EAN 2022 | Real-world studies show effectiveness of anti-CGRP mAbs in difficult to treat patients with migraine
Messoud Ashina, MD, PhD, University of Copenhagen, Copenhagen, Denmark, discusses the findings of accumulating real-world evidence assessing the efficacy, safety, and tolerability of anti-CGRP monoclonal antibodies (mAbs) for patients with migraine. Collecting data from patients treated in everyday clinical care settings adds valuable insights to our understanding of a given therapy. Investigative studies employ strict eligibility criteria, often leading to the exclusion of patients with complex presentation, certain co-morbidities, or taking other additional medications. Post-registration studies are more reflective of the general migraine population. Prof. Ashina shares findings from recent investigations that have demonstrated the efficacy of anti-CGRP antibodies in difficult-to-treat patients who have received as many as 7 prior therapies. This interview took place at the European Academy of Neurology (EAN) 2022 Congress in Vienna, Austria.
Transcript (edited for clarity)
What we know about the real-world studies is that the… Many different groups, research groups are in fact conducting these kinds of studies. And the first question is, why do we need these studies? And the reason why we need these studies is because data derived from the clinical trials, it’s something different. From the clinical trials we know about efficacy, tolerability, and safety in the group of patients without, let’s say major comorbidities that might influence your response to the drug...
What we know about the real-world studies is that the… Many different groups, research groups are in fact conducting these kinds of studies. And the first question is, why do we need these studies? And the reason why we need these studies is because data derived from the clinical trials, it’s something different. From the clinical trials we know about efficacy, tolerability, and safety in the group of patients without, let’s say major comorbidities that might influence your response to the drug. And that’s why real-world evidence studies conducted after registration of this medication are very important because they include the patients that we usually see in the clinical practice with the various comorbidities, with the complex clinical presentations, high frequency, persistent pain, also taking some other medications. All these aspects are important.
And that’s why when we have data, what we called real world data in this context, is important because it is kind of increase our confidence about the medications in terms of efficacy, safety, and tolerability and special group of patients showing that in… Even in this difficult to treat patients, that medications that we’re using now are efficacious. Okay? In the vast majority of patients. We see that they tried different medications before.
In one of our recent study from our group, we showed that even the patients taking… 50% of the patients tried seven different medications previously, they still responded to this new class of medication. In the real life, what is important now is that, to remember that these medications can be efficacious, even in the patients, with which we call difficult to treat, who tried different medications. We used to say, well, if the patients tried four or five medications, the likelihood that the new medication is going to work, it’s almost zero, right? But now from the evidence that we accumulating right now, we know that it’s not true. Even in these difficult to treat group of patients you can achieve nice results, such as let’s say that about 50 or 60% of the patient, they might report at least 50% reduction in monthly migraine days, which is a huge difference for somebody who has almost every day headache and very frequent migraine.
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Disclosures
Messoud Ashina is a consultant, speaker, or scientific advisor for AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis, Pfizer and Teva. Messoud Ashina is a primary investigator for ongoing AbbVie, Amgen and Lundbeck trials. Messoud Ashina has no ownership interest and does not own stocks of any pharmaceutical company.
