Tofacitinib (Xeljanz)

What is Tofacitinib?

Tofacitinib (Xeljanz, Xeljanz XR) is an oral Janus kinase (JAK) inhibitor. In the U.S., it is FDA-approved for several inflammatory conditions, including active psoriatic arthritis. In dermatology, it may sometimes be used off label for selected patients with immune-mediated skin or hair disease when the treating dermatologist believes it is an appropriate option based on the full clinical picture.

How does Tofacitinib work?

Tofacitinib works by blocking JAK signaling inside cells. JAK enzymes help transmit cytokine and growth-factor signals that affect immune-cell activity and inflammation. By interrupting that signaling pathway, tofacitinib helps reduce inflammatory immune activity.

What are possible side effects of Tofacitinib?

Common side effects can include:

  • Upper respiratory infections

  • Headache

  • Diarrhea

  • Cold-like nasal or throat symptoms

  • Shingles

More serious risks include:

  • Serious infections

  • Blood clots

  • Major cardiovascular events

  • Certain cancers

  • Gastrointestinal perforation

How is Tofacitinib used?

Tofacitinib is taken by mouth. In dermatology, when it is used off label, the treatment plan is individualized based on the condition being treated, prior treatment history, response, side effects, monitoring needs, access, and cost. Published dermatology literature describes off-label use for more common conditions such as alopecia areata, vitiligo, atopic dermatitis, and psoriasis.

Published reports and small series also describe use in lichen planus, lichen planopilaris, frontal fibrosing alopecia, hidradenitis suppurativa, pyoderma gangrenosum, dermatomyositis with prominent cutaneous disease, bullous pemphigoid, generalized granuloma annulare and cutaneous lupus erythematosus. For many of these more severe or less common conditions, the evidence is much more limited and often comes from case reports, small case series, or small uncontrolled studies rather than large trials.

Additional considerations

In the U.S., the dermatology-relevant FDA-approved indication is active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers. Before starting tofacitinib, providers generally review infection history, screen for tuberculosis and viral hepatitis, check blood counts and liver function, and update immunizations. Live vaccines are avoided during treatment, and tofacitinib is not recommended in combination with biologic immunomodulators or potent immunosuppressants such as azathioprine or cyclosporine. Because many dermatology uses are off label, insurance coverage can be inconsistent.

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