EFFICACY ACHIEVED across multiple clinical trials
The efficacy of APTIOM as adjunctive therapy in focal seizures was established in 3 randomized, double-blind, placebo-controlled, multicenter trials in adult patients.1
APTIOM was also proven effective in monotherapy trials.1
Actor Portrayals
- Arm 1
- Arm 2
1 in 4 patients achieved seizure freedom when APTIOM was the first add-on to levetiracetam or lamotrigine in a Phase IV study2
Arm 1 studied APTIOM as the first add-on treatment to levetiracetam or lamotrigine.
The real-world trial was open-label and multicenter. The study was not powered to compare the 2 arms.2
Select Efficacy Endpoints
25%
Arm 1 (n=40)
Seizure Freedom
Proportion of subjects who did not have a seizure as per the seizure diary during the 24-week maintenance phase2
Phase III trial results:
In the Phase III adjunctive pivotal trials, the seizure freedom rate was up to 2% in APTIOM-treated patients compared to 1% in placebo-treated patients. The results are not statistically significant.3
63%
Arm 1 (n=40)
Responder Rate
The percentage of patients who achieved ≥50% reduction in standardized seizure frequency from baseline to 24-week maintenance phase2
Phase III trial results:
In the Phase III adjunctive pivotal trials, up to 41% of APTIOM-treated patients had a ≥50% responder rate compared to 21% in placebo-treated patients. APTIOM 800 mg (P=0.0003), APTIOM 1200 mg (P<0.0001).3
Primary Endpoint
82%
Arm 1 (n=44)
Study Retention
The proportion of patients completing 24 weeks of adjunctive therapy during the maintenance phase2
The Phase IV clinical data is very important because it truly is real-world research.”
Learn how 2 epileptologists discuss Phase IV data when considering APTIOM
The information provided is for educational purposes only. Opinions expressed are those of the healthcare providers, and are not a substitute for your independent medical judgment.
All healthcare providers featured in this video series are paid consultants of Sumitomo Pharma America, Inc.
Up to 4 in 10 patients had a 50% or greater reduction in seizures across all 3 adult adjunctive pivotal trials4
Secondary endpoint:
Up to 41% responder rate* in adults taking APTIOM4
Up to 16% experienced 75% to 100% seizure reduction4
Placebo (n=406)
APTIOM 800 mg (n=375)
APTIOM 1200 mg (n=352)
Primary endpoint:
APTIOM showed reduced 4-week standardized seizure frequency during 12 weeks of maintenance therapy vs placebo (P<0.05). A statistically significant effect was observed with APTIOM 800 mg in Studies 3 and 4 (Study 5; P=0.058) and with APTIOM 1200 mg in all 3 studies.1
Secondary endpoint:
Responder rate—the proportion of patients with ≥50% reduction in seizures across all 3 double-blind adjunctive studies (pooled).4
*Response was defined as ≥50% reduction in standardized seizure frequency. Patients in APTIOM adult adjunctive therapy clinical studies experienced a range of treatment effects, from no response (an increase from baseline in seizure frequency to a modest reduction from baseline in seizure frequency) to a 100% reduction from baseline in seizure frequency.1,4
SEIZURE REDUCTIONS ACROSS ALL CATEGORIES
Secondary endpoint:
Proportion of patients by category of seizure reduction across all 3 double-blind adjunctive studies (pooled)
PERCENTAGE OF PATIENTS BY CATEGORY OF SEIZURE REDUCTION1,4
Placebo (n=406)
APTIOM 800 mg (n=375)
APTIOM 1200 mg (n=352)
Patients taking APTIOM tend to stay on APTIOM
APTIOM demonstrated retention to therapy in multiple studies
HIGH RETENTION IN A PHASE IV STUDY
Retention rate in Arm 1
(Primary endpoint) as the first add-on to lamotrigine or levetiracetam2
Retention rate in Arm 2
(Primary endpoint) as a later add-on to either 1 or 2 ASMs, including lamotrigine, levetiracetam, lacosamide, and valproic acid (all forms)2
82%
64%
Following a 2-week titration phase, patients remained on a stable dose of APTIOM for a 24-week maintenance phase and a safety follow-up/taper phase of 4 weeks, in a real-world setting.2
