Subcutaneous Immunoglobulin for CIDP
Condition: Chronic Inflammatory Demyelinating Polyneuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional

Summary: 
      The investigators are using self administered subcutaneous IG in patients with CIDP who
      require IVIG. Safety, efficacy, and patient satisfaction will be examined.
    

Detailed description: 
      Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune neurological
      disorder that causes limb weakness and numbness. Many patients require immunosuppressants and
      plasma exchange (PLEX) to control their symptoms. Intravenous immunoglobulin (IVIG)is also an
      effective treatment (Hughes et al, 2006 & 2008; Hughes, 2009; Cocito et al, 2010), and the
      American Academy of Neurology (AAN) guideline recommended that it should be offered in the
      long-term treatment of CIDP (Patwa et al, 2012). While effective, IVIG causes systemic side
      effects in about 5% of patients. These side effects include rash, pruritus, myalgia, fever,
      chills, headache, low back pain, nausea, vomiting, changes in blood pressure or heart rate,
      renal failure, and aseptic meningitis (Berger, 2008). For many patients who are chronically
      treated with IVIG, venous access may be a problem over time. An alternative is the
      subcutaneous (SC) route, which has been in use since 1980 for primary immune deficiency
      disorders and is the treatment of choice for this condition in Scandinavia and England
      (Radinsky et al, 2003). As compared to IV route, SC route maintains higher trough levels of
      immunoglobulins, increases patient independence, reduces systemic side-effects, and is better
      tolerated in those who are pregnant or sensitized to IgA (Radinsky et al, 2003). In a review
      of side effects associated with 33,168 SCIG infusions, no severe or anaphylactoid reactions
      occurred (Gardulf et al, 1995). Patients can self-administer medication, and hence, overall
      cost may be reduced. A retrospective study of 28 children with primary immunodeficiency in
      Canada showed that the mean difference in costs between IVIG and SCIG during the study period
      (1 year on IVIG and 1 year on SCIG) was $4,346 in favor of SCIG (Ducruet et al, 2011). A
      US$10,100 reduction in cost per year per patient associated with SCIG use was also reported
      by Gardulf et al (1995) in Sweden. Disadvantages of SCIG include more frequent infusions and
      local reactions at sites of infusion (transient swelling, soreness, redness, induration,
      local heat, and itching) in about 1% of patients.
    

Intervention name(s): Immune Globulin Subcutaneous (Human)
Intervention type(s): Drug
Intervention description(s): Patients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study.
Other intervention name(s): Hizentra
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other