John W Sleasman1, William R Lumry2, Iftikhar Hussain3, H James Wedner4, James B Harris5, Kecia L Courtney6, Elsa Mondou6, Jiang Lin6, Mark R Stein7. 1. Division of Allergy, Immunology, & Pulmonary Medicine, Duke University School of Medicine; DUMC Box 2644, 203 Research Drive, Room 133B MSRB 1, Durham, NC 27710, USA. 2. Allergy & Asthma Specialists; 10100 N. Central Expressway Suite 100 Dallas, TX 75231, USA. 3. Vital Prospects Clinical Research Institute, PC, 7307 S. Yale Avenue, Tulsa, OK 74136, USA. 4. Division of Allergy & Immunology, Washington University in St. Louis, 4921 Parkview Place, Fl 8, Saint Louis, MO 63110, USA. 5. Allergy & Immunology, The South Bend Clinic Center for Research; 211 North Eddy St. South Bend, IN 46617, USA. 6. Grifols Bioscience Research Group, Grifols, 4201 Research Commons, 79 TW Alexander Drive, Research Triangle Park, NC 27709, USA. 7. Good Samaritan Medical Center; 1309 N Flagler Dr, West Palm Beach, FL 33401, USA.
Abstract
Aim: This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human - klhw 20% solution (IGSC-C 20%) in participants with primary humoral immunodeficiency (PI), compared with immune globulin injection (human), 10% caprylate/chromatography purified (IGIV-C 10%). Patients & methods: About 53 participants enrolled. Total 44 received IGIV-C 10% in the run-in phase and then entered the IV phase (with an additional nine who were already receiving IGIV-C 10% and entered the IV phase directly) for steady-state IV PK assessments. Total 49 entered the SC phase (weekly doses of IGSC-C 20% for ∼24 weeks). The PK profiles of IGIV-C 10% and IGSC-C 20% and their safety and tolerability parameters were compared. Results: At a dose adjustment factor of 1.37, IGSC-C 20% provided comparable (noninferior and bioequivalent) overall total immunoglobulin G exposure to IGIV-C 10% over an equal time interval. About 33 participants reported 79 adverse events during run-in + IV phases; 41 participants reported 141 adverse events during the SC phase, with most being local infusion site reactions. The majority of infusion site reactions were mild to moderate in severity. Conclusion: IGSC-C 20% was bioequivalent to IGIV-C 10% and was well tolerated, with a safety profile comparable with IGIV-C 10%, in this study. Trial registration: ClinicalTrials.gov identifier: NCT02604810.
Aim: This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human - klhw 20% solution (IGSC-C 20%) in participants with primary humoral immunodeficiency (PI), compared with immune globulin injection (human), 10% caprylate/chromatography purified (IGIV-C 10%). Patients & methods: About 53 participants enrolled. Total 44 received IGIV-C 10% in the run-in phase and then entered the IV phase (with an additional nine who were already receiving IGIV-C 10% and entered the IV phase directly) for steady-state IV PK assessments. Total 49 entered the SC phase (weekly doses of IGSC-C 20% for ∼24 weeks). The PK profiles of IGIV-C 10% and IGSC-C 20% and their safety and tolerability parameters were compared. Results: At a dose adjustment factor of 1.37, IGSC-C 20% provided comparable (noninferior and bioequivalent) overall total immunoglobulin G exposure to IGIV-C 10% over an equal time interval. About 33 participants reported 79 adverse events during run-in + IV phases; 41 participants reported 141 adverse events during the SC phase, with most being local infusion site reactions. The majority of infusion site reactions were mild to moderate in severity. Conclusion: IGSC-C 20% was bioequivalent to IGIV-C 10% and was well tolerated, with a safety profile comparable with IGIV-C 10%, in this study. Trial registration: ClinicalTrials.gov identifier: NCT02604810.