Abstract
BACKGROUND: Alopecia areata (AA) is a chronic autoimmune disorder characterized by non-scarring hair loss and substantial psychological burden. Although Janus kinase (JAK) inhibitors such as tofacitinib have shown promising efficacy, evidence on their long-term real-world use, particularly in Middle Eastern populations, remains scarce. This study addresses this gap by evaluating extended real-world outcomes of oral tofacitinib in a Saudi Arabian cohort. METHODS: This retrospective cohort study evaluated patients with AA treated with oral tofacitinib at a tertiary care center between 2018 and 2024, providing up to six years of follow-up. Patients who received tofacitinib for at least 12 months were included. Demographic data, disease characteristics, treatment regimens, clinical response, adverse events, and laboratory parameters were extracted from electronic medical records. Associations were analyzed using appropriate statistical tests. RESULTS: Sixteen patients were included, 56.3% female (n = 9), with a mean age of 29.6 ± 9.2 years. Most patients had AA (93.8%, n = 15), and one had alopecia totalis (6.3%, n = 1). An effective response was achieved in 68.8% of patients (n = 11), while 31.3% (n = 5) showed no meaningful response. Hyperlipidemia was the most frequent adverse event (87.5%, n = 14) and was managed conservatively or with lipid-lowering therapy without treatment discontinuation. No serious adverse events or cardiovascular complications were observed. Ongoing side effects (62.5%, n = 10) were significantly associated with treatment response (p = 0.018). Some patients required dose escalation or were switched to alternative JAK inhibitors with favorable outcomes. CONCLUSION: In this six-year real-world Saudi cohort, oral tofacitinib demonstrated favorable long-term effectiveness in patients with AA. Despite frequent lipid abnormalities, adverse events were manageable with routine monitoring, supporting the feasibility of long-term tofacitinib therapy in carefully selected patients.