Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) Report.

Erkan2,  Doruk, Derksen6,  Ronald, Levy3,  Roger A., Machin5,  Samuel, Ortel1,  Thomas, Pierangeli4,  Silvia S., Roubey7,  Robert A. S.

Duke University Health System, Durham, NC
Hospital for Special Surgery, New York, New York, NY
Univ Estado Do Rio de Janeiro, Rio de Janeiro, Brazil
Univ of TX Medical Branch, Galveston, TX
University College London Hospitals, London, UK
University Medical Centre, Utrecht, Netherlands
University of North Carolina, Chapel Hill, NC

Background:

The 13th International Congress on Antiphospholipid Antibodies (aPL) was held in Galveston, TX in April 2010. The APS CRTF was one of six task forces developed by the meeting organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing guidelines for researchers to help improve the quality of APS research; and b) prioritizing the ideas for a well-designed multicenter clinical trial and discussing the pragmatics of getting such a trial done (organization, ideal protocols, practical protocols, and financing).

Objective:

The purpose of this abstract is to summarize the discussions and progress of APS CRTF.

Methods:

The original eight members of CRTF were chosen among experienced APS researchers. The task force working algorithm was: a) a questionnaire that was sent to the members before the congress; b) a summary report that was prepared based on the responses to facilitate discussions during the pre-meeting workshop; c) a pre-meeting workshop; d) two plenary sessions based on the conclusions of the task force discussions where input from all the meeting attendees was received; and e) a final report that was circulated among all the task force chairs for final remarks.

Results:

The task force identified five major issues that impede APS clinical research and the ability to develop evidence-based recommendations for the management of aPL positive patients: 1) aPL detection has been based on partially or non-standardized tests, and clinical (and basic) APS research studies have included patients with heterogeneous aPL profiles with different clinical event risks; 2) clinical (and basic) APS research studies have included a heterogeneous group of patients with different aPL-related manifestations (some controversial); 3) thrombosis and/or pregnancy risk stratification and quantification are rarely incorporated in APS clinical research; 4) most APS clinical studies include patients with single positive aPL results and/or low-titer aPL ELISA results; furthermore, study designs are mostly retrospective and not-population based, with limited number of prospective and/or controlled population studies; and 5) lack of information on the particular mechanisms of aPL-mediated clinical events limits the optimal clinical study design.

Conclusion:

The task force recommended that there is an urgent need for a true International collaborative approach to design and conduct well-designed prospective large-scale multi-center clinical trials of patients with persistent and clinically significant aPL profiles. An International collaborative meeting to formulate a good research question using "FINER" (Feasible; Interesting; Novel; Ethical; and Relevant) criteria will take place in early November and the conclusions will be presented at the ACR meeting.

To cite this abstract, please use the following information:
Erkan, Doruk, Derksen, Ronald, Levy, Roger A., Machin, Samuel, Ortel, Thomas, Pierangeli, Silvia S., et al; Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) Report. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :6
DOI: 10.1002/art.27776

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