New ACR/EULAR antiphospholipid syndrome criteria to ‘create homogenous patient population’
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Upcoming American College of Rheumatology and EULAR joint classification criteria for antiphospholipid syndrome will “create a homogenous patient population” to increase research, according to a presenter at the 2023 AWIR annual conference.
“The whole focus of this is to create a homogenous patient population to actually do more clinical trials and move the research in APS forward,” Sheetal B. Desai, MD, interim chief of the division of rheumatology at the University of California Irvine’s School of Medicine told attendees.
Although the document is yet to be published, Desai provided a brief overview of the process and components.
“It actually started well before the pandemic,” she said, noting that the large international effort featured investigators from around the world.
“The new criteria are now approved by EULAR, they were approved by ACR, they were just accepted for publication a couple months ago by [Arthritis & Rheumatology],” Desai added. “Because of that, I can’t actually share the criteria with you, but I can articulate it.”
The first highlight is that, much like the 2019 ACR lupus criteria, there will be a point system for classifying APS.
“The entry criteria will be that you have to have positive antibodies, you have to have some event, and then you will break it down into different domains,” Desai said.
The domains feature non-criteria manifestations, including thrombocytopenia, alveolar hemorrhage, valvular heart disease, myocardial infarction, digital necrosis or thrombotic renal disease. Other non-criteria manifestations may include thrombotic microangiopathies, retinal occlusion, osteonecrosis or white matter lesions.
“There are a lot of non-criteria manifestations included here,” Desai said.
The same three laboratory tests that were included in the 2006 document are also included here. They are lupus anticoagulant, anticardiolipin beta-2 and glycoprotein, according to Desai.
Meanwhile, points are assigned for patients with various biomarkers, she added.
“If you have IgM, you get one point, if you have IgG, you get two points,” Desai said. “If you have two, you get even more points, and if you have three, you get the maximum number of points. There is a differential weighting with different manifestations and how much they actually increase the likelihood of developing thrombosis.”
Desai noted that the 1999 Sapporo criteria for APS demonstrated a sensitivity of 99% but a specificity of just 86%. In the new criteria, the sensitivity decreased to 84% but the specificity is now 99%.
Looking ahead, Desai suggested that in addition to hydroxychloroquine and statins, B cell-depleting therapies and competent inhibition may play a role in the management of this disease.
“I really want you to think about immunomodulation in APS,” she said. “That is where the field is moving to.”
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Desai S. Top Ten List for APS Presented at: Association of Women in Rheumatology annual conference; Aug. 10-13, 2023; Orlando, Florida (hybrid meeting).
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