Sherman Oaks, CA -- The Spondylitis Association of America (SAA) today announced that the organization, along with prominent researchers from around the world, has forwarded a draft copy of the proposed "Ankylosing Spondylitis Guidance Document" to the U.S. Food and Drug Administration (FDA) for review. SAA and the Ankylosing Spondylitis Assessment Working Group (ASAS), a professional group, joined together to spear-head the project.

The purpose of the Guidance Document, when finalized by the FDA, is to guide physicians, clinical researchers and companies developing new therapies for ankylosing spondylitis (AS) and about how to measure improvement or remission.

"It is gratifying to see the efforts of so many researchers and physicians focused on bringing consensus to how we identify symptoms of ankylosing spondylitis and how we can ultimately quantify success of new treatments in development," said Michael Weisman, MD, Chief of Rheumatology at Cedars Sinai Medical Center in Los Angeles and facilitator for one of the six planning committees.

The draft Guidance Document was developed following a unique announcement in the Federal Register inviting proposals for submission to the FDA. On May 21, 2001 FDA published in the Federal Register a notice requesting outside assistance in developing guidance for industry on issues related to drugs, biologics and devices for the treatment of AS. FDA stated that the agency recognized the need for more information on AS and related disorders in light of the positive response to its guidance on rheumatoid arthritis. In October 2002 a meeting focused on six topics: scope; claims; signs and symptoms; function; structure and trial design was held in Bethesda, Md. All of these topics were then discussed to determine the most appropriate way to measure improvement, worsening or remission in AS. The draft Guidance Document is the culmination of two years worth of work by SAA in cooperation with more than 25 clinical researchers from around the world.

SAA Executive Director Jane Bruckel, BSN, RN said, "This guidance document effort is important to the 350,000 to one million people who have ankylosing spondylitis in the United States because it should spur additional interest in developing drugs to treat this disease."

The Draft Document Includes Recommendations:
1. To use standardized and composite measures to diagnose AS;
2. To include children in clinical studies (and therefore claims made in drug labeling) if there are either x-ray changes or inflammatory back pain in clinical studies, as x-ray changes often occur five to 10 years after the onset of symptoms;
3. The document also suggests changes on how to handle claims drug manufacturers can make about remission, dividing remission into two categories: what can be said while the patient is still on the drug and what can be said after the patient has been taken off the drug;
4. The document also points out that there are many areas of the disease that need to be studied further including prevalence data;
5. The document identifies a disease-specific instrument for assessing physical function;
6. The document also outlines how progression of structural damage may be achieved without improvement of signs and symptoms of the disease.

Désirée van der Heijde, M.D, Professor of Rheumatology University Maastricht, the Netherlands and Assessment in Ankylosing Spondylitis Work Group (ASAS) Chair said, "There are many different ways to measure improvement in the AS patient population and many gaps in terms of information we have about the prevalence and impact of treatment over the long term because this disease has not previously been studied extensively. My hope is that the work being conducted around the world will ultimately lead to better opportunity to care for patients who are in pain and have a poor quality of life, or who face poor quality of life without appropriate treatment. That is the ultimate goal of our efforts."

The draft Guidance Document will be reviewed by FDA and then published in the Federal Register for review in the Fall when the public will be asked to submit additional comments. A formal advisory committee will likely review the Guidance Document recommendations at a public forum in 2004 before publishing the final document.

Lee S. Simon, MD, the Director of the Division of Analgesic, Antiinflammatory, and Ophthalmologic Drug Products at FDA said, "This is a very exciting result. This project was a unique interaction with the public in the early development of a guidance document. This collaboration is a prime example of how FDA is utilizing innovative mechanisms to respond to the need to bring new therapies to market for patients in need."

About Ankylosing Spondylitis
AS, often called arthritis of the spine, is a painful and progressive form of spinal arthritis that usually affects people under the age of 35 years. AS typically begins in the late teens and early twenties and can result in fusing of the spinal vertebrae, hips and other joints. Often misdiagnosed as "just back pain," or undifferentiated arthritis, AS can affect vision and internal organs. The SAA estimates that between 350,000 and one million people in the United States suffer from AS or a related disease.

About Spondylitis Association of America
For over 25 years, SAA has helped improve the lives of people with AS and its related diseases. SAA has grown from a small dedicated group of patients and their families, to a national organization with members throughout the United States. Today, SAA offers information, events and services to people with AS and related diseases and works with medical thought-leaders in the United States on assessment tools, research and clinical studies to improve patient care.

About Asessements in Ankylosing Spondylitis
The Asessements in Ankylosing Spondylitis group is a group of more than 60 experts in the field of ankylosing spondylitis research. The group started in 1995 with the development of core sets of instruments for the use in clinical research. Response criteria have been defined as well as partial remission criteria. The group is very active in all aspects of clinical research. The mission statement of ASAS is to support and promote the study of ankylosing spondylitis. This includes increasing awareness and early diagnosis of the disease, development and validation of assessment tools, the evaluation of treatment modalities in order to promote clinical research with the ultimate goal to improve outcome of the disease.

For more information, call toll-free 800.777.8189 ext. 222. For media inquiries, contact Robin Shapiro at 206.861.1000.