UCB Pharma Research Articles

Lacosamide and pregnancy: Data from spontaneous and solicited reports.

In pregnancy, it is important to balance the risks of uncontrolled epileptic seizures to the mother and fetus against the potential teratogenic effects of antiseizure medications. Data are limited on pregnancy outcomes among patients taking lacosamide (LCM), particularly when taken as monotherapy. The objective of this analysis was to evaluate the pregnancy outcomes of LCM-exposed pregnancies. This analysis included all reports in the UCB Pharma pharmacovigilance database of exposure to LCM during pregnancy from spontaneous sources (routine clinical settings) or solicited reports from interventional clinical studies and noninterventional postmarketing studies. Prospective and retrospective reports were analyzed separately. At the data cutoff (August 31, 2021), there were 202 prospective pregnancy cases with maternal exposure to LCM and known outcomes. Among these cases, 44 (21.8%) patients received LCM monotherapy and 158 (78.2%) received LCM polytherapy. Most patients received LCM during the first trimester (LCM monotherapy: 39 [88.6%]; LCM polytherapy: 143 [90.5%]). From the prospective pregnancy cases with maternal LCM exposure, there were 204 reported outcomes (two twin pregnancies occurred in the polytherapy group). The proportion of live births was 84.1% (37/44) in patients who received LCM as monotherapy, and 76.3% (122/160) for LCM polytherapy. The overall proportion of abortions (for any reason) was 15.9% (7/44) with LCM monotherapy, and 22.5% (36/160) with LCM polytherapy. Congenital malformations were reported in 2.3% (1/44) of known pregnancy outcomes with maternal exposure to LCM monotherapy, and 6.9% (11/160) with polytherapy. Our preliminary data do not raise major concerns on the use of LCM during pregnancy. Most pregnancies with LCM exposure resulted in healthy live births, and no new safety issues were identified. These findings should be interpreted with caution, as additional data are needed to fully evaluate the safety profile of LCM in pregnancy.

Bimekizumab Efficacy in Patients with Moderate to Severe Plaque Psoriasis and Hypertension, Elevated Body Mass Index, or Hyperglycemia: Results Through 3 years of Treatment in 5 Phase 3/3b Trials

Introduction: Patients with moderate to severe plaque psoriasis have a higher risk of cardiometabolic comorbidities than the general population.1,2 Here, response to bimekizumab (BKZ) in psoriasis patients with hypertension, elevated body mass index (BMI), or hyperglycemia at baseline is reported through 3 years of treatment.
 Procedure/study: Data were pooled from the following trials: BE SURE, BE VIVID, BE READY, their open-label extension (OLE) BE BRIGHT, and BE RADIANT.3–7 Included patients received BKZ 320 mg every 4 weeks (Q4W) to Week 16, then Q4W or Q8W in the maintenance period and on OLE entry. All received BKZ Q8W from Week 64 (BE RADIANT)/OLE Week 48 (BE BRIGHT) or next scheduled visit (dose groups were combined in this analysis). Psoriasis Area and Severity Index (PASI) ≤2, ≥90% improvement from baseline in PASI (PASI 90), and PASI 100 responses were evaluated in patients with psoriasis and concurrent hypertension (systolic >130 mmHg or diastolic >85 mmHg), elevated BMI (>30 kg/m2), or hyperglycemia (≥140 mg/dL or ≥7.8 mmol/L), based on objective laboratory measurements at baseline. Data are reported using modified non-responder imputation: patients who discontinued due to lack of efficacy or treatment-related adverse events were considered non-responders at subsequent timepoints; multiple imputation was used for all other missing data.
 Results: Of 1,107 BKZ-randomized patients who entered the OLEs, 546, 493, and 81 had hypertension, elevated BMI, and hyperglycemia at baseline, respectively. At Week 16, 91.3% of all BKZ-treated patients had PASI ≤2; high response rates were also observed in patients with hypertension (88.9%), elevated BMI (87.8%), and hyperglycemia (87.7%). At Year 3 (OLE Week 96), PASI ≤2 response rates were 91.3% (all patients), 90.0% (hypertension), 89.4% (elevated BMI), and 91.1% (hyperglycemia). At Week 16, 90.9%/65.5% of all BKZ-treated patients achieved PASI 90/100; high responses were also observed in patients with hypertension (89.0%/62.8%), elevated BMI (87.6%/60.3%), and hyperglycemia (86.4%/64.2%). At Year 3, PASI 90/100 response rates were 90.7%/70.0% (all patients), 89.3%/66.3% (hypertension), 89.2%/66.2% (elevated BMI), and 87.9%/57.7% (hyperglycemia).
 Conclusion: High levels of complete/near-complete skin clearance achieved at Week 16 were durable through 3 years’ BKZ treatment in psoriasis patients, including those who had baseline hypertension, elevated BMI, or hyperglycemia.
 Funding: UCB Pharma.

