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6. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study

Author

Kappos, L., Bar-Or, A., Cree, B. A. C., Fox, R. J., Giovannoni, G., Gold, R., Vermersch, P., Arnold, D. L., Arnould, S., Scherz, T., Wolf, C., Wallstrom, E., Dahlke, F., Achiron, A., Achtnichts, L., Agan, K., Akman-Demir, G., Allen, A. B., Antel, J. P., Antiguedad, A. R., Apperson, M., Applebee, A. M., Ayuso, G. I., Baba, M., Bajenaru, O., Balasa, R., Balci, B. P., Barnett, M., Bass, A., Becker, V. U., Bejinariu, M., Bergh, F. T., Bergmann, A., Bernitsas, E., Berthele, A., Bhan, V., Bischof, F., Bjork, R. J., Blevins, G., Boehringer, M., Boerner, T., Bonek, R., Bowen, J. D., Bowling, A., Boyko, A. N., Boz, C., Bracknies, V., Braune, S., Brescia Morra, V., Brochet, B., Brola, W., Brownstone, P. K., Brozman, M., Brunet, D., Buraga, I., Burnett, M., Buttmann, M., Butzkueven, H., Cahill, J., Calkwood, J. C., Camu, W., Cascione, M., Castelnovo, G., Centonze, D., Cerqueira, J., Chan, A., Cimprichova, A., Cohan, S., Comi, G., Conway, J., Cooper, J. A., Corboy, J., Correale, J., Costell, B., Cottrell, D. A., Coyle, P. K., Craner, M., Cui, L., Cunha, L., Czlonkowska, A., da Silva, A. M., de Sa, J., de Seze, J., Debouverie, M., Debruyne, J., Decoo, D., Defer, G., Derfuss, T., Deri, N. H., Dihenia, B., Dioszeghy, P., Donath, V., Dubois, B., Duddy, M., Duquette, P., Edan, G., Efendi, H., Elias, S., Emrich, P. J., Estruch, B. C., Evdoshenko, E. P., Faiss, J., Fedyanin, A. S., Feneberg, W., Fermont, J., Fernandez, O. F., Ferrer, F. C., Fink, K., Ford, H., Ford, C., Francia, A., Freedman, M., Frishberg, B., Galgani, S., Garmany, G. P., Gehring, K., Gitt, J., Gobbi, C., Goldstick, L. P., Gonzalez, R. A., Grandmaison, F., Grigoriadis, N., Grigorova, O., Grimaldi, L. M. E., Gross, J., Gross-Paju, K., Gudesblatt, M., Guillaume, D., Haas, J., Hancinova, V., Hancu, A., Hardiman, O., Harmjanz, A., Heidenreich, F. R., Hengstman, G. J. D., Herbert, J., Herring, M., Hodgkinson, S., Hoffmann, O. M., Hofmann, W. E., Honeycutt, W. D., Hua, L. H., Huang, D., Huang, Y., Hupperts, R., Imre, P., Jacobs, A. K., Jakab, G., Jasinska, E., Kaida, K., Kalnina, J., Kaprelyan, A., Karelis, G., Karussis, D., Katz, A., Khabirov, F. A., Khatri, B., Kimura, T., Kister, I., Kizlaitiene, R., Klimova, E., Koehler, J., Komatineni, A., Kornhuber, A., Kovacs, K., Koves, A., Kozubski, W., Krastev, G., Krupp, L. B., Kurca, E., Lassek, C., Laureys, G., Lee, L., Lensch, E., Leutmezer, F., Li, H., Linker, R. A., Linnebank, M., Liskova, P., Llanera, C., Lu, J., Lutterotti, A., Lycke, J., Macdonell, R., Maciejowski, M., Maeurer, M., Magzhanov, R. V., Maida, E. -M., Malciene, L., Mao-Draayer, Y., Marfia, G. A., Markowitz, C., Mastorodimos, V., Matyas, K., Meca-Lallana, J., Merino, J. A. G., Mihetiu, I. G., Milanov, I., Miller, A. E., Millers, A., Mirabella, M., Mizuno, M., Montalban, X., Montoya, L., Mori, M., Mueller, S., Nakahara, J., Nakatsuji, Y., Newsome, S., Nicholas, R., Nielsen, A. S., Nikfekr, E., Nocentini, U., Nohara, C., Nomura, K., Odinak, M. M., Olsson, T., van Oosten, B. W., Oreja-Guevara, C., Oschmann, P., Overell, J., Pachner, A., Panczel, G., Pandolfo, M., Papeix, C., Patrucco, L., Pelletier, J., Piedrabuena, R., Pless, M., Polzer, U., Pozsegovits, K., Rastenyte, D., Rauer, S., Reifschneider, G., Rey, R., Rizvi, S. A., Robertson, D., Rodriguez, J. M., Rog, D., Roshanisefat, H., Rowe, V., Rozsa, C., Rubin, S., Rusek, S., Sacca, F., Saida, T., Salgado, A. V., Sanchez, V. E. F., Sanders, K., Satori, M., Sazonov, D. V., Scarpini, E. A., Schlegel, E., Schluep, M., Schmidt, S., Scholz, E., Schrijver, H. M., Schwab, M., Schwartz, R., Scott, J., Selmaj, K., Shafer, S., Sharrack, B., Shchukin, I. A., Shimizu, Y., Shotekov, P., Siever, A., Sigel, K. -O., Silliman, S., Simo, M., Simu, M., Sinay, V., Siquier, A. E., Siva, A., Skoda, O., Solomon, A., Stangel, M., Stefoski, D., Steingo, B., Stolyarov, I. D., Stourac, P., Strassburger-Krogias, K., Strauss, E., Stuve, O., Tarnev, I., Tavernarakis, A., Tello, C. R., Terzi, M., Ticha, V., Ticmeanu, M., Tiel-Wilck, K., Toomsoo, T., Tubridy, N., Tullman, M. J., Tumani, H., Turcani, P., Turner, B., Uccelli, A., Urtaza, F. J. O., Vachova, M., Valikovics, A., Walter, S., Van Wijmeersch, B., Vanopdenbosch, L., Weber, J. R., Weiss, S., Weissert, R., West, T., Wiendl, H., Wiertlewski, S., Wildemann, B., Willekens, B., Visser, L. H., Vorobeychik, G., Xu, X., Yamamura, T., Yang, Y. N., Yelamos, S. M., Yeung, M., Zacharias, A., Zelkowitz, M., Zettl, U., Zhang, M., Zhou, H., Zieman, U., Ziemssen, T., Bergmann A., Haas