MET

HO

DS

AD

DL

INFO

CO

NC

LUSI

ON

S

IN

TRO

DU

CTI

ON

Participants• A total of 910 participants were randomized, including 902 in the safety population and 873 in the efficacy analysis population (modified intent-to-treat population)

• Across all treatment groups, 88.5% (805/910) of participants completed the 12-week double-blind treatment period

• Participants were on average 41.6 years of age and primarily female, white, and on average overweight (Table 1)

• The mean (standard deviation [SD]) number of monthly migraine days ranged from 7.2 to 7.7 during the 3 months prior to starting treatment

Table 1. Baseline Demographics in the Safety Population

Placebo (n=222)

Atogepant 10 mg QD

(n=221)

Atogepant 30 mg QD

(n=228)

Atogepant 60 mg QD

(n=231)Total

(N=902)

Age, mean (SD), y

40.3 (12.8)

41.4 (12.1)

42.1 (11.7)

42.5 (12.4)

41.6 (12.3)

Sex, female 89.2% 90.5% 89.5% 86.1% 88.8%

Race, White 87.4% 81.9% 81.1% 83.1% 83.4%

Ethnicity, non-Hispanic 89.6% 90.5% 91.7% 93.9% 91.5%

BMI, mean (SD), kg/m2

30.8 (8.7)

30.4 (7.6)

31.2 (7.6)

29.9 (7.3)

30.6 (7.8)

BMI, body mass index; QD, once daily; SD, standard deviation.

Background• Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist in development for the preventive treatment of migraine

• The efficacy, safety, and tolerability of atogepant were first demonstrated in a phase 2/3 dose-ranging trial

• The current phase 3 trial examines the efficacy, safety, and tolerability of oral atogepant 10 mg, 30 mg, and 60 mg administered once daily compared with placebo for the preventive treatment of migraine

Objective• To evaluate the efficacy, safety, and tolerability of atogepant for the preventive treatment of migraine

• Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (NCT03777059)

• Adults (18–80 years) with ≥1-year history of migraine (with or without aura) based on International Classification of Headache Disorders, 3rd edition, criteria and experiencing 4–14 migraine days/month

• Participants were randomized 1:1:1:1 to atogepant 10 mg, 30 mg, or 60 mg or placebo taken orally once daily for 12 weeks (Figure 1)

• Efficacy assessments were recorded by the participant in an electronic diary at home or via eTablet at the trial site during clinic visits

Primary Efficacy Endpoint• Change from baseline in mean monthly migraine days (MMDs) across the 12-week treatment period

Thank you to all the participants and investigators who participated in this study!

This study was sponsored by Allergan (prior to its acquisition by AbbVie). Medical writing and editorial assistance were provided to the authors by Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and were funded by AbbVie. All authors met the ICMJE authorship criteria. Neither honoraria nor other form of payment was made for authorship. Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. Jessica Ailani, MD, has served as a consultant for AbbVie, Amgen, Axsome, CtrlM, Eli Lilly and Company, Lundbeck, Impel, Satsuma, Theranica, Teva, and Vorso; has served as a speaker for AbbVie, Amgen, Eli Lilly and Company, Lundbeck, and Teva; has received honoraria from Medscape; and has provided editorial services to Current Pain and Headache Reports, NeurologyLive, and SELF magazine. Her institute has received clinical trial support from AbbVie, the American Migraine Foundation, Biohaven, Eli Lilly and Company, Satsuma, and Zosano. Richard B. Lipton, MD, serves on the editorial boards of Neurology and Cephalalgia and is a senior advisor for Headache. He has received research support from the National Institutes of Health. He also receives support from the Migraine Research Foundation and the National Headache Foundation. He has reviewed for the National Institute on Aging and National Institute of Neurological Disorders and Stroke; serves as consultant, advisory board member, or has received honoraria or research support from AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector, and Vedanta Research. He receives royalties from Wolff’s Headache, 8th edition (Oxford University Press, 2009), and Informa. He holds stock options in Biohaven. Peter J. Goadsby, MD, PhD, DSc, reports personal fees from AbbVie and related grants and personal fees from Amgen and Eli Lilly and Company; personal fees from Alder Biopharmaceuticals, Autonomic Technologies Inc., Dr. Reddy’s Laboratories, electroCore LLC, eNeura, Novartis, Scion, Teva Pharmaceuticals, and Trigemina Inc.; personal fees from MedicoLegal work, Massachusetts Medical Society, Up-to-Date, Oxford University Press, and Wolters Kluwer; and a patent Magnetic stimulation for headache assigned to eNeura without fee. Hua Guo, PhD, Rosa Miceli, RN, BSN, CCRC, Lawrence Severt, MD, PhD, Michelle Finnegan, MPH, and Joel M. Trugman, MD are employees of AbbVie and may hold AbbVie stock.