Bimekizumab Efficacy Through 3 Years in Patients with Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from BE BRIGHT

Introduction: A key factor of biologic discontinuation in plaque psoriasis patients is loss of response over time; long-term treatment efficacy is therefore important.1 Here, 3-year efficacy of bimekizumab (BKZ) from a pooled analysis of patients with moderate to severe plaque psoriasis across 3 phase 3 clinical trials and their open-label extension (OLE) is reported.
 Procedure/study: Data were pooled from the 52-week BE VIVID and 56-week BE SURE and BE READY phase 3 trials, and their common OLE BE BRIGHT.2–5 Included patients received BKZ 320 mg every 4 weeks (Q4W) then switched to Q4W or Q8W maintenance dosing from Week 16 onwards, and entered the OLE; from OLE Week 48 or the next scheduled visit, all patients received BKZ 320 mg Q8W. Proportions of patients achieving ≥90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90), PASI 100, and Dermatology Life Quality Index (DLQI) 0/1 are reported through Year 3 using modified non-responder imputation: patients who discontinued treatment due to lack of efficacy or treatment-related adverse events were considered non-responders at subsequent timepoints; multiple imputation was used for all other missing data.
 Results: 771 patients received BKZ continuously in the feeder studies and entered the OLE. Among these, at Week 16, 90.9%, 65.8%, and 71.5% achieved PASI 90, PASI 100, and DLQI 0/1, respectively. At Year 1, 93.7%, 76.6%, and 83.1% of all BKZ-treated patients achieved PASI 90 (Week 52), PASI 100 (Week 52), and DLQI 0/1 (Week 48/52), respectively. Responses were durable to Year 3 (OLE Week 96): 91.0%, 70.3%, and 82.8% of all BKZ-treated patients achieved PASI 90, PASI 100, and DLQI 0/1, respectively. Similar trends were observed in the subset of patients that received BKZ Q4W/Q8W/Q8W (initial/maintenance/OLE).
 Conclusion: High and durable clinical and health-related quality of life responses were observed over 3 years of BKZ treatment across 3 phase 3 trials and their OLE.
 Funding: UCB Pharma.

Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders

Introduction: Patients (pts) with psoriasis have a greater risk of depression and suicidality than the general population.1 Here, we report Week (Wk)16 and longer-term depression and suicidal ideation and behavior (SIB) data in bimekizumab (BKZ)-treated pts with moderate to severe plaque psoriasis.
 Procedure/study: The Patient Health Questionnaire (PHQ)-9, scored 0–27, measured depression severity monthly to Wk16 (regular intervals during BE BRIGHT open-label extension);2,3 higher scores indicate worse depression. PHQ-9 data were pooled from Wk0–16 of BE VIVID/BE READY (BKZ 320mg every 4 weeks [Q4W] vs. placebo [PBO]);4,5 3-year BE BRIGHT data are also reported.3 An independent Neuropsychiatric Adjudication Committee evaluated potential SIB treatment-emergent adverse events (TEAEs) and elevated PHQ-9 scores. Adjudicated SIB (suicide completion/attempt/ideation) incidence/100 pt-years (yrs; PY) was pooled from nine BKZ phase 2/3/3b trials in psoriasis, including up to 5 yrs’ exposure.3–11
 Results: At Wk16, mean reduction from baseline in PHQ-9 with BKZ Q4W (N=670) vs. PBO (N=169) was 1.3 vs. 0.3; overall mean Wk16 scores were 1.2 and 2.4 for BKZ and PBO. Low mean BKZ PHQ-9 scores were maintained over 3 yrs of BE BRIGHT following the feeder studies (Wk144: 1.2). At Wk16, 92.9% of BKZ pts scored 0–4 in PHQ-9 (no/minimal depression) vs. 81.1% of PBO pts; 1.3% vs. 6.3% scored ≥10 (moderate–severe depression). Through Wk16, 0.7% BKZ vs. 4.1% PBO pts scored ≥15 (moderately severe–severe) in PHQ-9 at any visit. Over 7,166 PY of BKZ exposure (N=2,480), the rate of adjudicated SIB TEAEs was 0.126/100 PY.
 Conclusion: PHQ-9 scores were low through Wk16 and remained low with longer BKZ exposure. The vast majority of BKZ pts had no/minimal depression at Wk16. The long-term incidence rate of adjudicated SIB with BKZ was low and similar to the general psoriasis population (range: 0.09–0.54/100 PY).1,12
 Funding: UCB Pharma.