J., Mirabella M. (ORCID:0000-0002-7783-114X), Terzi M., Kappos, L., Bar-Or, A., Cree, B. A. C., Fox, R. J., Giovannoni, G., Gold, R., Vermersch, P., Arnold, D. L., Arnould, S., Scherz, T., Wolf, C., Wallstrom, E., Dahlke, F., Achiron, A., Achtnichts, L., Agan, K., Akman-Demir, G., Allen, A. B., Antel, J. P., Antiguedad, A. R., Apperson, M., Applebee, A. M., Ayuso, G. I., Baba, M., Bajenaru, O., Balasa, R., Balci, B. P., Barnett, M., Bass, A., Becker, V. U., Bejinariu, M., Bergh, F. T., Bergmann, A., Bernitsas, E., Berthele, A., Bhan, V., Bischof, F., Bjork, R. J., Blevins, G., Boehringer, M., Boerner, T., Bonek, R., Bowen, J. D., Bowling, A., Boyko, A. N., Boz, C., Bracknies, V., Braune, S., Brescia Morra, V., Brochet, B., Brola, W., Brownstone, P. K., Brozman, M., Brunet, D., Buraga, I., Burnett, M., Buttmann, M., Butzkueven, H., Cahill, J., Calkwood, J. C., Camu, W., Cascione, M., Castelnovo, G., Centonze, D., Cerqueira, J., Chan, A., Cimprichova, A., Cohan, S., Comi, G., Conway, J., Cooper, J. A., Corboy, J., Correale, J., Costell, B., Cottrell, D. A., Coyle, P. K., Craner, M., Cui, L., Cunha, L., Czlonkowska, A., da Silva, A. M., de Sa, J., de Seze, J., Debouverie, M., Debruyne, J., Decoo, D., Defer, G., Derfuss, T., Deri, N. H., Dihenia, B., Dioszeghy, P., Donath, V., Dubois, B., Duddy, M., Duquette, P., Edan, G., Efendi, H., Elias, S., Emrich, P. J., Estruch, B. C., Evdoshenko, E. P., Faiss, J., Fedyanin, A. S., Feneberg, W., Fermont, J., Fernandez, O. F., Ferrer, F. C., Fink, K., Ford, H., Ford, C., Francia, A., Freedman, M., Frishberg, B., Galgani, S., Garmany, G. P., Gehring, K., Gitt, J., Gobbi, C., Goldstick, L. P., Gonzalez, R. A., Grandmaison, F., Grigoriadis, N., Grigorova, O., Grimaldi, L. M. E., Gross, J., Gross-Paju, K., Gudesblatt, M., Guillaume, D., Haas, J., Hancinova, V., Hancu, A., Hardiman, O., Harmjanz, A., Heidenreich, F. R., Hengstman, G. J. D., Herbert, J., Herring, M., Hodgkinson, S., Hoffmann, O. M., Hofmann, W. E., Honeycutt, W. D., Hua, L. H., Huang, D., Huang, Y., Hupperts, R., Imre, P., Jacobs, A. K., Jakab, G., Jasinska, E., Kaida, K., Kalnina, J., Kaprelyan, A., Karelis, G., Karussis, D., Katz, A., Khabirov, F. A., Khatri, B., Kimura, T., Kister, I., Kizlaitiene, R., Klimova, E., Koehler, J., Komatineni, A., Kornhuber, A., Kovacs, K., Koves, A., Kozubski, W., Krastev, G., Krupp, L. B., Kurca, E., Lassek, C., Laureys, G., Lee, L., Lensch, E., Leutmezer, F., Li, H., Linker, R. A., Linnebank, M., Liskova, P., Llanera, C., Lu, J., Lutterotti, A., Lycke, J., Macdonell, R., Maciejowski, M., Maeurer, M., Magzhanov, R. V., Maida, E. -M., Malciene, L., Mao-Draayer, Y., Marfia, G. A., Markowitz, C., Mastorodimos, V., Matyas, K., Meca-Lallana, J., Merino, J. A. G., Mihetiu, I. G., Milanov, I., Miller, A. E., Millers, A., Mirabella, M., Mizuno, M., Montalban, X., Montoya, L., Mori, M., Mueller, S., Nakahara, J., Nakatsuji, Y., Newsome, S., Nicholas, R., Nielsen, A. S., Nikfekr, E., Nocentini, U., Nohara, C., Nomura, K., Odinak, M. M., Olsson, T., van Oosten, B. W., Oreja-Guevara, C., Oschmann, P., Overell, J., Pachner, A., Panczel, G., Pandolfo, M., Papeix, C., Patrucco, L., Pelletier, J., Piedrabuena, R., Pless, M., Polzer, U., Pozsegovits, K., Rastenyte, D., Rauer, S., Reifschneider, G., Rey, R., Rizvi, S. A., Robertson, D., Rodriguez, J. M., Rog, D., Roshanisefat, H., Rowe, V., Rozsa, C., Rubin, S., Rusek, S., Sacca, F., Saida, T., Salgado, A. V., Sanchez, V. E. F., Sanders, K., Satori, M., Sazonov, D. V., Scarpini, E. A., Schlegel, E., Schluep, M., Schmidt, S., Scholz, E., Schrijver, H. M., Schwab, M., Schwartz, R., Scott, J., Selmaj, K., Shafer, S., Sharrack, B., Shchukin, I. A., Shimizu, Y., Shotekov, P., Siever, A., Sigel, K. -O., Silliman, S., Simo, M., Simu, M., Sinay, V., Siquier, A. E., Siva, A., Skoda, O., Solomon, A., Stangel, M., Stefoski, D., Steingo, B., Stolyarov, I. D., Stourac, P., Strassburger-Krogias, K., Strauss, E., Stuve, O., Tarnev, I., Tavernarakis, A., Tello, C. R., Terzi, M., Ticha, V., Ticmeanu, M., Tiel-Wilck, K., Toomsoo, T., Tubridy, N., Tullman, M. J., Tumani, H., Turcani, P., Turner, B., Uccelli, A., Urtaza, F. J. O., Vachova, M., Valikovics, A., Walter, S., Van Wijmeersch, B., Vanopdenbosch, L., Weber, J. R., Weiss, S., Weissert, R., West, T., Wiendl, H., Wiertlewski, S., Wildemann, B., Willekens, B., Visser, L. H., Vorobeychik, G., Xu, X., Yamamura, T., Yang, Y. N., Yelamos, S. M., Yeung, M., Zacharias, A., Zelkowitz, M., Zettl, U., Zhang, M., Zhou, H., Zieman, U., Ziemssen, T., Bergmann A., Haas J., Mirabella M. (ORCID:0000-0002-7783-114X), and Terzi M.

