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1,024 results on '"Nakashima, I."'

1. P.011 Efficacy and safety of ravulizumab in adults with AQP4+ NMOSD: interim analysis from the ongoing phase 3 CHAMPION-NMOSD trial

Author

Pittock, SJ, primary, Barnett, M, additional, Bennett, JL, additional, Berthele, A, additional, de Sèze, J, additional, Levy, M, additional, Nakashima, I, additional, Oreja-Guevara, C, additional, Palace, J, additional, Paul, F, additional, Pozzilli, C, additional, Mashhoon, Y, additional, Allen, K, additional, Parks, B, additional, Kim, H, additional, and Vorobeychik, G, additional

Published
2024
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2. Treatment of MOG antibody associated disorders: results of an international survey

Author

Whittam, D. H., Karthikeayan, V., Gibbons, E., Kneen, R., Chandratre, S., Ciccarelli, O., Hacohen, Y., de Seze, J., Deiva, K., Hintzen, R. Q., Wildemann, B., Jarius, S., Kleiter, I., Rostasy, K., Huppke, P., Hemmer, B., Paul, F., Aktas, O., Pröbstel, A. K., Arrambide, G., Tintore, M., Amato, M. P., Nosadini, M., Mancardi, M. M., Capobianco, M., Illes, Z., Siva, A., Altintas, A., Akman-Demir, G., Pandit, L., Apiwattankul, M., Hor, J. Y., Viswanathan, S., Qiu, W., Kim, H. J., Nakashima, I., Fujihara, K., Ramanathan, S., Dale, R. C., Boggild, M., Broadley, S., Lana-Peixoto, M. A., Sato, D. K., Tenembaum, S., Cabre, P., Wingerchuk, D. M., Weinshenker, B. G., Greenberg, B., Matiello, M., Klawiter, E. C., Bennett, J. L., Wallach, A. I., Kister, I., Banwell, B. L., Traboulsee, A., Pohl, D., Palace, J., Leite, M. I., Levy, M., Marignier, R., Solomon, T., Lim, M., Huda, S., and Jacob, A.

Published
2020
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3. P-53 Efficacy and safety of ravulizumab in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder: Outcomes from the phase 3 CHAMPION-NMOSD trial

Author

Pittock, S., primary, Barnett, M., additional, Bennett, J.L., additional, Berthele, A., additional, de Sèze, J., additional, Levy, M., additional, Nakashima, I., additional, Oreja-Guevara, C., additional, Palace, J., additional, Paul, F., additional, Pozzilli, C., additional, Allen, K., additional, Mashhoon, Y., additional, Yountz, M., additional, and Kim, H.J., additional

Published
2023
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4. Network meta-analysis of food and drug administration-approved treatment options for adults with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder

Author

Wingerchuk, D.M., Zhang, I., Kielhorn, A., Royston, M., Levy, M., Fujihara, K., Nakashima, I., Tanvir, I., Paul, F., and Pittock, S.J.

Subjects
Function and Dysfunction of the Nervous System
Abstract

INTRODUCTION: Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune disease defined by attacks on the central nervous system that cause irreversible damage. Recent approval of NMOSD therapies warrants investigations of comparative efficacy to inform treatment decisions. METHODS: A network meta-analysis (NMA) of all U.S. Food and Drug Administration-approved therapies (eculizumab, inebilizumab, and satralizumab) for adults with aquaporin-4 immunoglobulin G-positive (AQP4+) NMOSD was conducted via a systematic literature review (SLR) using data from randomized controlled trials (RCTs). Database searches of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were executed for the SLR. A fixed-effects proportional hazards Bayesian NMA was used to estimate relative treatment effects based on data extracted from RCTs identified during the SLR (search end date: 11 September 2020). Four unique RCTs (N-MOmentum, PREVENT, SAkuraSky, and SAkuraStar) were identified, and data from 29 publications were extracted for analysis. Network scenarios describing the most comparable patient population groups (such as by treatment settings) were evaluated in our analyses. Relative treatment effects were evaluated based on time-to-first relapse and were expressed as hazard ratios (HRs) with 95% credible intervals (CrIs). RESULTS: In patients treated with a monoclonal antibody only, eculizumab was associated with a lower risk of relapse compared with satralizumab (HR 0.10, 95% CrI 0.01, 0.65) and inebilizumab (HR 0.11, 95% CrI 0.02, 0.68). In patients treated with monoclonal antibody with or without background immunosuppressive therapy (IST), patients treated with eculizumab ± IST were also less likely to relapse than patients treated with satralizumab ± IST (HR 0.24, 95% CrI 0.06, 0.98). CONCLUSION: The NMA results suggest that complement component 5 (C5) inhibition prevents NMOSD relapses more effectively than broader mechanisms of action.