Effectiveness and Tolerability of 12-Month Brivaracetam in the Real World: EXPERIENCE, an International Pooled Analysis of Individual Patient Records.

Real-world evidence studies of brivaracetam (BRV) have been restricted in scope, location, and patient numbers. The objective of this pooled analysis was to assess effectiveness and tolerability of brivaracetam (BRV) in routine practice in a large international population. EXPERIENCE/EPD332 was a pooled analysis of individual patient records from multiple independent non-interventional studies of patients with epilepsy initiating BRV in Australia, Europe, and the United States. Eligible study cohorts were identified via a literature review and engagement with country lead investigators, clinical experts, and local UCB Pharma scientific/medical teams. Included patients initiated BRV no earlier than January 2016 and no later than December 2019, and had ≥6 months of follow-up data. The databases for each cohort were reformatted and standardised to ensure information collected was consistent. Outcomes included ≥50% reduction from baseline in seizure frequency, seizure freedom (no seizures within 3 months before timepoint), continuous seizure freedom (no seizures from baseline), BRV discontinuation, and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Patients with missing data after BRV discontinuation were considered non-responders/not seizure free. Analyses were performed for all adult patients (≥16 years), and for subgroups by seizure type recorded at baseline; by number of prior antiseizure medications (ASMs) at index; by use of BRV as monotherapy versus polytherapy at index; for patients who switched from levetiracetam to BRV versus patients who switched from other ASMs to BRV; and for patients with focal-onset seizures and a BRV dose of ≤200mg/day used as add-on at index. Analysis populations included the full analysis set (FAS; all patients who received at least one BRV dose and had seizure type and age documented at baseline) and the modified FAS (all FAS patients who had at least one seizure recorded during baseline). The FAS was used for all outcomes other than ≥50% seizure reduction. All outcomes were summarised using descriptive statistics. Analyses included 1644 adults. At baseline, 72.0% were 16-49 years of age and 92.2% had focal-onset seizures. Patients had a median (Q1, Q3) of 5.0 (2.0, 8.0) prior antiseizure medications at index. At 3, 6, and 12 months, respectively, ≥50% seizure reduction was achieved by 32.1% (n=619), 36.7% (n=867), and 36.9% (n=822) of patients; seizure freedom rates were 22.4% (n=923), 17.9% (n=1165), and 14.9% (n=1111); and continuous seizure freedom rates were 22.4% (n=923), 15.7% (n=1165), and 11.7% (n=1111). During the whole study follow-up, 551/1639 (33.6%) patients discontinued BRV. TEAEs since prior visit were reported in 25.6% (n=1542), 14.2% (n=1376), and 9.3% (n=1232) of patients at 3, 6, and 12 months, respectively. This pooled analysis using data from a variety of real-world settings suggests BRV is effective and well tolerated in routine clinical practice in a highly drug-resistant patient population.

Rozanolixizumab: First Approval.

Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®) is a high affinity humanized immunoglobulin G4 monoclonal antibody directed against human neonatal Fc receptor (FcRn). Administered subcutaneously, it is being developed by UCB Pharma for the treatment of autoimmune diseases and received its first approval on 27June 2023 in the USA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. Rozanolixizumab is the first agent to be approved in the USA for both anti-AChR and anti-MuSK antibody-positive gMG. A regulatory assessment of rozanolixizumab for the treatment of gMG is currently underway in the EU and Japan. Clinical development is ongoing for the treatment of leucine-rich glioma-inactivated 1 autoimmune encephalitis, myelin oligodendrocyte glycoprotein (MOG) antibody disease and severe fibromyalgia syndrome. This article summarizes the milestones in the development of rozanolixizumab leading to this first approval for the treatment of gMG in adults who are anti-AChR or anti-MuSK antibody positive.

