Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

Inclusion Criteria:

   - At least 18 years old.

   - Must carry a diagnosis of lichen planus as determined by biopsy

   - Patients must have a score of 3 or greater on the physician global assessment (PGA).

   - Patient must be considered appropriate for systemic therapy based upon fulfilling one
   of the following criteria:

      1. inability to maintain weight due to pain with eating, chewing, or swallowing;

      2. dyspareunia or dysuria due to genital lesions;

      3. itch/pain of sufficient severity that activities of daily living are
      significantly affected

   - Must be off systemic lichen planus treatment for 4 weeks prior to starting etanercept

   - If using topical corticosteroid to the affected areas, the dose and frequency must be
   unchanged for 2 weeks prior to beginning the study agent and during the course of the
   study.

   - Must be off topical cyclosporine, tacrolimus, or pimecrolimus for 2 weeks prior to
   starting the study drug and for the entire duration of the study.

   - Must be able and willing to give written informed consent and comply with the
   requirements of the study protocol and must authorize release and use of protected
   health information.

   - Women of childbearing potential must have a negative pregnancy test at the time of
   entry into the study and must be practicing successful contraception for at least 3
   months prior to the study.

   - Subject or designee must have the ability to self-inject investigational product.

   - Screening laboratory results are within the following parameters:

      - Hemoglobin > 10 g/dL

      - White blood cells > 3.5 x 10^9/L

      - Neutrophils > 1.5 x 10^9/L

      - Platelets > 100 x 10^9/L

      - Lymphocytes > 0.5 x 10^9/L

      - Serum creatinine < 1.5 mg/dL

      - Hepatitis C serology - nonreactive

      - AST and ALT < 2X upper limit of normal (ULN)

Exclusion Criteria:

   - Subject is currently enrolled in another investigational device or drug trial(s), or
   subject has received investigational agent(s) within 90 days of baseline visit.

   - Known HIV-positive status, any other immuno-suppressive disease, or inability to
   practice safe sex during the length of the study

   - Subject has been diagnosed with a malignancy within the past 5 years

   - Subject has signs or symptoms of a lymphoproliferative disease.

   - Other skin or mucosal disease that might interfere with lichen planus assessments.

   - Lichen planus variants including hypertrophic, atrophic, follicular (including lichen
   planopilaris), and bullous cutaneous forms.

   - Patients with lichen sclerosis et atrophicus (LS&A)

   - Clinical history and lesion distribution suspicious for a lichenoid drug eruption

   - Severe co-morbidities

   - History of tuberculosis (TB) or positive PPD at screening. Known history of active
   hepatitis B or C, or lupus, SLE, history of multiple sclerosis or prior episode of
   central nervous system demyelination, transverse myelitis, optic neuritis, epilepsy,
   psychiatric condition, or other chronic serious medical illnesses.

   - Subject has a diagnosis of congestive heart failure (CHF) of any severity

   - Use of a live vaccine 90 days prior to, or during this study.

   - Previous exposure and/or known sensitivity to etanercept

   - Concurrent use, or failure of, any TNF-inhibitor

   - Previous exposure to alefacept or efalizumab within 6 weeks of administration of study
   drug

   - Concurrent sulfasalazine therapy

   - Prior or concurrent cyclophosphamide therapy

   - Active severe infections, or prior infection requiring hospitalization or
   oral/intravenous antibiotics within 4 weeks before screening visit, or between the
   screening and baseline visits.

   - Active inflammatory bowel disease or peptic ulcer disease

   - Drug or alcohol abuse within 12 months of screening visit.

   - History of non-compliance with other therapies

   - Pregnant or lactating

   - Documented presence of any of the following:

      - Proteinuria > 1+ by dipstick screening

      - 24 Hour protein excretion > 0.5 g

      - Symptomatic liver disease with serum albumin < 3 G/DL

      - PT or PTT > ULN, or

      - Chronic liver disease

   - Documented forced vital capacity < 50% of predicted