Erenumab is one of several CGRP monoclonal antibodies that are used for migraine prevention and its efficacy has been shown in several clinical trials and also in observational evidence. We know that many people have a very good efficacy from erenumab and other CGRP monoclonal antibodies, But we also know that individual responses can vary, and they may even vary considerably...
Erenumab is one of several CGRP monoclonal antibodies that are used for migraine prevention and its efficacy has been shown in several clinical trials and also in observational evidence. We know that many people have a very good efficacy from erenumab and other CGRP monoclonal antibodies, But we also know that individual responses can vary, and they may even vary considerably. So meaning that about almost half of patients do not achieve a 50% or more reduction in monthly migraine days. We don’t really know the reasons why there is such a large discrepancy and variation in the clinical response. So with this study, we wanted to look further into if there were any clinical predictors that could provide information on responses. Some studies have been conducted previously, but when you look at them, you often see inconsistency in replicating the findings. Yeah, so the aim of the REFORM study was to investigate predictors of response, both clinical predictors, but also especially biomarker predictors in a large deeply phenotyped real-world migraine cohort. And the design was it was a prospective observational study based in the Danish headache center, so a tertiary headache center. And all participants received open-label erenumab 140 milligrams subcutaneously for 24 weeks as part of a separate study. And participants, they were adults with migraine and all had migraine diagnosed according to the International Classification of Headache Disorders with at least four or more monthly migraine days. In total, we included 751 participants and 689 received the first dose of erenumab. The primary findings were that we looked at clinical predictors and the primary clinical predictors of a 50% or more reduction in monthly migraine days, that was a primary outcome. The strongest predictor was daily headache. Other important predictors of a response were number of preventive failures. So that was a negative predictor along with daily headache. Also, chronic migraine compared to episodic migraine was a strong predictor of a negative response, so less likelihood of response. In contrast, age was a positive predictor, so people who were older generally had a better response to erenumab. As exploratory analysis, we also looked at how at the different treatment patterns over time. So we looked at people who had the characteristics of people who had an early response to erenumab compared to those who had a later response to erenumab. And we saw that generally people who had a later response had more migraine days, more disability, were more likely to have bilateral headache and also had more ictal allodynia. Our results suggest that it’s very important that you should tailor erenumab treatment and possibly also other CGRP monoclonal antibodies depending on patient severity. So first of all, you cannot expect a 50% or more reduction in all people. Sometimes you need to aim for a lower target, such as 30%, especially in people who have a very severe phenotype or multiple preventive treatment failures. Also, severely affected patients may require longer to respond.
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