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1دورية أكاديمية
المؤلفون: Lewis R. A., Cornblath D. R., Hartung H. -P., Sobue G., Lawo J. -P., Mielke O., Durn B. L., Bril V., Merkies I. S. J., Bassett P., Cleasby A., van Schaik I. N., Sabet A., George K., Roberts L., Carne R., Blum S., Henderson R., Van Damme P., Demeestere J., Larue S., D'Amour C., Kunc P., Valis M., Sussova J., Kalous T., Talab R., Bednar M., Toomsoo T., Rubanovits I., Gross-Paju K., Sorro U., Saarela M., Auranen M., Pouget J., Attarian S., Le Masson G., Wielanek A., Desnuelle C., Delmon E., Clavelou P., Aufauvre D., Schmidt J., Zschuentzsch J., Sommer C., Kramer D., Hoffmann O., Goerlitz C., Haas J., Chatzopoulos M., Yoon R., Gold R., Berlit P., Jaspert-Grehl A., Liebetanz D., Kutschenko A., Stangel M., Trebst C., Baum P., Bergh F., Klehmet J., Meisel A., Klostermann F., Oechtering J., Lehmann H., Schroeter M., Hagenacker T., Mueller D., Sperfeld A., Bethke F., Drory I. V., Algom A., Yarnitsky D., Murinson B., Di Muzio A., Ciccocioppo F., Sorbi S., Mata S., Schenone A., Grandis M., Lauria G., Cazzato D., Antonini G., Morino S., Cocito D., Zibetti M., Yokota T., Ohkubo T., Kanda T., Kawai M., Kaida K., Onoue H., Kuwabara S., Mori M., Iijima M., Ohyama K., Baba M., Tomiyama M., Nishiyama K., Akutsu T., Yokoyama K., Kanai K., Eftimov F., Notermans N. C., Visser N., Faber C., Hoeijmakers J., Rejdak K., Chyrchel-Paszkiewicz U., Casanovas Pons C., Antonia M., Gamez J., Salvado M., Infante C. M., Benitez S., Lunn M., Morrow J., Gosal D., Lavin T., Melamed I., Testori A., Ajroud-Driss S., Menichella D., Simpson E., Lai E. C. -H., Dimachkie M., Barohn R. J., Beydoun S., Johl H., Lange D., Shtilbans A., Muley S., Ladha S., Freimer M., Kissel J., Latov N., Chin R., Ubogu E., Mumfrey S., Rao T., MacDonald P., Sharma K., Gonzalez G., Allen J., Walk D., Hobson-Webb L., Gable K.
المساهمون: Lewis R.A., Cornblath D.R., Hartung H.-P., Sobue G., Lawo J.-P., Mielke O., Durn B.L., Bril V., Merkies I.S.J., Bassett P., Cleasby A., van Schaik I.N., Sabet A., George K., Roberts L., Carne R., Blum S., Henderson R., Van Damme P., Demeestere J., Larue S., D'Amour C., Kunc P., Valis M., Sussova J., Kalous T., Talab R., Bednar M., Toomsoo T., Rubanovits I., Gross-Paju K., Sorro U., Saarela M., Auranen M., Pouget J., Attarian S., Le Masson G., Wielanek A., Desnuelle C., Delmon E., Clavelou P., Aufauvre D., Schmidt J., Zschuentzsch J., Sommer C., Kramer D., Hoffmann O., Goerlitz C., Haas J., Chatzopoulos M., Yoon R., Gold R., Berlit P., Jaspert-Grehl A., Liebetanz D., Kutschenko A., Stangel M., Trebst C., Baum P., Bergh F., Klehmet J., Meisel A., Klostermann F., Oechtering J., Lehmann H., Schroeter M., Hagenacker T., Mueller D., Sperfeld A., Bethke F., Drory I.V., Algom A., Yarnitsky D., Murinson B., Di Muzio A., Ciccocioppo F., Sorbi S., Mata S., Schenone A., Grandis M., Lauria G., Cazzato D., Antonini G., Morino S., Cocito D., Zibetti M., Yokota T., Ohkubo T., Kanda T., Kawai M., Kaida K., Onoue H., Kuwabara S., Mori M., Iijima M., Ohyama K., Baba M., Tomiyama M., Nishiyama K., Akutsu T.
