly in people with less extensive hair loss, a later onset of the condition, no nail changes, or no family history of AA. Nail changes, such as ridges and pits, can occur in some individuals, particularly those with more extensive hair loss.

Prevalence of Alopecia Areata

The prevalence of AA is not well known because epidemiological data on this condition is lacking, and much of the data is outdated.3,4 Older studies, with limited data, estimated the lifetime incidence risk of AA in the US at 1.7% and 2.1%.4 The percentage of patients who progressed to alopecia totalis or

alopecia universalis was reported at 4.5% to 36.1% in studies from 1969 through 2006. These older studies also found that the incidence of AA was the same in males and females and across all ages, racial and ethnic groups.2,4,5

Consistent with the older studies, current studies confirm the lifetime risk of AA in the US to be about 2%, with higher estimates sometimes reported in other parts of the world.3,4,6 Newer studies, however, have departed from the older studies on certain points: they report gender, race/ethnicity, and age variations in the prevalence of AA.4 For example, Mostaghimi, Gao, Ray, et al. (2023) reported a higher prevalence and incidence of AA, alopecia totalis, and alopecia universalis in female versus male patients, in adults versus children and adolescents, and in the Northeast region of the US compared to other parts of the country.4 In young people, AA’s prevalence seems to increase between the ages of 12-17 and peaks during the years 18- 44, and some studies report a higher incidence of AA in Asian and Hispanic children.4 They also reported that about 7.5% to 9.2% of AA patients develop alopecia totalis or alopecia universalis.4

The onset of AA can occur at any age, but 80% of the time, the first onset usually occurs by age 40 and 40% by age 20.4 Many AA patients recover within the first year of onset; however, 4.5% to 36.1% of patients progress to alopecia totalis or alopecia universalis.4 When AA appears in children < 10 years old, it is usually more extensive and progressive.2

Risk Factors of Alopecia Areata

Alopecia areata risk factors include a family history of the disease, as individuals with close relatives affected by AA have a heightened risk. However, for many, there is no family history, indicating that genetics alone may not be the sole determinant. Genetic research has identified numerous genes associated with AA, particularly those linked to immune system function.2

As mentioned above, Mostaghimi, Gao, Ray, et al., reported gender and age as risk factors for AA, including its more severe forms, alopecia totalis and alopecia universalis.4 They reported that female gender, increasing age, and geographic regions could be risk factors for AA.4 Ethnicity or race may be a risk factor since there are studies that found a higher prevalence of AA in Asian and Hispanic children.4

People with specific autoimmune conditions like psoriasis, thyroid disease, or vitiligo are at an increased risk of developing AA. Individuals with allergic conditions like hay fever may also be more susceptible. While emotional stress or illness can potentially trigger AA in those predisposed to the condition, in most cases, no specific trigger can be identified.2

Management and Treatment Options for Alopecia Areata

Treatment options for AA vary depending on the severity of the condition.7 In many cases, hair regrows without the need for treatment, particularly in milder cases. Some individuals with severe alopecia may choose not to pursue treatment and instead explore options like hair pieces or wigs to conceal hair loss. However, for those seeking treatment, doctors consider factors such as age and the extent of hair loss when developing a treatment plan. Recent systemic treatment approvals for adults with severe AA include baricitinib in 2022 and ritlecitinib in 2023.8,9 Additionally, medications approved for other conditions, including immunosuppressants, corticosteroids, and hair regrowth stimulants, may be used to manage the disease. The primary goal of treatment is to halt the immune system's attack on hair follicles and stimulate hair regrowth.7

Alopecia areata is typically managed by dermatologists who specialize in skin, hair, and nail conditions.7 Mental health professionals can assist individuals in coping with the psychosocial challenges associated with the disease, as AA may lead to elevated stress levels and an increased risk of depression and anxiety. Primary care doctors may also play a role in coordinating care among different healthcare providers and addressing other health concerns that may arise.7

Living with AA can impact one's emotional well-being, but there are coping strategies available.7 Building a support network, learning about the condition, and connecting with others who share similar experiences can be beneficial. In cases of emotional distress, consulting with a mental health professional is advisable. Protection of bare skin from the sun, keeping the scalp warm, and safeguarding the eyes from sun and dust are essential considerations. Cosmetic solutions such as wigs, hairpieces, or makeup can help conceal hair loss. Regular check-ups with a primary care doctor are crucial, as people with AA have a higher risk of certain diseases like thyroid disease or autoimmune conditions. Early diagnosis of these diseases allows for better management and control.7