Robust Completion Rates In Phase III Trials
Completion rate in Phase III
adjunctive pivotal trials when prescribed at 800 mg3
Completion rate in Phase III
adjunctive pivotal trials when prescribed at 1200 mg3
82%
71%
Following a 2-week titration phase, patients remained on a stable dose of APTIOM or placebo for a 12-week maintenance phase.3
Completion rate in Phase III
monotherapy trials when prescribed at 1200 mg for the 10-week monotherapy phase5
Completion rate in Phase III
monotherapy trials when prescribed at 1600 mg for the 10-week monotherapy phase5
75%
86%
Following a 2-week titration phase, baseline ASMs were gradually tapered over a 6-week withdrawal phase. Patients remained on a stable dose of APTIOM 1600 mg or 1200 mg for a 10-week monotherapy phase.1
Effective ASM therapy for pediatric patients 4 to 17 years of age1
The safety and effectiveness of APTIOM have been established in pediatric patients 4 to 17 years of age*
Use of APTIOM in this age group is supported by:
- Evidence from adequate and well-controlled studies of APTIOM in adult patients with focal seizures
- Pharmacokinetic data from adult and pediatric patients
- Safety data from clinical studies in 393 pediatric patients 4 to 17 years of age
*Safety and effectiveness in patients below 4 years of age have not been established.
1 in 4 patients achieved seizure freedom when APTIOM was the first add-on to levetiracetam or lamotrigine in a Phase IV study2
Arm 1
Arm 1 studied APTIOM as the first add-on treatment to levetiracetam or lamotrigine. The real-world trial was open-label and multicenter. The study was not powered to compare the 2 arms.2
Select Efficacy Endpoints
25%
Arm 1 (n=40)
Seizure Freedom
Proportion of subjects who did not have a seizure as per the seizure diary during the 24-week maintenance phase2
Phase III trial results:
In the Phase III adjunctive pivotal trials, the seizure freedom rate was up to 2% in APTIOM-treated patients compared to 1% in placebo-treated patients. The results are not statistically significant.3
63%
Arm 1 (n=40)
Responder Rate
The percentage of patients who achieved ≥50% reduction in standardized seizure frequency from baseline to 24-week maintenance phase2
Phase III trial results:
In the Phase III adjunctive pivotal trials, up to 41% of APTIOM-treated patients had a ≥50% responder rate compared to 21% in placebo-treated patients. APTIOM 800 mg (P=0.0003), APTIOM 1200 mg (P<0.0001)3
Primary Endpoint
82%
Arm 1 (n=44)
Study Retention
The proportion of patients completing 24 weeks of adjunctive therapy during the maintenance phase2
In treatment-resistant patients, 10% achieved seizure freedom for 24 weeks when APTIOM was added later to 1 or 2 ASMs2
Arm 2
Arm 2 studied APTIOM as the first add-on to either 1 or 2 ASMs, including lamotrigine, levetiracetam, lacosamide, and valproic acid (all forms). The study was not powered to compare the 2 arms2
Select Efficacy Endpoints
10%
Arm 2 (n=52)
Seizure Freedom
Proportion of subjects who did not have a seizure as per the seizure diary during the 24-week maintenance phase2
Phase III trial results:
In the Phase III adjunctive pivotal trials, the seizure freedom rate was up to 2% in APTIOM-treated patients compared to 1% in placebo-treated patients. The results are not statistically significant.3
39%
Arm 2 (n=52)
Responder Rate
The percentage of patients who achieved ≥50% reduction in standardized seizure frequency from baseline to 24-week maintenance phase2
Phase III trial results:
In the Phase III adjunctive pivotal trials, up to 41% of APTIOM-treated patients had a ≥50% responder rate compared to 21% in placebo-treated patients. APTIOM 800 mg (P=0.0003), APTIOM 1200 mg (P<0.0001)3
Primary Endpoint
64%
Arm 2 (n=58)
LATER ADD-ON TO 1 OR 2 ASMs
Study Retention
The proportion of patients completing 24 weeks of adjunctive therapy during the maintenance phase2
The Phase IV clinical data is very important because it truly is real-world research.”
