Patients' views on subcutaneous IgG (SCIG) Home Therapy: results from The UK Subgam ® Study.

patients with primary antibody deficiency (PAD) received weekly infusions of Subgam, an immunoglobulin G (IgG) recently licensed in the UK for subcutaneous (SC) use in adults and children. All patients had previously received intravenous (IV; n = 36) or SC (n = 14) IgG for at least 6 months. They were asked to complete a questionnaire rating comfort and convenience of their prior treatment. After 3 and 6 months on Subgam, they were asked to rate its comfort and convenience, how they felt their symptoms had been and how they liked Subgam overall compared with their previous treatment. For analysis, patients were separated according to the route of previous treatment and age (adult, teenager or child). Results at 6 months are summarised below: Ratings of convenience as 'very' plus 'quite' convenient were for: adults 93% for Subgam and 60% for prior IgG; teenagers 80% versus 40%; children 100% vs 42%. Comfort ratings of 'extremely' plus 'very' comfortable were for adults the same for both treatments (48%); teenagers 80% for Subgam vs 60% for prior IgG; children 58% vs 28%. Symptoms were regarded as being 'much better' plus 'better' in 52 % of adults, 58% of teenagers and 66% of children. Only 2 patients regarded symptoms as being worse and one of these continued with Subgam long-term. Overall preferences for Subgam were 'much more' plus 'more' for 72% of adults, 100% of teenagers and 80% of children. In conclusion, Subgam is suitable for Home Therapy and the regimen is popular with patients of all ages. Subgam is an IgG which is now licensed for subcutaneous use in adults and children. • Overall, 90% of patients found infusions with Subgam quite, very or extremely comfortable (55% found it very or extremely comfortable). • No patients thought that Subgam infusions were extremely uncomfortable. • Furthermore, 29% of patients gave Subgam‚ a higher rating for comfort than they gave their prior IgG compared with only 19% who gave Subgam a lower rating. Subgam is a 16% isotonic solution of IgG at pH 6.5-6.7, with no added stabilisers or antimicrobial preservatives. At least 98% of protein present in the solution is IgG of which at least 90% is monomeric. The subclass distribution is IgG1 (64%), IgG2 (29%), IgG3 (6%) and IgG4 (1%). Because of its purity, there is little or no contamination with IgA, which in assays of many batches has been shown to be <0.01% of protein. The product is prepared from plasma collected from screened, healthy, volunteer donors in the USA. Besides the conventional serological tests on each donation, minipools of donations are tested for HIV, HAV, HBV, HCV and parvovirus B19 by NAT (PCR). If any donation fails any of these tests it is discarded. The manufacturing process includes steps which purify the IgG and are shown to be able to remove model viruses, as well as the well-established solvent/detergent step specifically aimed at the major human pathogenic viruses potentially transmissible by plasma-derived products. Here we present patient opinions from The UK Subgam Study, set up by BPL in June 2000 to determine the long-term effects of Subgam by rapid subcutaneous infusion in a population of patients with primary antibody deficiency (PAD).