Ritlecitinib as a Treatment Option for Severe Alopecia Areata

On June 23, 2023, the Food and Drug Administration approved ritlecitinib, brand name LITFULO™, to treat severe alopecia areata.5,9,10

Mechanism of Action

Ritlecitinib is classified as a kinase inhibitor. Specifically, it acts as an irreversible inhibitor of Janus kinase 3 (JAK3) and the tyrosine kinase expressed in the hepatocellular carcinoma (TEC) kinase family by binding to the adenosine triphosphate (ATP) binding site. In cellular contexts, ritlecitinib functions by blocking the phosphorylation of STAT (signal transducer and activator of transcription) proteins induced by cytokines, which is typically mediated by receptors dependent on JAK3. Furthermore, it inhibits the signaling of immune receptors that rely on members of the TEC kinase family. The precise therapeutic implications of inhibiting specific JAK or TEC family enzymes are poorly understood.

Clinical Studies

The efficacy and safety of ritlecitinib were assessed in a 48-week randomized, double-blind, placebo-controlled trial (Trial AA-I) involving subjects aged 12 and older with AA, including those with ≥50% scalp hair

loss, alopecia totalis, and alopecia universalis. The study included 718 subjects who were divided into different treatment groups, with the recommended dose of 50 mg once daily being the focus of discussion. Most subjects were adults (85%), with a mean age of 33.7 years. A smaller percentage of subjects were 12 to <18 years old (15%), and even fewer were 65 years and older (3%). Most subjects also had abnormal eyebrows (83%) and eyelashes (75%) at baseline.

The primary measure of efficacy was the Severity of Alopecia Tool (SALT) score, assessing scalp hair loss. At Week 24, more subjects treated with ritlecitinib achieved a SALT score of ≤20 (20% or less of scalp hair loss) and ≤10 (10% or less of scalp hair loss) compared to those who received placebo. These results suggest a positive clinical response to ritlecitinib in reducing scalp hair loss in individuals with AA.

Indications

Ritlecitinib is indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older. However, it is important to note that it is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Dosing and Administration

The recommended dosage of ritlecitinib for the treatment of severe alopecia areata is 50 mg orally once daily, and it can be taken with or without food. It's important to swallow the capsules whole and not crush, split, or chew them. If a dose is missed, it should be administered as soon as possible, unless it is less than 8 hours before the next scheduled dose, in which case the missed dose should be skipped. Subsequently, regular dosing should be resumed at the scheduled time.

Contraindications, Warnings, and Precautions

Ritlecitinib is contraindicated in patients with a known hypersensitivity to ritlecitinib or any of its excipients. It should be avoided in patients with active, serious infections, and its use should be considered carefully in patients with chronic or recurrent infections, those exposed to TB, those with a history of serious infection or opportunistic infection, and those with underlying conditions that may predispose them to infection. Patients should be monitored for signs and symptoms of infection during and after treatment. Ritlecitinib should not be given to patients with active TB, and anti-TB therapy should be considered in those with latent TB or at high risk for TB. Viral reactivation, including herpes zoster, has been reported, and patients with evidence of HIV or hepatitis B or C infection were excluded from clinical trials.

There is an increased risk of all-cause mortality, including sudden cardiovascular death, in patients treated with JAK inhibitors compared to TNF blockers, especially in patients over 50 with cardiovascular risk factors. Malignancies, including non-melanoma skin cancer (NMSC), have been observed, and periodic skin examination is recommended for those at increased risk for skin cancer. Major adverse cardiovascular events (MACE), thromboembolic events, hypersensitivity reactions, and laboratory abnormalities, such as decreases in lymphocytes and platelets and liver enzyme elevations, have also been reported. Live attenuated vaccines should be avoided during or shortly prior to initiating ritlecitinib treatment, and patients should be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in accordance with current immunization guidelines.

Adverse Reactions

Several clinically significant adverse reactions are discussed in other sections of the labeling for ritlecitinib. These include serious infections, malignancy, lymphoproliferative disorders, thromboembolic events, hypersensitivity reactions, and laboratory abnormalities. It is important for

healthcare providers and patients to be aware of these potential adverse effects as they are critical considerations when using this medication.

