He noted that one item the panel could not agree on was the use of azathioprine in pregnant women.
"There was a pretty strong feeling in favor of this," he noted. "It is allowed almost everywhere else in the world, but in the US azathioprine has been considered teratogenic and there is concern about medico-legal liability, although this concern does not appear to be shared elsewhere. In the US this is still embedded in our culture."
He reported that although most panel members believed azathioprine was not teratogenic, there was a "strongly held minority view that it was so in the end we have published the result of the votes." This shows a median score of 8 for use of azathioprine in pregnancy, "so a strong degree of approval but the range was 1 to 9, showing that at least one person voted that the recommendation was highly appropriate and.at least one person voted that it was highly inappropriate. So we have provided information but we are leaving the final decision to the treating physician."
Dr Sanders believes this approach to formulating guidance should be used in other conditions. "There are many diseases in which there is wide variability with many different possible therapies. The goal is to put all those various different therapies into balance."
He acknowledges, however, that this is not a completely accepted approach as yet. "We had a challenge to get journals to accept this approach — it was a long and arduous process to get this paper published. But we now hope this guidance will be endorsed by organizations such as the American Academy of Neurology and the American Association of Neuromuscular & Electrodiagnostic Medicine."
A "Highly Commendable Effort"
In an accompanying editorial, Marinos C. Dalakas, MD, Thomas Jefferson University, Philadelphia, Pennsylvania, notes that myasthenia gravis requires long-term maintenance therapy but the immunosuppressive agents used are "variably applied, even among MG [myasthenia gravis] experts, depending on mentorship, immunotherapy background, and the way we assess existing trials."
He says, "Convening an experienced panel to provide consensus guidance on how best to treat MG is therefore helpful."
Dr Dalakas describes the current guidance document as "a highly commendable effort," adding that the authors have "acknowledged that other experts may have opposing views and assured readers that their goal was to offer guidance and not to dictate formal legally binding guidelines or to influence payment and insurance decisions. Accordingly, the consensus is an overall helpful guide for the practicing neurologist."
He points out that this is a living document that should be frequently updated with results from upcoming trials — most importantly, the just-completed thymectomy trial.
Consensus on MG treatment remains an unfinished business and so diversity of opinion may continue for some time," he concludes.
The guidance was supported by a grant from the Myasthenia Gravis Foundation of America. Dr Sanders is a consultant for Accordant Health Services, Cytokinetics, GlaxoSmithKline, and Jacobus Pharmaceutical Co. Dr Dalakas has disclosed no relevant financial relationships.
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