P94 Bimekizumab early treatment response translated into cumulative benefits in health-related quality of life in patients with moderate-to-severe plaque psoriasis: results from 2 years of the BE RADIANT phase IIIb trial

Abstract Speed of response is a key treatment goal for patients with psoriasis. This analysis aimed to assess how early clinical response translated into cumulative health-related quality of life (HRQoL) benefit in patients with moderate-to-severe plaque psoriasis over 2 years of bimekizumab (BKZ) treatment. Included patients from BE RADIANT were randomized to BKZ 320 mg every 4 weeks (Q4W), continued to receive Q4W dosing or switched to Q8W at week 16 and entered the open-label extension (OLE) at week 48 (receiving BKZ Q4W or Q8W; NCT03536884). The proportions of patients achieving Psoriasis Symptoms and Impacts Measure (P-SIM) 0 in itching, skin pain and scaling, and Dermatology Life Quality Index 0 or 1 (DLQI 0/1), were estimated using modified nonresponder imputation (mNRI); missing data were imputed via NRI for patients discontinuing due to the lack of efficacy or treatment-related adverse events and multiple imputation otherwise. Cumulative HRQoL and symptom benefit through to week 96 was estimated using the area under the curve (AUC0–96) by week 16 Psoriasis Area and Severity Index (PASI)-100 status (NRI), with week 16 and week 96 responses also reported. AUC0–96 was used to calculate the estimated number of days that each response was achieved. Of the 336 patients randomized to BKZ who entered the OLE, 216 achieved PASI 100 at week 16. Of these, 187/216 patients had already achieved PASI 100 at one or more visit(s) before week 16. Of the PASI-100 responders at week 16, 71.8%, 92.1%, 89.4% and 88.0% also achieved P-SIM 0 for itching, skin pain and scaling and DLQI 0/1, respectively, vs. 39.1%, 77.7%, 56.6% and 74.6% of nonresponders. Of the week 16 PASI-100 responders at week 96, 67.1%, 85.4%, 80.6% and 89.3% achieved P-SIM 0 for itching, skin pain and scaling and DLQI 0/1, respectively, vs. 55.6%, 77.7%, 63.7% and 80.8% of nonresponders. The total AUC0–96 for achievement of P-SIM 0 in itching, skin pain and scaling and DLQI 0/1 was greater for week 16 PASI-100 responders through 2 years, corresponding to a greater number of days achieving these outcomes vs. nonresponders (Table 1). A high proportion of patients achieved complete skin clearance at week 16, translating to a greater number of days achieving P-SIM 0 in itching, skin pain and scaling and DLQI 0/1 vs. week 16 PASI-100 nonresponders through 2 years of BKZ treatment.Table 1AUC0-96 by week 16 PASI-100 response over 2 years (mNRI)Week 16 PASI-100 responders (n = 216)Week 16 PASI-100 nonresponders (n = 120)P-SIM 0P-SIM 0ItchingSkin painScalingDLQI 0/1ItchingSkin painScalingDLQI 0/1AUC0–9666398504784982674918753957837584Days465595549579344528405531 Acknowledgment: Medical writing: Costello Medical. Funding sources: UCB Pharma.

PS14 Bimekizumab response up to 3 years in patients with moderate-to-severe plaque psoriasis who responded at week 16: post hoc results from the BE BRIGHT open-label extension trial

