For patients with an intermediate risk, he is likely to change the infusion rate. Instead of two days, Dr. Aggarwal may extend the infusion over three to five days.
The findings suggested that “doctors need to have a say in how fast an infusion can go. [If] they spend more time in giving their infusion, [they can] significantly decrease the side effects, [including] the serious side effects, [such as] thromboembolic events,” Dr. Aggarwal says. IVIG has also led his clinic to cut the tapering time for glucocorticoids in half, and the pace of tapering might increase even further, he says.
Perhaps even bigger than the guidance for patient management, he says, the trial has ignited new interest in developing new therapies for dermatomyositis. The TIS outcome measure and the disease activity measures were shown to be an acceptable measure that cleared regulatory hurdles.
“The classifications worked. The trial process worked. The time frame worked. The outcome measure worked. And that’s why the trial was positive,” Dr. Aggarwal says. “If any of these did not work then the trial would not have been positive…. This trial was, in certain people’s understanding, not proof that IVIG works. It’s proof that outcome measures and classification and the trial process worked.”
Myositis is no longer at the back of the line in terms of therapy development interest, according to Dr. Aggarwal.
“Previously what would happen is a drug would be tried in rheumatoid arthritis, maybe vasculitis, maybe lupus, and then people would pay attention to myositis,” he says. “That’s kind of changing.”
Another Perspective
Prateek Gandiga, MD, FACP, associate professor of medicine at Emory University, Atlanta, who specializes in treating myositis, says that, previously, he used IVIG only for those with severe disease or who had failed multiple medications.
“A big driver of that was, honestly, insurance coverage,” he says. With IVIG available more readily, more patients are able to benefit, with community physicians becoming more comfortable with it.
“I think people are shifting it earlier into the treatment paradigm and using it more often,” Dr. Gandiga says.
In one of his cases, a 65-year-old woman with dermatomyositis had persistent dysphagia, although her proximal muscle weakness and rash had resolved, and she had normal disease measures otherwise. To his surprise, the insurance provider allowed her to start on IVIG. Dr. Gandiga says he considered it a “Hail Mary pass,” but the woman’s dysphagia “completely turned around”—so much so that the lack of clarity of her speech, which he had initially thought was only her thick Southern accent, drastically improved.
