Patients saw 54% mean MMD reduction across 12 weeks with QULIPTA 60 mg1
Primary endpoint:
Mean MMD reduction across 12 weeks1
MMD reduction across 12 weeks with QULIPTA 60 mg (4.2 fewer MMD from 7.8 baseline) (n=222; P<0.001) vs 33% with placebo (2.5 fewer MMD from 7.5 baseline) (n=214)1
- 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
Response rate: 50%-100%
Secondary endpoint:
Percentage of patients who achieved ≥50% MMD reduction across 12 weeks1
Weeks 1-12
with QULIPTA 60 mg
(n=222; P<0.001) vs 29% with placebo (n=214)1
Similar 12-week average results 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% MMD reduction in Weeks 1-4, 5-8, and 9-122
Weeks 1-4
QULIPTA 60 mg (n=221)
Weeks 5-8
QULIPTA 60 mg (n=207)
Weeks 9-12
QULIPTA 60 mg (n=195)
LIMITATIONS: The additional endpoints were prespecified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
Response rate: 100%
Additional endpoint:
Percentage of patients who achieved 100% MMD reduction across 12 weeks4
Weeks 1-12
with QULIPTA 60 mg
(n=222) vs 1% with placebo (n=214)4
Similar 12-week average results were seen with other doses4:
- 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 1-4
QULIPTA 60 mg (n=221)
Weeks 5-8
QULIPTA 60 mg (n=207)
Weeks 9-12
QULIPTA 60 mg (n=195)
LIMITATIONS: The additional endpoints were prespecified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
study design
Patients with chronic migraine reclaimed an average of 1 week's worth of migraine-free days per month1
Migraine Day Reductions
Primary endpoint: Mean MMD reduction across 12 weeks1
QULIPTA 60 mg
-6.9 days from 19.2 baseline MMD
(n=256) (P<0.001)1
vs
Placebo
-5.1 days from 18.9 baseline MMD
(n=246)1
On average, at baseline, patients in this study had:
HIGH FREQUENCY
~19 MMD1
PREVENTIVE TREATMENT EXPERIENCE
83% had preventive exposure5
SEVERE DEBILITATION
>15 acute medication use days; ~43 MSQ-RFR score1
MEDICATION OVERUSE
Nearly two-thirds of patients who were studied overused acute medication6
study design
EPISODIC MIGRAINE
Continuous control with migraine reductions across 12 weeks1
study design
Open-label, long-term safety study for episodic migraine
Reductions observed across 52 weeks3
Exploratory endpoint: Change from baseline in MMD across 52 weeks3
Exploratory endpoint: Percentage of patients who achieved ≥50% MMD reduction in Weeks 49-52
In Weeks 49-52
Exploratory endpoint: Percentage of patients who achieved 100% MMD reduction in Weeks 49-52
In Weeks 49-52
LIMITATIONS: These are observations from the 52-week, open-label safety study for which efficacy measures were not an endpoint. 31/543 (5.7%) discontinued due to adverse events.3 This open-label safety 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.
study design
mITT=modified intent-to-treat; MMD=Monthly Migraine Days; MSQ-RFR=Migraine-Specific Quality of Life Role Function-Restrictive; QD=once daily; SE=standard error.
