Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases

Authors: Wasserman, RL; Gupta, S; Stein, M; Rabbat, CJ; Engl, W; Leibl, H; Yel, L

Affiliations: Research Department, Allergy Partners of North Texas Research, Dallas, TX 75230, USA; School of Medicine, University of California, Irvine, CA 92697, USA; Department of Medicine, Allergy Section, Good Samaritan Medical Center, West Palm Beach, FL 33401, USA; Allergy Associates of the Palm Beaches, North Palm Beach, FL 33401, USA; Global Medical Affairs, Takeda Development Center Americas, Inc., Bannockburn, IL 60015, USA; Baxalta Innovations GmbH, a Takeda company, Vienna, Austria; Clinical Medicine, Takeda Development Center Americas, Inc., Cambridge, MA 02139, USA Immunotherapy

Abstract: AIM: This post hoc analysis evaluated the efficacy and overall tolerability of immunoglobulin (Ig) treatment modalities (intravenous Ig [iv.Ig], subcutaneous Ig [sc.Ig] and facilitated sc.Ig [fsc.Ig]). MATERIALS & METHODS: A total of 30 participants with primary immunodeficiency diseases aged ≥2 years sequentially received iv.Ig, sc.Ig and fsc.Ig during consecutive clinical studies. RESULTS: For iv.Ig, sc.Ig and fsc.Ig, rates of validated acute serious bacterial infections/participant-year (0, 0.09 and 0.04, respectively) and all infections/participant year (4.17, 3.68 and 2.42, respectively) were similarly low; rates of systemic and local causally related adverse events/participant-year were 5.60, 1.93 and 0.88, respectively and 0.13, 0.92 and 1.57, respectively. CONCLUSION: fsc.Ig provided similar efficacy to iv.Ig and sc.Ig. Clinical Trial registration: NCT00546871, NCT00814320, NCT01175213 (ClinicalTrials.gov).