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

A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus

A 20 week study to assess 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.