Abstract

Background: No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor1,5 modulator, on disability progression in patients with SPMS. Methods: This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18–60 years) with SPMS and an Expanded Disability Status Scale score of 3·0–6·5 were randomly assigned (2:1) to once daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression (CDP) events. The primary endpoint was time to 3-month CDP. Efficacy was assessed for the full analysis set (ie, all randomly assigned and treated patients); safety was assessed for the safety set. This trial is registered with ClinicalTrials.gov, number NCT01665144. Findings: 1651 patients were randomly assigned between Feb 5, 2013, and June 2, 2015 (1105 to the siponimod group, and 546 to the placebo group). One patient did not sign the consent form, and five patients did not receive study drug, all of whom were in the siponimod group. 1645 patients were included in the analyses (1099 in the siponimod group and 546 in the placebo). At baseline, the mean time since first multiple sclerosis symptoms was 16·8 years (SD 8·3), and the mean time since conversion to SPMS was 3·8 years (SD 3·5); 1055 (64%) patients had not relapsed in the previous 2 years, and 918 (56%) of 1651 needed walking assistance. 903 (82%) patients receiving siponimod and 424 (78%) patients receiving placebo completed the study. 288 (26%) of 1096 patients receiving siponimod and 173 (32%) of 545 patients receiving placebo had 3-month CDP (hazard ratio 0·79, 95% CI 0·65–0·95; relative

