–Results from an open-label, multicenter extension to the pivotal Phase 3 ADVANCE trial evaluate the safety and tolerability of oral atogepant for the preventive treatment of migraine
–Data from the observational cross-sectional UNIVERSE study highlight the real-world effectiveness and patient satisfaction of ubrogepant in acute migraine
–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine
–These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum
NORTH CHICAGO, Ill., Sept. 8, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. The company will share a total of 23 abstracts, including two oral presentations and one abstract lecture.
“We continue to conduct research that seeks to provide additional insights into the safety, efficacy and clinical utility of our approved and investigational migraine therapies,” said Michael Gold, M.D., vice president, neuroscience development, AbbVie. “The data we’re presenting are a result of AbbVie’s ongoing commitment to driving progress in the migraine community.”
Among the new data being presented are results from an open-label, multicenter extension to the pivotal Phase 3 ADVANCE trial evaluating the long-term safety and tolerability of atogepant, an investigational, orally administered calcitonin gene-related peptide receptor antagonist developed for the preventive treatment of migraine over 40 weeks. Researchers will also share data from the Phase 1, single-center, open-label, multiple-dose study assessing the potential for pharmacokinetic drug-drug interactions between atogepant and topiramate; the observational cross-sectional UNIVERSE study examining real-world effectiveness and patient satisfaction of ubrogepant for acute migraine treatment; and the POLARIS study, a retrospective claims data analysis examining the real-world treatment patterns of oral migraine preventive medication by pharmacologic class in people with migraine.
Additional presentations will focus on the efficacy of atogepant for the preventive treatment of migraine based on further analyses from the ADVANCE trial, the safety and tolerability of investigational ubrogepant as a potential acute treatment for perimenstrual migraine, and real-world evidence regarding the safety and efficacy of CGRP monoclonal antibody therapy added to BOTOX® (onabotulinumtoxinA) for migraine prevention in adult patients with chronic migraine. Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluating the use of BOTOX® for chronic migraine will also be presented.
AbbVie abstracts and presentation details for IHC 2021 are outlined below.
| Abstract Title | Presentation DetailsAll times CT |
| Atogepant | |
| Long-Term Safety and Tolerability of Atogepant 60 mg Following Once Daily Dosing Over 1 Year for the Preventive Treatment of Migraine | ePosterSeptember 11, 20213:42 a.m. CT |
| Atogepant 60 mg Once-Daily Shows Efficacy for the Preventive Treatment of Migraine: Results From a 52-Week Open-Label Extension Trial | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Atogepant Significantly Reduces Mean Monthly Migraine Days in the Phase 3 Trial (ADVANCE) for the Prevention of Migraine | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Effects of Atogepant as Evaluated by the Activity Impairment in Migraine-Diary (AIM-D) and Headache Impact Test (HIT-6) in a 12-Week, Double-blind, Randomized Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Atogepant Improved Patient-Reported Migraine-Specific Quality of Life in a 12-Week Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Oral Daily Atogepant for the Preventive Treatment of Migraine Increases Responder Rates for Reduction in Mean Monthly Migraine Days | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Daily Dosing of Oral Atogepant Improved Patient-Reported Measures of Quality of Life, Activity Impairment, and Headache Impact in a 52-week Trial | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Daily Atogepant Provides a Rapid Onset and Sustained Benefit in the Preventive Treatment of Migraine | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Evaluation of The Long-Term Safety and Tolerability of Oral Atogepant 60 mg Once Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week, Multicenter Extension to the ADVANCE Trial | Abstract LectureSeptember 12, 20212:45-2:55 a.m. CT |
| Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Ubrogepant | |
| Preventive Oral Migraine Treatment Utilization Patterns (POLARIS STUDY): A Retrospective Claims Data Analysis | ePosterSeptember 11, 20214:51 a.m. CT |
| COmbining UbRogepAnt and Preventives for miGrainE (COURAGE) Study Using the Migraine Buddy Application: A Novel, Entirely Remote Design for Collecting Real-World Evidence | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Ubrogepant Users’ Experience – Patients on Ubrogepant, Characteristics and Outcomes (UNIVERSE STUDY) | Oral PresentationSeptember 11, 20213:20 a.m. CT |
| A Novel Approach to Defining Success in the Acute Treatment of Migraine: Demonstrating Therapeutic Benefit at 1 Hour Post-Dose in the Pooled ACHIEVE I and ACHIEVE II Trials | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| A Novel Approach to Defining Success in the Acute Treatment of Migraine: Pooled Results From the ACHIEVE I and ACHIEVE II Trials | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Ubrogepant Was Safe and Well Tolerated in the Acute Treatment of Perimenstrual Migraine | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Ubrogepant Treatment When Pain Is Mild Increases the Likelihood of Achieving Pain Freedom in Participants Who Treated Migraine Attacks of Mild and Moderate or Severe Pain | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| BOTOX® (onabotulinumtoxinA) | |
| Real-World Evidence for Control of Patients With Chronic Migraine Who Received Calcitonin Gene‒Related Peptide Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Optimal Acute Treatment Is Associated With Productivity Gains in People With Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study | ePosterSeptember 11, 20213:39 a.m. CT |
| Consecutive Headache-Free Days With OnabotulinumtoxinA Treatment in Patients With Chronic Migraine: A Pooled PREEMPT Analysis | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Real-World Evidence for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment for Migraine Prevention in Adult Patients with Chronic Migraine | ePosterSeptember 11, 20214:12 a.m. CT |
| Impact of Prior Monthly Headache Days on Migraine-Related Quality of Life: Results From the CaMEO Study | ePoster (on-demand only)September 8, 20211 a.m.-1:15 p.m. CT |
| Characterizing Preventive Treatment Gaps in Migraine: Results From the CaMEO Study | Oral PresentationSeptember 10, 20218:15 a.m. CT |
