Article
Clinical Neurology
Chao Zhu, Zhen Zhou, Izanne Roos, Daniel Merlo, Tomas Kalincik, Serkan Ozakbas, Olga Skibina, Jens Kuhle, Suzanne Hodgkinson, Cavit Boz, Raed Alroughani, Jeannette Lechner-Scott, Michael Barnett, Guillermo Izquierdo, Alexandre Prat, Dana Horakova, Eva Kubala Havrdova, Richard Macdonell, Francesco Patti, Samia Joseph Khoury, Mark Slee, Rana Karabudak, Marco Onofrj, Vincent Van Pesch, Julie Prevost, Mastura Monif, Vilija Jokubaitis, Anneke van der Walt, Helmut Butzkueven
Summary: Ocrelizumab and natalizumab are more effective than cladribine in reducing relapses in patients with relapsing-remitting multiple sclerosis switching from fingolimod. Additional observation time is needed to determine if the statistical difference in annualized relapse rate (ARR) results in long-term disability differences.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2022)
Article
Clinical Neurology
Heinz Wiendl, Tim Spelman, Helmut Butzkueven, Ludwig Kappos, Maria Trojan, Ray Su, Nolan Campbell, Pei-Ran Ho, Stephanie Licata
Summary: The results indicate that natalizumab treatment may benefit disability improvement, with 51.8% of patients experiencing disability improvement in the first year of treatment. Among patients with disability improvement, 56.6% had improvement greater than 1.5 points; 34.4% had improvement greater than 2.0 points.
MULTIPLE SCLEROSIS JOURNAL
(2021)
Article
Clinical Neurology
Tobias Monschein, Sarinah Dekany, Tobias Zrzavy, Markus Ponleitner, Patrick Altmann, Gabriel Bsteh, Barbara Kornek, Paulus Rommer, Christian Enzinger, Franziska Di Pauli, Jorg Kraus, Thomas Berger, Fritz Leutmezer, Michael Guger
Summary: With data from the Austrian Multiple Sclerosis Therapy Registry, the effectiveness and safety of natalizumab in multiple sclerosis patients were assessed for up to 14 years. The results showed that natalizumab was effective in treating relapsing-remitting multiple sclerosis and had a favorable safety profile during long-term use.
JOURNAL OF NEUROLOGY
(2023)
Article
Clinical Neurology
Alyssa A. Toorop, Zoe L. E. van Kempen, Maurice Steenhuis, Jessica Nielsen, L. G. F. Sinnige, Gert van Dijk, Christiaan M. Roosendaal, Edo P. J. Arnoldus, Elske Hoitsma, Birgit Lissenberg-Witte, Brigit A. de Jong, Bob W. van Oosten, Eva M. M. Strijbis, Bernard M. J. Uitdehaag, Theo Rispens, Joep Killestein
Summary: The study evaluated the change in natalizumab trough drug levels when switching from intravenous to subcutaneous administration. It was found that the drug levels were on average 55% lower with subcutaneous administration, leading to very low levels in some patients. Monitoring of trough drug levels is advised when switching to subcutaneous administration in patients with low intravenous drug levels, higher body mass index, or extended treatment intervals.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2023)
Article
Clinical Neurology
Filipe Palavra, Sonia Figueiroa, Ana Sofia Correia, Fernando Tapadinhas, Joao Cerqueira, Rui Pedro Guerreiro, Joao de Sa, Maria Jose Sa, Sofia Almeida, Patricia Mota, Livia Sousa
Summary: Natalizumab may be an effective and safe treatment for pediatric-onset multiple sclerosis, reducing disability status and relapse rate, especially after 12 months of treatment.
MULTIPLE SCLEROSIS AND RELATED DISORDERS
(2021)
Article
Clinical Neurology
Ilaria Callegari, Mika Schneider, Vera Aebischer, Margarete M. M. Voortman, Undine Proschmann, Tjalf Ziemssen, Raija Lindberg, Bettina Fischer-Barnicol, Michael Khalil, Ludwig Kappos, Jens Kuhle, Nicholas S. R. Sanderson, Tobias Derfuss
Summary: This study found that natalizumab can diffuse in different anatomical compartments, including cerebrospinal fluid and milk. By developing a flow-cytometry-based assay and applying it to quantify natalizumab in body fluids, including cerebrospinal fluid, breastmilk, and serum, a better understanding of the safety of therapeutic antibody administration during pregnancy and lactation can be achieved.
THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS
(2023)
Article
Medicine, General & Internal
Martha Rocio Hernandez-Preciado, Jazmin Marquez-Pedroza, Nayeli Alejandra Sanchez-Rosales, Jose de Jesus Garcia-Rivera, Antonio Kobayashi-Gutierrez, Blanca Miriam Torres-Mendoza, Efrain Chavarria-Avila, Raul Alejandro Montano-Serrano, Fernando Cortes-Enriquez, Mario Alberto Mireles-Ramirez
Summary: This study evaluates the clinical files of RRMS patients and compares the effectiveness of rituximab with second-line treatments. The results show that rituximab has significant benefits in improving EDSS scores and reducing relapse rates.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Clinical Neurology
Ki Hoon Kim, Su-Hyun Kim, Na Young Park, Jae-Won Hyun, Ho Jin Kim
Summary: This study evaluated the efficacy and safety of natalizumab in Korean patients with active MS, showing high efficacy in reducing annual relapse rate and improving or stabilizing disability in the majority of patients. NEDA-3 was achieved in 92% and 82% of patients at 1 and 2 years after initiating natalizumab treatment, respectively. No serious adverse events leading to discontinuation of natalizumab were observed.