مصطلحات موضوعية: CIDP, immunoglobulin, non-relapse, placebo, relapse, Human, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Immunologic Factor, Outcome Assessment, Health Care, Placebo Effect, Randomized Controlled Trials as Topic, Research Design
الوصف: The Polyneuropathy And Treatment with Hizentra (PATH) study required subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to placebo or one of two doses of subcutaneous immunoglobulin (SCIG). Nineteen of the 51 subjects (37%) randomized to placebo did not relapse over the next 24 weeks. This article explores the reasons for this effect. A post-hoc analysis of the PATH placebo group was undertaken. A literature search identified other placebo-controlled CIDP trials for review and comparison. In PATH, subjects randomized to placebo who did not relapse were significantly older, had more severe disease, and took longer to deteriorate in the IgG dependency period compared with those who relapsed. Published trials in CIDP, whose primary endpoint was stability or deterioration, had a mean non-deterioration (placebo effect) of 43%, while trials with a primary endpoint of improvement had a placebo response of only 11%. Placebo is an important variable in the design of CIDP trials. Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration.
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/32627277; info:eu-repo/semantics/altIdentifier/wos/WOS:000555688400001; volume:25; issue:3; firstpage:230; lastpage:237; numberofpages:8; journal:JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM; http://hdl.handle.net/2318/1836989Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85088987156
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2دورية أكاديمية
المؤلفون: Merkies I. S. J., van Schaik I. N., Leger J. -M., Bril V., van Geloven N., Hartung H. -P., Lewis R. A., Sobue G., Lawo J. -P., Durn B. L., Cornblath D. R., De Bleecker J. L., Sommer C., Robberecht W., Saarela M., Kamienowski J., Stelmasiak Z., Tackenberg B., Mielke O., Sabet A., George K., Roberts L., Carne R., Blum S., Henderson R., Van Damme P., Demeestere J., Larue S., D'Amour C., Kunc P., Valis M., Sussova J., Kalous T., Talab R., Bednar M., Toomsoo T., Rubanovits I., Gross-Paju K., Sorro U., Auranen M., Pouget J., Attarian S., Masson G. L., Wielanek-Bachelet A., Desnuelle C., Delmont E., Clavelou P., Aufauvre D., Schmidt J., Zschuentzsch J., Kramer D., Hoffmann O., Goerlitz C., Haas J., Chatzopoulos M., Yoon R., Gold R., Berlit P., Jaspert-Grehl A., Liebetanz D., Kutschenko A., Stangel M., Trebst C., Baum P., Bergh F., Klehmet J., Meisel A., Klostermann F., Oechtering J., Lehmann H., Schroeter M., Hagenacker T., Mueller D., Sperfeld A., Bethke F., Drory V., Algom A., Yarnitsky D., Murinson B., Di Muzio A., Ciccocioppo F., Sorbi S., Mata S., Schenone A., Grandis M., Lauria G., Cazzato D., Antonini G., Morino S., Cocito D., Zibetti M., Yokota T., Ohkubo T., Kanda T., Kawai M., Kaida K., Onoue H., Kuwabara S., Mori M., Iijima M., Ohyama K., Baba M., Tomiyama M., Nishiyama K., Akutsu T., Yokoyama K., Kanai K., Eftimov F., Notermans N. C., Visser N., Faber C., Hoeijmakers J., Rejdak K., Chyrchel-Paszkiewicz U., Casanovas Pons C., Antonia M., Gamez J., Salvado M., Infante C. M., Benitez S., Lunn M., Morrow J., Gosal D., Lavin T., Melamed I., Testori A., Ajroud-Driss S., Menichella D., Simpson E., Lai E. C. -H., Dimachkie M., Barohn R. J., Beydoun S., Johl H., Lange D., Shtilbans A., Muley S., Ladha S., Freimer M., Kissel J., Latov N., Chin R., Ubogu E., Mumfrey S., Rao T., MacDonald P., Sharma K., Gonzalez G., Allen J., Walk D., Hobson-Webb L., Gable K., Franques J., Morales R. J., Nguento A., Schrey C., Zwolinska G.
