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      • This website is for UK Healthcare Professionals only

      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.
      dekstop updated

      UK-AQP-240034. DOP: March 2025.

      PROGRESS study design 

      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

      a-p4-aw1 2

      Adapted from Pozo-Rosich P et al. 20232

      Patients were randomised 1:1:1 to receive atogepant 60 mg once-daily, atogepant 30 mg twice-daily or placebo.2 Data for atogepant 30 mg twice-daily is not included here as this is not a licensed dose.

      The data presented here is from the modified intent-to-treat (mITT) population, as per the prespecified 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
      See endpoints and inclusion criteria

      CGRP: calcitonin gene-related peptide; mITT: modified intent-to-treat; OTHE: off-treatment hypothetical estimand.

      References:

      1. AQUIPTA® Summary of Product Characteristics.
      2. Pozo-Rosich P, Ailani J et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double‑blind, placebo‑controlled, phase 3 trial. Lancet 2023;402(10404):775–785 (+ suppl)

      References:

      1. AQUIPTA® Summary of Product Characteristics.
      2. Pozo-Rosich P, Ailani J et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double‑blind, placebo‑controlled, phase 3 trial. Lancet 2023;402(10404):775–785 (+ suppl)

       

      Please refer to the AQUIPTA® Summary of Product Characteristics for further information on adverse events, contraindications and special warnings and precautions for use. The AQUIPTA® Summary of Product Characteristics can be found here.

      AQUIPTA® PRESCRIBING INFORMATION

      By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      UK-AQP-250089 | 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 (e.g. 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 (e.g. endocrine, cardiovascular, cerebrovascular or neurological)

      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 (e.g., 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 (e.g., endocrine, cardiovascular, cerebrovascular or neurological)

      overlay 2 table

      BMI: body mass index

      Prescribing information and adverse event reporting

      By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website.

      Reference: 2. Pozo-Rosich P, Ailani J et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double‑blind, placebo‑controlled, phase 3 trial. Lancet 2023;402(10404):775–785 (+ suppl)

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.