FRONTIERS IN NEUROLOGY
(2021)
Article
Clinical Neurology
Doriana Landi, Francesca Bovis, Alfonso Grimaldi, Pietro Osvaldo Annovazzi, Antonio Bertolotto, Alessia Bianchi, Giovanna Borriello, Vincenzo Brescia Morra, Sebastiano Bucello, Maria Chiara Buscarinu, Francesca Caleri, Marco Capobianco, Ruggero Capra, Maria Cellerino, Diego Centonze, Raffaella Cerqua, Clara Grazia Chisari, Marinella Clerico, Eleonora Cocco, Gaia Cola, Cinzia Cordioli, Erica Curti, Alessandro d'Ambrosio, Emanuele D'Amico, Giovanna De Luca, Massimiliano Di Filippo, Sonia Di Lemme, Roberta Fantozzi, Diana Ferraro, Elisabetta Ferraro, Antonio Gallo, Claudio Gasperini, Franco Granella, Matilde Inglese, Roberta Lanzillo, Lorena Lorefice, Giacomo Lus, Simona Malucchi, Monica Margoni, Giorgia Mataluni, Massimiliano Mirabella, Lucia Moiola, Carolina Gabri Nicoletti, Viviana Nociti, Francesco Patti, Federica Pinardi, Emilio Portaccio, Carlo Pozzilli, Paolo Ragonese, Sarah Rasia, Giuseppe Salemi, Elisabetta Signoriello, Francesca Vitetta, Rocco Totaro, Maria Pia Sormani, Maria Pia Amato, Girolama Alessandra Marfia
Summary: The study found that continuing natalizumab treatment throughout pregnancy and resuming it early after delivery can reduce the risk of clinical and radiological reactivation in women with multiple sclerosis. This approach has no major impact on newborns' outcomes.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2022)
Article
Medicine, General & Internal
Anna Jamroz-Wisniewska, Radoslaw Zajdel, Agnieszka Slowik, Monika Marona, Marcin Wnuk, Monika Adamczyk-Sowa, Bozena Adamczyk, Anetta Lasek-Bal, Przemyslaw Puz, Arkadiusz Steposz, Ewa Krzystanek, Maja Patalong-Ogiewa, Anna Pokryszko-Dragan, Slawomir Budrewicz, Dorota Koziarska, Anna Karbicka, Slawomir Wawrzyniak, Waldemar Fryze, Marzena Furtak-Niczyporuk, Konrad Rejdak
Summary: The study found that the NEDA-3 rate after the first year of therapy was higher for natalizumab compared to fingolimod. Patients with lower MRS on platform therapy had better outcomes when switching to second-line therapy. Early switching to second-line therapy may lead to better results for patients treated with natalizumab or fingolimod.
JOURNAL OF CLINICAL MEDICINE
(2021)
Article
Clinical Neurology
Kevin Bigaut, Laurent Kremer, Thibaut Fabacher, Guido Ahle, Mathilde Goudot, Marie Fleury, Claude Gaultier, Sylvie Courtois, Nicolas Collongues, Jerome de Seze
Summary: This study compared the effectiveness of ocrelizumab and fingolimod after natalizumab cessation. The results showed that ocrelizumab had a significantly lower relapse rate at 1 year compared to fingolimod.
JOURNAL OF NEUROLOGY
(2022)
Letter
Clinical Neurology
Harald Kropshofer, Dieter A. Haering, Ludwig Kappos, David Leppert, Jens Kuhle
Summary: The results of this study contradict with earlier large phase 3 studies, suggesting that high baseline serum neurofilament light chain levels are associated with increased risk of disability progression in MS. The authors hypothesize that this discrepancy may be due to the anti-inflammatory effects of natalizumab, which suppresses inflammatory activity and renders sNfL unrelated to disability progression.
Article
Clinical Neurology
Jing Chen, Ibrahima Diouf, Bruce Taylor, Tomas Kalincik, Ingrid van der Mei
Summary: In a large prospective cohort study, natalizumab showed superior outcomes over time in terms of patient-reported health and employment outcomes compared to other DMTs. These findings could impact treatment selection and cost-effectiveness analyses in clinical practice.
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
(2022)
Article
Medical Laboratory Technology
Lesley J. Page, Jacqueline Lagunas-Acosta, Raphaela Heussen, Edward T. Castellana, Bradley T. Messmer
Summary: A novel assay was developed to quantify unexchanged and exchanged natalizumab variants in clinical samples. This assay will enable investigations into the clinical significance of the relationship between PK/PD and the monovalent-to-bivalent ratio, as it relates to the efficacy of the drug and risk of PML.
THERAPEUTIC DRUG MONITORING
(2023)
Article
Clinical Neurology
Helmut Butzkueven, Ludwig Kappos, Tim Spelman, Maria Trojano, Heinz Wiendl, Ray Su, Shirley Liao, Robert Hyde, Stephanie Licata, Pei-Ran Ho, Nolan Campbell
Summary: This study, using propensity score-matched cohorts from the Tysabri Observational Program, demonstrates that the effectiveness of natalizumab is maintained in patients who switch from every-4-week (Q4W) dosing to every-6-week (Q6W) dosing after more than 1 year of treatment. Annualized relapse rates, probability of remaining relapse free, and safety outcomes did not differ significantly between Q6W and Q4W patients.
THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS
(2021)