AJOVY® clinical trials summary

*Documented failure was defined as at least one of the following: Lack of efficacy after at least 3 months of therapy at a stable dose, patient cannot tolerate the drug, drug is contraindicated for the patient, or drug is not suitable for the patient.5

†Preventive treatment classes were defined as: Beta-blockers (propranolol, metoprolol, atenolol, and bisoprolol), anticonvulsants (topiramate), tricyclic antidepressants (amitriptyline), calcium channel blocker (flunarizine), angiotensin II receptor antagonist (candesartan), onabotulinumtoxinA, and valproic acid.5

HALO EM and CM

The HALO Phase III trials were randomised, double-blind*, multicentre trials in patients
with episodic or chronic migraine

*Blinded to dosage regimen.

†Licensed starting dose for monthly treatment in chronic migraine is 225mg.

HALO EM secondary endpoints:2

Proportion of patients reaching ≥50% reduction in monthly average number of migraine days from Baseline to Week 12

Mean change from Baseline to Week 12 in monthly average number of days of acute headache medication use

Mean change from Baseline in the number of migraine days during the four-week period after the first dose

Mean change from Baseline to Week 12 in monthly average number of migraine days in patients not receiving concomitant preventive migraine medications

Mean change from Baseline to Week 12 in disability score, as measured by the Migraine Disability Assessment (MIDAS) questionnaire at four weeks after administration of the last dose

 

HALO CM secondary endpoints:3

Mean change from Baseline to Week 12 in monthly average number of migraine days

Proportion of patients reaching ≥50% reduction from Baseline to Week 12 in monthly average number of headache days of ≥moderate severity

Mean change from Baseline to Week 12 in monthly average number of days of acute headache medication use

Mean change from Baseline in monthly average number of headache days of ≥moderate severity during the four week period after the first dose

Mean change from Baseline to Week 12 monthly average number of headache days of ≥moderate severity in patients not receiving concomitant preventive migraine medications

Mean change from Baseline in the disability score, as measured by the Headache Impact Test (HIT-6) at four weeks after administration of the last dose

HALO patient Baseline characteristics

 

*Patients were allowed to use 1 of the following: beta blocker, calcium channel blocker/benzocycloheptene, antidepressant, anticonvulsant. †Defined as a calendar day with either at least 2 (HALO EM) or 4 (HALO CM) consecutive hours of a headache meeting criteria for migraine (with or without aura); probable migraine (only 1 migraine criterion absent); or a day, regardless of duration, when acute migraine-specific medication (triptans or ergots) was used to treat a headache. ‡Defined as a calendar day in which headache pain lasted at least 4 consecutive hours and had a peak severity of at least a moderate level, or a day in which acute migraine-specific medication (triptans or ergots) was used to treat a headache of any severity or duration. 

CM, chronic migraine; EM, episodic migraine; HIT-6, six-item headache impact test; MIDAS, migraine disability assessment; SD, standard deviation.

 

 

HALO LT

THE HALO LT Phase III trial was a randomised, double-blind*, multicentre,
parallel-group study in patients with episodic and chronic migraine4,6

*Blinded to dosage regimen.

†Licensed starting dose for monthly treatment in chronic migraine is 225mg.

HALO LT patient Baseline characteristics

 

*In the ITT population, defined as all randomised/rolled-over patients. †A calendar day in which the patient reported either headache pain that lasted ≥4 hours (CM) or ≥2 hours (EM) consecutively, which met criteria for migraine or probable migraine; or a day when a headache of any duration was treated with migraine-specific medications (triptans or ergots). ‡A calendar day in which the patient reported either a day with headache pain that lasted ≥4 hours consecutively with a peak severity of at least moderate severity, or a day when acute migraine-specific medications (triptans or ergots) were used to treat a headache of any severity or duration. 

CM, chronic migraine; EM, episodic migraine; LT, long-term; SD, standard deviation.

 

 

FOCUS

The FOCUS Phase IIIb trial was a randomised, double-blind, multicentre trial in episodic and chronic migraine patients who had documented failure* to 2–4 classes of prior preventive treatments5

*Documented failure was defined as at least one of the following: Lack of efficacy after at least 3 months of therapy at a stable dose, patient cannot tolerate the drug, drug is contraindicated for the patient, or drug is not suitable for the patient.

†Licensed starting dose for monthly treatment in chronic migraine is 225mg.

Secondary endpoints:5

Change from Baseline in the monthly average number of migraine days during the 4-week period after the first dose of AJOVY®

Proportions of patients with a ≥50% response (i.e. patients achieving a ≥50% reduction in the monthly average number of migraine days during the 4-week and 12-week periods

after the first dose of AJOVY®)

Change from Baseline in the monthly average number of headache days of at least moderate severity during the 4-week and 12-week periods

after the first dose of AJOVY®

Change from Baseline in the days of use of any acute headache medications during the 12-week period after the first dose of AJOVY®

 

Prespecified exploratory endpoints:5

Proportions of patients with a ≥75% response (i.e. participants achieving ≥75% reduction in the monthly average number of migraine days) and those with

a 100% response (no migraine days) during the 12-week period after the first dose of study drug

Proportion of patients with a 100% response (no migraine days) for at least 1 month over 12 weeks

Proportions of patients who achieved a ≥50% and ≥75% response during the first 4 weeks and maintained that response through 12 weeks

Mean changes from Baseline during the 12-week period after the first dose of study drug in the monthly average number of headache hours of at least moderate severity,

days with nausea or vomiting, days with photophobia and phonophobia, and days of use of migraine-specific acute headache medications

Mean changes from Baseline at 4 weeks after administration of the third dose of AJOVY® in disability scores including MIDAS and HIT-6

 

FOCUS patient Baseline characteristics5

 

SD, standard deviation.

 

 

Suggestions to explore next

Continue to Efficacy page of AJOVY

Significantly more migraine-free days vs placebo1-4,7

EFFICACY OF AJOVY®
Continue to Safety page of AJOVY

A generally well-tolerated treatment choice1-4,7

safety profile of ajovy®
Continue to Flexibility page of AJOVY

Flexibility to help you meet your patients’  needs1,5

Flexibility of ajovy®