ITN’s ACCESS Trial for Lupus Nephritis Enrolls First Patient

December 29, 2008

The Feinstein Institute in New York City has enrolled the first patient in the Immune Tolerance Network’s ACCESS clinical trial of abatacept and cyclophosphamide for lupus nephritis. The study is seeking to enroll 100 participants at clinical centers across the US and Mexico over the next three years.

Systemic lupus erythematosus (or ‘SLE’, commonly known as ‘lupus’) affects an estimated 1.5 million Americans, 90% of whom are women. The majority of people with systemic lupus erythematosus will develop lupus nephritis - kidney disease caused by lupus - at some point in the course of their disease. Although it is among the more common problems associated with lupus, it is also among the most serious. It is caused by an autoimmune attack and resulting inflammation in the kidneys. Left untreated, lupus nephritis can be so damaging that dialysis or a kidney transplant may be needed.

Current treatments for lupus nephritis generally involve high doses of corticosteroids accompanied by cytotoxic or immunosuppressive drugs such as cyclophosphamide (Cytoxan) or mycophenolate mofetil (MMF). Despite these aggressive therapies, 65%–90% of patients do not achieve remission within 6 months. Even if these treatments are continued for 24 months, approximately one-third of SLE patients have an inadequate response. It has been 50 years since a new drug has been approved for treatment of Lupus.

ACCESS is short for “Abatacept and Cyclophosphamide Combination: Efficacy and Safety Study.” Preclinical studies have shown that the combination of the costimulatory blocker abatacept (CTLA4Ig) with cyclophosphamide may have a greater-than-additive effectiveness. Abatacept is a fusion protein that prevents the activation of T cells, which are involved in the autoimmune attack. A low dose cyclophosphamide regimen is used in combination with abatacept.

Researchers are optimistic that this combination might eventually offer an improvement upon existing treatment regimens, although careful to point out that it is still an experimental treatment.

“We’re extremely excited to see this study open to enrollment,” said co-principal investigator of the study, Dr. David Wofsy, who is also the George A. Zimmermann Distinguished Professor of Rheumatology at University of California, San Francisco. “Clinical trials like the ACCESS trial are important, as we dearly need an expanded arsenal of treatment options for lupus.”

Dr. Betty Diamond, a well known lupus researcher from the Feinstein Institute is the other co-principal investigator of the research study.

The study is seeking individuals 16 years of age or older who have been diagnosed with lupus nephritis, (kidney disease caused by lupus). More information on the study can be found at clinicaltrials.gov.

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The participating clinical centers are (note that not all sites may be open yet, consult clinicaltrials.gov listing for current status):

  • University of California San Francisco, CA
  • Feinstein Institute, Manhasset, NY
  • Cedars Sinai Medical Center, Los Angeles, CA
  • Wayne State University, Detroit, MI
  • Oklahoma Medical Research Foundation, Oklahoma City, OK
  • University of Chicago, Chicago, IL
  • Temple University, Philadelphia, PA
  • University of Pittsburgh Lupus Center of Excellence, Pittsburgh, PA
  • UNC Chapel Hill, Chapel Hill, NC
  • University of Michigan, Ann Arbor, MI
  • Ohio State University Medical Center, Columbus, OH
  • University of Miami, Miami, FL
  • University of California San Diego, La Jolla, CA
  • UT Southwestern, Dallas, TX
  • University of Alabama, Birmingham, AL
  • University of Rochester, Rochester, NY
  • Brigham and Women's Hospital , Boston, MA
  • New York University, New York, NY
  • Columbia University, New York, NY
  • El Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INNSZ), Mexico City, Mexico

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