In a crowded migraine treatment landscape, AbbVie is aiming to differentiate itself by redefining migraine treatment beyond just counting headache days and other traditional clinical endpoints. At the European Headache Congress (EHC), the company touted its patient-centered approach in evaluating quality of life, daily functioning, rapid relief, and balanced benefit-risk profiles, while aiming to continue addressing unmet needs in the disease area.
“Everyone always talks about patient centricity, but really showing that with our treatments is what matters and what we highlighted with atogepant,” said Michael J. Seminerio, global therapeutic lead at AbbVie. “We actually improved function, quality of life and disability across all trials.”
The ELEVATE, PROGRESS, and ADVANCE atogepant trials
This approach was a guiding principle in the ELEVATE, PROGRESS, and ADVANCE studies, all featured at EHC. The trio of studies concentrated on atogepant (Qulipta), a calcitonin gene-related peptide (CGRP) receptor antagonist. The ELEVATE study evaluated the impact of atogepant on daily functioning and quality of life in the first month of treatment in participants with episodic migraine who had experienced prior inadequate response to treatment. Meanwhile, the PROGRESS trial assessed the early onset of the effect of atogepant on functioning and quality of life in chronic migraine sufferers. That study focused on improvements in daily activities and physical impairment, as well as quality of life measures such as 5-level version of the European Quality of Life – 5 Dimensions (EQ-5D-5L) and visual analogue scale scores. Finally, the ADVANCE trial compared the benefit-risk profile of atogepant with CGRP monoclonal antibodies in a mixed population of episodic and chronic migraine patients, highlighting its comparable efficacy and safety, with a median NNT (Number Needed to Treat) of 4.2, similar to CGRP monoclonal antibodies in the blended episodic and chronic migraine population.
At EHC, AbbVie also announced results from new health economics and outcomes research (HEOR) on atogepant and data on BOTOX (onabotulinumtoxinA) for the potential treatment and management of chronic migraine conditions. In all, the company presented a total of 18 abstracts, including posters and one oral presentation.
The HEOR analysis focused on the responder rate (RR), defined as the proportion of participants with a ≥50% reduction in moderate-to-severe monthly headache days. In the base case analysis, atogepant showed a 64.9% RR, compared to 51.8% for rimegepant (Brand name Nurtec ODT) and 44.1% for placebo. The Cost Per Responder (CPR) against placebo was $15,069 for atogepant versus $69,551 for rimegepant.
ELEVATE: Targeting episodic migraines with atogepant
ELEVATE assessed atogepant across a range of metrics, including migraine and headache days, acute medication use, and patient-reported outcomes such as functioning, quality of life, and disability, in patients who had tried and failed two to four other migraine preventives. “It was able to reduce headache days, monthly migraine days, improve their quality of life, and improve their function,” Seminerio said.
The study found that atogepant 60 mg once daily led to greater improvements in daily activities and reductions in physical impairment as early as the first week, continuing through weeks 2, 3, and 4 compared to placebo. ELEVATE found a rapid onset of benefits, where clinical trial observers noted improvements in daily activities and physical impairment as early as the first week of treatment.
PROGRESS and ADVANCE explore broader impacts on chronic migraine management
Similarly, the PROGRESS study demonstrated atogepant’s benefits for chronic migraine patients, an especially challenged group. “We were able to show in these patients that have previously failed migraine preventives that atogepant was able to have an impact,” Seminerio said. “It was able to reduce headache days, monthly migraine days. It was able to improve their quality of life, improve their function. Specifically, in the PROGRESS study, atogepant showed significant improvements in functioning and quality of life metrics as early as the first week of treatment for chronic migraine patients”.
By thoroughly evaluating efficacy as well as quality of life factors, the ADVANCE study also signaled the potential of atogepant to mitigate migraine frequency and enhance patient wellbeing. In ADVANCE, atogepant “was able to reduce headache days, monthly migraine days. It was able to improve their quality of life, improve their function.”
“A patient can get treated with migraine and they can actually have a reduction in their severity or intensity but still have a migraine day,” Seminerio said. “ But what they’re now able to do is they’re now able to function and return [to activities]… we’re happy to show that with our treatments.”
Measuring migraine impact in ELEVATE and PROGRESS
In terms of the outcome measures used in the studies, ELEVATE and PROGRESS incorporated the Performance of Daily Activities (PDA) and Physical Impairment (PI) domains of the Activity Impairment in Migraine – Diary (AIM-D), which provided detailed data into the daily life impairments caused by migraines. Additionally, the EQ-5D-5L descriptive system and visual analogue scale (VAS) scores provided a measure of the broader quality of life aspects.
Meanwhile, the ADVANCE study evaluated the benefit-risk assessment of atogepant and CGRP monoclonal antibodies versus placebo, focusing on the number needed to treat (NNT) and the number needed to harm (NNH). The NNT was based on achieving a ≥50% reduction in mean monthly migraine days over 12 weeks. The study calculated NNH by using the proportion of participants discontinuing treatment owing to adverse events.
AbbVie’s internal migraine support program
To deepen its understanding of migraine, AbbVie has implemented a comprehensive internal program to support employees living with migraine by creating a more accommodating and understanding work environment. This includes offering employees with migraines the use of natural lighting, providing access to quiet rooms, filtered air and hydration, allowing flexible schedules, and offering education to promote awareness. The company partnered with the European Migraine & Headache Association (EMHA) to receive formal recognition of its migraine-friendly policies through the Migraine Friendly Workplace Stamp.
The program provides a tool to counter the stigma of migraines being “‘just a headache,’” Seminerio said, It’s not just a headache. People miss work and need various things to even get through the workday. There are a few companies that recognize this to this capacity and afford employees with things to mitigate the migraine. But again, this is just the start of addressing this stigma of migraines, which are often dismissed as just a bad headache that ‘you can work through this. You don’t need anything else.’ That’s why it’s great to see some companies, including AbbVie, taking a more proactive approach there.
Through the program, the company can also “generate the data to really understand some of those quality of life measures that are impacted by migraine specifically within our company,” Seminerio said. “We’re helping patients, but we’re also advancing the science within our own company.”
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