Two therapeutic options now available for treating severe alopecia areata in Canada

Alopecia areata is T cell-mediated autoimmune disease affecting the hair follicles.1 About 775,000 Canadians have alopecia areata, with most people starting to show signs in their teens through to their 30s.2 It is characterized by rapid hair loss that results in patches of baldness on the scalp, eyebrows and eyelashes, and sometimes total hair loss.3 Treatment options for severe alopecia areata have included topical (contact) immunotherapy. Intralesional or topical corticosteroids (off-label) can be added to immunotherapy for spot treatment, but they are only modestly effective. Systemic corticosteroids and methotrexate (off-label) are also effective, but adverse effects limit their use.3,4The first two Health Canada-approved treatment options for the management of severe alopecia areata are now available in Canada—Litfulo (ritlecitinib capsules) and Olumiant (baricitinib tablets).2,5-7RitlecitinibPfizer is introducing Litfulo (ritlecitinib 50 mg capsules) for the treatment of severe alopecia areata in patients 12 years of age or older. The drug is not recommended for use in combination with Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.5Ritlecitinib is an oral inhibitor of JAK 3 and tyrosine kinase expressed in the hepatocellular carcinoma (TEC) family. JAK3 and TEC family-mediated signalling pathways are both involved in alopecia areata pathogenesis, although the pathophysiology is not fully understood.5The recommended dosage of ritlecitinib is 50 mg orally once daily, with or without food. Capsules should be swallowed whole, not crushed, split or chewed.5 The most common adverse effects of ritlecitinib are diarrhea, acne, upper respiratory tract infections, urticaria, rash, folliculitis and dizziness. More serious potential adverse effects include serious infections (e.g., active tuberculosis, invasive fungal infections, bacterial infections and viral infections, including herpes zoster). Malignancies, including nonmelanoma skin cancer, have been reported. Major adverse cardiovascular events, deep venous thrombosis and pulmonary embolism have also occurred. Hypersensitivity reactions, including urticaria, rash and anaphylactic reaction, are possible. The product monograph should be consulted for recommended laboratory monitoring.5 In terms of drug interactions, CYP3A inducers decrease plasma concentrations of ritlecitinib. Coadministration with strong CYP3A inducers (e.g., rifampin) is not recommended. Ritlecitinib may also increase the plasma concentrations of CYP3A substrates (e.g., midazolam) and CYP1A2 substrates (e.g., caffeine).5Medical Letter consultants have noted that ritlecitinib significantly increased hair regrowth compared to placebo in one 48-week trial in adolescents and adults with severe alopecia areata. They point out that serious adverse effects, including infections and thromboembolism, are a concern. In addition, how ritlecitinib compares to other drugs for alopecia areata, including baricitinib (discussed below) remains to be determined.3BaricitinibEli Lilly’s Olumiant (baricitinib) is now indicated for the treatment of severe alopecia areata in adults. The drug was originally approved only for use in the treatment of moderate to severe rheumatoid arthritis in adults.6Baricitinib is a selective, reversible JAK1 and JAK2 inhibitor. JAK inhibition may interrupt cytokine signalling implicated in the pathogenesis of alopecia areata.8The recommended dosage of baricitinib for severe alopecia areata is 2 mg once daily. The dose may be increased to 4 mg once daily if the response to treatment is inadequate. For patients with nearly complete or complete scalp hair loss, and/or substantial eyelash or eyebrow hair loss, a starting dose of 4 mg once daily can be considered. Once an adequate response is seen with 4 mg/day, consideration should be given to decreasing to 2 mg once daily. The lowest effective dose should be used to minimize adverse effects.6 Eli Lilly will soon be introducing a new 4 mg tablet strength of Olumiant for use in patients with alopecia areata; it will join the original 2 mg tablet. In the interim, patients with alopecia areata who require a 4 mg dose can use two 2 mg tablets. Medical Letter consultants have highlighted that baricitinib was effective in promoting hair regrowth in patients with severe alopecia areata in two short-term (36-week) clinical trials. However, they indicated that serious adverse effects, including infections and thromboembolism, are a concern and longer trials are needed.8 In a more recently published longer-term trial, baricitinib demonstrated a high level of maintenance of efficacy (~90%) over 104 weeks in patients with severe alopecia areata receiving either 2 mg or 4 mg daily doses. Efficacy increased in Week 52 “mixed responders,” illustrating that long-term treatment is necessary to observe maximum benefit in some patients. No new safety signals were seen.9 In a press release accompanying the announcement of the new indication for Olumiant, Dr. Perla Lansang, Assistant Professor and Staff Dermatologist in the Division of Dermatology, University of Toronto stated that "The impact of alopecia areata on patients who suffer from the disease is very much underappreciated. There has been a paucity of treatment options for our patients suffering from alopecia areata until now."7 References:Canadian Alopecia Areata Foundation. What is alopecia areata? (accessed March 5, 2024).Pfizer Canada. Litfulo receives Health Canada approval, becoming the first approved treatment for severe alopecia areata in Canada. December 4, 2023. (accessed March 5, 2024). Anon. Ritlecitinib (Litfulo) for severe alopecia areata. Med Lett Drugs Ther 2023;65:185-6. Sibbald C. Alopecia areata: an updated review for 2023. J Cutan Med Surg 2023;27(3):241-59. (accessed March 5, 2024).Pfizer Canada ULC. Litfulo (ritlecitinib capsules) product monograph. Kirkland, QC; November 29, 2023. (accessed March 5, 2024).Eli Lilly Canada Inc. Olumiant (baricitinib tablets) product monograph. Toronto, ON; January 26, 2024. (accessed March 5, 2024). Eli Lilly Canada Inc. Lilly’s Olumiant (baricitinib) now authorized in Canada for adults with severe alopecia areata. January 30, 2024. (accessed March 5, 2024). Anon. Baricitinib (Olumiant) for severe alopecia areata. Med Lett Drugs Ther 2022;64:139-41.Senna M, Mostaghimi A, Ohyama M, et al. Long-term efficacy and safety of baricitinib in patients with severe alopecia areata: 104-week results from BRAVE-AA1 and BRAVE-AA2. J Eur Acad Dermatol Venereol 2024;38(3):583-93. doi: 10.1111/jdv.19665.

Two therapeutic options now available for treating severe alopecia areata in Canada

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