Patients experienced significantly more migraine-free days with AJOVY vs placebo in the HALO + Long-Term Extension Studies1,3-5
See Study Design
Consider limitations of Long-Term Extension study design when interpreting efficacy results.
Patients randomized to monthly dosing had a mean baseline of 8.9 migraine days per month and experienced, on average1:
4.3 fewer migraine days at month 3 vs 3.1 with placebo (P<0.001).1,3
Patients randomized to quarterly dosing had a mean baseline of 9.2 migraine days per month and experienced, on average1:
4.2 fewer migraine days at month 3 vs 3.1 with placebo (P<0.001).1,3
*Mean baseline of 8.9 migraine days per month with monthly dosing.1
†Reduction in monthly average number of migraine days from the Long-Term Extension study was 5.1 with monthly dosing.3
No evidence of “wearing off” with AJOVY was
observed from one dose to the next2
POST HOC WEEKS 1-3 VS 4
Mean number of weekly migraine days during weeks 1-3
vs week 4 at months 3, 6, 9, and 15 with monthly dosing2‡
POST HOC WEEKS 1-2 VS 11-12
Mean number of weekly migraine days in weeks 1-2
vs weeks 11-12 with quarterly dosing2‡
For all post hoc analyses, no determination of statistical significance can be made and no conclusions should be drawn.
‡Study design: Of the patients who rolled over from the HALO studies, 611 from the HALO CM study (monthly, n=305; quarterly, n=306) and 432 from the HALO EM study (monthly, n=215; quarterly, n=217) had received AJOVY injection during the respective HALO study and were included in post hoc analyses during the long-term, open-label extension study.2
Listen to Dr Torphy review data related to episodic migraine and the long-acting effect of AJOVY.1*Show Transcript
Hello - thanks for joining me today to learn more about long-acting protection against migraine with AJOVY. Before we get into it, allow me to introduce myself. I’m Dr Brad Torphy—Managing Director of Chicago Headache Center and Research Institute.
Something important to consider when prescribing a preventive migraine medication—will it wear off or last to the next dose? That’s why I want to talk to you today about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine.
As a reminder, AJOVY is indicated for the preventive treatment of migraine in adults. Please note, AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.
During this presentation, we’ll take an in-depth look at the clinical trials to review how AJOVY demonstrated sustained efficacy, reductions in use of acute medication, and no evidence of wearing off from one dose to the next. Before reviewing the clinical results, let’s first look at the trial designs for both the HALO trial and the Long-Term Extension study. The HALO study consisted of two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials. Patients were randomized in either AJOVY monthly dosing, AJOVY quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, and a run-in period, followed by a 12-week intervention period, with final evaluation at Week 12.
Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial. The Long-Term Extension study was not placebo controlled, but patients were blinded as to the dosing regimen.
Please note, today we will only be looking at the episodic migraine results. If you’d like to see the results for chronic migraine, please visit AJOVYhcp.com.
The primary endpoint in the HALO episodic migraine trial was mean change from baseline in the monthly average number of migraine days for both monthly and quarterly dosing options during the 12-week period. As you can see, AJOVY demonstrated a statistically significant improvement in the mean reduction from baseline of 4.3 migraine days at month 3 versus 3.1 days for placebo. The Long-Term Extension study further demonstrated a mean reduction of 5.1 migraine days with monthly dosing. Similar results were observed for patients taking quarterly dosing.
Be aware that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
I want to also mention a secondary endpoint of the HALO trial—change in use of acute medication. During the 12-week treatment period, patients with episodic migraine receiving the AJOVY monthly dosing regimen had a 3-day reduction in the average number of days of use of acute headache medication compared with 1.6 days for placebo. Similar results were also seen in chronic migraine. This endpoint tells us that patients taking AJOVY significantly decreased their need for acute medication. What might these data mean for your patients?
Now I want to take you through the post hoc analyses that showed no evidence of AJOVY wearing off from one dose to the next. To assess these dosing periods, data for patients with chronic and episodic migraine from the HALO trials who rolled over into the Long-Term Extension study were included in the post hoc analyses. We will, again, only be discussing the episodic patients.
The analyses looked at the mean number of weekly migraine days in patients on monthly dosing during months 3, 6, 9, and 15. Each of these months—3, 6, 9, and 15—was split into two: weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Let’s look at the figures for the weekly average number of migraine days during weeks 1 through 3. And now, let’s compare them with the number of migraine days during week 4. As you can see, the weekly number of migraine days was similar between the beginning and the end of the dosing period, across all months shown. Note, for all post hoc analyses, no determination of statistical significance can be made, and no conclusions should be drawn.
Now, let’s think back to our consideration for preventive migraine therapy, “Will it wear off or last until the next dose?” With these data in mind, wouldn’t you consider AJOVY an appropriate option for your patients needing preventive therapy?
Of course, safety must be considered before making any decisions, so let’s take a look at those results from the HALO and Long-Term Extension studies. Shown here are the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo from the HALO trial.
In the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients. It’s important to mention that no new safety signals were identified in the Long-Term Extension study.
Before we wrap things up, I want to remind you that patients have an option to take AJOVY either monthly or quarterly. Having such options may help your patients stay protected—whatever their lifestyle and schedules demand from them. You and your patients should decide together which option would be best.
Thank you for watching my presentation today. I hope the information I’ve shared helps you and your practice.
Remember, AJOVY is the long-acting anti-CGRP injection with lasting protection against migraine. If you need additional details, or the full Prescribing Information, please visit AJOVYhcp.com.