STOWE, VT. – These are the early days of the “CGRP monoclonal antibody era,”
In an interview at the annual meeting of the Headache Cooperative of New England, Dr. McAllister said, “We are comforted that we have now 1-year, 3-year, and 5-year data” from clinical trials, but the sample size is small.
In the time since the first three drugs were approved, “we have probably in the ballpark of over 200,000 patients who have received a monoclonal antibody, and so far there has been nothing that makes us stop cold in our tracks and say there’s something wrong here. That is very comforting,” he said. Dr. McAllister is the medical director of the New England Institute for Neurology and Headache in Stamford, Conn.
What is still unknown, however, is the long-term safety and efficacy; what happens in a larger pool of patients taking these drugs; what happens in pregnancy and effects on the fetus; how and when to safely switch from one monoclonal antibody to another; the systemic effects of these drugs; and other concerns that may arise in postmarketing studies.