BACKGROUND:

The availability, licensing and commercialization of human immunoglobulin G (IG) as a therapeutic product has drastically changed the course of several diseases. Currently IG represents first line therapy for at least 10 different diseases, and is used as off-label in many other conditions. The majority of such conditions are rare diseases (i.e. affecting < 1 in 2,000 individuals), which imposes a considerable obstacle for the generation of robust clinical evidence from randomized clinical trials.

OBJECTIVE:

To develop evidence-based clinical guidelines for the use of IG as replacement or immunomodulation therapy in our country.

MATERIAL AND METHODS:

We conformed a group of several clinical experts from different specialties (work-group) to develop a critical and systematic analysis of the current evidence for the different uses of IG. We carried systematic reviews through Medical Subject Headings (MeSH) terms and the Spanish equivalent “Descriptores en Ciencias de la Salud (DeCS)” specific for each clinical condition and looking for clinical practice guidelines, other types of guidelines, systematic reviews, meta-analysis, randomized clinical trials, non-randomized clinical trials, descriptive, observational and economic studies. We used the PICO construct whenever possible using the following databases: MEDLINE, EMBASE, BVS/LILACS, NGS, NICE, CENETEC, Imbiomed, TripDatabase, and Medigraphic. We organized 8 smaller specialty-specific groups to study corresponding evidence within their área of expertise and answer the clinical questions and write specific recommendations to make a draft. Such document was discussed in a plenary session to agree a final document which was then submitted to external validation by the major representatives of the academia in our country. Finally, we wrote this document as a reference for clinicians regarding the therapeutic uses of IG in our country.

CONCLUSIONS:

We see this document as an instrument to allow clinicians in the second and third level of health care of our country to correctly use IG as replacement and/or immune-modulation. Therapeutic use of IG is an active area of clinical research; this document shall be reviewed, modified and enriched accordingly and in a timely-manner.