Published
2018

7. Phase III Dose-Comparison Study of Glatiramer Acetate for Multiple Sclerosis

Author

Comi, G, Cohen, Ja, Arnold, Dl, Wynn, D, Filippi, M, FORTE Study Group, Rocc, Ma, Perego, E, Absinta, M, Mesaros, S, Vuotto, R, Misci, P, Petrolini, M, Coyle, P, Wolinsky, J, Antel, J, Zamvil, S, Feigin, P, Carra, Aj, Bettinelli, Rj, Luetic, Gg, Vrech, Ca, Dubois, Bd, Metz, L, Bar Or, A, Bhan, V, Myles, M, Havrdova, E, Ehler, E, Kanovsky, P, Talab, R, Zapletalova, O, Gross Paju, K, Taba, P, Elovaara, I, Erälinna, Jp, Kinnunen, E, Koivisto, K, Reunanen, M, Brochet, B, Camu, W, Damier, P, Defer, G, Tumani, H, Becker, E, Buettner, T, Diener, Hc, Franz, P, Haas, J, Heesen, C, Heidenreich, F, Koelmel, Hw, Reifschneider, G, Retzlaff, K, Thoemke, F, Ziemssen, T, Rozsa, C, Bartos, L, Csanyi, A, Deme, I, Komoly, S, Panczel, G, Simo, M, Achiron, A, Milo, R, Bergamaschi, R, Bertolotto, A, Capra, R, Caputo, D, Cavalla, P, Centonze, D, Cottone, S, DE STEFANO, Nicola, Gasperini, C, Mancardi, G, Provinciali, L, Ruggieri, S, Scarpini, E, Zaffaroni, M, Metra, M, Kizlaitiene, R, Vaitkus, A, Zwanikken, Cp, Hupperts, Rm, Jongen, Pj, Szczudlik, A, Fryze, W, Kazibutowska, Z, Pierzchaa, K, Pniewski, J, Podemski, R, Stepień, A, Bajenaru, O, Campeanu, A, Marginean, I, Popescu, Cd, Toldisan, I, Boiko, A, Gustov, A, Malkova, N, Perfilyev, S, Poverennova, I, Saykhunov, M, Shutov, A, Skoromets, A, Spirin, N, Stolyarov, I, Volkova, L, Rodriguez Antigüedad, A, Arbizu, T, Arroyo, R, Barcena, J, Casanova, B, Fernández, O, Montalban, X, Ramió, L, Saiz Hinarejos, A, Sharrack, B, Silber, E, Young, C, Agius, M, Birnbaum, G, Campagnolo, D, Chaudhary, K, Cohen, J, Ford, C, Fox, E, Goodman, A, Green, B, Gupta, A, Hughes, B, Javed, A, Jeffery, D, Kasper, L, Kaufman, M, Khan, O, Kresa Reahl, K, Leist, T, Lynch, S, Markowitz, C, Mattson, D, Moses, H, Parks, B, Parry, G, Phillips, T, Picone, M, Rammohan, K, Rizvi, S, Royal, W, Scarberry, S, Sheppard, C, Simnad, V, Thrower, B, Whitham, R, Wynn, D., Comi, G, Cohen, Ja, Arnold, Dl, Wynn, D, Filippi, M, FORTE Study, Group, Diener, Hans Christoph (Beitragende*r), Klinische Neurowetenschappen, and RS: MHeNs School for Mental Health and Neuroscience

Subjects
Male, Medizin, MULTICENTER, Relapsing-Remitting, Gastroenterology, law.invention, DOUBLE-BLIND, Randomized controlled trial, law, Recurrence, Drug Toxicity, Clinical endpoint, Secondary Prevention, administration /&/ dosage/adverse effects/therapeutic use, Middle Aged, drug therapy, Intention to Treat Analysis, Treatment Outcome, Neurology, Tolerability, Disease Progression, RELAPSE RATE, TRIAL, Female, Settore MED/26 - Neurologia, Drug, Immunosuppressive Agents, medicine.drug, Adult, medicine.medical_specialty, Multiple Sclerosis, Drug-Related Side Effects and Adverse Reactions, Adolescent, Endpoint Determination, DOUBLE-BLIND, RELAPSE RATE, FOLLOW-UP, DISABILITY, TRIAL, MULTICENTER, MS, Dose-Response Relationship, Multiple Sclerosis, Relapsing-Remitting, Adolescent, Adult, Disease Progression, Dose-Response Relationship, Drug, Drug Toxicity, Endpoint Determination, Female, Humans, Immunosuppressive Agents, administration /&/ dosage/adverse effects/therapeutic use, Intention to Treat Analysis, Male, Middle Aged, Multiple Sclerosis, drug therapy, Multiple Sclerosis, drug therapy, Peptides, administration /&/ dosage/adverse effects/therapeutic use, Recurrence, prevention /&/ control, Treatment Outcome, Internal medicine, medicine, Humans, Glatiramer acetate, Expanded Disability Status Scale, Intention-to-treat analysis, Peptides, Dose-Response Relationship, Drug, business.industry, DISABILITY, MS, Glatiramer Acetate, Confidence interval, Surgery, Relative risk, prevention /&/ control, Neurology (clinical), FOLLOW-UP, business
Abstract

