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Madalina Leanca¹´² , Carmen Burloiu², Diana Barca²´³, Oana Tarta-Arsene²´³,

The XXIV- th National Conference of The Romanian Society Against Epilepsy. Results of Everolimus treatment on epilepsy in romanian children patients with Tuberous Sclerosis Complex. Madalina Leanca¹´² , Carmen Burloiu², Diana Barca²´³, Oana Tarta-Arsene²´³,

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Madalina Leanca¹´² , Carmen Burloiu², Diana Barca²´³, Oana Tarta-Arsene²´³,

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  1. The XXIV-th National Conference of The Romanian Society Against Epilepsy Results of Everolimus treatment on epilepsy in romanian children patients with Tuberous Sclerosis Complex Madalina Leanca¹´², Carmen Burloiu², Diana Barca²´³, Oana Tarta-Arsene²´³, Ioana Minciu ²´³Catrinel Iliescu²´³, Niculina Butoianu²´³, Cristina Pomeran¹´²´³, Rodica Gherghiceanu2,Alice Dica¹´², Carmen Sandu¹´²´³, Dana Craiu²´³ ¹ Romanian foundation of neurology and epileptology RONEP -Bucharest, Romania ² Child Neurology Clinic of “Alexandru Obegia” Hospital– Bucharest, Romania ³ Pediatric Neurology, "Carol Davila" University of Medicine – Bucharest, Romania

  2. The XXIV-th National Conference of The Romanian Society Against Epilepsy NATIONAL HEALTH PROGRAMME – RARE DISEASE TUBEROUS SCLEROSIS COMPLEX CHILD NEUROLOGY • ROMANIA STARTED NOV 2014 ADULT NEUROLOGY ADULT NEPHROLOGY

  3. The XXIV-th National Conference of The Romanian Society Against Epilepsy Indication for treatment with EVEROLIMUS • SEGA (SubependymalGiant Cell Astrocytoma ) associate TSC (neurology, child neurology) • RENAL ANGIOMYOLIPOMA associate TSC (nephrologist, urologist )

  4. The XXIV-th National Conference of The Romanian Society Against Epilepsy EVEROLIMUS – mTOR inhibitor • Initial dose – 4,5 mg/square meter • The dose is increased gradually seric concentration 3-15 ng/ml • Measuring serum concentration • 2 weeks of treatment started • After stabilization • Every 3-6 months • After any change in dose/ pharmaceutical form • After initiating therapy with inhibitors or inducers of CYP3A4

  5. The XXIV-th National Conference of The Romanian Society Against Epilepsy SEGA monitoring response to treatment • Measuring SEGA volume – every 3 months after treatment initiation • Imaging tests – cerebral MRI: • Every 3 months in the first year of treatment • Every 6 months if SEGA >1 cm • Every 12 months after second year of treatment

  6. The XXIV-th National Conference of The Romanian Society Against Epilepsy Adjunctive everolimus therapy for treatment-resistant focal-onset seizures associated with tuberous sclerosis (EXIST-3): a phase 3, randomised, double-blind, placebo-controlled study Jacqueline A French, John A Lawson, ZuhalYapici, Hiroko Ikeda, TilmanPolster, RimaNabbout, Paolo Curatolo, Petrus J de Vries, Dennis J Dlugos, Noah Berkowitz, Maurizio Voi, SeverinePeyrard, Diana Pelov, David N Franz Lancet 2016; 388: 2153–63 Published Online September 6, 2016 http://dx.doi.org/10.1016/ S0140-6736(16)31419-2

  7. The XXIV-th National Conference of The Romanian Society Against Epilepsy ROMANIAN RESULTS

  8. The XXIV-th National Conference of The Romanian Society Against Epilepsy 13 PATIENTS FOLLOW UP 2 YEARS(NOV 2014-NOV 2016) 1 ADULT IUN2016 12 CHILDREN 10 CHILDREN 2 CHILDREN REFUSE TREATMENT

  9. The XXIV-th National Conference of The Romanian Society Against Epilepsy

  10. The XXIV-th National Conference of The Romanian Society Against Epilepsy MEDIAN AGE 10 YEARS

  11. The XXIV-th National Conference of The Romanian Society Against Epilepsy

  12. The XXIV-th National Conference of The Romanian Society Against Epilepsy ONSET SEIZURES AGE (MO)

  13. The XXIV-th National Conference of The Romanian Society Against Epilepsy

  14. The XXIV-th National Conference of The Romanian Society Against Epilepsy ANTIEPILEPTIC THERAPY AT ONSET

  15. The XXIV-th National Conference of The Romanian Society Against Epilepsy SEIZURE

  16. The XXIV-th National Conference of The Romanian Society Against Epilepsy TYPE OF SEIZURE BEFORE VOTUBIA EXIST 3 Lancet 2016; 388: 2153–63 Published Online September 6, 2016 http://dx.doi.org/10.1016/ S0140-6736(16)31419-2

  17. The XXIV-th National Conference of The Romanian Society Against Epilepsy NUMBER OF AED EXIST 3 Lancet 2016; 388: 2153–63 Published Online September 6, 2016 http://dx.doi.org/10.1016/ S0140-6736(16)31419-2

  18. The XXIV-th National Conference of The Romanian Society Against Epilepsy AED

  19. The XXIV-th National Conference of The Romanian Society Against Epilepsy ADVERSE EVENTS

  20. The XXIV-th National Conference of The Romanian Society Against Epilepsy NUMBER OF SEIZURE PER MONTH

  21. The XXIV-th National Conference of The Romanian Society Against Epilepsy 9 CHILDREN 5 CHILDREN 4 CHILDREN

  22. The XXIV-th National Conference of The Romanian Society Against Epilepsy • Everolimus effective treatment option not only for SEGA and AML, but also for TSC-related epilepsies. • Everolimus was well tolerated, with adverse effects similar to those reported in previous studies. • TAKE HOME MESSAGE

  23. The XXIV-th National Conference of The Romanian Society Against Epilepsy • Everolimus is effective and safe in infants and young children with epilepsy and SEGA associated with TSC • Everolimus can be a potential disease modifying therapy for TSC • TAKE HOME MESSAGE

  24. The XXIV-th National Conference of The Romanian Society Against Epilepsy i THANK YOU !!!

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