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Patient-Reported Outcomes Data on Adverse Events


A migraine expert discusses clinical trial data on 2 CGRP monoclonal antibodies regarding adverse events and safety primary end points.


Neil Minkoff, MD: The change between looking at claims data for overall effectiveness vs being able to manage or evaluate it on a per-patient basis, my understanding, and I’ll ask Dr Nahas if she could comment on this, is that 2 of the agents have some quality-of-life data. Erenumab and fremanezumab have some data, in terms of looking either at patient-reported outcomes or quality-of-life studies. Is that something you could touch on, please?

Stephanie J. Nahas, MD, MSEd, FAHS, FAAN: Sure. There are data with respect to quality of life and patient-reported outcomes for all of these treatments.

Neil Minkoff, MD: OK.

Stephanie J. Nahas, MD, MSEd, FAHS, FAAN: But in the interest of time, we’ll focus on just a couple of them. With erenumab specifically, there was a study looking at a number of different measures of quality of life. A Migraine-Specific Quality of Life Questionnaire was used, which asks about role functioning and emotional functioning. Two other measures of disability used were the HIT-6 [Headache Impact Test-6], which is the headache impact test, a 6-item questionnaire, and the MIDAS screener which was mentioned earlier, or the Migraine Disability Assessment Scale. There is also PROMIS, or a Patient-Reported Outcomes Measurement Information System. That also has scales to measure pain interference, for example. All of these patient-reported outcome measures were looked at with erenumab.

In the 12-week trials, all of these, at 3 months, showed significant improvements above and beyond those patients who were treated with placebo. Even at 1 month, most of these end points were met, above and beyond, for those patients treated with active drug vs placebo. Erenumab was studied in 2 different doses, 70 mg or 14 mgs monthly, against placebo. Both of these doses performed similarly.

With respect to the MIDAS scale specifically, this asks about time lost in days. When you look at the end of 3 months, the patients who had active treatment got 20 functional days of their lives back, compared with about 7 and a half days back for those treated with placebo. Again, it speaks to the importance of not just looking at pain and other symptoms, but giving time back to our patients. This is a life-robbing disease.

We have other data for fremanezumab. This was an interesting subpopulation of the overall clinical trials. This looked at, in the entire group of about 1000 trial participants, 30% of whom had previously used topiramate. We have 338 individuals we’re talking about here. Again, this looked at placebo vs both dosing options of fremanezumab, either the monthly injection of 225 mg every 4 weeks or the quarterly injection of 675 mg every 12 weeks.

Looking at the Migraine-Specific Quality of Life Questionnaire, the role scores improved, whereas the emotional scores did not, for the patients who were on treatment vs placebo. This is in a subset of patients who previously had had topiramate, and had already been let down by topiramate, which is one of the most commonly used preventive medications that we’ve had available until these monoclonal antibodies came out. It speaks to how these drugs can make an impact on people’s lives, even if they’ve experienced prior treatment failures.

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