It was also obvious, adds Dr. Maksymowych, that there simply “weren’t a sufficient number of investigators in any one country to address the question of assessments. Therefore, it was important that we try and forge an international community of investigators who shared similar interests in outcome assessment and would work together. What ASAS is really about,” he explains, “is forging a common language that is accepted by people internationally.”
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Explore This IssueDecember 2010
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1995 – First annual meeting convened at the EULAR Congress in Amsterdam by the Ankylosing Spondylitis working group
1997 – Preliminary core data sets identified
1999 – Selection of core set instruments
2001 – Preliminary definition of short-term improvement and partial remission in AS (ASAS 20 and ASAS partial remission)
2003 – ASAS recommendations on use of anti-TNF agents in AS8
2004 – Definition of improvement criteria (ASAS 40 and ASAD 5/6)9
2005 – FDA guidance document for conducting clinical trials in AS, an ASAS/SAA collaborative effort, is published
2006 – ASAS/EULAR recommendations for the management of AS10
2007 – Validation of scoring methods for MRI of the spine11
2009 – ASAS Handbook; criteria for axial spondyloarthritis published; ASDAS published; first ASAS educational workshop held in Rome12-14
2010 – Criteria for peripheral spondyloarthritis published
Meeting Unmet Needs
“We were lucky that this group of rheumatologists with an academic interest in ankylosing spondylitis and spondyloarthritis already existed and could really serve to fill in this gap and work on these unmet needs,” notes Dr. Rudwaleit.
Désirée van der Heijde, MD, PhD, professor of rheumatology at Leiden University Medical Center in Leiden, The Netherlands, a long-time investigator in the field and leader of the ASsessment in Ankylosing Spondylitis International Working Group, has been president of ASAS since its beginning. Fairly quickly, she recalls, the original ASAS group identified preliminary core sets for endpoints in AS. Using a literature search and small group meetings and plenary discussions, they identified five domains (physical function, pain, spinal mobility, spinal stiffness/inflammation, and the patient’s global assessment) to be used in the setting of symptom-modifying antirheumatic drugs in combination with physical therapy. At a later stage, the domain of fatigue was added. In the setting of clinical recordkeeping, two domains were added: acute phase reactants and peripheral joints/entheses.1 Finally, in the setting of disease-controlling antirheumatic therapy, assessment of spinal radiographs was added. After the selection of the domains, specific instruments for each domain were chosen.
Since its early days, ASAS has worked closely with OMERACT (Outcome Measures in Rheumatology, formerly Outcome Measures in Rheumatology Clinical Trials), subjecting their assessment instruments to the rigorous evaluation process of that organization. At the 1998 OMERACT conference, the selections made by ASAS were endorsed by OMERACT.2 The group then published their preliminary definition of short-term improvement and partial remission in AS3 and then used a three-round Delphi exercise with an expert panel to compare the specificity and sensitivity of the recently selected criteria to results from NSAID trials in 55 AS patients. The results of that exercise showed that the criteria did identify patients who were likely to be responders to drug therapies.4 Later, stricter criteria for improvement were defined.