Drug Interactions

Ritlecitinib is known to inhibit CYP3A and CYP1A2 enzymes, affecting the metabolism of drugs that rely on these enzymes. When ritlecitinib is used alongside drugs metabolized by CYP3A (acetaminophen, cyclosporin, atorvastatin) or CYP1A2 (caffeine, clozapine, propranolol), it can increase the concentrations of these drugs in the body, potentially raising the risk of adverse reactions associated with them. Healthcare providers should consider additional monitoring, and pharmacists, as part of the shared decision-making team, may need to adjust dosages to prevent serious adverse reactions when using ritlecitinib in combination with such drugs. Using strong CYP3A inducers like rifampin alongside ritlecitinib is not recommended, as it may reduce the effectiveness of ritlecitinib. Proper monitoring and intervention are crucial to manage these drug interactions effectively, ensuring the safety and efficacy of the medications involved.

Special Populations

There is limited data in clinical trials regarding ritlecitinib in pregnant women, with no conclusive evidence of major birth defects or adverse maternal or fetal outcomes. However, animal studies indicate potential fetal harm at high exposures. The background risks of birth defects and miscarriages in the general population should also be considered. While no data exist on ritlecitinib's presence in human milk, it is found in the milk of lactating rats. Due to potential risks to the infant, women are advised not to breastfeed during ritlecitinib treatment and for approximately 14 hours after the last dose.

Ritlecitinib is approved for use in pediatric patients aged 12 and older, with adolescent efficacy and safety profiles similar to adults. Its use in pediatric patients under 12 years old is not established. For geriatric patients over 65, no dose adjustment is required. However, caution is advised due to

the higher incidence of infections in the elderly. Ritlecitinib does not require dose adjustment in patients with mild or moderate hepatic impairment but is not recommended for those with severe hepatic impairment.

Overdosage

Ritlecitinib overdose, even at a high single oral dose of 800 mg, did not reveal specific toxic effects in clinical trials. Based on pharmacokinetic data, over 90% of the administered dose is expected to be eliminated within 48 hours. In the event of an overdose, there is no specific antidote, and treatment should focus on managing symptoms and providing supportive care. Patients should be monitored for signs of adverse reactions, and for guidance on the latest recommendations in case of an overdose, healthcare providers can contact the Poison Control Center at 1-800-222-1222.

Storage and Handling

Ritlecitinib should be stored within the temperature range of 20°C to 25°C (68°F to 77°F), with allowable excursions between 15°C to 30°C (59°F to 86°F), as specified by USP Controlled Room Temperature standards. The Medication Guide advises storing ritlecitinib in its original packaging.

Interdisciplinary Approach and Collaboration

Alopecia areata is typically treated by dermatologists, who specialize in skin, hair, and nail conditions.6 Other key healthcare team members may include mental health professionals, who provide support for the psychosocial challenges associated with the condition, as well as pharmacists and pharmacy technicians. Additionally, primary care doctors, such as family physicians or internal medicine specialists, play a crucial role in coordinating care among different healthcare providers and addressing any other health issues that may arise in patients with AA. This collaborative approach ensures comprehensive care and support for individuals dealing with this condition.

Pharmacy technicians play a vital role in patient communication regarding ritlecitinib. They should emphasize the importance of not crushing or splitting ritlecitinib capsules. They should advise patients against receiving live vaccines while on ritlecitinib and recommend informing their healthcare provider before vaccination. The manufacturer recommends pregnant patients report their pregnancy to the Pfizer Inc. pregnancy registry at 1-877-390- 2940. The FDA-approved label recommends against breastfeeding during ritlecitinib treatment and for 14 hours after the last dose. Patients can also be referred to the National Alopecia Areata Foundation (NAAF) for support and additional resources.11

Summary

Alopecia areata is a condition characterized by hair loss, which can manifest in different types, including patchy alopecia areata, alopecia totalis, and alopecia universalis. It primarily affects hair but can also impact nails. Although it often starts with small, round, or oval patches of hair loss, it can progress to more extensive loss. The prevalence of AA in the United States has shown a slight increase, with certain risk factors including family history and autoimmune conditions. Dermatologists typically manage the condition, but an interdisciplinary approach involving mental health professionals, primary care doctors, pharmacists, and pharmacy technicians can provide comprehensive care. Pharmacy technicians play a crucial role in patient education, emphasizing proper medication administration, avoiding live vaccines during treatment, reporting pregnancies, and refraining from breastfeeding during treatment with medications like Ritlecitinib, which is indicated for severe alopecia areata.

Course Test

What is the most common type of alopecia areata (AA)?

Alopecia Totalis

Patchy Alopecia Areata

Alopecia Universalis

Full-body Alopecia Areata

What is a characteristic feature of hair loss in AA?

