Tofacitinib Ointment Uses
Tofacitinib ointment is NOT commercially available or FDA-approved in any topical formulation—only oral tofacitinib is approved for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. 1 However, topical tofacitinib has been investigated in clinical trials for dermatologic conditions.
Investigational Topical Use (Not FDA-Approved)
Chronic Plaque Psoriasis
- A phase 2a randomized controlled trial evaluated 2% tofacitinib ointment applied twice daily for 4 weeks to a 300 cm² treatment area in patients with mild-to-moderate plaque psoriasis 2
- One formulation (ointment 1) demonstrated statistically significant improvement with 54.4% reduction in Target Plaque Severity Score versus 41.5% for vehicle 2
- Secondary endpoints including target plaque area and itch severity showed similar improvements 2
- The treatment was well-tolerated with minimal systemic absorption, and all adverse events were mild or moderate 2
- No serious adverse events or discontinuations occurred, with only one application-site reaction (erythema) reported 2
Important Clinical Context
Oral Tofacitinib in Dermatology
While topical formulations remain investigational, oral tofacitinib has demonstrated efficacy in dermatologic conditions:
- Psoriasis: Oral tofacitinib 5-10 mg twice daily showed superiority over placebo at week 16, though PASI response rates (43% PASI75 in methotrexate-inadequate responders, 21% in TNF-inhibitor failures at 10 mg twice daily) are numerically lower than IL-17/IL-23 inhibitors 1, 3
- Off-label dermatologic uses: Oral tofacitinib is being explored for atopic dermatitis, alopecia areata, and vitiligo, though these remain off-label indications 4, 5
Critical Safety Considerations
- Oral tofacitinib carries FDA black box warnings for major adverse cardiovascular events, venous thromboembolism, malignancies, and death based on data from rheumatoid arthritis patients ≥50 years with cardiovascular risk factors 6, 3
- These warnings apply to the oral formulation; topical formulations showed minimal systemic absorption in trials 2
Clinical Bottom Line
If you are seeking tofacitinib ointment for clinical use, it is not available—only oral formulations are approved. 1 The topical formulation studied in psoriasis trials showed promise but has not progressed to FDA approval or commercial availability. 2 For dermatologic conditions, consider FDA-approved topical therapies or discuss oral JAK inhibitors (upadacitinib, abrocitinib, baricitinib) approved for atopic dermatitis, recognizing that oral tofacitinib remains off-label for most dermatologic indications. 1, 6