Autor: |
Martin Stangel, K. George, Inna Rubanovits, A. Kutschenko, Michael Schroeter, Juliane Klehmet, Tsugio Akutsu, Robert D. Henderson, S. Mumfrey, Takuya Ohkubo, Helmar C. Lehmann, Mari Auranen, Paul Bassett, Giuseppe Lauria, A. Di Muzio, Kenichi Kaida, David Yarnitsky, S. Larue, R. Gold, Fabian Klostermann, Karissa L. Gable, Ivo N. van Schaik, Gens Sobue, A Schenone, U. Sorro, Jeffrey A. Allen, S. Attarian, A. Algom, U. Chyrchel-Paszkiewicz, J. Haas, Jens Ejbye Schmidt, I. N. van Schaik, Jasper M. Morrow, Ingemar S. J. Merkies, R. Carne, C. Marquez Infante, Michael P. Lunn, Khema Sharma, E. Chi Ho Lai, Billie L. Durn, Satoshi Kuwabara, D. Kramer, David Gosal, P. MacDonald, Janneke G. J. Hoeijmakers, Giovanni Antonini, Senda Ajroud-Driss, S. Muley, Takanori Yokota, Tim Hagenacker, Eroboghene E. Ubogu, M. Kawai, Maria Salvado, Jean Pouget, Mika Saarela, John T. Kissel, Alexander Shtilbans, K. Kanai, B. Murinson, Olaf Hoffmann, Claudia Sommer, Sandro Sorbi, P. Berlit, Norman Latov, Nora A. Visser, C. G. Faber, A. Wielanek, J. Demeestere, Ericka Simpson, Ginna Gonzalez, Konrad Rejdak, C. Casanovas Pons, Alessandro Testori, Orell Mielke, T. Kalous, Alexa Cleasby, Vera Bril, J. Sussova, D. Mueller, Katrin Gross-Paju, Dale J. Lange, Nicolette C. Notermans, Florian Then Bergh, R. Talab, Kazumasa Yokoyama, M. Zibetti, C. Trebst, Marina Grandis, Miriam Freimer, E. Delmon, David R. Cornblath, Masahiro Mori, H. Onoue, Richard J. Barohn, D. Liebetanz, M. Chatzopoulos, J. Oechtering, F. Ciccocioppo, T. Rao, P. Van Damme, A. Sabet, Takashi Kanda, J. Zschuentzsch, Hans-Peter Hartung, S. Benitez, D. Aufauvre, M. Bednar, M. Tomiyama, G. Le Masson, C. D'Amour, Richard A. Lewis, Anne D. Sperfeld, I. Melamed, Lisa D. Hobson-Webb, Stefan Blum, Dario Cocito, K. Nishiyama, Daniele Cazzato, F. Bethke, Toomas Toomsoo, Said R. Beydoun, Leslie Roberts, David Walk, Josep Gamez, Masahiro Iijima, A. Jaspert-Grehl, Israel V. Drory, P. Kunc, John-Philip Lawo, C. Goerlitz, H. Johl, R. Yoon, Daniela M. Menichella, T. Lavin, Stefania Morino, K. Ohyama, Masayuki Baba, M. Antonia, Shafeeq Ladha, Claude Desnuelle, Pierre Clavelou, Andreas Meisel, Martin Vališ, Filip Eftimov, P. Baum, Sabrina Matà, Russell L. Chin, Mazen M. Dimachkie |
Přispěvatelé: |
ANS - Neuroinfection & -inflammation, Neurology, AII - Inflammatory diseases |
Jazyk: |
angličtina |
Rok vydání: |
2020 |
Předmět: |
|
Zdroj: |
Journal of the peripheral nervous system, 25(3), 230-237. Wiley-Blackwell Journal of the Peripheral Nervous System |
ISSN: |
1085-9489 |
Popis: |
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. |
Databáze: |
OpenAIRE |
Externí odkaz: |
|