Zoe
"When a migraine strikes and I've taken a triptan, side effects like dizziness8-14 can throw me off."
UBRELVY works differently. It directly blocks CGRP, which is linked to causing migraine.2,15
UBRELVY®
PATIENT EXPERIENCE
In pivotal clinical studies, patients took UBRELVY within 4 hours of migraine headache onset.1 21% of patients experienced pain freedom at 2 hours (co-primary endpoint). UBRELVY 100 mg (95/448) vs 12% placebo (54/456).2,3 Pain freedom was defined as a reduction from moderate or severe headache pain to no pain.1 See similar results for patients taking UBRELVY 50 mg.4 See ACHIEVE pivotal trials design for more detail, including additional co-primary endpoint data.
Real-World Evidence Study
PROSPECTIVE, OBSERVATIONAL, LONGITUDINAL, REAL-WORLD STUDY COMPARING
PATIENT-REPORTED OUTCOMES IN THE ACUTE TREATMENT OF MIGRAINE 5
The UNIVERSE II survey study was a prospective, observational, longitudinal real-world study comparing patient-reported outcomes in the acute treatment of migraine in the United States.5
Objective: Evaluate patient-reported outcomes in participants with migraine who switched from a prior oral triptan* either to another oral triptan or to UBRELVY. Patients were followed for a period of 4 weeks and outcomes were collected via the Migraine Buddy app.5,6
Migraine Buddy app: Migraine Buddy is a free smartphone app that is widely used by individuals worldwide to self-report their patterns of migraine, characteristics, and coping mechanisms by regularly logging their migraine details into the app, including triggers, symptoms, and impact of migraine on their daily lives.6
Eligible participants who met the screening criteria were invited to participate in the study by completing an electronic Informed Consent Form (ICF). After completing the ICF, participants were directed to complete a baseline assessment the next day in an electronic diary format in the Migraine Buddy app. Participants then received daily reminders to complete daily assessments for the next 4 weeks (days 2-29). The final assessment was completed on day 30.6
The Migraine Buddy application undergoes regular quality control testing to ensure it runs as intended on all platforms. User Acceptance Testing (UAT) is performed to ensure that the questionnaires display as intended, the survey flow works as specified in the protocol, and that the participant responses properly feed the study database. No “ease of use” testing was performed in the target population. Evidence of content validity (eg, relevance of the items, comprehensibility, clarity) of the satisfaction and treatment preference survey questions has not been established. Participants using the Migraine Buddy app might have more severe or frequent migraine attacks than patients who do not feel the need to use an app for recording personal health information about their migraine attacks. The results of this study may not be generalizable to the general population.6
Change from baseline at 4 weeks included6:
- Migraine-related disability as assessed by the modified Migraine Disability Assessment (mMIDAS)
- There were no treatment differences reported for:
- Missed school or work days
- Days with reduced work or school productivity by half or more
- Days with missed household work
- Days with reduced household productivity by half or more
- Missed social/leisure activity days
- There were no treatment differences reported for:
- WPAI:
- No analyses were conducted due to insufficient sample size
Eligibility criteria5:
- ≥18 years of age
- Experienced ≥6 headache days in the last 90 days
- Had access to enough medication to treat ≥3 migraine attacks over the following 4 weeks
- Switched from an oral triptan (used to treat ≥2 attacks) to a new oral triptan or UBRELVY in the week prior to screening
Patient-reported outcome assessments at 4 weeks included5:
- Experience vs prior triptan for long-lasting migraine relief (64% UBRELVY [71/111] vs 58% triptan [58/100])
- Likelihood of continuing treatment with either UBRELVY or new triptan (77% UBRELVY [85/111] vs 68% triptan [68/100])
- Experience vs prior triptan for return to normal function (68% UBRELVY [75/111] vs 55% triptan [55/100])
- Medication preference vs prior triptan (76% UBRELVY [84/111] vs 63% triptan [63/100]) (see additional information in the Patient Preference tab)
- Experience vs prior triptan for complete migraine relief at 2 hours (76% UBRELVY [84/111] vs 59% triptan [59/100])
- Satisfaction with treating pain associated with migraine (69% UBRELVY [77/111] vs 42% triptan [42/100]) (see additional information in the Patient Satisfaction tab)
- Satisfaction with alleviating most bothersome symptom (69% UBRELVY [77/111] vs 42% triptan [42/100])†
Preventive medication use was assessed at baseline and at week 46
There were also optional Daily Diary Assessments on days 2-296
Additional considerations:
- Use of concomitant medications and dosing was not restricted for the purposes of this observational study6
- Triptans with other routes of administration (nasal, subcutaneous) were excluded from this study7
Survey questions to determine satisfaction with treating pain associated with migraine and treatment preference6:
- Rate your satisfaction with your UBRELVY or new triptan in treating pain associated with migraine (on a 7-point Likert scale ranging from ‘extremely satisfied’ to ‘extremely dissatisfied’)‡
- Compared to your previous treatment, which medication do you prefer? (on a 5-point scale ranging from ‘prefer previous triptan—I was a lot more satisfied’ to ‘prefer [new triptan/UBRELVY]—I am a lot more satisfied’)§
WPAl=Work Productivity and Activity Impairment questionnaire.
