How well does Qulipta work for migraine?
Qulipta, an oral prescription medicine used to prevent migraine headaches, has been shown in studies to lead to a 54% reduction in monthly migraine days in patients with episodic migraine (a 4.2-day reduction) and a 36% reduction in patients with chronic migraine headaches (6.9-day reduction).
Qulipta (atogepant) from AbbVie was first approved by the FDA in September of 2021 for the prevention of episodic migraine, and then in April 2023 for prevention of chronic migraine headaches.
How well does Qulipta work for episodic migraine?
The ADVANCE trial was a 12-week long, double-blind, placebo controlled study with 910 adult patients who received Qulipta 10 mg, 30 mg or 60 mg once daily or a placebo (inactive pill) for 12 weeks.
During the study, patients were allowed to use acute headache treatments (i.e., triptans, ergotamine derivatives, NSAIDs, acetaminophen, and opioids) as needed.
Patients who normally had an average of 7.8 days of migraine headaches per month experienced a 4.2-day reduction when treated with 60 mg of Qulipta, a 54% reduction in monthly migraine days. Similar reductions in monthly migraine days (49%) were seen with the 10 mg and 30 mg doses.
In addition, a secondary goal of the study was to determine the percent of patients who reduced their monthly migraine migraine days by one-half (50%) or more. Over the 12 week period, 56% to 61% of patients across all Qulipta dose groups (10 mg, 30 mg or 60 mg) achieved a 50% to 100% reduction in migraine days, compared to 29% of patients in the placebo arm (all dose groups vs. placebo, p<.001).
The percent of patients who achieved a 100% response rate, equal to no monthly migraine days over the 12 week period, was an average of 8% in the Qulipta 60 mg group compared to 2% taking a placebo.
Overall, patients who received Qulipta met all the goals of the study and, on average, had significantly fewer migraine days over a month compared to the group that received a placebo (an inactive agent).
How well does Qulipta work for chronic migraine?
In the Phase 3, PROGRESS trial in 521 participants with chronic migraine (15 or more migraine days per month), the average monthly migraine days (MMDs) at baseline (beginning of the study) was 19 days. Patients were treated with Qulipa 60 mg per day or a placebo for 12-weeks.
During the study, patients were allowed to use acute headache treatments (i.e., triptans, ergotamine derivatives, NSAIDs, acetaminophen, and opioids) as needed.
The effectiveness of Qulipta was determined by looking at the change from baseline (the start of study) in the average number of monthly migraine days across the 12-week treatment period.
Patients experienced a 6.9-day reduction in monthly migraine days when treated with 60 mg of Qulipta per day (a 36% reduction). This result was significant when compared to a reduction of 5.1 days (a 27% reduction) in the placebo group.
The trial also demonstrated that treatment with Qulipta resulted in significant improvements in all 6 secondary endpoints, including the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period.
Results from studies also showed that Qulipta can help you maintain or improve your function related to daily activities as a whole, which include:
- work, concentration and productivity
- leisure activities
- relationships
- energy levels
The most common side effects across all doses with Qulipta include constipation (6%-8%), nausea (5% to 9%) and feeling sleepy / fatigue (4% to 5%).
Learn more: How does Qulipta work? What is its mechanism of action (MOA)?
This is not all the information you need to know about Qulipta (atogepant) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.
Related questions
References
- Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Trugman JM; ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706. doi: 10.1056/NEJMoa2035908. PMID: 34407343.
- Qulipta (atogepant) prescribing information. June 2023. AbbVie Inc. North Chicago, Illinois. Accessed Nov 13, 2023 at https://www.rxabbvie.com/pdf/QULIPTA_pi.pdf
- Qulipta.com. AbbVie Inc. Accessed Nov 13, 2023 at https://www.quliptahcp.com/powerful#episodic
- Data on file. AbbVie Inc.
Read next
How long does Qulipta take to work?
Qulipta can begin working on the first day of treatment to help prevent your episodic migraine headaches. Researchers observed that 88% (185 / 211) patients did not have a migraine the day after taking a Qulipta 60 mg dose, compared to 75% (151 / 202) taking an inactive placebo pill. Continue reading
When is the best time of the day to take Qulipta?
Take your prescribed dose each day at about the same time, with or without food. Some people feel tired or sleepy when taking Qulipta. If this occurs, ask your healthcare provider if you can take your dose at bedtime. If you feel nauseous, take your daily dose at mealtime. Continue reading
Does Qulipta (atogepant) cause hair loss?
No, Qulipta (generic name: atogepant) did not lead to hair loss (alopecia) during clinical trials submitted for FDA-approval. Qulipta is an oral CGRP receptor antagonist (gepant) used to help prevent migraine headache pain. Hair loss is not listed as a side effect in its FDA-approved product label. Continue reading
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Drug information
- Qulipta Information for Consumers
- Qulipta prescribing info & package insert (for Health Professionals)
- Side Effects of Qulipta (detailed)
- Qulipta user reviews (156)
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