Published
2022

8. Long-term safety and efficacy of Eculizumab in Aquaporin-4 IgG-positive NMOSD

Author

Wingerchuk, D.M., Fujihara, K., Palace, J., Berthele, A., Levy, M., Kim, H.J., Nakashima, I., Oreja-Guevara, C., Wang, K.-C., Miller, L., Shang, S., Sabatella, G., Yountz, M., Pittock, S.J., Villa, A., Garcea, O., Manin, A., Melamud, L., Aguirre, F., Fernandez, V., Munoz, D.J., Amor, J., Bocchiardo, C., Obregon, C.D.D., Laffue, A., Paez, M.F., Perez, R.M., Rocchi, V., Teijeiro, L., De Virgiliis, M., Cordoba, M., Ingolotti, M., Lupinacci, A., Ballario, C., Chiesa, A., Gomez, H., Mainella, C., Lattini, H., Barnett, M., Barton, J., Beadnall, H., Garber, J., Hardy, T., Pollard, J., Trewin, B., Shuey, N., Bryson, A., French, A., Laing, J., Law, L.Y., Plummer, C., Sanders, L., Sedal, L., Winkel, A., Neal, A., Habek, M., Adamec, I., Barun, B., Crnosija, L., Gabelic, T., Pitha, J., Nytrova, P., Novakova, I., Tyblova, M., Krasulova, E., Pavlickova, J., Petersen, T., Rasmussen, P., Stilund, M., Svendsen, K., Diem, R., Platten, M., Berberich, A., Jaschonek, H., Wildemann, B., Biberacher, V.M., Brinkhoff, K., Golkowski, D., Kowarik, M., Lehmann-Horn, K., Pongratz, V., Zettl, U., Klinke, J., Loebermann, M., Meister, S., Rimmele, F., Winkelmann, A., Lau, A.Y.L., Au, L.W.C., Fan, S.Y.F., Ip, V.H.L., Ma, S.H., Ma, K.Y.K., Mok, C.T.V., Patti, F., Messina, S., Proietto, M., Filla, A., Morra, V.B., Costabile, T., Nozzolillo, A., Sacc, Sacca, Tackley, George, and MATUR, ZELİHA

Subjects
0301 basic medicine, medicine.medical_specialty, Neuromyelitis optica, business.industry, Maintenance dose, Eculizumab, Placebo, Interim analysis, medicine.disease, Confidence interval, ddc, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Aquaporin 4, Neurology, Internal medicine, Medicine, Neurology (clinical), Adverse effect, business, Research Articles, 030217 neurology & neurosurgery, Research Article, medicine.drug
Abstract

