The Safety and Efficacy of Etanercept (Enbrel®) for the Treatment of Discoid Lupus Erythematosus

Inclusion Criteria:

- Subjects with discoid lupus erythematosus .Subjects require to have confirmation of
diagnosis by a skin biopsy .This can be undertaken at the screening visit if no
previous biopsy confirmation available.

And;

- Having failed steroids (topical, intralesional, systemic) and are candidates for
antimalarial therapy

- Negative ANA

Have no history of latent or active TB prior to screening.

Exclusion Criteria:

- Subjects allergic to sunscreens

- Prior treatment with anti-TNF therapies

- Subjects who do not have a previous skin biopsy result confirming a DLE diagnosis and
who are unwilling to undergo this procedure at screening.

- Subjects currently receiving systemic steroid therapy (or have received in the last 3
months)

- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to
have antibodies to etanercept.

- Prior or concurrent use of cyclophosphamide therapy

- Concurrent sulfasalazine therapy.

- Known HIV-positive status or known history of any other immuno-suppressing disease.

- Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family
member with TB, positive purified protein derivative (PPD) or taking
anti-tuberculosis medication

- Active or chronic infection within 4 weeks before screening visit, or between the
screening and baseline visits.

- Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or
myocardial infarction, cerebrovascular accident or transient ischemic attack within 6
months of screening visit; unstable angina pectoris; uncontrolled hypertension
(sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg);
oxygen-dependent severe pulmonary disease; history of cancer within 5 years [other
than resected cutaneous basal or squamous cell carcinoma of the skin or in situ
cervical cancer])

- Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis,
optic neuritis or seizure disorder.