Objective: To evaluate the safety, tolerability, and efficacy of glatiramer acetate (GA) 40mg compared to a 20mg dose. Methods: Patients with multiple sclerosis (MS) with ≥1 documented relapse in 12 months prior to screening, or ≥2 documented relapses in 24 months prior to screening, and Expanded Disability Status Scale (EDSS) score 0 to 5.5 were enrolled. Patients were evaluated at screening, baseline, and at months 1, 2, 3, 6, 9, and 12. Primary endpoint was rate of confirmed relapses observed during 12-month study. Analysis was by intent-to-treat. Results: A total of 1,155 patients randomized to GA 20mg (n = 586) or 40mg (n = 569). The groups were well-matched at baseline on demographic, clinical, and magnetic resonance imaging (MRI) characteristics. The primary endpoint was similar in both groups (relative risk [RR] = 1.07; 95% confidence interval [CI], 0.88–1.31; p = 0.486) with mean annualized relapse rates (ARRs) of 0.33 for the 20mg group, 0.35 for the 40mg group, and 0.27 for patients from both groups who completed the entire 1-year treatment. A total of 77% of patients remained relapse-free in both groups. Both groups showed a reduction in mean number of gadolinium-enhancing and new T2 lesions over time with trend for faster reduction in the first trimester with the 40mg dose compared with 20mg dose. Both doses were well-tolerated with a safety profile similar to that observed in previous studies of 20mg GA. Interpretation: In relapsing-remitting MS patients, both the currently-approved GA 20mg and 40mg doses were safe and well-tolerated, with no gain in efficacy for the higher dose. Ann Neurol 2011;69:75–82.

Published
2011
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13. The Effect of Therapeutic Plasma Exchange on the Bioavailability of Interferon Beta. Pilot Study.

Author

Giedraitiene, N., Kizlaitiene, R., Budrys, V., Kaubrys, G., Griskevicius, L., Valceckiene, V., Stoskus, M., Griskevicius, A., and Audzijoniene, J.

Subjects
*PLASMA exchange (Therapeutics), *INTERFERONS, *DRUG bioavailability, *IMMUNOGLOBULINS, *MULTIPLE sclerosis treatment, *MESSENGER RNA, *GENE expression
Abstract

Back ground and purpose. The development of neutralizing antibodies (NAbs) against interferon beta (IFN-β) during IFN-β treatment in multiple sclerosis (MS) patients has been a significant clinical problem. Persistent, high-titer NAbs-IFN-β reduce or eliminate biological activity of IFN-β therapies for MS and are associated with reduction in efficacy. Therapeutic plasma exchange (TPE) removes the circulating antibodies that are thought to be active in the diseases, so we hypothesized that TPE can restore the ability of IFN-β to induce the Myxovirus Resistance Protein A (MxA) mRNA expression and the maintenance plasmapheresis can sustain the bioavailability of IFN-β. Methods. Eligible patients under went primarily four separate plasma exchange sessions and after the induction TPE sessions they were transferred to the maintenance plasma pheresis. Bioactivity of interferon beta was expressed as in vivo MxA mRNA induction in whole blood using real time PCR. Results. Six patients with RRMS and low IFN-β bioavailability detected by the MxA mRNA response were included. Four patients after induction plasmapheresis be came biological responders. In two patients an in crease of MxA mRNA expression was found, but the values persisted be low the cut-off and the patients remained as "poor biological responders". The effect of maintenance plasmapheresis was quite transient: MxA mRNA expression values reverted to the base line levels after one or two months. Conclusion. Plasma exchange may restore the bioavailability of IFN-β in some patients, but the effect of maintenance plasmapheresis on the bioavailability of IFN-β is transient. [ABSTRACT FROM AUTHOR]

Published
2013

14. Effects of betahistine on patient-reported outcomes in routine practice in patients with vestibular vertigo and appraisal of tolerability: Experience in the OSVaLD study