*Triptans are a class of prescription acute treatments for migraine.5
†Sensitivity to light (triptan, 34.0%; UBRELVY, 35.1%), and pain with routine activities (triptan, 19.0%; UBRELVY, 14.4%; excluding head pain) were reported as the most bothersome migraine symptoms in both cohorts.5
‡Responders were defined as patients who reported they were 'extremely satisfied' or 'satisfied' on a 7-point Likert scale.6
§Responders were defined as patients who reported they were 'a little more satisfied' or 'a lot more satisfied' with their new medication compared to their previous triptan.5
PROSPECTIVE, OBSERVATIONAL, LONGITUDINAL, REAL-WORLD STUDY COMPARING
PATIENT-REPORTED OUTCOMES IN THE ACUTE TREATMENT OF MIGRAINE 5
Limitations:
- The results represent real-world, observational treatment utilization and outcomes and do not describe results from randomized controlled, head-to-head clinical trials6
- There was no prespecified statistical procedure to assess study outcomes in a hierarchical order, the study cohorts lacked randomization of subjects, and there was no adjustment for multiplicity to control for the overall Type 1 error rate (false positive rate). The analyses do not ascertain whether these findings were attributable to treatment with UBRELVY, rather than merely due to chance, and are susceptible to bias6
- No causal relationships, including conclusions related to comparative clinical efficacy and safety, can be drawn from study results2
- All observations were self-reported, and study assessments were designed to gather responses that occurred within the last 1 week to 4 weeks, which introduced the possibility of recall error6
- Migraine Buddy app:
- The Migraine Buddy application undergoes regular quality control testing to ensure it runs as intended on all platforms. User Acceptance Testing (UAT) is performed to ensure that the questionnaires display as intended, the survey flow works as specified in the protocol, and that the participant responses properly feed the study database. No “ease of use” testing was performed in the target population
- Evidence of content validity (eg, relevance of the items, comprehensibility, clarity) of the satisfaction and treatment preference survey questions has not been established
- Participants using the Migraine Buddy app might have more severe or frequent migraine attacks than patients who do not feel the need to use an app for recording personal health information about their migraine attacks. The results of this study may not be generalizable to the general population6
PROSPECTIVE, OBSERVATIONAL, LONGITUDINAL, REAL-WORLD STUDY COMPARING
PATIENT-REPORTED OUTCOMES IN THE ACUTE TREATMENT OF MIGRAINE 5
No head-to-head trials have been conducted between UBRELVY and triptans, therefore no conclusions regarding safety or efficacy can be drawn. Data collected may be subject to bias and recall error.6
SATISFACTION DATA FOR ORAL TRIPTAN PATIENTS WHO CHANGED
TO UBRELVY VS THOSE WHO CHANGED TO ANOTHER TRIPTAN 5
Survey Question:
Overall, how satisfied are you with your UBRELVY/Triptan for treating pain associated with your migraine? (on a 7-point Likert scale ranging from 'extremely satisfied' to 'extremely dissatisfied.' Responders included those who selected 'extremely satisfied' or 'satisfied.')6
LIMITATIONS5,6: The results represent real-world, observational treatment utilization and outcomes and do not describe results from randomized controlled/head-to-head clinical trials. No causal relationships, including conclusions related to comparative clinical efficacy and safety, can be drawn from study results. There was no planned statistical procedure to adjust for multiplicity, so there was no control of the overall Type 1 error rate (false positive rate). The analyses do not ascertain whether these findings were attributable to treatment with UBRELVY, rather than merely due to chance, and are susceptible to bias. All observations were self-reported, and study assessments were designed to gather responses that occurred within the last 1 week to 4 weeks, which introduced the possibility of recall error.
