Drug updated on 9/4/2024
| Dosage Form | Capsule (oral; 50 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for or the treatment of severe alopecia areata in adults and adolescents 12 years and older.
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Summary
- Litfulo (ritlecitinib) is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Baricitinib (4 mg) had the highest probability of being the most effective treatment for alopecia areata (AA), with a SUCRA of 0.7949656, followed by ritlecitinib (200/50 mg) with a SUCRA of 0.7391906, and ivarmacitinib (4 mg) with a SUCRA of 0.7292594. Other treatments like dupilumab, secukinumab, tralokinumab, and apremilast were less effective.
- Oral JAK inhibitors, including baricitinib, ritlecitinib, deuruxolitinib, and brepocitinib, showed significant effectiveness in inducing hair regrowth, with baricitinib receiving FDA approval for severe AA and ritlecitinib and deuruxolitinib receiving breakthrough therapy designations. PDE-4 inhibitors and biologics demonstrated limited efficacy.
- In randomized controlled trials (RCTs), oral JAK inhibitors showed a higher good response rate compared to controls (RR: 6.86, 95% CI: 2.91-16.16), with non-RCTs reporting pooled good response rates of 63% for oral, 28% for topical, and 11% for sublingual JAK inhibitors. The recurrence rate after JAK inhibitor withdrawal was 54%. Subgroup analyses indicated better outcomes for ruxolitinib in AA compared to AT/AU.
- Common adverse events (AEs) associated with JAK inhibitors in patients with alopecia areata included hypercholesterolemia (18.2%, OR = 1.9), headache (6.1%-21.4%, OR = 1.0-2.7), acne (10.4%-13.6%, OR = 2.6-3.3), and elevated creatinine (27.7%, OR = 8.6). Respiratory infections were also noted, including upper respiratory infections (7.3%-23.4%, OR = 1.0-2.6) and nasopharyngitis (12.5%-14.6%, OR = 1.0-7.3).
- Systemic JAK inhibitors were generally well-tolerated, with most adverse events being mild, and a low withdrawal rate due to adverse events (1.6% vs. 2.2% for placebo). Laboratory abnormalities (40.1%) such as elevated cholesterol, transaminases, and occasional neutro/lymphocytopenia were observed, along with increased rates of respiratory, skin, urogenital, and gastroenterological tract infections.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Litfulo (ritlecitinib) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative efficacy of oral Janus kinase inhibitors and biologics in adult alopecia areata: a systematic review and Bayesian network meta-analysis. | 2024 | Journal of the European Academy of Dermatology and Venereology |
| Safety of Janus Kinase inhibitors in patients with alopecia areata: a systematic review. | 2023 | Clinical Drug Investigation |
| Adverse events in patients treated with Jak-inhibitors for alopecia areata: a systematic review. | 2023 | Journal of the European Academy of Dermatology and Venereology |
| Systematic review of newer agents for the management of alopecia areata in adults: Janus kinase inhibitors, biologics and phosphodiesterase-4 inhibitors. | 2023 | Journal of the European Academy of Dermatology and Venereology |
| The efficacy and safety of JAK inhibitors for alopecia areata: a systematic review and meta-analysis of prospective studies. | 2022 | Frontiers in Pharmacology |