Long, thinning hair

Short, broken hair resembling "exclamation point" hairs

Hair with white tips

Curly hair appearing in straight-haired individuals

At what age does alopecia areata most commonly first appear?

After age 50

Before age 10

By age 40

Any age after birth

When AA appears in children < 10 years old, it is

usually more extensive and progressive.

usually self-resolving within a year.

referred to as alopecia universalis.

untreatable throughout the remainder of the patient’s life.

Significant adverse reactions from ritlecitinib use include

serious infections.

malignancy

thromboembolic events.

All of the above

Which of the following statements is true about the use of ritlecitinib for treating severe alopecia areata?

Ritlecitinib can be used in combination with other JAK inhibitors.

Ritlecitinib should be used with another immunosuppressant.

Ritlecitinib is indicated for use in adults and adolescents aged 12 years and older.

Ritlecitinib is not indicated in children of any age.

Which of the following statements is correct regarding the use of ritlecitinib in special population groups?

Due to potential risks to the infant, women are advised not to breastfeed during ritlecitinib treatment and for approximately 14 hours after the last dose.

Data shows that ritlecitinib is present in the human milk of lactating women taking the drug.

For geriatric patients over 65, dose adjustments are required.

Ritlecitinib’s recommended dose must be adjusted in patients with mild or moderate hepatic impairment

Ritlecitinib is classified as a

kinase promoter.

antibiotic.

kinase inhibitor.

corticosteroid.

Which of the following is an important precaution for the use of Ritlecitinib?

Ritlecitinib should not be used in male patients.

Ritlecitinib should not be used in patients with serious infections.

Ritlecitinib should not be used in patients over the age of 65.

Ritlecitinib is not indicated for children of any age.

Which of the following medical professionals are typically involved in the interdisciplinary management of alopecia areata?

Dermatologists and cardiologists

Dermatologists and mental health professionals

Gastroenterologists and neurologists

Oncologists and podiatrists

References

Nowaczyk J, Makowska K, Rakowska A, Sikora M, Rudnicka L. Cyclosporine With and Without Systemic Corticosteroids in Treatment of Alopecia Areata: A Systematic Review. Dermatol Ther (Heidelb). 2020;10(3):387-399. doi:10.1007/s13555-020-00370-2

National Institute of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Alopecia Areata. Overview of Alopecia Areata. NIH-NIAMSD. 2021. https://www.niams.nih.gov/health-topics/alopecia-areata. Accessed December 20, 2023.

Benigno M, Anastassopoulos KP, Mostaghimi A, et al. A Large Cross- Sectional Survey Study of the Prevalence of Alopecia Areata in the United States. Clin Cosmet Investig Dermatol. 2020;13:259-266. Published 2020 Apr 1. doi:10.2147/CCID.S245649

Mostaghimi A, Gao W, Ray M, et al. Trends in Prevalence and Incidence of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis Among Adults and Children in a US Employer-Sponsored Insured Population. JAMA Dermatol. 2023;159(4):411-418.

doi:10.1001/jamadermatol.2023.0002

Guttman-Yassky E, Pavel AB, Diaz A, et al. Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers. J Allergy Clin Immunol. 2022;149(4):1318-1328. doi:10.1016/j.jaci.2021.10.036

Jabbari A, Sansaricq F, Cerise J, et al. An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch-Type Alopecia Areata, Totalis, and Universalis. J Invest Dermatol. 2018;138(7):1539-1545. doi:10.1016/j.jid.2018.01.032

National Institute of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Alopecia Areata. Alopecia Areata: Diagnosis, Treatment, and Steps to Take. NIH-NIAMSD. 2021. https://www.niams.nih.gov/health-topics/alopecia-areata/diagnosis- treatment-and-steps-to-take. Accessed December 20, 2023.

U.S. Food and Drug Administration. FDA Approves First Systemic Treatment for Alopecia Areata. FDA. June 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves- first-systemic-treatment-alopecia-areata. Accessed January 20, 2024.

U.S. Food and Drug Administration. Label: Ritlecitinib (LITFULO) - FDA Approval Letter. 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215830s0 00lbl.pdf. Accessed December 29, 2023.

Blair HA. Ritlecitinib: First Approval [published correction appears in Drugs. 2023 Oct;83(15):1457]. Drugs. 2023;83(14):1315-1321. doi:10.1007/s40265-023-01928-y

National Alopecia Areata Foundation. What is Alopecia Areata? NAAF.

2024. https://www.naaf.org/. Accessed January 20, 2024.

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