Tofacitnib for the Treatment of Alopecia Areata and Variants

Tofacitnib for the Treatment of Alopecia Areata and Variants

The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Inclusion Criteria:

• Age >= 18 years old
• Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
• Hair loss present for at least 6 months
• No treatment for alopecia areata in past 2 months
• No evidence of hair regrowth
• Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication

Exclusion Criteria:

• Age <18 years old
• Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
• Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
• Patients known to be HIV or hepatitis B or C positive
• Patients with positive tuberculin skin test or positive QuantiFERON TB test
• Patients with leukopenia or anemia
• Patients with renal or hepatic impairment
• Patients with peptic ulcer disease
• Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
• Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
• Women who are pregnant or nursing