المساهمون: Merkies I.S.J., van Schaik I.N., Leger J.-M., Bril V., van Geloven N., Hartung H.-P., Lewis R.A., Sobue G., Lawo J.-P., Durn B.L., Cornblath D.R., De Bleecker J.L., Sommer C., Robberecht W., Saarela M., Kamienowski J., Stelmasiak Z., Tackenberg B., Mielke O., Sabet A., George K., Roberts L., Carne R., Blum S., Henderson R., Van Damme P., Demeestere J., Larue S., D'Amour C., Kunc P., Valis M., Sussova J., Kalous T., Talab R., Bednar M., Toomsoo T., Rubanovits I., Gross-Paju K., Sorro U., Auranen M., Pouget J., Attarian S., Masson G.L., Wielanek-Bachelet A., Desnuelle C., Delmont E., Clavelou P., Aufauvre D., Schmidt J., Zschuentzsch J., Kramer D., Hoffmann O., Goerlitz C., Haas J., Chatzopoulos M., Yoon R., Gold R., Berlit P., Jaspert-Grehl A., Liebetanz D., Kutschenko A., Stangel M., Trebst C., Baum P., Bergh F., Klehmet J., Meisel A., Klostermann F., Oechtering J., Lehmann H., Schroeter M., Hagenacker T., Mueller D., Sperfeld A., Bethke F., Drory V., Algom A., Yarnitsky D., Murinson B., Di Muzio A., Ciccocioppo F., Sorbi S., Mata S., Schenone A., Grandis M., Lauria G., Cazzato D., Antonini G., Morino S., Cocito D., Zibetti M., Yokota T., Ohkubo T., Kanda T., Kawai M., Kaida K., Onoue H., Kuwabara S.
مصطلحات موضوعية: CIDP, efficacy, IVIG, PATH, PRIMA, Adult, Aged, 80 and over, Double-Blind Method, Europe, Female, Human, Immunoglobulins, Intravenou, Immunologic Factor, Male, Middle Aged, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Prospective Studie, Young Adult, Outcome Assessment, Health Care
الوصف: Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was −1.0 (interquartile range −2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/30672091; info:eu-repo/semantics/altIdentifier/wos/WOS:000461226700005; volume:24; issue:1; firstpage:48; lastpage:55; numberofpages:8; journal:JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM; http://hdl.handle.net/2318/1836994Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85061703237
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3دورية أكاديمية
المؤلفون: Mielke O., Bril V., Cornblath D. R., Lawo J. -P., van Geloven N., Hartung H. -P., Lewis R. A., Merkies I. S. J., Sobue G., Durn B., Shebl A., van Schaik I. N., Sabet A., George K., Roberts L., Carne R., Blum S., Henderson R., Van Damme P., Demeestere J., Larue S., D'Amour C., Kunc P., Valis M., Sussova J., Kalous T., Talab R., Bednar M., Toomsoo T., Rubanovits I., Gross-Paju K., Sorro U., Saarela M., Auranen M., Pouget J., Attarian S., Le Masson G., Wielanek-Bachelet A., Desnuelle C., Delmont E., Clavelou P., Aufauvre D., Schmidt J., Zschuentzsch J., Sommer C., Kramer D., Hoffmann O., Goerlitz C., Haas J., Chatzopoulos M., Yoon R., Gold R., Berlit P., Jaspert-Grehl A., Liebetanz D., Kutschenko A., Stangel M., Trebst C., Baum P., Bergh F., Klehmet J., Meisel A., Klostermann F., Oechtering J., Lehmann H., Schroeter M., Hagenacker T., Mueller D., Sperfeld A., Bethke F., Drory V., Algom A., Yarnitsky D., Murinson B., Di Muzio A., Ciccocioppo F., Sorbi S., Mata S., Schenone A., Grandis M., Lauria G., Cazzato D., Antonini G., Morino S., Cocito D., Zibetti M., Yokota T., Ohkubo T., Kanda T., Kawai M., Kaida K., Onoue H., Kuwabara S., Mori M., Iijima M., Ohyama K., Baba M., Tomiyama M., Nishiyama K., Akutsu T., Yokoyama K., Kanai K., Eftimov F., Notermans N. C., Visser N., Faber C., Hoeijmakers J., Rejdak K., Chyrchel-Paszkiewicz U., Casanovas Pons C., Antonia M., Gamez J., Salvado M., Infante C. M., Benitez S., Lunn M., Morrow J., Gosal D., Lavin T., Melamed I., Testori A., Ajroud-Driss S., Menichella D., Simpson E., Lai E. C. -H., Dimachkie M., Barohn R. J., Beydoun S., Johl H., Lange D., Shtilbans A., Muley S., Ladha S., Freimer M., Kissel J., Latov N., Chin R., Ubogu E., Mumfrey S., Rao T., MacDonald P., Sharma K., Gonzalez G., Allen J., Walk D., Hobson-Webb L., Gable K.