Objective\udDuring PREVENT (NCT01892345), eculizumab significantly reduced relapse risk versus placebo in patients with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG+ NMOSD). We report an interim analysis of PREVENT's ongoing open-label extension (OLE; NCT02003144) evaluating eculizumab's long-term safety and efficacy.\ud\udMethods\udPatients who completed PREVENT could enroll in the OLE to receive eculizumab (maintenance dose = 1,200 mg/2 weeks, after a blinded induction phase). Safety and efficacy data from PREVENT and its OLE (interim data cut, July 31, 2019) were combined for this analysis.\ud\udResults\udAcross PREVENT and the OLE, 137 patients received eculizumab and were monitored for a median (range) of 133.3 weeks (5.1–276.9 weeks), for a combined total of 362.3 patient-years (PY). Treatment-related adverse event (AE) and serious adverse event (SAE) rates were 183.5 in 100 PY and 8.6 in 100 PY, respectively. Serious infection rates were 10.2 in 100 PY in eculizumab-treated patients versus 15.1 in 100 PY in the PREVENT placebo group. No patient developed a meningococcal infection. At 192 weeks (3.7 years), 94.4% (95% confidence interval [CI], 88.6–97.3) of patients remained adjudicated relapse-free. The adjudicated annualized relapse rate was 0.025 (95% CI = 0.013–0.048) in all eculizumab-treated patients versus 0.350 (95% CI = 0.199–0.616) in the PREVENT placebo group. During the OLE, 37% of patients (44 of 119 patients) stopped or decreased background immunosuppressive therapy use.\ud\udInterpretation\udThis analysis demonstrates that eculizumab's long-term safety profile in NMOSD is consistent with its established profile across other indications. This analysis also demonstrated the sustained ability of long-term eculizumab treatment to reduce relapse risk in patients with AQP4-IgG+ NMOSD. ANN NEUROL 2021;89:1088–1098

Published
2021

9. Long-Term Safety and Efficacy of Eculizumab in Aquaporin-4 IgG-Positive NMOSD.

Author

Wingerchuk, DM, Fujihara, K, Palace, J, Berthele, A, Levy, M, Kim, HJ, Nakashima, I, Oreja-Guevara, C, Wang, K-C, Miller, L, Shang, S, Sabatella, G, Yountz, M, Pittock, SJ, PREVENT Study Group, Wingerchuk, DM, Fujihara, K, Palace, J, Berthele, A, Levy, M, Kim, HJ, Nakashima, I, Oreja-Guevara, C, Wang, K-C, Miller, L, Shang, S, Sabatella, G, Yountz, M, Pittock, SJ, and PREVENT Study Group

Abstract

OBJECTIVE: During PREVENT (NCT01892345), eculizumab significantly reduced relapse risk versus placebo in patients with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG+ NMOSD). We report an interim analysis of PREVENT's ongoing open-label extension (OLE; NCT02003144) evaluating eculizumab's long-term safety and efficacy. METHODS: Patients who completed PREVENT could enroll in the OLE to receive eculizumab (maintenance dose = 1,200 mg/2 weeks, after a blinded induction phase). Safety and efficacy data from PREVENT and its OLE (interim data cut, July 31, 2019) were combined for this analysis. RESULTS: Across PREVENT and the OLE, 137 patients received eculizumab and were monitored for a median (range) of 133.3 weeks (5.1-276.9 weeks), for a combined total of 362.3 patient-years (PY). Treatment-related adverse event (AE) and serious adverse event (SAE) rates were 183.5 in 100 PY and 8.6 in 100 PY, respectively. Serious infection rates were 10.2 in 100 PY in eculizumab-treated patients versus 15.1 in 100 PY in the PREVENT placebo group. No patient developed a meningococcal infection. At 192 weeks (3.7 years), 94.4% (95% confidence interval [CI], 88.6-97.3) of patients remained adjudicated relapse-free. The adjudicated annualized relapse rate was 0.025 (95% CI = 0.013-0.048) in all eculizumab-treated patients versus 0.350 (95% CI = 0.199-0.616) in the PREVENT placebo group. During the OLE, 37% of patients (44 of 119 patients) stopped or decreased background immunosuppressive therapy use. INTERPRETATION: This analysis demonstrates that eculizumab's long-term safety profile in NMOSD is consistent with its established profile across other indications. This analysis also demonstrated the sustained ability of long-term eculizumab treatment to reduce relapse risk in patients with AQP4-IgG+ NMOSD. ANN NEUROL 2021;89:1088-1098.

