The FOCUS study demonstrated significant reduction in average monthly migraine days compared to placebo after inadequate response to 2 or more classes of preventive treatments (primary endpoint)1
Change from baseline in average monthly migraine days during the focus phase 3b study1,2
Improvements were seen as early as week 1 and were sustained throughout the 3-month treatment period (exploratory endpoint)1†
Patients who achieved ≥50% reduction in monthly average migraine days1
PERCENTAGE OF PATIENTS ACHIEVING ≥50% REDUCTION IN AVERAGE MONTHLY MIGRAINE DAYS VS PLACEBO DURING THE 12-WEEK STUDY PERIOD (SECONDARY ENDPOINT)1,2
34% of patients achieved a ≥50% reduction of average monthly migraine days with either monthly or quarterly dosing vs 9% for placebo (P<0.0001) (secondary endpoint)1
Results in patients with an inadequate response to anticonvulsants or neurotoxins (exploratory analysis)‡
- 3.8 mean reduction from baseline in monthly average migraine days for both monthly and quarterly arms vs 1.0 for placebo in patients with previous anticonvulsant use2
- 2.7 and 3.2 mean reduction from baseline in monthly average migraine days for both monthly and quarterly dosing arms, respectively, vs 0.2 for placebo in patients who previously used neurotoxins2
‡For all exploratory analyses, no determination of statistical significance can be made and no conclusions should be drawn.
Patients experienced a significant reduction in the monthly average number of days using migraine-specific acute headache medication (secondary endpoint)2
- Mean reduction of 3.9 days for monthly dosing and 3.7 days for quarterly dosing of migraine-specific acute headache medication use vs 0.6 days with placebo2
Were you referred a patient for the management of their migraine? See why Dr Ailani thinks AJOVY may be an appropriate treatment option.Show Transcript
Hello. Thank you for joining us to learn more about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Today I’d like to discuss with you: what does sustained efficacy mean with AJOVY?
My name is Dr Jessica Ailani and I’m a board-certified neurologist with a sub-specialty in headache as well as a professor of clinical neurology at Medstar Georgetown University Hospital.
I’m sure you’ve experienced something similar to the following scenario: a patient is referred to you because their migraine is not well controlled with their treatment plan, and so you decide that a change is needed. Which preventive therapy would you prescribe next?
Let’s take a look at why AJOVY may be an appropriate option for your patients. We’ll cover how AJOVY is different and review its clinical profile.
AJOVY is indicated for the preventive treatment of migraine in adults. It is also contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.
So—How is AJOVY different?
AJOVY is a fully humanized IgG2Δa monoclonal antibody.
It also has a long half-life of 31 days. Once steady state is reached, elimination of AJOVY is similar for monthly and quarterly dosing, which is approximately 5 to 6 half-lives.
Furthermore, the binding of AJOVY is selective. AJOVY was found to attach to what it’s supposed to target—that is, the CGRP ligand—and not to other related calcitonin family members. It’s helpful when starting your patients on a preventive therapy to know that AJOVY selectively targets the CGRP ligand and nothing more.
As we move on to review the clinical profile, keep in mind 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.
Let us now take a look at the clinical profile that established…
…sustained efficacy with no evidence of “wearing off” for AJOVY, starting with data from the HALO and Long-Term Extension studies. Afterwards we will review the FOCUS trial and see how its findings may also be relevant to your clinical practice in treating patients who aren’t seeing a sufficient improvement with their migraine.
AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials.
Patients were randomized to either AJOVY Monthly dosing, AJOVY Quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, run-in period, followed by a 12-week intervention period, with a 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.
Please note that the long-term extension study was not placebo-controlled, but patients were blinded as to the dosing regimen.
The primary endpoint investigated during this 12-week period in the HALO chronic migraine trial was the mean change from baseline in the monthly average number of headache days of at least moderate severity for both monthly and quarterly dosing options.
Please note that in today's presentation, we'll only be looking at data from the chronic migraine trial. If you'd like to review the results for episodic migraine, please visit AJOVYhcp.com.
In the HALO Chronic Migraine study, AJOVY monthly dosing demonstrated a statistically significant improvement, with a mean reduction from baseline of 5.1 headache days at month 3 versus 3.3 days for placebo, as we see here. In the long-term extension study, the mean reduction was 6.8 headache days with monthly dosing. Similar results were seen in patients with quarterly dosing.
Let’s now take a look at the post hoc analyses that investigated “wearing off” for selected dosing periods of AJOVY.
These selected dosing periods were assessed by looking at data for patients from the HALO trials who rolled over into the Long-Term Extension study. Once again, let’s focus on patients with chronic migraine.
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 weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Here are the numbers for the weekly average number of migraine days during weeks 1 through 3. And now compared to the number of migraine days during the end of the dosing period, or week 4. As we can see, the weekly number of migraine days was similar between weeks 1 through 3 and week 4, and that was true across all the months shown. Note, for all post hoc analyses, no determination of statistical significance can be made and no conclusions should be drawn.
We therefore see that there is no evidence of “wearing off” for AJOVY from one dose to the next. Have you observed any such trends in your clinical practice? With AJOVY, you can give your patients the chance to experience lasting protection against migraine.
Please be reminded that the most common adverse reactions in clinical trials (at least 5% and greater than placebo) were injection site reactions.
The adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo in the HALO trials are shown here.
And in the Long-Term Extension study, the adverse reactions that occurred in more than 6% of patients were as shown above.
Another study that may be relevant to your clinical practice is the FOCUS trial. FOCUS was a phase 3b, 12-week, multicenter, randomized, double-blind, placebo-controlled study. It evaluated chronic and episodic migraine patients, on monthly or quarterly doses of AJOVY, who experienced an inadequate response to 2 or more classes of prior preventive treatments. The most common reason for inadequate response was poor efficacy in all arms of the study.
The primary endpoint looked at the mean change from baseline in the monthly average number of migraine days during the 12-week period.
Here are the results: patients who received the monthly dose of AJOVY experienced 4.1 fewer monthly migraine days on average versus 0.6 days with placebo. Patients on the quarterly dose experienced similar results.
Furthermore, during the 12-week period, 34% of patients on a monthly dose of AJOVY saw a 50% reduction or more in their mean monthly number of migraine days versus 9% on placebo. Similar results were seen in patients on the quarterly dose of AJOVY.
These findings suggest that AJOVY may be appropriate for your migraine patients who, based on your clinical experience, you believe may not be getting results that are adequate. It’s something to consider when choosing a preventive therapy for your patients.
We’ve finished reviewing the FOCUS study with the safety data you see here. These were the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo.
With all the information we presented here today, we hope you find the right migraine therapy for your patients who are experiencing an inadequate efficacy response from their current treatment. Living with migraine is a great challenge too many people face, and so we hope your patients get the results they seek. To give them a chance to have more migraine-free days, prescribe AJOVY—the long-acting, anti-CGRP injection with lasting protection against migraine. You can learn more about AJOVY at AJOVYhcp.com, where you can consult the full Prescribing Information and more. Thank you very much for watching.