Real-world evidence can inform and shape best practice guidelines
Real-world studies provide evidence on efficacy and safety for regulatory authorities and for experts writing guidelines
Real-world evidence refers to any data collected outside restricted randomized controlled trials, said Professor Cristina Tassorelli, Pavia, Italy. Sources include diverse and unrestricted electronic health and claims databases, and observational prospective or retrospective studies.
Real-world studies have become increasingly important in providing evidence on efficacy and safety in the real world for regulatory authorities and for experts writing guidelines, and are also helping to address unanswered questions, Professor Tassorelli said.
Real-world data on discontinuing and switching anti-CGRP mAbs
Migraine frequency may increase after withdrawal of an anti-CGRP mAb3
The latest real-world evidence is providing information on unanswered questions about outcomes for patients after cessation of an anti-CGRP mAb2 and after switching to a different anti-CGRP mAb following a failure to respond to a first anti-CGRP mAb,3 said Professor Messoud Ashina, Copenhagen, Denmark, as follows:
- Migraine frequency significantly increased 16 weeks after discontinuation of an anti-CGRP mAb;2 care is therefore required when withdrawing an anti-CGRP mAb
- Switching to a different anti-CGRP mAb resulted in a ≥50% reduction in monthly migraine days from baseline to month 6 in 32% of patients who had previously failed to respond to a first anti-CGRP mAb3
In individuals with an inadequate response to one anti-CGRP mAb, switching to another anti-CGRP mAb may be an option4
Professor Ashina highlighted that the positive real-world finding that switching from one anti-CGRP mAb to another can provide beneficial efficacy contributed to the following 2022 update to the European Headache Federation guidelines, which now states:
- “In individuals with migraine with an inadequate response to one anti-CGRP mAb, there is insufficient evidence on the potential benefits of antibody switch but switching may be an option4”
Latest data on tolerability and safety
Anti-CGRP mAbs are well tolerated and safe
Both long-term clinical studies and real-world studies are demonstrating that anti-CGRP mAbs are well tolerated and safe when used as recommended,5–7 said Professor Hans-Christoph Diener, Duisberg, Germany. Most adverse events (AEs) are mild to moderate in severity and injection site reactions are the most common.
Injection site reactions are the most common adverse event
Because CGRP is abundant in the vasculature,8 Professor Diener suggested that anti-CGRP mAbs should be avoided in patients with cardio- or cerebrovascular disease.9 Anti-CGRP mAbs should also be avoided during pregnancy.9
Support for this satellite symposium was provided by Teva.