Frontiers in Neurology (Mar 2025)
Nusinersen for children with type I spinal muscular atrophy: 4 years’ clinical experience in Turkish cohort
- Ömer Bektaş,
- Murat Gülşen,
- Onur Burak Dursun,
- Ahmet Tekin,
- Deniz Yüksel,
- Ercan Demir,
- Gülten Öztürk,
- Sema Saltık,
- Özlem Hergüler,
- Ayşe Aysima Özçelik,
- Hüseyin Tan,
- Bilge Özgör,
- Arzu Ekici,
- Merve Feyza Yüksel,
- Süleyman Şahin,
- Özgür Duman,
- Mustafa Kömür,
- Figen Baydan,
- Edibe Pembegül Yıldız,
- Bülent Kara,
- Uluç Yiş,
- Seda Kanmaz,
- Kürşat Bora Çarman,
- Elif Acar Arslan,
- Mehmet Canpolat,
- Ahmet Sami Güven,
- Gökçen Öztuncer,
- Aycan Ünalp,
- Didem Ardıçlı,
- Aynur Ayşe Karaduman,
- Gökmen Zararsız,
- Gülhis Deda,
- Turkish SMA Study Group,
- Ömer Bektaş,
- Murat Gülşen,
- Onur Burak Dursun,
- Ahmet Tekin,
- Deniz Yüksel,
- Ercan Demir,
- Gülten Öztürk,
- Sema Saltık,
- Özlem Hergüler,
- Ayşe Aysima Özçelik,
- Hüseyin Tan,
- Bilge Özgör,
- Arzu Ekici,
- Merve Feyza Yüksel,
- Süleyman Şahin,
- Özgür Duman,
- Mustafa Kömür,
- Figen Baydan,
- Edibe Pembegül Yıldız,
- Bülent Kara,
- Uluç Yiş,
- Seda Kanmaz,
- Kürşat Bora Çarman,
- Elif Acar Arslan,
- Mehmet Canpolat,
- Ahmet Sami Güven,
- Gökçen Öztuncer,
- Aycan Ünalp,
- Didem Ardıçlı,
- Aynur Ayşe Karaduman,
- Gökmen Zararsız,
- Nurşah Yeniay Süt,
- Olcay Ünver,
- Tuğçe Damla Dilek,
- Eif Yıldırım,
- Faruk İncecik,
- Meral Karadağ,
- Mehmet Fatih Bütün,
- Burçin Gönüllü Polat,
- Yiğithan Güzin,
- Mehmet Akif Kılıç,
- Adnan Deniz,
- Gamze Sarıkaya Uzan,
- Sanem Yılmaz Keskin,
- Fatih M. Özdemir,
- Coşkun Yarar,
- Nihal Yıldız,
- Hamit Acer,
- Hüseyin Çaksen,
- Seren Aydın,
- Pakize Karaoğlu,
- Ayşe Neşe Çıtak,
- Tanıl Kendirli,
- Birkan Sonel Tur,
- Gülcan Akyüz,
- Ceren Bibinoğlu Amirov,
- Gülen Gül Mert,
- Mahmut Aslan,
- Şenay Haspolat,
- Özlem Ersoy,
- Osman Kipoğlu,
- Defne Alikılıç,
- Hasan Tekgül,
- Ülkühan Kaya,
- Arife Derda Yücel Şen,
- Pınar Özkan Kart,
- Hüseyin Per,
- Ayşe Aksoy,
- Ünsal Yılmaz,
- Serap Teber,
- Özben Akıncı Göktaş,
- Dilşad Türkdoğan,
- Fitnat Uluğ,
- Serap Bilge,
- Orhan Coşkun,
- Merve Öztürk,
- Esra Atmaca,
- Ali Cansu,
- Hakan Gümüş,
- Evrim Karadağ Saygı,
- Ömer Karaca,
- Serdal Güngör,
- Nazan Çobanoğlu,
- Melek Sezgin,
- Miraç Yıldırım,
- Yasemin Gökdemir,
- Esma Şengenç,
- Yılmaz Zindar,
- Özlem Yayıcı,
- Serkan Köken,
- Mesut Güngör,
- Serkan Kırık,
- Meltem Çobanoğulları Direk,
- Gülhis Deda
Affiliations
- Ömer Bektaş
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Ankara University, Ankara, Türkiye
- Murat Gülşen
- Ministry of Health, General Directorate of Health Services, Department of Autism, Mental Special Needs, and Rare Diseases, Ankara, Türkiye
- Onur Burak Dursun
- Ministry of Health, General Directorate of Health Services, Department of Autism, Mental Special Needs, and Rare Diseases, Ankara, Türkiye
- Ahmet Tekin
- Ministry of Health, General Directorate of Health Services, Ankara, Türkiye
- Deniz Yüksel
- Division of Pediatric Neurology, Department of Pediatrics, Dr. Sami Ulus Research and Training Hospital, University of Health Sciences Turkey, Ankara, Türkiye
- Ercan Demir
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Gazi University, Ankara, Türkiye
- Gülten Öztürk
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Marmara University, İstanbul, Türkiye
- Sema Saltık
