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 PROGRESS study, AQUIPTA® achieved improvements in health‑related quality of life versus placebo2
The PROGRESS study
PROGRESS 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 chronic migraine.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 35.9% reduction from baseline in mean monthly migraine days for patients receiving AQUIPTA® 60 mg once-daily (n=256) across 12 weeks of treatment versus 27% with placebo (n=246). The mean difference from placebo was -1.8 days (95% CI: -2.9 to -0.8, p=0.0009).2
In patients with chronic migraine, AQUIPTA® significantly improved patients’ quality of life at 12 weeks of treatment versus placebo, as shown by two different measures (additional endpoints: Migraine-Specific Quality of Life Questionnaire (MSQ v2.1), and Headache Impact Test Total Score (HIT-6)).2
The Headache Impact Test-6 (HIT-6) measures the adverse impact of headache in the past month3
HIT-6 consists of the
following six items:3,4
- 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’3,4
The total of the participants’ responses is then summed to produce an aggregate HIT-6 score, which ranges from 36–78:4
> <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.5
AQUIPTA® significantly reduced the impact of migraine on daily life versus placebo based on HIT-6 scores2*†
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)2
Adapted from Pozo-Rosich P et al. 20232
Off-treatment hypothetical estimand population.
*AQUIPTA® was evaluated for the prophylaxis of chronic migraine. The chronic migraine study (PROGRESS) enrolled patients who met International Classification of Headache Disorders criteria for chronic migraine. Patients with myocardial infarction, stroke or transient ischaemic attacks within 6 months prior to screening were excluded.2
†Additional endpoints in the PROGRESS pivotal clinical trial included change from baseline at Week 12 for HIT‑6 total score. The HIT‑6 measures the impact of headache on ability to function. A reduction in scores from baseline indicates improvement.2,5
‡Between-group difference exceeded minimally important difference of -1.5 points and within‑group change exceeded -5.0 points, which is considered clinically meaningful.5
UK-AQP-250086 | 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
PROGRESS study design
PROGRESS: 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 chronic migraine.2
PRIMARY ENDPOINT2
Change from baseline in the mean number of migraine days/ month across 12 weeks of treatment.
ADDITIONAL ENDPOINTS2
> Change from baseline in mean monthly headache days
> Change from baseline in mean monthly acute medication use days
> Proportion of patients achieving ≥50% and ≥75% reduction from baseline in mean monthly migraine days (3‑month average)
> Change from baseline at Week 12 for Headache Impact Test-6 (HIT-6) and Migraine‑Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function‑Restrictive (RFR)
INCLUSION CRITERIA2
> Aged 18-80 years
> History of chronic migraine (≥1 year)
> ≥15 headache days per month in the 3 months prior to Visit 1 and ≥15 headache days, of which ≥8 were migraine days, during the 4-week screening/ baseline period
EXCLUSION CRITERIA2
> International Classification of Headache Disorders, 3rd Edition (ICHD-3)-defined history of migraine accompanied by diplopia or decreased level of consciousness
> Retinal migraine
> A current diagnosis of new persistent daily headache
> Trigeminal autonomic cephalalgia (eg cluster headache)
> Painful cranial neuropathy
> History of inadequate response to more than four preventative migraine treatments (at least two with different mechanisms)
> Use of opioids or barbiturates for at least 4 days per month in the 3 months before Visit 1 or during the baseline period
> Women who were pregnant, planning to become pregnant during the trial or currently lactating
> Participants with any clinically significant diseases (eg endocrine, cardiovascular, cerebrovascular or neurological)
BMI: body mass index
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Reference: 2. Pozo‑Rosich P et al. Lancet 2023;402:775-785 (+ suppl)