Author

Benecke, H., Pérez-Garrigues, H., Bin Sidek, D., Uloziene, I., Kuessner, D., Sondag, E., Theeuwes, A., Boari, L., Chaves, A. G., Dorigueto, R. S., Ganança, F. F., Gonçalves, D. U., Hyppolito, M. A., Korn, G. P., Munhoz, M. S., Oliveira, J. A., Ajisafe, O., Angilleta, B., Bracalenti, I., Carlos, J. M., Dada, O., Ho, M., Kopyto, A., Laliberté, A., Lau, Y., Medina, X., Mercier, C., Nijmeh, P., Pietraszek, B., Roberge, C., Vincent, S., Zeitouni, A., Aras, I., Bencic, I., Bonifacic, M., Branica, S., Dovzak-Kokic, D., Drvis, P., Gortan, D., Grdinic, B., Grigic, J., Handzic, I., Ivkovic, M., Juros, V., Kovacic, J., Krstic, E., Lucin, Z., Maksimovic, Z., Maslovara, S., Rak, I., Resler Seks, A., Ries, M., Trotic, R., Rosenberg, A., Gaal, A., Badacsonyi, M., Balogh, G., Bandula, M., Baranya, E., Jeges, B., Brajnovits, T., Bucsai, A., Tubony, C., Csill, R., Czegledi, I., Olah, L., Draveczky, E., Vaszkun, L., Siro, E., Fain, A., Foth, A., Gerlinger, I., Gestelyi, G., Getachen, K., Ghayada, R., Gilincsek, L., Guth, I., Hegedus, E., Hegyi, I., Jofeju, E., Kerepesi, L., Krisan, I., Laszlo, K., Lorincz, T., Marisch, I., Mihalecz, K., Breznyan, M., Mori, I., Nagy, L., Manhalter, N., Pal, A., Papp, M., Peter, J., Prunk Eger, F., Radai, F., Szihalmy, I., Torma, E., Torok, K., Trencsenyi, G., Varga, E., Vincze, A., Vogel, R., Szakolczay, Z., Zsilinszky, Z., Rovo, Z., Tamas, L., Mester, B., Hudak, I., Toth, L., Merczel, A., Agarwal, V. K., Bhatia, R., Bhimani, B., Biswal, R. N., Biswas, A., Chowdary, V. S., Dhond, P., Dube, T. N., Gopakumar, G., Kansara, A., Khound, G., Kirtane, M. V., Mukherjee, A., Nagpal, T., Ravikumar, A., Reddy, V., Sampat, N., Shaikh, S., Sinha, S., Vaid, N., Valsangkar, S., Vasnoi, S., Vishwanathan, A., Blumberga, I., Bucina, B., Cakule, G., Demidova, L., Dolge, A., Dzirgause, M., Freimane, A., Fricbergs, J., Frolova, V., Ganus, I., Gavare, I., Grigs, V., Grusle, M., Levins, E., Veidule, I., Indrane, M., Saihulova, I., Jeca, A., Jegere, D., Ivanova, A., Kalitas, N., Kalnina, Z., Kanepe, K., Karlovska, M., Kokina, I., Krigere, R., Krisjane, D., Kukurane, S., Kundrate, G., Kukaine, S., Kukute, I., Lagzdina, L., Lapsa-Arenta, S., Madre, S., Matusevica, A., Mežale, I., Melnika, V., Mickevica, S., Morlata, N., Naudina, M. 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16. Autologous hematopoietic stem cell transplantation is superior to alemtuzumab in patients with highly active relapsing multiple sclerosis and severe disability.

Author

Vaisvilas M, Kaubrys G, Kizlaitiene R, Taluntiene V, and Giedraitiene N

Subjects
Humans, Alemtuzumab therapeutic use, Prospective Studies, Treatment Outcome, Recurrence, Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting diagnostic imaging, Multiple Sclerosis, Relapsing-Remitting drug therapy, Hematopoietic Stem Cell Transplantation
Abstract

Objective: To assess the differences of treatment outcomes regarding disease activity in patients with highly active relapsing multiple sclerosis (RMS), treated with autologous hematopoietic stem cell transplantation (HSCT) or alemtuzumab (ATZ)., Methods: Open-label prospective single-center observational cohort study, enrolling patients with highly active RMS for treatment with ATZ or HSCT between 2014 and 2021., Results: A total of 50 patients (31/50 (62 %) in HSCT vs 19/50 (38 %) in ATZ group) were included. There were no significant differences in relapse rate, MRI activity or disability worsening between the two study groups during the first two years after treatment onset. However, at 3 to 5 years follow-up, HSCT was superior to ATZ in all the aforementioned aspects. Kaplan-Meier analysis at 5 years post treatment revealed superiority of HSCT in relapse rate (69.6 % vs 95.7 %, p = 0.027), MRI activity (54.5 % vs 75.1 %, p = 0.038) and disability worsening (57.1 % vs 90.9 %, p =  0.031)., Conclusions: ATZ may halt disability progression early in the course of highly active RMS, but the disability starts accumulating later, while in HSCT patients disability improvement is consistent both 3 and 5 years after treatment onset., Competing Interests: Declaration of Competing Interest M.V. Conception and design of the study, primary data analysis, drafting of the manuscript; G.F.K. Overall revision for accuracy of the data, tables and Figures, scientific accuracy of the manuscript; R.K. Concept of the study, revision of the manuscript for scientific accuracy; V.T. Data analysis, drafting of the manuscript, revision for scientific accuracy; N.G. conception and design of the study, acquisition of the data, analysis and interpretation of the data, and drafting of the manuscript, revision for scientific accuracy. All of the authors discussed the results and contributed to and approved the final manuscript., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2023
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17. Cognitive Decline in Multiple Sclerosis Is Related to the Progression of Retinal Atrophy and Presence of Oligoclonal Bands: A 5-Year Follow-Up Study.