Published
2021

15. Late breaking abstracts

Author

Kronfli, T., Bellinger, K., Grace, E., Sarlani, E., Whang, K., Buenaver, L., Smith, M., Atwood, C., Bourisaw, M., Pitts, J., Shigeta, M., Kadono, M., Ozasa, K., Watanabe, Y., Ueda, M., Nakazawa, A., Yamakado, K., Kitamura, M., Miyoshi, H., Hirai, N., Harashima, K., Hayakawa, T., Abe, T., Kato, S., Teixeira, L., Lowden, A., Moreno, C., Turte, S., Nagai, R., Latorre, M., Fischer, F., Mcdonagh, B., Gibson, J., Guptan, R., Bornemann, M. C., Mahowald, M., Schenck, C., Zilberg, E., Byrnes, G., Burton, D., Rochford, P., Kanbayashi, T., Nakashima, I., Shimohata, T., Takahashi, T., Tanaka, K., Nakamura, M., Sagawa, Y., Tokunaga, J., Yamauchi, M., Walsh, J., Scharf, M., Hull, S., Feldman, N., Lankford, A., Knowles, L., Tasker, T., Hunneyball, I., Baddock, S., Galland, B., Taylor, B., Bolton, D., Marshall, M., Hogan, A., Bucks, R., Rees, D., Kirkham, F., Kunz, D., Kaempfe, N., Bohner, G., Klingebiel, R., Mahlberg, R., Dingemanse, J., Dorffner, G., Göran, H., Benes, H., Danker-Hopfe, H., Polo, O., Saletu, B., Barbanoj, M., Pillar, G., Banks, S., Van Dongen, H., Dinges, D., Baumann, C., Bassetti, C., Valko, P., Haybaeck, J., Keller, M., Clark, E., Ludwig, S., Tolnay, M., Scammell, T., Ruehland, W., Singh, P., Thornton, A., Bonjean, M., Dang-Vu, T. T., Phillips, C., Maquet, P., Sepulchre, R., and Sejnowski, T.

Published
2007
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16. Epidemiology of neuromyelitis optica spectrum disorder and its prevalence and incidence worldwide

Author

Hor, J.Y., Asgari, N., Nakashima, I., Broadley, S.A., Leite, M.I., Kissani, N., Jacob, A., Marignier, R., Weinshenker, B.G., Paul, F., Pittock, S.J., Palace, J., Wingerchuk, D.M., Behne, J.M., Yeaman, M.R., and Fujihara, K.

Subjects
Function and Dysfunction of the Nervous System
Abstract

Neuromyelitis optica spectrum disorder (NMOSD) is an uncommon inflammatory disease of the central nervous system, manifesting clinically as optic neuritis, myelitis, and certain brain and brainstem syndromes. Cases clinically diagnosed as NMOSD may include aquaporin 4 (AQP4)-antibody-seropositive autoimmune astrocytopathic disease, myelin oligodendrocyte glycoprotein (MOG)-antibody-seropositive inflammatory demyelinating disease, and double-seronegative disease. AQP4-antibody disease has a high female-to-male ratio (up to 9:1), and its mean age at onset of ~40 years is later than that seen in multiple sclerosis. For MOG-antibody disease, its gender ratio is closer to 1:1, and it is more common in children than in adults. Its clinical phenotypes differ but overlap with those of AQP4-antibody disease and include acute disseminated encephalomyelitis, brainstem and cerebral cortical encephalitis, as well as optic neuritis and myelitis. Double-seronegative disease requires further research and clarification. Population-based studies over the past two decades report the prevalence and incidence of NMOSD in different populations worldwide. One relevant finding is the varying prevalence observed in different racial groups. Consistently, the prevalence of NMOSD among Whites is ~1/100,000 population, with an annual incidence of

Published
2020

34. Longitudinal changes in 18 F‐ THK 5351 positron emission tomography in corticobasal syndrome

Author

Ezura, M., primary, Kikuchi, A., additional, Ishiki, A., additional, Okamura, N., additional, Hasegawa, T., additional, Harada, R., additional, Watanuki, S., additional, Funaki, Y., additional, Hiraoka, K., additional, Baba, T., additional, Sugeno, N., additional, Oshima, R., additional, Yoshida, S., additional, Kobayashi, J., additional, Kobayashi, M., additional, Tano, O., additional, Nakashima, I., additional, Mugikura, S., additional, Iwata, R., additional, Taki, Y., additional, Furukawa, K., additional, Arai, H., additional, Furumoto, S., additional, Tashiro, M., additional, Yanai, K., additional, Kudo, Y., additional, Takeda, A., additional, and Aoki, M., additional

Published
2019
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