المساهمون: Mielke O., Bril V., Cornblath D.R., Lawo J.-P., van Geloven N., Hartung H.-P., Lewis R.A., Merkies I.S.J., Sobue G., Durn B., Shebl A., van Schaik I.N., Sabet A., George K., Roberts L., Carne R., Blum S., Henderson R., Van Damme P., Demeestere J., Larue S., D'Amour C., Kunc P., Valis M., Sussova J., Kalous T., Talab R., Bednar M., Toomsoo T., Rubanovits I., Gross-Paju K., Sorro U., Saarela M., Auranen M., Pouget J., Attarian S., Le Masson G., Wielanek-Bachelet A., Desnuelle C., Delmont E., Clavelou P., Aufauvre D., Schmidt J., Zschuentzsch J., Sommer C., Kramer D., Hoffmann O., Goerlitz C., Haas J., Chatzopoulos M., Yoon R., Gold R., Berlit P., Jaspert-Grehl A., Liebetanz D., Kutschenko A., Stangel M., Trebst C., Baum P., Bergh F., Klehmet J., Meisel A., Klostermann F., Oechtering J., Lehmann H., Schroeter M., Hagenacker T., Mueller D., Sperfeld A., Bethke F., Drory V., Algom A., Yarnitsky D., Murinson B., Di Muzio A., Ciccocioppo F., Sorbi S., Mata S., Schenone A., Grandis M., Lauria G., Cazzato D., Antonini G., Morino S., Cocito D., Zibetti M., Yokota T., Ohkubo T., Kanda T., Kawai M., Kaida K., Onoue H., Kuwabara S., Mori M., Iijima M., Ohyama K., Baba M., Tomiyama M., Nishiyama K., Akutsu T.
مصطلحات موضوعية: chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory neuropathy cause and treatment (INCAT), intravenous immunoglobulin (IVIG), polyneuropathy and treatment with Hizentra (PATH), Privigen, Adult, Aged, 80 and over, Female, Follow-Up Studie, Human, Immunoglobulin G, Immunoglobulins, Intravenou, Immunologic Factor, Male, Middle Aged, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Young Adult, Outcome Assessment, Health Care
الوصف: In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/30672067; info:eu-repo/semantics/altIdentifier/wos/WOS:000461226700008; volume:24; issue:1; firstpage:72; lastpage:79; numberofpages:8; journal:JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM; http://hdl.handle.net/2318/1836998Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85062531892
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4دورية أكاديمية
المؤلفون: Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, Zwolinska, G
الوصف: Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].
العلاقة: Merkies, I. S. J., van Schaik, I. N., Leger, J. -M., Bril, V., van Geloven, N., Hartung, H. -P., Lewis, R. A., Sobue, G., Lawo, J. -P., Durn, B. L., Cornblath, D. R., De Bleecker, J. L., Sommer, C., Robberecht, W., Saarela, M., Kamienowski, J., Stelmasiak, Z., Tackenberg, B., Mielke, O. ,. Zwolinska, G. (2019). Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies. JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, 24 (1), pp.48-55. https://doi.org/10.1111/jns.12302Test.; http://hdl.handle.net/11343/250444Test
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5دورية أكاديمية
المؤلفون: Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K
الوصف: In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.