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, İstanbul University Cerrahpaşa, İstanbul, Türkiye
- Özlem Hergüler
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Çukurova University, Adana, Türkiye
- Ayşe Aysima Özçelik
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Gaziantep University, Gaziantep, Türkiye
- Hüseyin Tan
- 0Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Atatürk University, Erzurum, Türkiye
- Bilge Özgör
- 1Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Turgut Ozal Research Center, Inonu University, Malatya, Türkiye
- Arzu Ekici
- 2Division of Pediatric Neurology, Department of Pediatrics, Bursa Yüksek İhtisas Research and Training Hospital, University of Health Sciences Turkey, Ankara, Türkiye
- Merve Feyza Yüksel
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Ankara University, Ankara, Türkiye
- Süleyman Şahin
- Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Ankara University, Ankara, Türkiye
- Özgür Duman
- 3Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Akadeniz University, Antalya, Türkiye
- Mustafa Kömür
- 4Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Mersin University, Mersin, Türkiye
- Figen Baydan
- 5Division of Pediatric Neurology, Department of Pediatrics, Tepecik Research and Training Hospital, İzmir, Türkiye
- Edibe Pembegül Yıldız
- 6Division of Pediatric Neurology, Department of Pediatrics, İstanbul University, İstanbul, Türkiye
- Bülent Kara
- 7Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Kocaeli University, Kocaeli, Türkiye
- Uluç Yiş
- 8Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Dokuz Eylül University, İzmir, Türkiye
- Seda Kanmaz
- 9Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Ege University, İzmir, Türkiye
- Kürşat Bora Çarman
- 0Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Eskişehir Osmangazi University, Eskişehir, Türkiye
- Elif Acar Arslan
- 1Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Karadeniz Teknik University, Trabzon, Türkiye
- Mehmet Canpolat
- 2Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Erciyes University, Kayseri, Türkiye
- Ahmet Sami Güven
- 3Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Necmettin Erbakan University, Konya, Türkiye
- Gökçen Öztuncer
- 4Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Ondokuz Mayıs University, Samsun, Türkiye
- Aycan Ünalp
- 5Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Dr. Behçet Uz Children’s Education and Research Hospital, University of Health Sciences Turkey Izmir, Izmir, Türkiye
- Didem Ardıçlı
- 6Division of Pediatric Neurology, Department of Pediatrics, Ankara City Hospital, University of Health Sciences Turkey, Ankara, Türkiye
- Aynur Ayşe Karaduman
- 7Department of Physiotherapy and Rehabilitation, Faculty of Medicine, Lokman Hekim University, Ankara, Türkiye
- Gökmen Zararsız
- 8Department of Biostatistics, Erciyes University School of Medicine, Kayseri, Türkiye
- Gülhis Deda
- 9Turkish Medicines and Medical Devices Agency, Ankara, Türkiye
- Turkish SMA Study Group
- Ömer Bektaş
- Murat Gülşen
- Onur Burak Dursun
- Ahmet Tekin
- Deniz Yüksel
- Ercan Demir
- Gülten Öztürk
- Sema Saltık
- Özlem Hergüler
- Ayşe Aysima Özçelik
- Hüseyin Tan
- Bilge Özgör
- Arzu Ekici
- Merve Feyza Yüksel
- Süleyman Şahin
- Özgür Duman
- Mustafa Kömür
- Figen Baydan
- Edibe Pembegül Yıldız
- Bülent Kara
