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EPISODIC MIGRAINE Continuous Control

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12 WEEKS

Continuous control with migraine day reductions across 12 weeks1

Graph showing 12-week migraine reduction for episodic migraine. The majority of impact occurred within weeks 1-4. Baseline monthly migraine days was, on average, 7.7.

DAY 1 DATA WEEK 1 DATA

EM=episodic migraine; MMD=Monthly Migraine Days.

ADDITIONAL ENDPOINT: DAY 1

Reductions observed as early as Day 1

 

Additional endpoint:

Day 1

88%

of EM patients

(185/211)

88% of EM patients (185/211) did not have a migraine day on Day 1
after the initial dose vs 75% placebo3 (151/202)*

 

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.

*Proportion of participants with a migraine day on Day 1 after the first dose: 12.3% (26/211) of QULIPTA 60 mg patients had a migraine day vs 25.2% (51/202) of placebo patients.3

EM=episodic migraine.

ADDITIONAL ENDPOINT: WEEK 1

QULIPTA—reductions observed as early as Week 1

Additional endpoint: Week 1

Graph showing a 53% migraine day reduction for EM patients taking Qulipta 60 mg (n=216) vs 15% for placebo (n=211) at week 1.

*Change from baseline in weekly migraine days (WMD): Week 1 QULIPTA 60 mg: -1.03 WMD from 1.93 baseline; Week 1 placebo: -0.29 WMD from 1.88 baseline.

EM=episodic migraine.

 

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.

 

EXPLORATORY ENDPOINTS: 52 WEEKS

Open-label, long-term safety study for EM

Reductions observed across 52 weeks

 

Exploratory endpoint: Change from baseline in MMD across 52 weeks3

Graph showing reduction in monthly migraine days over a 52 week period. Baseline monthly migraine days was, on average, 7.3.
52-week open-label, long-term safety data for EM

Exploratory endpoint: Percentage of patients who achieved 50%-100% MMD reduction at specified intervals3

In Weeks 49-52

84%

of patients achieved
50%-100% MMD reduction3

(n=335)

Graph of patients who achieved 50%-100% MMD reduction: 60% in weeks 1-4 (n=513). 70% in weeks 9-12 (n=466). 75% in weeks 21-24 (n=417). 81% in weeks 33-36 (n=379). 84% in weeks 49-52 (n=335).

Exploratory endpoint: Percentage of patients who achieved 100% MMD reduction at specified intervals3

In Weeks 49-52

48%

of patients achieved
100% MMD reduction3

(n=335)

Graph of patients who achieved 100% MMD reduction: 21% in weeks 1-4 (n=513). 26% in weeks 9-12 (n=466). 38% in weeks 21-24 (n=417). 40% in weeks 33-36 (n=379). 48% in weeks 49-52 (n=335).

LIMITATIONS: These are observations from the 52-week, open-label safety study for which efficacy measures were not an endpoint. 31/543 EM patients (5.7%) discontinued due to adverse events.3 Data from this open-label safety study have limitations as the study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Results should be interpreted with these factors in mind.

 

EM=episodic migraine; mITT=modified intention-to-treat; MMD=Monthly Migraine Days.

See the safety profile of QULIPTA.

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