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Drug Trials Snapshots: AIMOVIG

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the AIMOVIG Package Insert for complete information.

AIMOVIG (erenumab-aooe)
AIM-oh-vig
Amgen
Approval date: May 17, 2018


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

AIMOVIG is a drug used for the preventive treatment of migraine in adults.

A migraine is a type of headache that can be associated with nausea, vomiting, and sensitivity to light, sound, or smell.

How is this drug used?

AIMOVIG is an injection given under the skin (subcutaneous) once a month.

What are the benefits of this drug?

Patients treated with AIMOVIG experienced fewer days of migraine headaches per month in comparison to patients who received placebo treatment.

What are the benefits of this drug (results of trials used to assess efficacy)?

The figures below summarize efficacy results for the evaluated subjects for Trials 1, 2, and 3. The primary outcome was the change in monthly migraine days (MMD).

Figure 4: Change from Baseline in Monthly Migraine Days in Trial 1a

Figure summarizes efficacy results for clinical trial 1.

a Least square means and 95% confidence intervals are presented.

Change from Baseline in Monthly Migraine Days in Trial 2a

Table summarizes efficacy results for clinical trial 2.

a Least square means and 95% confidence intervals are presented.

Figure 5: Change from Baseline in Monthly Migraine Days in Trial 3a

Table summarizes efficacy results for clinical trial 1.

a Least square means and 95% confidence intervals are presented.

AIMOVIG Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex AIMOVIG worked similarly in men and women.
  • Race: The majority of patients were White. The number of patients in other races were limited; therefore, differences in side effects among races could not be determined.
  • Age: AIMOVIG worked similarly in patients younger or older than 40 years of age.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The tables below summarize efficacy results by sex, race and age. Racial subgroup differences were investigated between White race and all other races combined since the majority of patients were White.

Table 2. MMD Findings in Subgroup Populations (Trial 1)

Sub-group Arm Baseline Mean (SE) Change over Months 4, 5, 6 Effect Diff (95% CI)
  Sex Female Placebo 8.31 (2.55) -1.73  
AIMOVIG 70 mg 8.32 (2.46) -3.36 -1.62 (-2.15, -1.09)
AIMOVIG 140 mg 8.40 (2.47) -3.7 -1.97 (-2.49, -1.44)
Male Placebo 7.89 (2.20) -2.48  
AIMOVIG 70 mg 8.28 (2.37) -2.5 -0.02 (-1.25, 1.21)
AIMOVIG 140 mg 7.92 (2.49) -3.49 -1.00 (-2.24, 0.24)
Race Non-White Placebo 7.88 (2.47) -4.43  
AIMOVIG 70 mg 8.47 (2.85) -4.17 0.26 (-1.26, 1.77)
AIMOVIG 140 mg 8.84 (2.99) -3.65 0.77 (-0.86, 2.41)
White Placebo 8.31 (2.51) -1.56  
AIMOVIG 70 mg 8.29 (2.40) -3.19 -1.63 (-2.14, -1.11)
AIMOVIG 140 mg 8.28 (2.43) -3.73 -2.17 (-2.67, -1.66)
  Age <>
(42.0)
Placebo 8.52 (2.58) -1.81  
AIMOVIG 70 mg 8.23 (2.40) -2.93 -1.12 (-1.83, -0.42)
AIMOVIG 140 mg 8.13 (2.36) -3.41 -1.60 (-2.30, -0.90)
≥Median Placebo 7.98 (2.41) -1.9  
AIMOVIG 70 mg 8.39 (2.50) -3.47 -1.57 (-2.24, -0.90)
AIMOVIG 140 mg 8.53 (2.58) -3.86 -1.96 (-2.63, -1.28)

Adapted from FDA Review

Table 3 MMD Findings in Subgroup Populations (Trial 2)

Sub-group Arm Baseline Mean (SE) Change at Week 12 Effect Diff (95% CI)

Sex
 
Female Placebo 8.53 (2.66) -1.77  
AIMOVIG 70 mg 8.18 (2.52) -2.99 -1.22 (-1.84, -0.60)
Male Placebo 7.55(2.02) -2.20  
AIMOVIG 70 mg 7.85(2.88) -2.35 -0.14 (-1.58, 1.29)
Race Non- White Placebo 8.65 (3.31) -4.39   
AIMOVIG 70 mg 7.26 (2.26) -3.28 1.03 (-0.91, 2.97)
White Placebo 8.35 (2.49) -1.62   
AIMOVIG 70 mg 8.22 (2.59) -2.92 -1.31 (-1.90, -0.72)
Age <>
(42.0)
Placebo 8.37 (2.49) -1.53   
AIMOVIG 70 mg 8.07 (2.55) -2.75 -1.22 (-2.10, -0.33)
≥Median Placebo 8.39 (2.67) -2.14   
AIMOVIG 70 mg 8.19 (2.59) -3.02 -0.87 (-1.61, -0.14)

