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Do European guidelines for axial spondylitis adequately address patient needs on the other side of the Atlantic?
Axial spondylitis (axSpa) and ankylosing spondylitis (AS) patients in North America are oceans apart from their counterparts in Europe – and need their own disease management guidelines, says the incoming chair of the US-based Spondyloarthritis Research and Treatment Network (SPARTAN). For one thing, there’s no agreement on existing axSpA classification criteria in the US.
“We can’t just import guidelines from Europe. Rheumatologists who practice here need to be invested in the guidelines,” remarks Atul Deodhar, MD, who is Professor and Medical Director of Rheumatology Clinics in the Division of Arthritis & Rheumatic Diseases at Oregon Health & Science University in Portland.
“The sole purpose for creating guidelines is to give patients the best treatments and improve outcomes, but the recommendations must be specific to their country and circumstances,” Deodhar told Rheumatology Network in an interview. “Many treatments approved in Europe are not approved here. Clinical practices and healthcare resources here are different.”
For example, the tumor necrosis factor (TNF) inhibitors adalimumab (Humira) and certolizumab pegol (Cimzia) are approved in Europe for axSpA and non-radiographic axSpA (nr-axSpA). But in 2013, the FDA declined to approve them here.
The agency felt the classification criteria set by the Europe-based Assessment for Spondyloarthritis International Society (ASAS) were “overly broad,” Deodhar told the first-ever joint meeting of SPARTAN and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), held in New York City.
In a survey published in May, most SPARTAN members agreed that better criteria are needed for axSpA before TNF drugs can be prescribed. While 60% of respondents use the ASAS criteria to diagnose axSpA, 88% agreed that existing criteria should be changed or new ones developed.
The new recommendations, covering disease monitoring, treatments, surgery, rehabilitation, and preventive care for AS and axSpA, are being drafted jointly by SPARTAN, the American College of Rheumatology (ACR), and the Spondylitis Association of America (SAA), a patient education and advocacy organization. (See "Seeking True Guidelines for Spondyloarthropathies" published previously here.) Like SPARTAN, these groups are all based on this side of the Atlantic, Deodhar points out.
The FDA’s rejection of the two TNF blockers for nr-axSpA should not affect the joint recommendations, Deodhar says, since it is possible to use medications off-label if a clinician determines that the benefits outweigh the risks in a particular case.
He stresses that the joint recommendations will be based on “PICO” questions – an acronym for Patient/Population, Intervention, Comparison, Outcomes – developed through a clinician-led process of literature reviews, evidence evaluation and grading.
“Our guidelines are based on the strongest evidence to support which intervention is best for a patient compared to another. There is no mention of what is ‘approved’ or ‘not approved.’ We might say ‘we strongly recommend’ or ‘we conditionally recommend’ based on the evidence,” he explains. “If a drug is included in the treatment recommendations, rheumatologists can tell insurers ‘this is the best intervention for this particular patient'.”
The recommendations are expected to be formally unveiled at the upcoming 2014 meeting of the ACR this November.
Dr. Deodhar reports financial relationships with the drug makers Amgen, AbbVie, Novartis, Pfizer, and UCB.