Universität zu Köln

Merkies, Ingemar S. J., van Schaik, Ivo N., Leger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Bjoern, Mielke, Orell, 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., 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., 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., Gable, K., De Bleecker, J. L., Saarela, M., Franques, J., Leger, J. -M., Morales, R. Juntas, Sommer, C., Nguento, A., Schmidt, J., Schrey, Ch., Kamienowski, J., Stelmasiak, Z. and Zwolinska, G. (2019). Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies. J. Peripher. Nerv. Syst., 24 (1). S. 48 - 56. HOBOKEN: WILEY. ISSN 1529-8027

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Abstract

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)-naive 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.].

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Merkies, Ingemar S. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Schaik, Ivo N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Leger, Jean-Marc 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 Durn, Billie L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornblath, David R. UNSPECIFIED UNSPECIFIED UNSPECIFIED De Bleecker, Jan L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sommer, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Robberecht, Wim UNSPECIFIED UNSPECIFIED UNSPECIFIED Saarela, Mika UNSPECIFIED UNSPECIFIED UNSPECIFIED Kamienowski, Jerzy UNSPECIFIED UNSPECIFIED UNSPECIFIED Stelmasiak, Zbigniew UNSPECIFIED UNSPECIFIED UNSPECIFIED Tackenberg, Bjoern UNSPECIFIED UNSPECIFIED UNSPECIFIED Mielke, Orell 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 Kunc, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Valis, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sussova, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kalous, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Talab, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bednar, M. 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 Zschuentzsch, 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 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 De Bleecker, J. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Saarela, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Franques, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Leger, J. -M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Morales, R. Juntas UNSPECIFIED UNSPECIFIED UNSPECIFIED Sommer, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nguento, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schrey, Ch. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kamienowski, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stelmasiak, Z. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zwolinska, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-155342
DOI:	10.1111/jns.12302
Journal or Publication Title:	J. Peripher. Nerv. Syst.
Volume:	24
Number:	1
Page Range:	S. 48 - 56
Date:	2019
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1529-8027
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INFLAMMATORY DEMYELINATING POLYNEUROPATHY; INTRAVENOUS IMMUNOGLOBULIN; MAINTENANCE TREATMENT; OPEN-LABEL; PHASE-III; POLYRADICULONEUROPATHY; PREVALENCE Multiple languages Clinical Neurology; Neurosciences Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15534