Multiple subcutaneous
immunoglobulin (SCIG) products are available to treat
primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (
Vivaglobin(®) ) was compared with 20% SCIG (
Hizentra(®) ) in PAD subjects. The study was a prospective, single-centre, open-label study of PAD subjects transitioning
Vivaglobin to equivalent
Hizentra doses, rounded to the nearest vial size. Comparisons included
immunoglobulin (Ig)G levels;
tetanus,
varicella and Streptococcus pneumoniae titres; adverse events (AEs), annual
infection rate and quality of life during 8 weeks of
Vivaglobin and 24 weeks of
Hizentra. Thirty-two subjects (aged 2-75 years) participated. Rounding to the nearest
Hizentra vial size resulted in a 12·8% (± 2·9%) increase in SCIG dose. Median
immunoglobulin (Ig)G level following 8 weeks of
Vivaglobin was similar to 24 weeks of
Hizentra (1050 versus 1035 mg/dl, respectively; P = 0·77). Both products had similar protective titres to
tetanus,
varicella and serotypes of S. pneumoniae, which were variable but well above protective levels. After 12 weeks of
Hizentra, subjects reported fewer local site reactions compared with
Vivaglobin. Switching products resulted in increased systemic AEs in some subjects but, overall, not significantly higher than during
Vivaglobin treatment. Average infusion time decreased from 104·7 min (3·3 sites) with
Vivaglobin to 70·7 min (2·2 sites) with
Hizentra (P = 0·0005). Acute serious
bacterial infections were similar. Treatment satisfaction was superior with
Hizentra.
Hizentra and
Vivaglobin have similar pharmacokinetics and efficacy. Although transition to a different SCIG product initially increased AEs,
Hizentra is well tolerated and can be infused more rapidly and with fewer sites compared to
Vivaglobin.