Adapted from FDA Review

Table 4. MMD Findings in Subgroup Populations (Trial 3)

Sub-group Arm Baseline Mean (SE) Change at Week 12 Effect Diff (95% CI)

Sex
  
Female Placebo 8.53 (2.66) -4.13   
AIMOVIG 70 mg 17.96 (0.35) -6.75 -2.62 (3.79, -1.45)
AIMOVIG 140 mg 17.99 (0.35) -6.59 -2.46 (-3.64, -1.29)
Male Placebo 18.21 (0.70) -4.41   
AIMOVIG 70 mg 17.78 (0.60) -6.18 -1.76 (-4.56, 1.03)
AIMOVIG 140 mg 16.62 (1.1) -6.83 -2.42 (-5.03, 0.18)
Race Non- White Placebo 17.39 (1.28) -4.39  
AIMOVIG 70 mg 17.77 (1.05) -8.31 -3.92 (-7.86, 0.01)
AIMOVIG 140 mg 16.00 (1.67) -7.51 -3.12 (-8.27, 2.02)
White Placebo 18.30 (0.29) -4.17  
AIMOVIG 70 mg 17.96 (0.33) -6.48 -2.30 (-3.41, -1.19)
AIMOVIG 140 mg 17.84 (0.35) -6.61 -2.44 (-3.53, -1.34)
Age <>
(43.0)
Placebo 18.32 (0.40) -4.65  
AIMOVIG 70 mg 18.29 (0.43) -8.02 -3.37 (-4.95, -1.79)
AIMOVIG 140 mg 18.72 (0.60) -7.23 -2.58 (-4.25, -0.91)
≥Median Placebo 18.16 (0.39) -3.8  
AIMOVIG 70 mg 17.58 (0.47) -5.24 -1.45 (-2.88, -0.02)
AIMOVIG 140 mg 17.1 (0.39) -6.18 -2.39 (-3.76, -1.02)

Adapted from FDA Review

What are the possible side effects?

The most common side effects of AIMOVIG are injection site reactions and constipation.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions in adult patients with chronic or episodic migraine headaches in combined trials (safety population).

Table 5. Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIG and at Least 2% Greater than Placebo During the First 3 Months (12 Weeks) in Trials 1, 2, and 3

Adverse Reaction Preferred Term AIMOVIG
70 mg Once Monthly
(N = 787)
%
AIMOVIG
140 mg Once Monthly
(N = 507)
%
Placebo
(N = 890)
%
Injection site reactionsa 6 5 3
Constipation 1 3 1
Cramps, muscle spasms <> 2 <>

aInjection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema.

AIMOVIG Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
  • Age: The occurrence of side effects was similar in patients younger or older than 40 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes the occurrence of the most common adverse reaction, injection site reaction, by subgroup.

Table 6 Subgroup Analysis of Injection Site Reaction (safety population)

Demographic Parameters AIMOVIG
n/N (%)
PLACEBO
n/N (%)
Sex
Male 4/189 (2.1%) 11/147 (7.5%)
Female 87/1105 (7.9%) 45/743 (6.1%)
Race
White 80/1186 (6.7%) 50/798 (6.3%)
Black or African American 9/81 (11.1%) 5/62(8.1%)
Asian 1/13 (7.7%) 0
Other 1/14 (7.1%) 1/18 (5.6%)
Age Group
40 years of age 53/555 (9.5%) 30/401 (7.5%)
> 40 years of age 338/739 (5.1%) 26/489 (5.3%)

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved AIMOVIG based on evidence from 3 clinical trials, Trial 1 (# NCT02456740), Trial 2 (#NCT02483585) and Trial 3 (#NCT02066415) of 2184 patients with chronic or episodic migraine headaches.

Trials were conducted at 219 sites in Canada, Europe, and the United States.

Figure 1 summarizes how many men and women were enrolled in the clinical trials used to evaluate safety.

Figure 1. Baseline Demographics by Sex (safety population)

Pie chart summarizing how many males and females were in the clinical trials. In total, 336 males (15%) and 1848 (85%) females participated in the clinical trials.

FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trials used to evaluate safety.

Figure 2. Baseline Demographics by Race (safety population)

Pie chart summarizing the percentage of patients by race enrolled in the clinical trials. In total, 1984 White (91%), 143 Black or African American (7%), 26 Asian (1%) and 31 Other patients (1%) participated in the clinical trials.

FDA Review

Table 1. Demographics of Safety Trials by Race

Race Number of Patients Percentage of Patients
White 1984 91%
Black or African American 143 7%
Asian 26 1%
Other 31 1%

FDA Review

Figure 3. Baseline Demographics by Age (safety population)

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trials. In total, 956 patients (44%) were 18 to 40 years old, and 1228 patients (56%) were 41 years and older

FDA Review

Who participated in the trials?