To obtain a PDF of this poster, • Scan the QR code

OR

• Visit: www.allergancongressposters.com/118808

Charges may apply. No personal information is stored.

Presented at the 2021 DHCREF Virtual Congress

Please note that the references are included within the document accessible via the QR code below.

Primary Efficacy Endpoint Was Met With All Atogepant Doses• Statistically significant reductions in mean MMDs across the 12-week treatment period were observed across all atogepant treatment groups vs placebo (Figure 2)

Figure 2. Reductions From Baseline in Mean MMDs at 12 Weeks

Atogepant 10 mg QD(n=214)

Atogepant 30 mg QD(n=223)

Atogepant 60 mg QD(n=222)

Placebo(n=214)

LS M

ean

Cha

nge

(SE

) in

MM

Ds

From

B

asel

ine

Acr

oss

the

12-W

eek

Trea

tmen

t Per

iod

–1.21*

–1.38*–1.72*

–5

–4.5

–4

–3.5

–3

–2.5

–2

–1.5

–1

–0.5

0

–2.48

–3.69–3.86

–4.20

*Statistically significant vs placebo; adjusted P<0.0001.Standard error = 0.21 for all treatment groups.LS, least squares; MMD, monthly migraine day; QD, once daily; SE, standard error.

Significant Improvements Were Achieved Across All 6 Secondary Endpoints• Atogepant 30 mg and 60 mg met all 6 secondary endpoints; atogepant 10 mg met the first 4 secondary endpoints (Figure 3)

Figure 3. Improvements in Secondary Efficacy Endpoints

Placebo(n=214)

Atogepant10 mg QD(n=214)

Atogepant30 mg QD(n=223)

Atogepant60 mg QD(n=222)

Par

ticip

ants

With

≥50

% R

educ

tion

in3-

Mon

th A

vera

ge M

MD

s, %

29%

+27%*

+30%*

+32%*

56% 59% 61%

0%

20%

40%

60%

80%

100%

P=0.0002 atogepant 60mg; P=0.0021 atogepant 30mg; P=0.0856 atogepant 10mg.

P<0.0001 atogepant 60mg; P=0.0005 atogepant 30mg; P=0.0856 atogepant 10mg.

P<0.0001 all doses.

P<0.0001 all doses.

P<0.0001 all doses.

P<0.0001 all doses.

≥50% Reduction in 3-Month Average of Monthly Migraine Days

Change from baseline in mean MHDs across the 12-week treatment period

Change from baseline in mean monthly acute medication use days across the 12-week treatment period

Change from baseline in MSQ v2.1 Role Function–Restrictive domainscore at week 12

Change from baseline in mean monthly AIM-D Performance of Daily Activitiesdomain score across the 12-week treatment period

Change from baseline in mean monthly AIM-D Physical Impairment domainscore across the 12-week treatment period

≥50% reduction in 3-month average of MMDs

*Statistically significant vs placebo; adjusted P<0.0001.Odds ratios and P-values are based on logistic regression with terms including treatment group and baseline value.AIM-D, Activity Impairment in Migraine–Diary; MHD, monthly headache day; MMD, monthly migraine day; MSQ v2.1, Migraine-Specific Quality of Life Questionnaire version 2.1; QD, once daily.