العلاقة: Mielke, O., Bril, V., Cornblath, D. R., Lawo, J. -P., van Geloven, N., Hartung, H. -P., Lewis, R. A., Merkies, I. S. J., Sobue, G., Durn, B., Shebl, A., van Schaik, I. N., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P. ,. Gable, K. (2019). Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study. JOURNAL OF THE PERIPHERAL NERVOUS SYSTEM, 24 (1), pp.72-79. https://doi.org/10.1111/jns.12303Test.; http://hdl.handle.net/11343/251120Test
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6دورية أكاديمية
المؤلفون: Van Schaik, Ivo N, Bril, Vera, Van Geloven, Nan, Hartung, Hans-peter, Lewis, Richard A, Sobue, Gen, Lawo, John-philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S. J, Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'amour, C., Bril, V., Breiner, A., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentssch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., G. LAURIA PINTER, Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., Van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-paszkiewicz, U., Casanovas Pons, C., Alberti Aguiló, M., Gamez Carbonell, J., Figueras, M., Marquez Infante, C., Benitez Rivero, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-driss, S., Menichella, D., Simpson, E., Chi-ho Lai, E., Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., Macdonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-webb, L., Gable, K.
المساهمون: V.S. Ivo N, B. Vera, V.G. Nan, H. Hans-peter, L. Richard A, S. Gen, L. John-philip, P. Michaela, M. Orell, D. Billie L, C. David R, M. Ingemar S. J, S. A., G. K., R. L., C. R., B. S., H. R., V.D. P., D. J., L. S., D. C., B. V., B. A., K. P., V. M., S. J., K. T., T. R., B. M., T. T., R. I., S. U., S. M., A. M., P. J., A. S., L.M. G., W. A., D. E., C. P., A. D., Z. J., S. C., K. D., H. O., G. C., H. J., C. M., Y. R., G. R., B. P., J. A., L. D., K. A., T. C., B. F., K. J., M. A., K. F., O. J., L. H., H. T., M. D., D. V., A. A., Y. D., M. B., D.M. A., C. F., S. S., M. S., G. M., G. LAURIA PINTER, C. D., A. G., Z. M., Y. T., O. T., K. M., K. K., O. H., K. S., M. M., I. M., O. K., T. M.
مصطلحات موضوعية: Quality-of-life, primary antibody deficiencie, IGG self-infusion, muscle strenght, therapy, polyradiculoneuropathy, CIDP, replacement, globulin, MMN, Settore MED/26 - Neurologia
الوصف: Background Approximately two-thirds of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) need long-term intravenous immunoglobulin. Subcutaneous immunoglobulin (SCIg) is an alternative option for immunoglobulin delivery, but has not previously been investigated in a large trial of CIDP. The PATH study compared relapse rates in patients given SCIg versus placebo. Methods Between March 12, 2012, and Sept 20, 2016, we studied patients from 69 neuromuscular centres in North America, Europe, Israel, Australia, and Japan. Adults with definite or probable CIDP who responded to intravenous immunoglobulin treatment were eligible. We randomly allocated participants to 0.2 g/kg or 0.4 g/kg of a 20% SCIg solution (IgPro20) weekly versus placebo (2% human albumin solution) for maintenance treatment for 24 weeks. We did randomisation in a 1: 1:1 ratio with an interactive voice and web response system with a block size of six, stratified by region (Japan or non-Japan). The primary outcome was the proportion of patients with a CIDP relapse or who were withdrawn for any other reason during 24 weeks of treatment. Patients, caregivers, and study personnel, including those assessing outcomes, were masked to treatment assignment. Analyses were done in the intention-to-treat and per-protocol sets. This trial is registered with ClinicalTrials. gov, number NCT01545076. Findings In this randomised, double-blind, placebo-controlled trial, we randomly allocated 172 patients: 57 (33%) to the placebo group, 57 (33%) to the low-dose group, and 58 (34%) to the high-dose group. In the intention-to-treat set, 36 (63% [95% CI 50-74]) patients on placebo, 22 (39% [27-52]) on low-dose SCIg, and 19 (33% [22-46]) on high-dose SCIg had a relapse or were withdrawn from the study for other reasons (p=0.0007). Absolute risk reductions were 25% (95% CI 6-41) for low-dose versus placebo (p=0.007), 30% (12-46) for high-dose versus placebo (p=0.001), and 6% (-11 to 23) for high-dose versus low-dose (p=0.32). Causally related adverse ...