Abstract Treatment with the interleukin-17A/F inhibitor bimekizumab (BKZ) has demonstrated maintenance of efficacy and health-related quality of life (HRQoL) outcomes over 2 years. The objective of this analysis was to assess the long-term response in patients with moderate-to-severe plaque psoriasis who achieved Psoriasis Area and Severity Index (PASI) ≤ 2, a key treat-to-target outcome, after 16 weeks of BKZ treatment over 3 years. Patients who completed a 52- (BE VIVID) or 56-week (BE SURE and BE READY) phase III feeder study were eligible to enrol in the BE BRIGHT open-label extension (OLE) (NCT03370133, NCT03412747, NCT03410992 and NCT03598790). Upon OLE entry, patients received BKZ 320 mg Q4W or Q8W based on feeder study treatment and week 52/56 PASI 90 (≥ 90% improvement in PASI) response. Patients switched from BKZ Q4W to Q8W at OLE week 24 (based on investigator discretion and PASI 90 response), or OLE week 48/next scheduled visit (all patients). Achievement of body surface area (BSA) ≤ 1% and PASI 0 (all studies), and Dermatology Life Quality Index (DLQI)0/1 (BE SURE and BE READY only due to schedule differences) is reported among week 16 PASI ≤ 2 responders through year 1 (feeder study week 52/56) and year 3 (OLE week 96). Analysed patients were randomized to BKZ, received BKZ maintenance dosing from feeder study week 16 and entered the OLE, including a subset who received BKZ Q4W through to week 16 then continuous BKZ Q8W (Q4W/Q8W/Q8W). Missing data were imputed using modified nonresponder imputation (mNRI): patients who discontinued treatment due to lack of efficacy or treatment-related adverse events were considered nonresponders; multiple imputation was used for all other missing data. The week 16 responder rate is also reported (NRI). At baseline, 989 patients were randomized to BKZ; 87.8% (n = 868) achieved PASI ≤ 2 at week 16. Of these, 694 entered the OLE. Among week 16 PASI ≤ 2 responders (n = 694), 91.9% and 82.3% achieved BSA ≤ 1% and PASI 0 after year 1 (52 weeks), and 88.6% and 74.1% after year 3, respectively. Among week 16 PASI ≤ 2 responders (n = 445), 87.8% and 86.8% achieved DLQI 0/1 after year 1 (56 weeks) and year 3, respectively. Of the week 16 PASI ≤ 2 responders who received BKZ Q4W/Q8W/Q8W (n = 189), 95.2% and 87.6% achieved BSA ≤ 1% and PASI 0 after 1 year (52 weeks), and 93.4% and 79.7% after 3 years, respectively. Among the Q4W/Q8W/Q8W patients, 94.1% and 91.2% achieved DLQI 0/1 after year 1 (56 weeks) and year 3, respectively. The BKZ provided long-term efficacy and HRQoL benefits. Among week 16 PASI ≤ 2 responders, the vast majority sustained high levels of clinical and HRQoL responses through 3 years of BKZ treatment, including those who received BKZ Q4W/Q8W/Q8W. Funding: UCB Pharma. Medical writing: Costello Medical.

Efficacy of Rozanolixizumab in Generalized Myasthenia Gravis: Subgroup Analyses from the Randomized Phase 3 MycarinG Study (S5.007)

Efficacy of Rozanolixizumab in Generalized Myasthenia Gravis: Subgroup Analyses from the Randomized Phase 3 MycarinG Study (S5.007)

12-Month Effectiveness and Tolerability of Brivaracetam in the Real-World: The International EXPERIENCE Pooled Analysis (P11-1.003)

12-Month Effectiveness and Tolerability of Brivaracetam in the Real-World: The International EXPERIENCE Pooled Analysis (P11-1.003)

Long-term Efficacy and Safety of Symptom-driven Cyclic Rozanolixizumab Treatment in Patients with Generalized Myasthenia Gravis: A Pooled Analysis of a Phase 3 Study and Two Open-label Extension Studies (P1-5.012)

Long-term Efficacy and Safety of Symptom-driven Cyclic Rozanolixizumab Treatment in Patients with Generalized Myasthenia Gravis: A Pooled Analysis of a Phase 3 Study and Two Open-label Extension Studies (P1-5.012)

Subgroup outcomes from RAISE: A randomized, Phase 3 trial of zilucoplan in generalized myasthenia gravis (P1-5.006)

Subgroup outcomes from RAISE: A randomized, Phase 3 trial of zilucoplan in generalized myasthenia gravis (P1-5.006)

Treatment Outcomes During Brivaracetam Treatment by Seizure Freedom Status at Baseline: Post hoc Analysis of a Real-world, US Study (P14-1.001)

Treatment Outcomes During Brivaracetam Treatment by Seizure Freedom Status at Baseline: Post hoc Analysis of a Real-world, US Study (P14-1.001)

Predictors of Achievement of Response With Cenobamate: Post-hoc Subset Analysis From a Phase 3, Open-Label Safety Study (S44.006)

Predictors of Achievement of Response With Cenobamate: Post-hoc Subset Analysis From a Phase 3, Open-Label Safety Study (S44.006)

