Authors' objectives:

The aim of this report was to assess the effectiveness and cost-effectiveness of immunoglobulin replacement therapy (IgRT) for patients with primary immunoglobulin deficiency (PID) and immunoglobulin deficiency secondary to chronic lymphocytic leukemia (CLL).

Authors' results and conclusions: Effectiveness: general results 17 studies involving PID participants (including 3 parallel and 14 crossover trials) and 5 studies involving CLL patients (including 3 parallel and 2 crossover trials) were included. The sample size of the studies was generally small and the methodological quality of the studies was also generally poor. There were major shortcomings in the design, analysis, and reporting of the crossover trials. The trials were however often done many years ago when methodological standards were not as clearly defined. Effectiveness: results for PID No studies comparing IgRT with placebo or no treatment were identified. Evidence from two old trials showed that administering IgG by the intravenous route (IVIG) is significantly more effective than the intramuscular route (IMIG) in reducing infection or infection-related events. A further small trial showed that the IVIg had more infection episodes (67 vs 45) but less mild and moderate reactions than subcutaneous immunoglobulin (SCIg). Higher doses of IVIG in 3 trials seemed to offer greater reductions in infection. Most of the included studies compared one type of preparation with another, these are described in detail in the main report. Serious adverse events with IgRT were very rare across all the RCTs. Similarly, no evidence of IgRT associated death was found from the identified RCTs. Effectiveness: results for CLL IVIg significantly reduced infection events compared to placebo or no treatment, but tended to induce more adverse events. One trial reported patients becoming positive for anti-HCV antibodies while receiving IVIG therapy.

Authors' recommendations: IgRT, particularly IVIg and SCIg, is effective in terms of reduction of infection in both PID and CLL. In PID, IgRT appears to be cost-effective, although this assessment depends on evidence on effects on survival and utility that are not derived from RCTs. In contrast, in CLL, IgRT is not cost-effective. There appear to be no major implications for practice, bar encouraging use of home based IgRT, or unless IgRT is being extensively used in the treatment of patients with CLL. There are implications for research particularly further development and testing of the new health economic model on IgRT in PID and improving the accuracy of the parameters used in it. Re-running the previously published health economic model on IgRT in CLL, might also be justified, particularly if it focused on cost-utility in groups with high levels of infection.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.birmingham.ac.uk/Documents/college-mds/haps/projects/WMHTAC/REPreports/2005/IgRT.pdf

Year Published: 2005

URL for published report: http://www.birmingham.ac.uk/research/activity/mds/projects/HaPS/PHEB/WMHTAC/REP/reports-list.aspx

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: West Midlands Health Technology Assessment Collaboration

Contact Address: Elaena Donald-Lopez, West Midlands Health Technology Assessment Collaboration, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT Tel: +44 121 414 7450; Fax: +44 121 414 7878

Contact Name: louise.a.taylor@bham.ac.uk

Contact Email: louise.a.taylor@bham.ac.uk

Copyright: University of Birmingham