A much higher risankizumab dose is recommended for Crohn’s disease, and drug-induced liver injury has been seen, so monitoring for liver enzymes and bilirubin is recommended, Dr. Nair said.
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A new warning has been issued for collagenase clostridium histolyticum, which is used to treated Dupuytren contracture, regarding syncope and pre-syncope seen in post-marketing trials. These symptoms usually occur immediately after an injection procedure, and the recommendation is that patients remain lying down until they resolve, said Dr. Nair.
He also discussed new concerns with hydroxychloroquine and phospholipidosis, a lysosomal storage disorder involving excessive accumulation of intracellular phospholipids in various tissues, such as the heart, liver, kidney and skeletal muscle, causing cardiomyopathy and renal toxicity, both of which have been reported with hydroxychloroquine use, Dr. Nair said.
“The first step is to see whether you suspect someone that has phospholipidosis to any of these organ systems, and then you may need to do further evaluation which may include biopsy,” he said. “And the recommendation is that if you do have someone who has biopsy-proven phospholipidosis, that you halt hydroxychloroquine.”
A rheumatologist in the audience expressed surprise about the new concerns about hydroxychloroquine: “Hydroxychloroquine is very important to us and to tell me it is not very safe it’s really like a shock to me,” she said.
Dr. Nair said that any risk seems to be with chronic use rather than acute use.
“When we’re talking about renal toxicity and we’re talking about a condition like lupus, there can be many different reasons somebody could be having renal toxicity,” he said. “Basically, it is looking at the patient to see what’s going on, and if it does seem that phospholipidosis could be occurring in that patient, you would investigate further.”
Nikolay Nikolov, MD, director of the Division of Rheumatology and Transplant Medicine of the FDA, underscored that the problem doesn’t seem to be widespread.
“We just want to emphasize that this signal came from post-marketing data with a limited number of cases,” he said. “So we assume that based on the wide prescription of hydroxychloroquine, this toxicity is not common. And we certainly recognize that hydroxychloroquine has a significant role in the management of our patients.”
After being questioned about the practicality of the FDA’s recommendation that TNF blockers be used before JAK inhibitors in RA, given that TNF inhibitors may not be the most effective option for every patient, Dr. NIkolov acknowledged that it’s not a simple scenario to navigate, but that the only available data directly comparing safety of JAK inhibitors is with TNF inhibitors.