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 a reduction in monthly migraine/headache days vs placebo across 12 weeks1
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
AQUIPTA® 60 mg once-daily demonstrated a significant reduction from baseline versus placebo in mean monthly migraine days across 12 weeks (primary endpoint)2
Primary endpoint: change from baseline in mean monthly migraine days across 12 weeks2
Adapted from Pozo-Rosich P et al. 20232
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 Pozo-Rosich P et al. 20232
mITT population.
Change from baseline in mean monthly days of acute medication use across 12 weeks2
Adapted from Pozo-Rosich P et al. 20232
mITT population.
AQUIPTA® 60 mg once-daily was generally well tolerated versus placebo in the PROGRESS trial across 12 weeks2
Adverse events occurring in ≥5% 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-250085 | 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)