All atogepant doses demonstrated significant

improvements over placebo for the primary endpoint of reduction

in mean monthly migraine days

Atogepant appeared to be generally safe and well-tolerated with the

most commonly reported adverse event being

constipation

Atogepant offers the prospect of an effective and

well-tolerated once-daily migraine preventive

treatment

Figure 1. Study Design

Baseline/Screening

4 weeks

Placebo, QDAtogepant 10 mg, QDAtogepant 30 mg, QD Atogepant 60 mg, QD

Ran

dom

izat

ion

(Day

1)

Wee

k 12

Wee

k 16

(End

of T

rial)

Scre

enin

g/B

asel

ine

(Wee

k -4

)

V1

Double-blindTreatment12 weeks

Follow-up

4 weeks

V2 V3 V4 V5 V6 V7 V8

QD, once daily; V, visit.

Secondary Efficacy Endpoints• Change from baseline in mean monthly headache days (MHDs) across the 12-week treatment period

• Change from baseline in mean monthly acute medication use days across the 12-week treatment period

• ≥50% reduction in 3-month average of MMDs

• Change from baseline in Migraine-Specific Quality of Life Questionnaire, version 2.1 (MSQ v2.1) Role Function–Restrictive domain score at week 12

• Change from baseline in mean monthly Performance of Daily Activities domain score of the Activity Impairment in Migraine–Diary (AIM-D) across the 12-week treatment period

• Change from baseline in mean monthly Physical Impairment domain score of the AIM-D across the 12-week treatment period

Safety Results• Rates of adverse events (AEs) were similar across all treatment groups (Table 2)

• Serious AEs were reported by 2 participants in both placebo and atogepant 10 mg groups; none were reported for atogepant 30 mg or atogepant 60 mg

• Rates of discontinuation due to AEs were low across all treatment groups and not dose dependent

• Most commonly reported AEs were constipation and nausea; none were considered serious Constipation (7.7%, 7.0%, and 6.9% with atogepant 10 mg, atogepant 30 mg, and atogepant 60 mg, respectively, vs 0.5% with placebo)

Nausea (5.0%, 4.4%, and 6.1% with atogepant 10 mg, atogepant 30 mg, and atogepant 60 mg, respectively, vs 1.8% with placebo)

• Cases of constipation were primarily mild (71.4%) or moderate (26.5%) in severity One was considered severe with atogepant 10 mg: worsening of pre-existing constipation; the participant was treated with over-the-counter medications, completed the trial, and entered the open-label extension

• All reported cases of nausea were mild (77.1%) or moderate (22.9%) in severity

Table 2. Adverse Events in the Safety Population

n (%) Placebo(n=222)

Atogepant10 mg QD

(n=221)

Atogepant30 mg QD

(n=228)

Atogepant60 mg QD

(n=231)Adverse event (AE)

126 (56.8)

117 (52.9)

119 (52.2)

124 (53.7)

Serious AE 2 (0.9)

2 (0.9) 0 0

AE leading to treatment discontinuation

6 (2.7)

9 (4.1)

4 (1.8)

6 (2.6)

QD, once daily.

Atogepant Significantly Reduces Mean Monthly Migraine Days in the Phase 3 Trial (ADVANCE) for the Prevention of MigraineJessica Ailani,1 Richard B. Lipton,2 Peter J. Goadsby,3,4 Hua Guo,5 Rosa Miceli,5 Lawrence Severt,5 Michelle Finnegan,5 Joel M. Trugman5 1Georgetown University, Washington, DC, USA; 2Albert Einstein College of Medicine, Bronx, NY, USA; 3NIHR-Wellcome Trust King’s Clinical Research Facility, King’s College London, UK; 4University of California, Los Angeles, CA, USA; 5AbbVie, Madison, NJ, USA

RES

ULT

S