Author

Giedraitiene N, Drukteiniene E, Kizlaitiene R, Cimbalas A, Asoklis R, and Kaubrys G

Abstract

Background: Brain atrophy, which is associated with cognitive impairment and retinal nerve fiber layer (RNFL) atrophy, is the main biomarker of neurodegeneration in multiple sclerosis (MS). However, data on the relationship between inflammatory markers, such as oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF), and cognition, RNFL atrophy, and brain atrophy are scarce. The aim of this study was to assess the influence of RNFL thickness, brain atrophy markers, intrathecal OCBs, and the immunoglobulin G (IgG) index on cognitive decline over a 5-year period in patients with MS. Methods: This prospective, single-center, observational cohort study included 49 patients with relapsing MS followed up over 5 years. At baseline, the patients underwent brain magnetic resonance imaging (MRI). Cognitive evaluation was performed using the Brief International Cognitive Assessment for MS (BICAMS), and RNFL thickness was assessed using optical coherence tomography (OCT). OCBs and IgG levels in the CSF were evaluated at baseline. The BICAMS, OCT, and MRI findings were re-evaluated after 5 years. Results: A significant reduction in information processing speed, visual learning, temporal RNFL thickness, the Huckman index, and third ventricle mean diameter was found in all 49 patients with relapsing MS over the observation period ( p < 0.05). Of the patients, 63.3% had positive OCBs and 59.2% had elevated IgG indices. The atrophy of the temporal segment and papillomacular bundle and the presence of OCBs were significantly related to a decline in information processing speed in these patients ( p < 0.05). However, brain atrophy markers were not found to be significant on the general linear models. Conclusions: RNFL atrophy and the presence of OCBs were related to cognitive decline in patients with MS over a 5-year follow-up period, thereby suggesting their utility as potential biomarkers of cognitive decline in MS., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Giedraitiene, Drukteiniene, Kizlaitiene, Cimbalas, Asoklis and Kaubrys.)

Published
2021
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19. Quantitative body symmetry assessment during neurological examination.

Author

Daunoraviciene K, Ziziene J, Ovcinikova A, Kizlaitiene R, and Griskevicius J

Subjects
Biomechanical Phenomena, Humans, Lower Extremity, Neurologic Examination, Movement, Multiple Sclerosis diagnosis
Abstract

Background: A lack of movement coordination characterized by the undershoot or overshoot of the intended location with the hand, arm, or leg is often found in individuals with multiple sclerosis (MS). Standardized as Finger-to-Nose (FNT) and The Heel-to-Shin (HST) tests are the most frequently used tests for qualitative examination of upper and lower body coordination. Inertial sensors facilitate in performing quantitative motion analysis and by estimating body symmetry more accurately assess coordination lesion and imbalance., Objectives: To assess the body symmetry of upper and lower limbs quantitatively, and to find the best body symmetry indices to discriminate MS from healthy individuals (CO)., Methods: 28 MS patients and 23 CO participated in the study. Spatiotemporal parameters obtained from six Inertial Measurement Units (IMUs) were placed on the upper and lower extremities during FNT and HST tests. All data were analyzed using statistical methods in MATLAB., Results: Asymmetry indices of temporal parameters showed a significant increase in upper body and lower body asymmetry of MS compared to CO. However, CO have a greater kinematic asymmetry compared to MS., Conclusion: Temporal parameters are the most sensitive to body asymmetry evaluation. However, range of motion is completely inappropriate if it is calculated for one movement cycle.

Published
2020
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20. Incidence rate and sex ratio in multiple sclerosis in Lithuania.

Author

Valadkeviciene D, Kavaliunas A, Kizlaitiene R, Jocys M, and Jatuzis D

Subjects
Adult, Aged, Cohort Studies, Female, Humans, Incidence, Linear Models, Lithuania epidemiology, Male, Middle Aged, Sex Ratio, Multiple Sclerosis epidemiology
Abstract

Objectives: To determine the temporal changes in incidence rates of multiple sclerosis (MS) over the past 15 years in Lithuania with prediction up to 2020, and to estimate female-to-male sex ratio and its changes among MS patients., Materials and Methods: We conducted a descriptive incidence study. The crude incidence rates (CIR) were calculated using 15-year period, sex, age-groups, and the number of newly registered MS patients. Standardized incidence rates (SIR) were calculated using European standard in order to evaluate the influence of resident structure changes on incidence of MS during the last 15 years. The data were processed using Minitab set to estimate a linear trend model for the temporal changes of 16 parameters., Results: The data showed a substantial growth of the incidence rate of MS in Lithuania during the period of 2001-2015. In 2001, MS was diagnosed to 162 new individuals, whereas 343 new cases of MS were diagnosed in 2015. During 2001-2015, the incidence of MS was on average 6.5 (95% CI 5.70-7.30) cases per 100,000 residents, and 4.9 (95% CI 4.46-5.34) and 8.1 (5.86-9.34) for 100,000 male and female, respectively. Female-to-male sex ratio in MS in Lithuania had a tendency to increase over the period. Females were affected from 1.5 to 2 times more often than males., Conclusions: In 2020, the incidence rate of MS is estimated to reach 13 cases per 100,000 persons and females are expected to be diagnosed with MS two times more often than males., (© 2018 The Authors. Brain and Behavior published by Wiley Periodicals, Inc.)

Published
2019
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21. Cognition During and After Multiple Sclerosis Relapse as Assessed With the Brief International Cognitive Assessment for Multiple Sclerosis.

