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 improvements in health‑related quality of life versus placebo2
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.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
Primary endpoint: change from baseline in the mean number of migraine days per month across 12 weeks of treatment2†
There was a significant 53.8% reduction from baseline in mean monthly migraine days for patients receiving AQUIPTA® 60 mg once-daily (n=222) across 12 weeks of treatment versus 33.3% with placebo (n=214). The mean difference from placebo was -1.7 days (95% CI: -2.3 to -1.2, p<0.001).2
†Participants recorded their daily migraine duration in a diary. A migraine day was when the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the baseline phase, from Day -28 to Day -1. Negative change from baseline indicates improvement. A mixed‑effects model for repeated measures was used for analysis.2
In patients with episodic migraine, AQUIPTA® also significantly improved patients’ quality of life at 12 weeks of treatment versus placebo, as shown by three different measures (secondary endpoints: Migraine-Specific Quality of Life Questionnaire (MSQ v2.1), Activity Impairment in Migraine - Diary (AIM-D) and Headache Impact Test Total Score (HIT-6)).3
The Headache Impact Test-6 (HIT-6) measures the adverse impact of headache in the past month4
HIT-6 consists of the
following six items:4,5
- Headache pain
- Social functioning
- Role functioning
- Vitality
- Cognitive functioning
- Psychological distress
Participants respond to these items using a 5-point Likert scale, from ‘never’ to ‘always’4,5
The total of the participants’ responses is then summed to produce an aggregate HIT-6 score, which ranges from 36-78:5
> <50: no adverse impact of headache
> 50–55: some adverse impact of headache
> 56–59: substantial impact of headache
> >59: severe adverse impact of headache
A >5 point reduction on the HIT-6 is considered clinically meaningful.3
AQUIPTA® significantly reduced the impact of migraine on daily life versus placebo based on HIT-6 scores1‡§
Secondary endpoint: mean change from baseline in total HIT-6 score at Week 12
AQUIPTA® 60 mg once-daily achieved a significant and clinically meaningful‖ improvement on the effect of migraine on daily life and ability to function at work and in social situations versus placebo; -3.9 difference (95% CI: -5.4 to -2.5; p<0.001)1,3
Adapted from AQUIPTA® Summary of Product Characteristics1
Off-treatment hypothetical estimand population.
‡AQUIPTA® was evaluated for the prophylaxis of migraine in patients with 4–14 migraine days/month. The ADVANCE study enrolled patients who met International Classification of Headache Disorders criteria for a diagnosis of migraine with or without aura. Patients with myocardial infarction, stroke or transient ischaemic attacks within 6 months prior to screening were excluded.1,3
§Additional endpoints in the ADVANCE pivotal clinical trial included change from baseline at Week 12 for HIT-6 total score.1,2
‖Between-group difference exceeded minimally important difference of -1.5 points and within-group change exceeded -5.0 points, which is considered clinically meaningful.3
UK-AQP-250081 | 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)