- Uluç Yiş
- Seda Kanmaz
- Kürşat Bora Çarman
- Elif Acar Arslan
- Mehmet Canpolat
- Ahmet Sami Güven
- Gökçen Öztuncer
- Aycan Ünalp
- Didem Ardıçlı
- Aynur Ayşe Karaduman
- Gökmen Zararsız
- Nurşah Yeniay Süt
- Olcay Ünver
- Tuğçe Damla Dilek
- Eif Yıldırım
- Faruk İncecik
- Meral Karadağ
- Mehmet Fatih Bütün
- Burçin Gönüllü Polat
- Yiğithan Güzin
- Mehmet Akif Kılıç
- Adnan Deniz
- Gamze Sarıkaya Uzan
- Sanem Yılmaz Keskin
- Fatih M. Özdemir
- Coşkun Yarar
- Nihal Yıldız
- Hamit Acer
- Hüseyin Çaksen
- Seren Aydın
- Pakize Karaoğlu
- Ayşe Neşe Çıtak
- Tanıl Kendirli
- Birkan Sonel Tur
- Gülcan Akyüz
- Ceren Bibinoğlu Amirov
- Gülen Gül Mert
- Mahmut Aslan
- Şenay Haspolat
- Özlem Ersoy
- Osman Kipoğlu
- Defne Alikılıç
- Hasan Tekgül
- Ülkühan Kaya
- Arife Derda Yücel Şen
- Pınar Özkan Kart
- Hüseyin Per
- Ayşe Aksoy
- Ünsal Yılmaz
- Serap Teber
- Özben Akıncı Göktaş
- Dilşad Türkdoğan
- Fitnat Uluğ
- Serap Bilge
- Orhan Coşkun
- Merve Öztürk
- Esra Atmaca
- Ali Cansu
- Hakan Gümüş
- Evrim Karadağ Saygı
- Ömer Karaca
- Serdal Güngör
- Nazan Çobanoğlu
- Melek Sezgin
- Miraç Yıldırım
- Yasemin Gökdemir
- Esma Şengenç
- Yılmaz Zindar
- Özlem Yayıcı
- Serkan Köken
- Mesut Güngör
- Serkan Kırık
- Meltem Çobanoğulları Direk
- Gülhis Deda
- DOI
- https://doi.org/10.3389/fneur.2025.1541507
- Journal volume & issue
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Vol. 16
Abstract
BackgroundSMA Type 1 is the most severe form of spinal muscular atrophy with early symptom onset, limited motor development, and poor prognosis. Recent genetic-based therapies, such as nusinersen, have transformed disease outcomes. We aimed to evaluate the long-term effects of nusinersen on motor, bulbar, and respiratory functions in both symptomatic and presymptomatic SMA Type 1 patients over a period of up to 4 years.MethodsThis prospective, non-interventional study included 310 patients with genetically confirmed spinal muscular atrophy at 24 pediatric neurology centers in Turkey. Patients treated with nusinersen were divided into five age-based cohorts at treatment initiation: Cohort A (0–3 months), Cohort B (4–6 months), Cohort C (7–12 months), Cohort D (13–24 months), and Cohort E (>24 months). Efficacy was assessed using the CHOP-INTEND and WHO Motor Milestone Scale. This study also analyzed the respiratory support needs, gastrostomy requirements, and mortality rates across cohorts.ResultsPatients treated before 12 months of age showed the most significant improvements in motor milestones, with 58.7% of Cohort A achieving independent sitting. CHOP-INTEND scores increased notably in all cohorts, with the largest improvement observed in Cohort A (93.5%). Ventilator and gastrostomy requirements decreased in the early treated cohorts. Adverse events were rare, with one discontinuation due to hydrocephalus. The overall mortality rate was 21.3%, with most of the deaths occurring within the first year.InterpretationNusinersen treatment initiated before 12 months of age, especially before 3 months of age, yielded the most favorable motor outcomes in patients with SMA type 1. Early initiation is associated with improved motor milestones and reduced need for ventilatory support. However, no significant improvements were observed in the bulbar function or in patients requiring extensive respiratory support.
Keywords