Tofacitinib Dosing for Vitiligo
For vitiligo treatment, start tofacitinib at 5 mg orally twice daily, which is the standard off-label dose that balances efficacy with safety, and combine it with light exposure (either natural sunlight or narrowband UVB phototherapy) to achieve repigmentation.
Standard Dosing Regimen
The recommended dose is 5 mg orally twice daily for vitiligo, based on extrapolation from psoriasis dosing guidelines and clinical evidence in vitiligo patients 1, 2, 3.
This 5 mg twice daily dose provides a favorable risk-benefit profile compared to the 10 mg twice daily dose, which carries significantly higher risks of serious infections, cytopenia, and pulmonary embolism 1, 4, 5.
Critical Requirement: Light Exposure
Tofacitinib monotherapy is insufficient for vitiligo repigmentation—concurrent light exposure is mandatory 6.
Light exposure can be achieved through either:
The mechanism requires JAK inhibition to suppress the autoimmune T-cell response while light stimulates melanocyte regeneration 6.
Dose Modifications
Renal or Hepatic Impairment:
- Reduce to 5 mg once daily for patients with moderate to severe renal or hepatic impairment 1, 5.
- Avoid tofacitinib entirely in severe hepatic impairment 1.
Drug Interactions:
- Reduce to 5 mg once daily when taking potent CYP3A4 inhibitors (e.g., ketoconazole) or combinations causing moderate CYP3A4 and potent CYP2C19 inhibition (e.g., fluconazole) 1, 5.
Mandatory Pre-Treatment Screening
Before initiating tofacitinib, you must obtain 5:
- Complete blood count with differential
- Comprehensive metabolic panel
- Lipid profile
- Tuberculosis screening (QuantiFERON or PPD)
- Hepatitis B and C screening
- Pregnancy test if applicable
- Lymphocyte count <500 cells/mm³
- Absolute neutrophil count <1000 cells/mm³
- Hemoglobin <9 g/dL
- Active serious infection present
Ongoing Monitoring Requirements
Laboratory monitoring schedule 5:
- CBC with differential: at 4-8 weeks, then every 3 months
- Comprehensive metabolic panel: at 4-8 weeks, then every 3 months
- Lipid profile: at 4-8 weeks, then annually
Discontinue tofacitinib immediately if 1, 5:
- Lymphocyte count <500 cells/mm³ (confirmed by repeat)
- ANC <500 cells/mm³ (confirmed by repeat)
- Hemoglobin decreases ≥2 g/dL or falls <8.0 g/dL
Expected Timeline for Response
- Significant repigmentation typically begins at 8 weeks when combined with phototherapy 2.
- Response rates are significantly higher than phototherapy alone starting at 4 weeks 2.
- Continued improvement occurs over months to years of treatment 3.
- Maintenance of repigmentation may be achievable with tofacitinib monotherapy after initial response 6.
Critical Safety Warnings
Absolute contraindications 5:
- Active serious infection
- Should not combine with other potent immunosuppressants (azathioprine, cyclosporine) or biologics 1, 5
- Avoid live vaccines during treatment 1, 5
High-risk populations requiring extreme caution 5:
- History of malignancy (FDA boxed warning for lung and breast cancer)
- Age >50 years with cardiovascular risk factors (increased pulmonary embolism risk)
- History of recurrent infections
- Patients at risk for herpes zoster (consider Shingrix vaccination before starting) 1, 5
Pregnancy considerations 1, 5:
- Use only if potential benefit justifies fetal risk
- Generally advised against in pregnancy and lactation
Common Pitfalls to Avoid
- Do not use tofacitinib without light exposure—monotherapy without phototherapy or sunlight exposure is ineffective for repigmentation 6.
- Do not escalate to 10 mg twice daily for vitiligo—the 5 mg dose is effective when combined with light, and higher doses substantially increase serious adverse events including five-fold increased pulmonary embolism risk 4, 5.
- Do not skip baseline screening—serious infections including tuberculosis reactivation can occur 4, 5.
- Do not combine with other systemic immunosuppressants—this increases infection and malignancy risk 1, 5.