Universität zu Köln

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:	Creators Email ORCID ORCID Put Code van Schaik, Ivo N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mielke, Orell UNSPECIFIED UNSPECIFIED UNSPECIFIED Bril, Vera UNSPECIFIED UNSPECIFIED UNSPECIFIED van Geloven, Nan UNSPECIFIED UNSPECIFIED UNSPECIFIED Hartung, Hans-Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Lewis, Richard A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sobue, Gen UNSPECIFIED UNSPECIFIED UNSPECIFIED Lawo, John-Philip UNSPECIFIED UNSPECIFIED UNSPECIFIED Praus, Michaela UNSPECIFIED UNSPECIFIED UNSPECIFIED Durn, Billie L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornblath, David R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Merkies, Ingemar S. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sabet, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED George, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Roberts, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Carne, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Blum, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Henderson, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Damme, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Demeestere, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Larue, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED D'Amour, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bril, V UNSPECIFIED UNSPECIFIED UNSPECIFIED Breiner, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kunc, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Michal, V UNSPECIFIED UNSPECIFIED UNSPECIFIED Sussova, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tomas, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Talab, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Michal, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Toomsoo, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubanovits, I UNSPECIFIED UNSPECIFIED UNSPECIFIED Gross-Paju, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sorro, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Saarela, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Auranen, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pouget, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Attarian, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Le Masson, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wielanek-Bachelet, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Desnuelle, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Delmont, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Clavelou, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Aufauvre, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zschumtszsch, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sommer, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kramer, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoffmann, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goerlitz, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Haas, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chatzopoulos, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Yoon, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gold, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Berlit, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaspert-Grehl, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Liebetanz, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kutschenko, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stangel, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Trebst, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baum, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bergh, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Klehmet, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Meisel, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Klostermann, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Oechtering, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmann, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroeter, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hagenacker, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sperfeld, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bethke, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Drory, V UNSPECIFIED UNSPECIFIED UNSPECIFIED Algom, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Yarnitsky, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Murinson, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Di Muzio, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ciccocioppo, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sorbi, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mata, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schenone, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Grandis, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lauria, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cazzato, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Antonini, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Morino, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cocito, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zibetti, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Yokota, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ohkubo, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kanda, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kawai, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaida, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Onoue, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuwabara, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mori, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Iijima, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ohyama, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baba, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tomiyama, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nishiyama, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Akutsu, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Yokoyama, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kanai, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Schaik, I. N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Eftimov, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Notermans, N. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Visser, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Faber, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoeijmakers, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rejdak, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chyrchel-Paszkiewicz, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Casanovas Pons, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Antonia, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gamez, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salvado, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Marquez Infante, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Benitez, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lunn, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Morrow, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gosal, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lavin, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Melamed, I UNSPECIFIED UNSPECIFIED UNSPECIFIED Testori, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ajroud-Driss, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Menichella, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Simpson, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lai, E. Chi-Ho UNSPECIFIED UNSPECIFIED UNSPECIFIED Dimachkie, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barohn, R. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Beydoun, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Johl, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lange, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Shtilbans, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Muley, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ladha, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Freimer, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kissel, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Latov, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chin, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ubogu, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mumfrey, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rao, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED MacDonald, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sharma, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gonzalez, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Allen, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Walk, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hobson-Webb, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gable, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language INFLAMMATORY DEMYELINATING POLYNEUROPATHY; MUSCLE STRENGTH; MMN Multiple languages Clinical Neurology; Neurosciences Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14193