This promotional material is intended for UK healthcare professionals (HCPs) experienced in the diagnosis and management of migraine only. Prescribing Information and adverse event reporting information can be found below.
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In the ADVANCE study, AQUIPTA® achieved a reduction in monthly migraine/headache days vs placebo across 12 weeks1,2
The ADVANCE study
ADVANCE was a 12-week, multicentre, double-blind, parallel‑group, randomised, placebo‑controlled phase III trial to examine the efficacy and safety of AQUIPTA® for the prevention of migraine in patients with 4–14 migraine days/month.1,2
The data presented here is from the modified intent-to-treat (mITT) population, as per the pre-specified analysis in the studies. It therefore may differ slightly from the data in the AQUIPTA® Summary of Product Characteristics, which uses the off-treatment hypothetical estimand (OTHE) population at the request of the European Medicines Agency. Both populations consisted of all randomised participants who received at least one dose of study treatment, had an evaluable baseline period and at least one evaluable post‑baseline 4-week period (Weeks 1–4, 5–8 and 9–12) of diary data, but the latter was:2
> during the double-blinded treatment period for the mITT population
> during the combined double-blind treatment period and follow-up period, regardless of whether on or off study treatment, for the OTHE population
AQUIPTA® 60 mg once-daily demonstrated a significant reduction from baseline versus placebo in mean monthly migraine days across 12 weeks (primary endpoint)1,2
Primary endpoint: change from baseline in mean monthly migraine days across 12 weeks2
Adapted from Ailani J et al. 20212
mITT population.
AQUIPTA® 60 mg once-daily demonstrated a significant reduction from baseline versus placebo in mean monthly headache days across 12 weeks (secondary endpoint)2
Secondary endpoint: change from baseline in mean monthly headache days across 12 weeks2
Adapted from Ailani J et al. 20212
mITT population.
Mean change from baseline in mean number of days of use of acute medication for treatment of migraine attacks across 12 weeks2
Adapted from Ailani J et al. 20212
mITT population.
AQUIPTA® 60 mg once-daily was generally well tolerated versus placebo in the ADVANCE trial across 12 weeks2
Adverse events occurring in ≥4% of patients in any trial group (safety population)2
Please refer to the AQUIPTA® SmPC by clicking here for further information on adverse events, contraindications and special warnings and precautions for use.
UK-AQP-250084 | Date of preparation: March 2025.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk
Adverse events should also be reported to AbbVie on GBPV@abbvie.com
ADVANCE study design
ADVANCE: a 12-week, multicentre, double‑blind, parallel‑group, randomised, placebo‑controlled phase III trial to examine the efficacy and safety of AQUIPTA®▼ (atogepant) for the prevention of migraine in patients with 4-14 migraine days/ month.1,2
PRIMARY ENDPOINT2
Change from baseline in the mean number of migraine days per month across 12 weeks' treatment
SECONDARY ENDPOINT2
> Change from baseline in the mean number of headache days per month across 12 weeks of treatment
> Change from baseline in the mean number of days of acute medication use across 12 weeks of treatment
> ≥50% reduction from baseline in the 3‑month average of migraine days per month
> Change from baseline in the score on the Migraine‑Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function‑Restrictive (RFR) at Week 12
> Change from baseline in the mean monthly score of Activity Impairment in Migraine - Diary (AIM-D) performance of daily activities (PDA) and physical impairment (PI) domains across 12 weeks’ treatment
> Change from baseline in Headache Impact Test-6 (HIT-6) total score at Week 12
INCLUSION CRITERIA2
> Aged 18-80 years
> 4-14 migraine days per month in the 3 months before Visit 1 and during the 4-week screening period
> At least a 1-year history of migraine with or without aura, diagnosed as specified in the International Classification of Headache Disorders, 3rd edition (ICHD-3)
> Migraine onset before 50 years of age
EXCLUSION CRITERIA2
> Patients with myocardial infarction, stroke or transient ischaemic attacks within 6 months prior to screening
> A history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
> Current diagnosis of chronic migraine, new daily persistent headache, trigeminal autonomic cephalalgia or painful cranial neuropathy
> History of inadequate response to >4 oral medications prescribed for the preventative treatment of migraine (≥2 having different mechanisms of action)
> Clinically significant haematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal or neurologic disease
> Women who are pregnant, planning to become pregnant or currently breastfeeding
BMI: body mass index
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References: 1. AQUIPTA® Summary of Product Characteristics. Available at GB: medicines.org.uk; EU: ema.europa.eu. Accessed March 2024; 2. Ailani J et al. N Engl J Med 2021;385:695-706 (+ suppl)
