“We were involved in some of the early tacrolimus studies in children. In between the time the studies were completed and the drug was approved, the company allowed children who'd been enrolled in the trials to continue to use the 0.1% ointment in open-label fashion,” he recalled.
“When approval came with the differential recommendations based on age, we switched the kids to 0.03% to try to be on label. Probably 30% of the kids who'd been in excellent control flared within 2 months. So, yeah, I think there's a dose-dependent effect. We try to stay on-label, but the more severe the patient's disease is, the more I'll go right to the 0.1%,” Dr. Eichenfield said.
Dr. Eichenfield, Dr. Siegfried, and Dr. Friedlander serve as consultants to numerous pharmaceutical companies, including Novartis, which markets pimecrolimus. Dr. Frieden is on the speakers' bureau for Novartis.
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'I always document our discussion of the genuine risks, but … I don't know why we'd need to do it for TCIs.' DR. COHEN