HIGH FREQUENCY
~19 MMD1
Powerful Reductions
EPISODIC MIGRAINE
Powerful migraine day reductions that help give patients zero-migraine days
Significant reductions across 12 weeks1
Primary endpoint: mean monthly migraine day reduction across 12 weeks1
(4.2 fewer MMD from 7.8 baseline)
vs 33% (2.5 fewer MMD from 7.5 baseline) with placebo1
QULIPTA 60 mg (n=222; P<0.001); placebo (n=214)1
Similar percentages were seen with other doses across 12 weeks1:
- QULIPTA 30 mg: 49% MMD reduction (3.9 fewer MMD from 7.9 baseline) (n=223; P<0.001)1
- QULIPTA 10 mg: 49% MMD reduction (3.7 fewer MMD from 7.5 baseline) (n=214; P<0.001)1
MMD=Monthly Migraine Days.
Majority of patients achieved a 50% to 100% reduction in monthly migraine days1
Response rates
50%-100% Response Rate
Secondary endpoint:
Percentage of patients who
achieved 50%-100% MMD reduction
across 12 weeks1
12-Week Average
QULIPTA 60 mg
vs 29% placebo1 (n=214)
Similar 12-week average percentages were seen with other doses1:
- 59% for QULIPTA 30 mg (n=223) (P<0.001)
- 56% for QULIPTA 10 mg (n=214) (P<0.001)
Additional endpoint:
Percentage of patients who
achieved 50%-100% MMD reduction in
Weeks 1-4, 5-8, 9-122
Weeks 9-12
QULIPTA 60 mg
vs 44% placebo3 (n=196)
Similar additional endpoint results were seen in Weeks 1-4 and Weeks 5-83:
- Weeks 1-4: 61% for QULIPTA 60 mg (n=221) vs 27% for placebo (n=212)
- Weeks 5-8: 66% for QULIPTA 60 mg (n=207) vs 47% for placebo (n=204)
LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
75%-100% Response Rate
Additional endpoint:
Percentage of patients who
achieved 75%-100% MMD reduction
across 12 weeks2
12-Week Average
QULIPTA 60 mg
vs 11% placebo3 (n=214)
Similar 12-week average percentages were seen with other doses3:
- 30% for QULIPTA 30 mg (n=223)
- 30% for QULIPTA 10 mg (n=214)
Additional endpoint:
Percentage of patients who achieved 75%-100% MMD reduction in
Weeks 1-4, 5-8, 9-122
Weeks 9-12
QULIPTA 60 mg
vs 21% placebo3 (n=196)
Similar additional endpoint results were seen in Weeks 1-4 and Weeks 5-83:
- Weeks 1-4: 39% for QULIPTA 60 mg (n=221) vs 10% for placebo (n=212)
- Weeks 5-8: 41% for QULIPTA 60 mg (n=207) vs 17% for placebo (n=204)
LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
100% Response Rate
NO MIGRAINE DAYS
Additional endpoint:
Percentage of patients who
achieved 100% MMD reduction
across 12 weeks2
12-Week Average
QULIPTA 60 mg
vs 1% placebo3 (n=214)
Similar 12-week average percentages were seen with other doses3:
- 5% for QULIPTA 30 mg (n=223)
- 8% for QULIPTA 10 mg (n=214)
Additional endpoint:
Percentage of patients who
achieved 100% MMD reduction in
Weeks 1-4, 5-8, and 9-122
Weeks 9-12
QULIPTA 60 mg
vs 11% placebo3 (n=196)
Similar additional endpoint results were seen in Weeks 1-4 and Weeks 5-83:
- Weeks 1-4: 19% for QULIPTA 60 mg (n=221) vs 4% for placebo (n=212)
- Weeks 5-8: 24% for QULIPTA 60 mg (n=207) vs 8% for placebo (n=204)
LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
CHRONIC MIGRAINE
Powerful migraine day reductions in chronic migraine
On average, at baseline patients in this study had:
PREVENTIVE TREATMENT EXPERIENCE
83% had preventive exposure3
SEVERE DEBILITATION
>15 acute medication use days; ~43 MSQ-RFR score1
MEDICATION OVERUSE
Nearly two-thirds of patients who were studied overused acute medication3
Migraine Day Reductions
Primary endpoint: mean monthly migraine day reduction across 12 weeks1
Patients with chronic migraine reclaimed an average of 1 week's worth of migraine-free days per month1
QULIPTA 60 mg: -6.9 days from 19.2 baseline MMD
(n=256) (P<0.001)1
Placebo: -5.1 days from 18.9 baseline MMD
(n=246)1
MMD=Monthly Migraine Days; MSQ-RFR=Migraine-Specific Quality of Life Role Function-Restrictive.
FUNCTION
QULIPTA has the power to help patients with migraine do more
Improvement in function related to daily social & work-related activities, as measured by MSQ-RFR
Higher scores indicate lesser impact of migraine on daily activities, and increases from baseline indicate improvement.1
Secondary endpoint: change from baseline at Week 12 for MSQ-RFR scores1
EPISODIC: +67% QULIPTA 60 mg (31.3 higher MSQ-RFR score from 46.8 baseline) (n=222) vs +44% placebo (20.5 higher MSQ-RFR score from 46.8 baseline) (n=214) (P<0.001)1
+69% QULIPTA 30 mg (30.5 higher MSQ-RFR score from 44.0 baseline) (n=223; P<0.001)1
+68% QULIPTA 10 mg (30.4 higher MSQ-RFR score from 44.9 baseline) (n=214; P<0.001)1
CHRONIC: +54% QULIPTA 60 mg (23.3 higher MSQ-RFR score from 43.4 baseline) (n=256) vs +39% placebo (17.2 higher MSQ-RFR score from 43.9 baseline) (n=246) (P<0.001)1
Composite endpoint includes:
Work Activities
Concentration
Leisure Activities
Productivity
Ability to
Perform at Work
Social Activities
Relationships
Energy Levels
Overall scales were not designed to assess these components individually.
MSQ-RFR=Migraine-Specific Quality of Life Role Function-Restrictive.
Migraine-Specific Quality of Life Questionnaire version 2.1 Role Function-Restrictive domain scores assess how often migraine impacts function related to daily social and work-related activities over the past 4 weeks, with scores ranging from 0 to 100.1
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