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/29122523; info:eu-repo/semantics/altIdentifier/wos/WOS:000418570500021; volume:17; issue:1; firstpage:35; lastpage:46; numberofpages:12; journal:LANCET NEUROLOGY; http://hdl.handle.net/2434/529168Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85033221920
الإتاحة: https://doi.org/10.1016/S1474-4422Test(17)30378-2
http://hdl.handle.net/2434/529168Test -
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المؤلفون: Kailyn R. Li, Josue Avecillas‐Chasin, Thanh D. Nguyen, Kelly M. Gillen, Alexey Dimov, Eileen Chang, Carly Skudin, Brian H. Kopell, Yi Wang, Alexander Shtilbans
المصدر: Journal of neuroimaging : official journal of the American Society of NeuroimagingREFERENCES. 32(2)
مصطلحات موضوعية: Substantia Nigra, Cross-Sectional Studies, Iron, Brain, Humans, Radiology, Nuclear Medicine and imaging, Parkinson Disease, Neurology (clinical), Magnetic Resonance Imaging
الوصف: Excessive brain iron deposition is involved in Parkinson's disease (PD) pathogenesis. However, the correlation of iron accumulation in various brain nuclei is not well-established in different stages of the disease. This cross-sectional study aims to evaluate quantitative susceptibility mapping (QSM) as an imaging technique to measure brain iron accumulation in PD patients in different stages compared to healthy controls.Ninety-six PD patients grouped by their Hoehn and Yahr (HY) stages and 31 healthy controls were included in this analysis. The magnetic susceptibility values of the substantia nigra (SN), red nucleus (RN), caudate, putamen, and globus pallidus were obtained and compared.Iron level was increased in the SN of PD patients in all stages versus controls (p .001), with no significant difference within stages. Iron in the RN was significantly increased in stage II versus controls (p = .013) and combined stages III and IV versus controls (p .001). The iron levels in caudate, putamen, and globus pallidus were not different between any groups.Our data suggest iron accumulation occurs early in the disease course and only in the SN and RN of these patients. This is a large cross-sectional study of brain iron deposition in PD patients according to HY staging. Prospective studies are warranted to further validate QSM as a method to follow brain iron, which could serve as a disease biomarker and a therapeutic target.
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::63db61fb619cb563e20f6beb33728877Test
https://pubmed.ncbi.nlm.nih.gov/34904328Test -
8دورية أكاديمية
المؤلفون: Tuvin, Daniel, Berger, Yaniv, Aycart, Samantha N., Shtilbans, Tatiana, Hiotis, Spiros, Labow, Daniel M., Sarpel, Umut
المصدر: International Journal of Hyperthermia ; volume 32, issue 3, page 311-315 ; ISSN 0265-6736 1464-5157
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9كتاب
المصدر: Perioperative Care of the Orthopedic Patient ; page 233-244 ; ISBN 9783030355692 9783030355708
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10دورية أكاديمية
المؤلفون: Li, Kailyn R., Avecillas‐Chasin, Josue, Nguyen, Thanh D., Gillen, Kelly M., Dimov, Alexey, Chang, Eileen, Skudin, Carly, Kopell, Brian H., Wang, Yi, Shtilbans, Alexander
المصدر: Journal of Neuroimaging ; volume 32, issue 2, page 363-371 ; ISSN 1051-2284 1552-6569
الوصف: Background and Purpose Excessive brain iron deposition is involved in Parkinson's disease (PD) pathogenesis. However, the correlation of iron accumulation in various brain nuclei is not well‐established in different stages of the disease. This cross‐sectional study aims to evaluate quantitative susceptibility mapping (QSM) as an imaging technique to measure brain iron accumulation in PD patients in different stages compared to healthy controls. Methods Ninety‐six PD patients grouped by their Hoehn and Yahr (H&Y) stages and 31 healthy controls were included in this analysis. The magnetic susceptibility values of the substantia nigra (SN), red nucleus (RN), caudate, putamen, and globus pallidus were obtained and compared. Results Iron level was increased in the SN of PD patients in all stages versus controls ( p < .001), with no significant difference within stages. Iron in the RN was significantly increased in stage II versus controls ( p = .013) and combined stages III and IV versus controls ( p < .001). The iron levels in caudate, putamen, and globus pallidus were not different between any groups. Conclusions Our data suggest iron accumulation occurs early in the disease course and only in the SN and RN of these patients. This is a large cross‐sectional study of brain iron deposition in PD patients according to H&Y staging. Prospective studies are warranted to further validate QSM as a method to follow brain iron, which could serve as a disease biomarker and a therapeutic target.
