Tuan Vu, MD Department of Neurology, University at Tampa Florida, discusses the ADAPT-SC study for the treatment of patients with generalized myasthenia gravis (gMG)
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As this turns out, the efficacy seems almost equal. Then you look at the results, they’re right on top of each other, so there’s no sacrificing efficacy for convenience. If the drug can be given by the patient, I think that’s a big plus because then you can take it anywhere, you don’t have to be tied to a place. You can go on vacation and take it along.
But the fact that it has that ACP administration requirements damper things, but I think that’s going to change in the future when these companies come up with a self-administration device. But I think for convenience’s sake, it’s much preferable to have to go somewhere for your IV infusion.
The ADAPT study was the IV formulation, and for the ADAPT-SC study, we didn’t have to go back and do everything over again, we just showed that it does the same thing in terms of reducing IgG level. The study basically divides patients into two groups, one to one. One of them got treated with IV VYVGART and the other one was subcue VYVGART. Then the endpoint was basically how well thttps://checkrare.com/?p=52186&preview=truehey reduced the IgG level. The secondary measure was efficacy in terms of ADL and all that.
After the ADAPT-SC study, they can go into open-label where they get treatment again and the next cycle can start no earlier than 28 days from the last dose of the previous cycle. Then, unlike the previous trial, in this trial, the patients do not have to come back to their baseline level of ADL to get the next cycle, but rather by the investigator discretion, which is more of in line with what would you do in the clinical setting. That is, you initiate the treatment when the patient feels like he or she needs it. That’s the advantage.
During the open-label, we found that at least six cycles, the response to treatment remained the same. There seems to be durability effects and the adverse event did not increase. In fact, with the first cycle, the injection site reaction was in the low 30%, and by the 6th cycle, it went down to about 11.5%. People get more tolerant of it over time.
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