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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.
Mielke, Orell; Bril, Vera; Cornblath, David R; Lawo, John-Philip; van Geloven, Nan; Hartung, Hans-Peter; Lewis, Richard A; Merkies, Ingemar S J; Sobue, Gen; Durn, Billie; Shebl, Amgad; van Schaik, Ivo N.
Afiliação
  • Mielke O; CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.
  • Bril V; Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.
  • Cornblath DR; Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
  • Lawo JP; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
  • van Geloven N; CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.
  • Hartung HP; Medical Statistics, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.
  • Lewis RA; Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
  • Merkies ISJ; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California.
  • Sobue G; Department of Neurology, Maastricht University Medical Center, Maastricht, the Netherlands.
  • Durn B; Department of Neurology, St Elisabeth Hospital, Willemstad, Curaçao.
  • Shebl A; Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • van Schaik IN; CSL Behring, Marburg, Germany, and King of Prussia, Pennsylvania.
J Peripher Nerv Syst ; 24(1): 72-79, 2019 03.
Article em En | MEDLINE | ID: mdl-30672067
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Imunoglobulina G / Avaliação de Resultados em Cuidados de Saúde / Imunoglobulinas Intravenosas / Polirradiculoneuropatia Desmielinizante Inflamatória Crônica / Fatores Imunológicos Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Peripher Nerv Syst Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Imunoglobulina G / Avaliação de Resultados em Cuidados de Saúde / Imunoglobulinas Intravenosas / Polirradiculoneuropatia Desmielinizante Inflamatória Crônica / Fatores Imunológicos Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Peripher Nerv Syst Ano de publicação: 2019 Tipo de documento: Article