Efficacy Study of Humira in the Treatment of Cutaneous Sarcoidosis
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of cutaneous sarcoidosis.
Sarcoidosis is a multisystem disease. Cutaneous involvement occurs in approximately 25% of patients with lesion morphologies varying widely. There is no universally accepted treatment for sarcoidosis. Systemic agents such as oral corticosteroids are frequently necessary for treatment, but long-term therapy is limited by a multitude of serious adverse effects. Steroid-sparing agents such as methotrexate, azathioprine, anti-malarials, pentoxifylline, allopurinol, and thalidomide have been shown beneficial for select patients, but are limited due to significant toxicities of their own or inconsistencies in efficacy.
Infliximab is a chimeric, monoclonal antibody directed against TNF-α and is currently approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding domain of the human TNF receptor linked to the Fc portion of human IgG1. Etanercept has been approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Treatment with infliximab and etanercept was generally well tolerated and safe in these reports.
To date, there have been no reports describing the treatment of sarcoidosis with adalimumab. Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis. Given that adalimumab targets the same cytokine as infliximab and etanercept, one would expect that adalimumab may also be effective in the treatment of sarcoidosis. Treatment with adalimumab is advantageous over infliximab through differences in drug delivery. Infliximab is delivered intravenously in the office. This requires routine office visits and vital sign monitoring by a health care professional.
Adalimumab, on the other hand, is administered subcutaneously once weekly or every other week by the patient at home. Patients can be instructed on proper injection technique during one nurse visit. Additionally, because adalimumab is fully human, patients may be less likely to form antibodies against the medication. Because of the lack of alternative safe, effective treatment for sarcoidosis, a clinical trial to evaluate the efficacy of adalimumab in the treatment of sarcoidosis is warranted.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Wright State University
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00731757
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sarcoidosis affecting predominantly the lungs, the site most frequently involved and most commonly causing morbidity and mortality in sarcoidosis. Pulmonary sarcoidosis is characterized by sharply circumscribed granulomas in the alveolar, bronchial, and vascular walls, composed of tightly packed cells derived from the mononuclear phagocyte system. The clinical symptoms when present are dyspnea upon exertion, nonproductive cough, and wheezing. (Cecil Textbook of Medicine, 19th ed, p431)
A manifestation of sarcoidosis marked by chronic inflammation of the parotid gland and the uvea.
A chronic, benign, and usually painless inflammatory swelling of the lacrimal and salivary glands. It is considered by some to include the glandular enlargement associated with other diseases, such as Sjogren's syndrome, sarcoidosis, lupus erythematosus, etc.
An idiopathic systemic inflammatory granulomatous disorder comprised of epithelioid and multinucleated giant cells with little necrosis. It usually invades the lungs with fibrosis and may also involve lymph nodes, skin, liver, spleen, eyes, phalangeal bones, and parotid glands.
Inflammation in which both the anterior and posterior segments of the uvea are involved and a specific focus is not apparent. It is often severe and extensive and a serious threat to vision. Causes include systemic diseases such as tuberculosis, sarcoidosis, and syphilis, as well as malignancies. The intermediate segment of the eye is not involved.
The purpose of the study is to see if Humira is effective and safe in the treatment of sarcoidosis.
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