Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)

Discoid Lupus Erythematosus (DLE ) and systemic lupus erythematosus (SLE) can be devastating
diseases with a significant impact on quality of life. DLE is currently treated with potent
topical steroids, antimalarials, and immunosuppressants. Recent research has determined that
DLE is a Th1 mediated disease. There is increasing evidence that JAK inhibitors such as
tofacitinib can treat the Th1 mediated diseases such as alopecia areata. Therefore the goal
of this study is to determine if JAK inhibitors can successfully treat DLE. Tofacitinib has
not previously been studied in DLE. This will be a pilot study that is descriptive for early
clinical impressions and molecular mechanisms in order to obtain initial information to
potentially design an appropriately -powered phase 2 or 3 study for efficacy of JAK
inhibitors that could take place in the future

Inclusion Criteria:

- Adults 18 years to ≤ 65 years of age with clinical diagnosis of DLE (and at least
half of patients with a diagnosis of SLE) as determined by the Principal Investigator
by medical history and physical exam.

- Able to understand consent procedure

- Able to comply with protocol activities

- Have had a diagnosis of biopsy proven DLE for at least 6 months prior to Visit 1
(Baseline/Day 1).

- At Screening and Visit 1 (Baseline/Day 1), have had DLE covering at least 5% of total
body surface area (BSA) or SLE with DLE covering at least 2% of BSA as determined by
the hand print method (one palm is equivalent to 1% BSA).

Exclusion Criteria:

- Patients not able to understand consent procedure

- Patients unable to comply with protocol activities

- Other skin conditions at Baseline that would interfere with evaluation of DLE.

- Topical corticosteroid within the past 2 weeks

- Systemic therapy is allowed if on a stable dose and using for at least 3 months
-background therapies outlined in Protocol

- Concomitant use of moderate to potent inhibitors and inducers of CYP3A4/5

- Women who are pregnant or wish to become pregnant, or who are lactating. Women of
childbearing potential must use effective contraceptive methods in order to
participate in tofacitinib clinical studies

- History of infection requiring hospitalization, parenteral antimicrobial therapy
within 6 months prior to first dose of study drug or history of infection requiring
antimicrobial therapy within 2 weeks prior to first dose of study drug