PROSPECTIVE, OBSERVATIONAL, LONGITUDINAL, REAL-WORLD STUDY COMPARING
PATIENT-REPORTED OUTCOMES IN THE ACUTE TREATMENT OF MIGRAINE 5
No head-to-head trials have been conducted between UBRELVY and triptans, therefore no conclusions regarding safety or efficacy can be drawn. Data collected may be subject to bias and recall error.2
PATIENT PREFERENCE DATA FOR UBRELVY
OR ANOTHER ORAL TRIPTAN VS PRIOR ORAL TRIPTAN 5
Survey Question:
Compared to your previous treatment, which medication do you prefer? (on a 5-point scale ranging from 'prefer previous triptan - I was a lot more satisfied' to 'prefer [new triptan/UBRELVY] - I am a lot more satisfied.’ Responders included those who selected 'prefer [new triptan/UBRELVY] - I am a lot more satisfied or I am a little more satisfied.')6
LIMITATIONS5,6: The results represent real-world, observational treatment utilization and outcomes and do not describe results from randomized controlled/head-to-head clinical trials. No causal relationships, including conclusions related to comparative clinical efficacy and safety, can be drawn from study results. There was no planned statistical procedure to adjust for multiplicity, so there was no control of the overall Type 1 error rate (false positive rate). The analyses do not ascertain whether these findings were attributable to treatment with UBRELVY, rather than merely due to chance, and are susceptible to bias. All observations were self-reported, and study assessments were designed to gather responses that occurred within the last 1 week to 4 weeks, which introduced the possibility of recall error.
THE TRIPTAN-EXPERIENCED PATIENT: ZOE IS UBRELVY® -READY
Not an actual patient.
Model and quote are for illustrative purposes only.
CGRP=calcitonin gene-related peptide.
WHO IS ZOE?
- 39 years old
- Junior high school teacher
- Has 1 child, 10 years old
TREATMENT JOURNEY
- Has been on her first triptan for the past 3 months
- Migraine attacks keep her from a productive workday and time with her child
- When a migraine strikes and she takes her triptan, side effects like dizziness8-14 can throw her off
- Due for a follow-up visit and may not express her concerns with her first triptan
TREATMENT GOALS
- Looking for a migraine acute treatment that may help her carry on with her day when a migraine strikes
- Upon further discussion, she is curious about another treatment option
IS IT TIME TO START UBRELVY INSTEAD OF ANOTHER TRIPTAN?
Patient Survey Data
These are patient perceptions around the experience of taking UBRELVY
IN A 2024 SURVEY OF CURRENT UBRELVY PATIENTS ||¶
WISHED THEY HAD STARTED UBRELVY SOONER
IN THEIR MIGRAINE TREATMENT JOURNEY 16
FOUND THAT UBRELVY WAS EASY TO GET FROM
THE PHARMACY AND TO AFFORD ONCE PRESCRIBED 17
BELIEVED THEY COULD GO ON WITH
THE REST OF THEIR DAY WHEN TAKING UBRELVY 18
||Source: Online survey conducted by Ipsos Healthcare on behalf of AbbVie Inc., between August 20, 2024, and September 24, 2024, among 500 adults aged 18-64, of which 200 were using UBRELVY at the time of the survey.16-18
¶Survey respondents could choose from the following to indicate their agreement with the provided statement: strongly disagree, disagree, somewhat disagree, neither disagree nor agree, somewhat agree, agree, or strongly agree. The percentage represents those who answered somewhat agree, agree, and strongly agree.16-18
