Result card

  • SAF2: Do the incidence and severity of adverse events of IVIG change with different dosing and administration schemes when used in patients with Mild Cognitive Impairment or Alzheimer’s disease?
English

Do the incidence and severity of adverse events of IVIG change with different dosing and administration schemes when used in patients with Mild Cognitive Impairment or Alzheimer’s disease?

Authors: Luca Vignatelli, Luciana Ballini, Susanna Maltoni, Jelena Barbaric, Mirjana Huic, Pernilla Östlund

Internal reviewers: Gerardo Atienza, Lavinia Panait

The same methodology was used as described in section for the whole domain.

MCI

No trials on patients with MCI were retrieved.

AD

Data from three RCTs (1 multiple dose study, Arai 2014, 1 phase 2 dose-finding study, Dodel 2013, and 1 phase 3 study, NCT00818662} and one interventional prospective non-controlled study {Relkin 2009} were available for analysis. The multiple dose RCT {Arai 2014} applied 2 different administration schemes for IVIG: 0.2 g/kg and 0.4 g/kg every 2 weeks. The authors stated that they did not record any adverse event due to dose effect. The phase 2 dose-finding RCT {Dodel 2013} applied 6 different administration schemes for IVIG: 0.2 g/kg, 0.5 g/kg, 0.8 g/kg every 4 weeks, and 0.1 g/kg, 0.25 g/kg, 0.4 g/kg every 2 weeks. The authors stated that they did not record any adverse event due to dose effect. The phase 3 RCT {NCT00818662} applied 2 different administration schemes for IVIG: 200 mg/kg and 400 mg/kg, every 2 weeks. No data on possible adverse event due to dose effect were reported. The study by {Relkin 2009}, including 8 patients, applied four different administration schemes for IVIg: 0.4 g/kg/2 weeks, 0.4 g/kg/week, 1 g/kg/2 weeks and 2 g/kg/4 weeks for 6 months of treatment. Then IVIG was discontinued during a 3-month washout period including months 7, 8, and 9. And finally all patients were treated with 1 g IVIg/kg every 2 weeks starting in month 10 through month 12 and then with 0.4 g/kg/2 weeks starting in month 13 through month 18. Authors did not report any adverse event due to dose effect.

Critical
Completely
Vignatelli L et al. Result Card SAF2 In: Vignatelli L et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 31 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267

References