Outcomes from A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents (AMPA) in Patients with Focal-Onset Seizures with vs without Focal to Bilateral Tonic-Clonic Seizures
Abstract number :
2.122
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2022
Submission ID :
2204535
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:25 AM
Authors :
Sara Casciato, MD – IRCCS Neuromed, Pozzilli, Italy; Samantha Goldman, MD, B.Sc (Hons) – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Martina Chiacchiaretta, PhD – Eisai s.r.l., Milan, Italy; Paola Mansi, MD – Eisai s.r.l., Milan, Italy; Ricardo Sáinz-Fuertes, LMS, MSc, MRCPsych, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Anna Patten, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Anna Gentile, PhD – Eisai s.r.l., Milan, Italy
Rationale: In the U.S. and EU, perampanel is approved for focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), in patients aged ≥ 4 years (US, monotherapy/adjunctive; EU, adjunctive), and generalized tonic-clonic seizures in patients aged ≥ 12 (≥ 7, EU) years (adjunctive). The AMPA Study (NCT04257604; Study 501) was a prospective, observational 12-month study to evaluate the efficacy and safety of adjunctive perampanel in patients with FOS, with/without FBTCS, in routine clinical practice in Italy. Here, we report a post hoc analysis of clinical outcomes in the AMPA Study, particularly the treatment-emergent adverse events (TEAEs), by seizure type.
Methods: Patients aged ≥ 12 years with insufficiently controlled FOS, with/without FBTCS, while receiving 1–3 anti-seizure medications (ASMs) were prescribed adjunctive perampanel per the approved indication. The primary endpoint was median percent reduction from baseline in seizure frequency/28 days at Month 6 (secondary endpoints: Months 3 and 12). Safety endpoints during the study included monitoring of TEAEs up to 12 months.
Results: Of the 234 patients who received adjunctive perampanel (Safety Analysis Set [SAS]; with FBTCS, n=90; without FBTCS, n=144), 135 completed the study (with FBTCS, n=55; without FBTCS, n=80). Overall, 202 patients had baseline/post-baseline seizure data and formed the Intent-to-Treat (ITT) Analysis Set (with FBTCS, n=80; without FBTCS, n=122). The mean (standard deviation [SD]) duration of perampanel exposure was 41.2 (18.8) weeks and 36.2 (19.3) weeks in patients with and without FBTCS, respectively; mean perampanel doses were 5.4 (2.1) mg/day vs. 5.3 (1.9) mg/day, respectively. The median percent reduction in seizure frequency/28 days from baseline is presented in Figure 1 (ITT Analysis Set). The incidence of TEAEs and treatment-related TEAEs was comparable between patients with/without FBTCS (SAS; Table 1). Serious TEAEs were reported by 5.6% of patients with FBTCS and 6.3% of patients without FBTCS; no deaths occurred in either group of patients. TEAEs that were deemed mild occurred in 31.1% (n=28/90) vs. 31.3% (n=45/144) of patients with and without FBTCS, respectively; these rates were 24.4% (n=22/90; with FBTCS) vs. 20.1% (n=29/144; without FBTCS) for TEAEs that were deemed moderate, and were 1.1% (n=1/90; with FBTCS) vs. 4.9% (n=7/144; without FBTCS) for TEAEs that were deemed severe. TEAEs leading to perampanel dose adjustment were reported by 35.6% of patients with FBTCS and 38.9% of patients without FBTCS. The most common TEAE was dizziness/vertigo (24.4% vs. 20.1% for patients with/without FBTCS, respectively).
Conclusions: These data suggest that adjunctive perampanel was efficacious and generally well tolerated in patients with FOS, with/without FBTCS, in a real-world setting; incidences of TEAEs were comparable between patients with/without FBTCS, and no unexpected safety signals emerged.
Funding: Eisai s.r.l.
Clinical Epilepsy