Author

Giedraitiene N, Kaubrys G, and Kizlaitiene R

Subjects
Adolescent, Adult, Female, Humans, Male, Middle Aged, Recurrence, Young Adult, Cognition, Multiple Sclerosis physiopathology, Neuropsychological Tests
Abstract

There is some evidence that cognition may be impaired during multiple sclerosis (MS) relapse. The aims of this study were to assess the cognitive status with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) in MS patients during relapse, in stable patients, and in healthy controls; to evaluate cognitive changes up to 3 months after relapse; and to estimate the impact of different factors on cognition after relapse. BICAMS was performed in 60 relapsing, 30 stable patients and 30 controls. Relapsing MS patients were assessed during relapse and one and three months after relapse. SDMT score was lower in relapsing than in stable patients. The mean scores of all BICAMS tests were higher one month after relapse than during relapse (p < 0.001). SDMT score after relapse improved in younger patients, who had more severe relapse (p < 0.05). BVMT-R score improved more in men, in patients with biologically active interferon-beta, in patients treated with methylprednisolone and in patients who were rehabilitated (p < 0.05). CVLT-II score improved in women and in patients with shorter relapse (p < 0.05). A neuropsychological assessment, like the evaluation of physical disability, is important during relapse. BICAMS may be suitable for a quick and effective assessment of cognition during relapse.

Published
2018
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22. Quantitative assessment of upper extremities motor function in multiple sclerosis.

Author

Daunoraviciene K, Ziziene J, Griskevicius J, Pauk J, Ovcinikova A, Kizlaitiene R, and Kaubrys G

Subjects
Adult, Biomechanical Phenomena, Evaluation Studies as Topic, Female, Humans, Male, Multiple Sclerosis physiopathology, Psychomotor Performance physiology, Upper Extremity physiopathology
Abstract

Background: Upper extremity (UE) motor function deficits are commonly noted in multiple sclerosis (MS) patients and assessing it is challenging because of the lack of consensus regarding its definition. Instrumented biomechanical analysis of upper extremity movements can quantify coordination with different spatiotemporal measures and facilitate disability rating in MS patients., Objective: To identify objective quantitative parameters for more accurate evaluation of UE disability and relate it to existing clinical scores., Methods: Thirty-four MS patients and 24 healthy controls (CG) performed a finger-to-nose test as fast as possible and, in addition, clinical evaluation kinematic parameters of UE were measured by using inertial sensors., Results: Generally, a higher disability score was associated with an increase of several temporal parameters, like slower task performance. The time taken to touch their nose was longer when the task was fulfilled with eyes closed. Time to peak angular velocity significantly changed in MS patients (EDSS > 5.0). The inter-joint coordination significantly decreases in MS patients (EDSS 3.0-5.5). Spatial parameters indicated that maximal ROM changes were in elbow flexion., Conclusions: Our findings have revealed that spatiotemporal parameters are related to the UE motor function and MS disability level. Moreover, they facilitate clinical rating by supporting clinical decisions with quantitative data.

Published
2018
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23. Therapeutic Plasma Exchange in Multiple Sclerosis Patients with Abolished Interferon-beta Bioavailability.

Author

Giedraitiene N, Kaubrys G, Kizlaitiene R, Bagdonaite L, Griskevicius L, Valceckiene V, and Stoskus M

Subjects
Adult, Antibodies, Neutralizing immunology, Biological Availability, Biomarkers metabolism, Female, Humans, Interferon-beta immunology, Male, Middle Aged, Myxovirus Resistance Proteins metabolism, Pilot Projects, Reverse Transcriptase Polymerase Chain Reaction, Interferon-beta pharmacokinetics, Multiple Sclerosis metabolism, Multiple Sclerosis therapy, Plasma Exchange methods, Plasmapheresis methods
Abstract

Background: Neutralizing antibodies (NAb) to interferon-beta (IFN-β) are associated with reduced bioactivity and efficacy of IFN-β in multiple sclerosis (MS). The myxovirus resistance protein A (MxA) gene expression is one of the most appropriate markers of biological activity of exogenous IFN-β. We hypothesized that therapeutic plasma exchange (TPE) can restore the ability of IFN-β to induce the MxA mRNA expression and that maintenance plasmapheresis can sustain the bioavailability of IFN-β., Material and Methods: Eligible patients underwent 4 primary separate plasma exchange sessions. After the induction TPE sessions, they were transferred to maintenance plasmapheresis. Bioactivity of IFN-β was expressed as in vivo MxA mRNA induction in whole blood using RT-qPCR., Results: Six patients with low IFN-β bioavailability detected by the MxA mRNA response were included. Four patients became biological responders after induction plasmapheresis. In 2 patients an increase of MxA mRNA expression was found, but the values persisted below the cut-off and the patients remained as "poor biological responders". The effect of maintenance plasmapheresis was transient: MxA mRNA expression values reverted to the baseline levels after 1-2 months., Conclusions: Therapeutic plasma exchange is able to restore the bioavailability of IFN-β in the majority of studied patients, but the effect of TPE on the IFN-β bioavailability was transient.

Published
2015
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