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Dr. Bril: 
This is CME on ReachMD, and I'm Dr. Vera Bril. Here with me today is Dr. Nicholas Silvestri.

We would be remiss if we didn't also look at any issues related to the FcRn antagonists we spoke of in the last episode. I will begin by looking at these agents for possible longer-term treatment for gMG and also what attributes cause potential concern.

So at this point, we have to think about the adverse effects that might be associated with FcRn antagonist treatments. And as we suppress immunoglobulins, the natural concern is that of increased infections. And indeed, there is a slight increase of infections, commonly upper respiratory tract infections or urinary tract infections, that occur with treatment with FcRn antagonists.

What is really interesting is that if you treat patients with long-term FcRn antagonists that go up to 3 years in the case of efgartigimod, you do not see an increasing percentage of patients who have infections. The infection rate remains stable and low. Usually, these are mild and easily managed, and the drugs are well tolerated. This is true of all the FcRn antagonists. And so I think that although there is this risk, it is not unmanageable. Patients must be monitored for patient possible side effects and treated appropriately if these occur with infections.

The other common complaint is headache. In any kind of intravenous or sub-q administration, headache seems to be one of the side effects. And these are, again, easily managed with over-the-counter medications, and the patient can continue with treatment.

Some other things such as diarrhea or myalgias have been described, or other less frequent side effects, but none that have prevented use of these medications. And when you compare treatment with an FcRn antagonist to intravenous immunoglobulin, the side effects are far less, and also if you compare to the possible side effects with PLEX.

So really, you need to monitor the patient responses and adjust doses. Because the main outcome in most of these trials has been the MG-Activities of Daily Living,  that is usually used by insurers and payers to enroll patients in these therapies and also to monitor the response to treatment and examine therapeutic outcomes. Other outcome measures have also been used, but the ADL is universal and easily administered. An outcome such as the Quantitative Myasthenia Gravis score is more objective but takes 20 minutes and specialized equipment and not done very routinely.

Dr. Silvestri:
Thanks, Dr. Bril. I echo your comments, and I would just make 2 points. I think the first being that anytime we treat an autoimmune disease or manipulating the immune system or suppressing the immune system, we assume some degree of risk, particularly the risk of infection. Thankfully, with the targeted therapy like FcRn, as you pointed out, that risk is there, but it does seem to be less in general than what, say, with more broad-spectrum, traditionally used immunosuppression.

I think the second point I would make based on your most recent comments regarding monitoring treatment response, I would make another plug for the MG-ADL or using patient-reported outcome measures in your practice. It's a great way to supplement the history and the exam. And from a practical perspective, as you point out, Dr. Bril, payers will ask for them. They'll ask for pretreatment MG-ADLs. They'll ask for on-treatment MG-ADLs so that they can be assured that there's some measure that we're following, that patients are, in fact, responding to therapy.

And I think patients like to fill it out, like to see how they're doing, like to track their own results. I have most of my patients track it weekly and report back to me. And again, I think it's a nice supplement to the history and the exam, particularly when you're dealing with a disease that can be fluctuating in nature. And as you pointed out in a previous episode, patients can look great in clinic but, in point of fact, between those clinic visits may or may not be doing well.

So this has been a brief but great discussion. I hope you found this information useful. And thanks for tuning in.

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