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

Qulipta 60 mg: 54% migraine day reduction across 12 weeks.

(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

61%

of patients

(n=222)
(P<0.001)

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

71%

of patients

(n=195)

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

38%

of patients

(n=222)

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

50%

of patients

(n=195)

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

8%

of patients

(n=222)

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

28%

of patients

(n=195)

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:

HIGH FREQUENCY
~19 MMD1

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

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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

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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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