Significant Improvements in SEIzure InterVAL (Time Between Seizure Clusters) Across Time Irrespective of Age or Change in Concomitant Treatments in a Long-Term, Open-Label Safety Study of Diazepam Nasal Spray (P9-1.010)

Significant Improvements in SEIzure InterVAL (Time Between Seizure Clusters) Across Time Irrespective of Age or Change in Concomitant Treatments in a Long-Term, Open-Label Safety Study of Diazepam Nasal Spray (P9-1.010)

Perampanel for Treatment of Focal and Generalized Epilepsy in Everyday Clinical Practice: Evidence from PERMIT and PROVE (P11-1.008)

Perampanel for Treatment of Focal and Generalized Epilepsy in Everyday Clinical Practice: Evidence from PERMIT and PROVE (P11-1.008)

Design of REACH: Phase 3 Randomized, Double-Blind, Placebo-Controlled, 48-Week Study of the Efficacy and Safety of Losmapimod in FSHD (P6-8.007)

Design of REACH: Phase 3 Randomized, Double-Blind, Placebo-Controlled, 48-Week Study of the Efficacy and Safety of Losmapimod in FSHD (P6-8.007)

MANOEUVRE Study Design: A Study of GYM329 (RO7204239) in Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) (S2.010)

MANOEUVRE Study Design: A Study of GYM329 (RO7204239) in Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) (S2.010)

Predictors of Sustainability of Response With Cenobamate: Post-hoc Subset Analysis of a Phase 3, Open-Label, Study (P14-1.005)

Predictors of Sustainability of Response With Cenobamate: Post-hoc Subset Analysis of a Phase 3, Open-Label, Study (P14-1.005)

Concomitant Drug Load Reduction During Adjunctive Cenobamate Therapy: Post-hoc Analysis of a Phase 3, Open-Label Study (P11-1.006)

<h3>Objective:</h3> Changes in concomitant antiseizure medication (ASM) drug load after adding cenobamate were evaluated post-hoc in a subset of the open-label, phase 3 safety study. <h3>Background:</h3> Many patients with epilepsy require adjunctive therapy, which can increase their ASM drug load. <h3>Design/Methods:</h3> Patients 18–70 years old with uncontrolled focal seizures taking stable doses of 1–3 ASMs were enrolled. Total concomitant ASM drug load (not including cenobamate) was calculated by dividing the patient’s prescribed dose for each ASM by its defined daily dose, a World Health Organization standardized daily maintenance dose, then summing the ratios. Changes in concomitant ASM drug load were measured from baseline in 3-month intervals up to 24 months by both total and class-specific ASM drug load. Subgroups of interest included: older adults (65–70 years), prior epilepsy-related surgery vs none, and baseline seizure frequency &lt;3 vs ≥3 seizures/28 days. <h3>Results:</h3> Data from 240 patients were available (median exposure duration 30.2 months, mean age 41.8 years, mean baseline drug load 3.57). Following cenobamate initiation, mean percent reductions in concomitant ASM drug load occurred at Month 12 (29.44%) and 24 (31.82%), and in all assessed ASM drug classes, with the largest reduction in benzodiazepines (55.24% at Month 24). All assessed patient subgroups exceeded 30% reduction in concomitant ASM drug load at Month 24. Patients with low (−0.25 to &lt;0), moderate (−0.59 to −0.25), or high (−3.3 to −0.59) change in concomitant ASM drug load vs no change, respectively, had similar maintenance of ≥50% (89.29%, 86.42%, 90.57% vs 85.99%) and 100% response rates (80.65%, 84.29%, 70.00% vs 82.00%). <h3>Conclusions:</h3> Adding cenobamate led to reduced mean concomitant ASM drug load during Year 1 and Year 2. Reductions occurred regardless of ASM drug class, patient age, or epilepsy disease characteristics. Reductions in ASM drug load did not impact maintenance of response rates. See also abstract by O’Dwyer et al. <b>Disclosure:</b> Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. Louis Ferrari has received personal compensation for serving as an employee of SK Life science. Mr. Stern has received personal compensation for serving as an employee of SK Life Science. Mr. Wade has nothing to disclose. Dr. Weingarten has received personal compensation for serving as an employee of SK Life Science. The institution of Dr. Connor has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for SK Life Sciences. The institution of Dr. Connor has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Science. The institution of Dr. Rosenfeld has received research support from SK Life Science. The institution of Dr. Rosenfeld has received research support from UCB Pharma.