Table 7. Summary of Demographic Characteristics (Safety population)

Demographics AIMOVIG Treatment Group Placebo Total
70mg
N=787
n (%)
140mg
N=507
n (%)
N=890
n (%)
N=2184
n (%)
Sex
Male 113 (14.4) 76 (15.0) 147 (16.5) 336 (15.4)
Female 674 (85.6) 431 (85.0) 743 (83.5) 1848 (84.6)
Race
White 711 (90.3) 475 (93.7) 798 (89.7) 1984 (90.8)
Black or African American   57 (7.2)   24 (4.7)   62 (7.0)   143 (6.5)
Asian 10 (1.3) 4 (0.8) 12 (1.3) 26 (1.2)
American Indian or Alaska Native 0 1 (0.2) 2 (0.2) 3 (0.1)
Native Hawaiian or Other Pacific Islander 0 1 (0.2) 1 (0.1) 2 (0.1)
Other or multiple 9 (1.1) 2 (0.4) 15 (1.7) 26 (1.2)
Age, years
Mean years (SD) 41.7 (11.2) 41.3 (11.2) 41.8 (11.1) 41.5 (11.2)
Median (years) 43 43 42 42
Min, max (years) 18, 65 18, 65 18, 66 18, 66
Age Group
18-40 338 (42.9) 217 (42.8) 401 (45.0) 956 (43.8)
41-55 357 (45.4) 239 (47.1) 370 (41.6) 966 (44.2)
56-66 92 (11.7) 51 (10.1) 119 (13.4) 262 (12.0)
Ethnicity
Hispanic or Latino 54 (6.9) 32 (6.3) 75 (8.4) 161 (7.4)
Not Hispanic or Latino   733 (93.1)   475 (93.7)   815 (91.6)   2023 (92.6)
Region
North America (USA/CAN) 383 (48.7) 248 (48.9) 461 (51.8) 1092 (50.0)
Rest of the World 404 (51.3) 259 (51.1) 429 (48.2) 1092 (50.0)

Clinical Trial Data

 

How were the trials designed?

The benefit and side effects of AIMOVIG were evaluated in three clinical trials of adult patients 18 – 65 years of age with a history of migraine headaches. Each trial was designed differently.

Trial 1 enrolled patients with a history of episodic migraine headaches. Patients were assigned to receive one of two doses of AIMOVIG or placebo injections every month for 6 months. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of AIMOVIG was assessed based on the change in the number of migraine days per month in the last 3 months of treatment, comparing patients in the AIMOVIG and placebo groups.

Trial 2 enrolled patients with a history of episodic migraine headaches. Patients were assigned to AIMOVIG or placebo injections every month for 3 months. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of AIMOVIG was assessed based on the change in the number of migraine days per month from start of the trial to the last month of the treatment, comparing patients in the AIMOVIG and placebo groups.

Trial 3 enrolled patients with a history of chronic migraine headaches. Patients were assigned to receive one of two doses of AIMOVIG or placebo injection every month for 3 months. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of AIMOVIG was assessed based on the change in the number of migraine days per month from start of the trial to the last month of treatment, comparing the AIMOVIG and placebo groups.

How were the trials designed?

The efficacy and safety of AIMOVIG were evaluated in three clinical trials.

Trial 1 was a randomized, multi center, 6-month, placebo controlled, double blind trial evaluating AIMOVIG for the preventive treatment of episodic migraine, in adult patients, with a history of less than 15 headache days per month with 4 to 14 migraine days per month. Patients were randomized to receive AIMOVIG 140 mg, AIMOVIG 70 mg, or placebo every month for 6 months. Patients were allowed to use acute headache treatments. The primary efficacy endpoint was the change in MMD from baseline to the last 3 months of the 6-month treatment period.

Trial 2 was a randomized, multi center, 3-month, placebo controlled, double blind trial evaluating AIMOVIG for the preventive treatment of episodic migraine in adult patients with a history of migraine with or without aura for 12 months or longer and 4 – 14 migraine days per month. Patients were randomized to receive a subcutaneous injection of AIMOVIG 70 mg or placebo monthly for 3 months. Patients were allowed to use acute headache treatments (including triptans, ergotamine derivatives and NSAIDs) during the trial. The primary efficacy endpoint was the change in monthly migraine days (MMD) from baseline to the last month of the 3-month treatment period.

Trial 3 This trial was a randomized, multi center, 3-month, placebo controlled, double blind trial evaluating AIMOVIG for the preventive treatment of chronic migraine, in adult patients, with a history of at least 15 headache days per month with 8 or more migraine days per month. Patients were randomized to receive AIMOVIG 140 mg, AIMOVIG 70 mg, or placebo monthly for 3 months. Patients were allowed to use acute headache treatments during the trial. The primary efficacy endpoint was the change in MMD from baseline during the last month of the 3-month treatment period.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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