‍Summary of Leqselvi (Deuruxolitinib) FDA Approval for the Treatment of Alopecia Areata and Key Information

Alopecia areata is an autoimmune condition where the immune system, specifically T lymphocytes, targets the hair follicles, leading to non-scarring hair loss. This can manifest as small, localized patches of hair loss, commonly on the scalp, eyebrows, eyelashes, or other body hair. In more severe cases, it may progress to complete scalp hair loss (alopecia totalis) or total body hair loss (alopecia universalis). A key feature of the condition is its sudden onset.

The disorder occurs equally across all genders, ages, races, and ethnicities. However, individuals with certain autoimmune diseases, such as thyroid disorders, or those with Down syndrome, have a higher likelihood of developing alopecia areata. Patients with atopic conditions, like eczema, tend to have a worse prognosis.

Though drug-induced cases are rare, certain medications, including TNF inhibitors (e.g., adalimumab, etanercept, infliximab), proton pump inhibitors, and immune checkpoint inhibitors (used for cancer treatment), have been linked to alopecia areata. There have also been reports of the condition occurring after COVID-19 infection or vaccination.

Alopecia areata is unpredictable in its course, varying in severity and duration among individuals. Hair regrowth often occurs spontaneously, but recurrences are common. Although treatments exist, there is no definitive cure for the condition. It affects around 7 million people in the U.S., and while it is often perceived as a cosmetic issue, it can have significant emotional, psychological, and social impacts.

FDA Approval:  

Leqselvi (deuruxolitinib), an oral Janus kinase (JAK1/JAK2) inhibitor, was approved by the FDA in July 2024 for the treatment of severe alopecia areata in adults. This is a significant development for people suffering from this autoimmune disorder, which leads to significant hair loss.

Research Findings:  

LEQSELVI's approval was based on the results of the THRIVE-AA1 and THRIVE-AA2 Phase 3 clinical trials. Over 1,220 patients with at least 50% scalp hair loss for six months or more participated in these trials. After 24 weeks, over 30% of patients showed ≥80% hair regrowth, and nearly 25% regained almost full scalp coverage (≥90% hair coverage). The benefits were seen consistently throughout the study period, with no signs of diminishing results by week 24.

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Recommended Evaluations and Immunizations Before and During LEQSELVI Treatment:

Before starting LEQSELVI, certain evaluations and tests are recommended to ensure the safety and efficacy of the treatment:

-CYP2C9 Genotype Testing: Patients should be tested for variations in the CYP2C9 gene, as LEQSELVI is contraindicated for individuals who are poor metabolizers of CYP2C9 (those with decreased CYP2C9 enzyme function). No FDA-approved test exists currently for detecting CYP2C9 variants in the context of LEQSELVI use.

-CYP2C9 Inhibitors: LEQSELVI should not be used in patients taking moderate to strong inhibitors of the CYP2C9 enzyme.

-Tuberculosis (TB) Screening: An evaluation for both active and latent TB is necessary. LEQSELVI is not recommended for patients with active TB, while those with latent TB or at high risk should start preventive treatment before using LEQSELVI.

-Hepatitis Screening: Patients should be screened for hepatitis B and C in accordance with clinical guidelines. LEQSELVI is not recommended for patients with active hepatitis B or C infections. If hepatitis B is detected, clinical guidelines should be followed, and the patient monitored for reactivation during treatment.

-Complete Blood Count (CBC): LEQSELVI is not recommended for patients with an absolute lymphocyte count (ALC) below 500 cells/mm³, an absolute neutrophil count (ANC) below 1,000 cells/mm³, or hemoglobin levels below 8 g/dL. Regular CBC monitoring during treatment is advised, and dosage should be adjusted accordingly.

-Immunizations: Any necessary vaccinations, including herpes zoster vaccinations, should be completed before beginning LEQSELVI, in line with current immunization guidelines.

To read these guidelines in more detail see page 4

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Recommended Dose & Duration:  

LEQSELVI is taken as an 8 mg oral tablet, twice daily. Treatment duration depends on patient response and clinical judgment, but significant results were observed within 24 weeks.

Side Effects:  

Common side effects include headaches, acne, and nasopharyngitis. However, serious side effects include risks of infections, malignancies, thrombosis, gastrointestinal perforations, and some lab abnormalities.

Contraindications:  

LEQSELVI is contraindicated in patients who are poor metabolizers of CYP2C9 or those taking moderate to strong CYP2C9 inhibitors, as this could impact the drug's effectiveness and safety.

Clinical Considerations & Patient Criteria:  

LEQSELVI is designed for adults with severe alopecia areata, especially those experiencing substantial scalp hair loss (≥50% scalp hair loss for at least six months). It offers a promising option for patients who have not responded to other treatments. Monitoring for side effects, especially infections or lab abnormalities, is crucial during therapy.

LEQSELVI is expected to hit the market later this year, providing a new option for alopecia patients in need of effective hair regrowth solutions. The price has yet to be revealed, but reps will be providing samples and assisting with finding ways to decrease the cost. If you’re interested in learning more and getting involved in increasing education, awareness, and access to care, consider working with the Alopecia Areata Foundation. The National Alopecia Areata Foundation (NAAF) provides education and support to those affected by the condition. They aim to advance research for treatments and a potential cure. https://www.naaf.org/

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Kimberly Madison, DNP, AGPCNP-BC

I am a nurse practitioner with a passion for writing, entrepreneurship, education, and mentorship. I created this blog to share my journey as source of motivation and as a blueprint as you embark on your journey. Most importantly, I’m looking forward to increasing access to dermatology education and clinical training for aspiring and practicing nurse practitioners. I invite you to view the mission and vision statement on the homepage to see how we can best partner to make our dreams align.

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