Learn how 2 epileptologists discuss Phase IV data when considering APTIOM
The information provided is for educational purposes only. Opinions expressed are those of the healthcare providers, and are not a substitute for your independent medical judgment.
All healthcare providers featured in this video series are paid consultants of Sumitomo Pharma America, Inc.
Up to 4 in 10 patients had a 50% or greater reduction in seizures across all 3 adult adjunctive pivotal trials4
Secondary endpoint:
Up to 41% responder rate* in adults taking APTIOM4
Up to 16% experienced 75% to 100% seizure reduction4
Placebo (n=406)
APTIOM 800 mg (n=375)
APTIOM 1200 mg (n=352)
Primary endpoint:
APTIOM showed reduced 4-week standardized seizure frequency during 12 weeks of maintenance therapy vs placebo (P<0.05). A statistically significant effect was observed with APTIOM 800 mg in Studies 3 and 4 (Study 5; P=0.058) and with APTIOM 1200 mg in all 3 studies.1
Secondary endpoint:
Responder rate—the proportion of patients with ≥50% reduction in seizures across all 3 double-blind adjunctive studies (pooled).4
*Response was defined as ≥50% reduction in standardized seizure frequency. Patients in APTIOM adult adjunctive therapy clinical studies experienced a range of treatment effects, from no response (an increase from baseline in seizure frequency to a modest reduction from baseline in seizure frequency) to a 100% reduction from baseline in seizure frequency.1,4
SEIZURE REDUCTIONS
ACROSS ALL CATEGORIES
Secondary endpoint:
Proportion of patients by category of seizure reduction across all 3 double-blind adjunctive studies (pooled)
PERCENTAGE OF PATIENTS BY CATEGORY OF SEIZURE REDUCTION1,4
Placebo (n=406)
APTIOM 800 mg (n=375)
APTIOM 1200 mg (n=352)
Patients taking APTIOM
tend to stay on APTIOM
APTIOM demonstrated retention to therapy in multiple studies
HIGH RETENTION IN A
PHASE IV STUDY
Retention rate in Arm 1
(Primary endpoint) as the first add-on to lamotrigine or levetiracetam2
Retention rate in Arm 2
(Primary endpoint) as a later add-on to either 1 or 2 ASMs, including lamotrigine, levetiracetam, lacosamide, and valproic acid (all forms)2
Following a 2-week titration phase, patients remained on a stable dose of APTIOM for a 24-week maintenance phase and a safety follow-up/taper phase of 4 weeks, in a real-world setting.2
ROBUST COMPLETION RATES IN
PHASE III TRIALS
Completion rate in Phase III
adjunctive pivotal trials when prescribed at 800 mg3
Completion rate in Phase III
adjunctive pivotal trials when prescribed at 1200 mg3
Following a 2-week titration phase, patients remained on a stable dose of APTIOM or placebo for a 12-week maintenance phase.3
Completion rate in Phase III
monotherapy trials when prescribed at 1200 mg for the 10-week monotherapy phase5
Completion rate in Phase III
monotherapy trials when prescribed at 1600 mg for the 10-week monotherapy phase5
Following a 2-week titration phase, baseline ASMs were gradually tapered over a 6-week withdrawal phase. Patients remained on a stable dose of APTIOM 1600 mg or 1200 mg for a 10-week monotherapy phase.1
Effective ASM therapy for pediatric patients 4 to 17 years of age1
The safety and effectiveness of APTIOM have been established in pediatric patients 4 to 17 years of age*
Use of APTIOM in this age group is supported by:
- Evidence from adequate and well-controlled studies of APTIOM in adult patients with focal seizures
- Pharmacokinetic data from adult and pediatric patients
- Safety data from clinical studies in 393 pediatric patients 4 to 17 years of age
*Safety and effectiveness in patients below 4 years of age have not been established.