van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, 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., Michal, V, Sussova, J., Tomas, K., Talab, R., Michal, B., 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., Zschumtszsch, 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., van Schaik, I. N., 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., 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, E. Chi-Ho, 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. and Gable, K. (2019). Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP PATH extension study. Neurol.-Neuroimmunol. Neuroinflammation, 6 (5). PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 2332-7812

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Abstract

Objective To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP). Methods In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and-if clinically stable-switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score. Results Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs. Conclusions Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
van Schaik, Ivo N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mielke, OrellUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bril, VeraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Geloven, NanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hartung, Hans-PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lewis, Richard A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sobue, GenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lawo, John-PhilipUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Praus, MichaelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Durn, Billie L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cornblath, David R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merkies, Ingemar S. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sabet, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
George, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roberts, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carne, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blum, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henderson, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Van Damme, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Demeestere, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Larue, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
D'Amour, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bril, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Breiner, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kunc, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michal, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sussova, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tomas, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Talab, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Michal, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Toomsoo, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubanovits, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gross-Paju, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sorro, U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Saarela, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Auranen, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pouget, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Attarian, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Le Masson, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wielanek-Bachelet, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Desnuelle, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delmont, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Clavelou, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aufauvre, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zschumtszsch, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sommer, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kramer, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoffmann, O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goerlitz, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haas, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chatzopoulos, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yoon, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gold, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berlit, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jaspert-Grehl, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Liebetanz, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kutschenko, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stangel, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trebst, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baum, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bergh, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klehmet, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meisel, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klostermann, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oechtering, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lehmann, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schroeter, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hagenacker, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sperfeld, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bethke, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Drory, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Algom, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yarnitsky, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Murinson, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Di Muzio, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ciccocioppo, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sorbi, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mata, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schenone, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grandis, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lauria, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cazzato, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Antonini, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morino, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cocito, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zibetti, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yokota, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ohkubo, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kanda, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kawai, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaida, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Onoue, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuwabara, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mori, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Iijima, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ohyama, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baba, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tomiyama, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nishiyama, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Akutsu, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yokoyama, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kanai, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Schaik, I. N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eftimov, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Notermans, N. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Visser, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faber, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeijmakers, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rejdak, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chyrchel-Paszkiewicz, U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Casanovas Pons, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Antonia, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gamez, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salvado, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marquez Infante, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benitez, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lunn, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morrow, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gosal, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lavin, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Melamed, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Testori, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ajroud-Driss, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Menichella, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simpson, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lai, E. Chi-HoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dimachkie, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barohn, R. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beydoun, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Johl, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lange, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shtilbans, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Muley, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ladha, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Freimer, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kissel, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Latov, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chin, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ubogu, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mumfrey, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rao, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
MacDonald, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sharma, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gonzalez, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allen, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Walk, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hobson-Webb, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gable, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-141931
DOI: 10.1212/NXI.0000000000000590
Journal or Publication Title: Neurol.-Neuroimmunol. Neuroinflammation
Volume: 6
Number: 5
Date: 2019
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 2332-7812
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INFLAMMATORY DEMYELINATING POLYNEUROPATHY; MUSCLE STRENGTH; MMNMultiple languages
Clinical Neurology; NeurosciencesMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/14193

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