Tomas Milota1, Marketa Bloomfield2, Pavlina Kralickova3, Dalibor Jilek4, Vitezslav Novak5, Jiri Litzman6, Helena Posova7, Lucie Mrazova8, Jana Poloniova8, Miroslav Prucha9, Pavel Rozsival10, Vlasta Rauschova11, Gunnar Philipp12, Anna Sediva13. 1. Department of Immunology, Motol University Hospital, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic. Electronic address: tomas.milota@fnmotol.cz. 2. Department of Immunology, Motol University Hospital, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic; Department of Pediatrics, Thomayer's Hospital, Prague, Czech Republic and 1st Faculty of Medicine, Charles University, Prague, Czech Republic. 3. Institute of Clinical Immunology and Allergy, University Hospital Hradec Kralove, Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic. 4. Centre of Immunology and Microbiology, Regional Institute of Public Health, Usti nad Labem, Czech Republic. 5. Department of Immunology and Allergy, Public Health Institute Ostrava, Ostrava, Czech Republic. 6. Department of Clinical Immunology Allergy, St Annés University Hospital, Brno, Czech Republic; Faculty of Medicicne, Masaryk University, Brno, Czech Republic. 7. Institute of Immunology 1st Medical Faculty, Charles University, Prague, Czech Republic. 8. Allergy and Clinical Immunology, Regional Hospital in Ceske Budejovice, Czech Republic. 9. Department of Clinical Biochemistry, Haematology and Immunology, Na Homolce Hospital, Prague, Czech Republic. 10. Department of Pediatrics, University Hospital Hradec Kralove, Faculty of Medicine, Charles University, Hradec Kralove, Czech Republic. 11. CSL Behring s.r.o, Prague, Czech Republic. 12. CSL Behring AG, Bern, Switzerland. 13. Department of Immunology, Motol University Hospital, 2nd Faculty of Medicine, Charles University, Prague, Czech Republic.
Abstract
PURPOSE: Immunoglobulin substitution therapy is an essential therapeutic approach for patients with primary antibody deficiencies. Different methods of administration, including intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) preparations, provide effective and tolerable treatment and enable the adjustment of therapy to patients' needs. A new 20% SCIG represents a new therapeutic option and a new route of administration using rapid-push application. The aim of the Czech Hizentra Noninterventional Study With Rapid Push (CHHINSTRAP) is to evaluate patient satisfaction with as well as the tolerability and efficacy of nonmedical switch to 20% SCIG from previous treatment with IVIG or SCIG and rapid push as a new way to administer SCIG. CHHINSTRAP is the first Phase IV, noninterventional, open-label, prospective, multicentric study of this type conducted in Central and Eastern Europe. METHODS: Primary end points, including efficacy, adverse effects, convenience of use, and overall satisfaction, were evaluated by Treatment Satisfaction Questionnaire for Medication version II. Secondary end points, such as serum IgG trough levels, infusion duration, number of application sites, frequency of infections, related hospital admissions, and antibiotic consumption, were obtained from patients at each follow-up visit. FINDINGS: Together, 50 eligible patients with primary antibody deficiency were switched from SCIG or IVIG to an equivalent dose of 20% SCIG and were followed up for 12 months during 5 consecutive visits. The results indicate that patients switched from previous IVIG or SCIG preparations had significantly higher serum trough IgG levels and a lower incidence of infections and related events, such as hospital admissions or consumption of antibiotics. These findings were also reflected in gradually increasing convenience of use and overall satisfaction reported by patients. Apart from duration of application, no differences were found between patients previously receiving SCIG or IVIG. Moreover, our study found a high level of safety of 20% SCIG rapid push, which was comparable to other preparations and application methods. IMPLICATIONS: On the basis of the results of CHHINSTRAP study, we conclude that 20% SCIG is a tolerable and effective immunoglobulin preparation, representing a new therapeutic approach in patients with primary antibody deficiencies. Its efficacy and tolerability have been found in patients on nonmedical switch from previous treatment with IVIG or SCIG.
PURPOSE: Immunoglobulin substitution therapy is an essential therapeutic approach for patients with primary antibody deficiencies. Different methods of administration, including intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) preparations, provide effective and tolerable treatment and enable the adjustment of therapy to patients' needs. A new 20% SCIG represents a new therapeutic option and a new route of administration using rapid-push application. The aim of the Czech Hizentra Noninterventional Study With Rapid Push (CHHINSTRAP) is to evaluate patient satisfaction with as well as the tolerability and efficacy of nonmedical switch to 20% SCIG from previous treatment with IVIG or SCIG and rapid push as a new way to administer SCIG. CHHINSTRAP is the first Phase IV, noninterventional, open-label, prospective, multicentric study of this type conducted in Central and Eastern Europe. METHODS: Primary end points, including efficacy, adverse effects, convenience of use, and overall satisfaction, were evaluated by Treatment Satisfaction Questionnaire for Medication version II. Secondary end points, such as serum IgG trough levels, infusion duration, number of application sites, frequency of infections, related hospital admissions, and antibiotic consumption, were obtained from patients at each follow-up visit. FINDINGS: Together, 50 eligible patients with primary antibody deficiency were switched from SCIG or IVIG to an equivalent dose of 20% SCIG and were followed up for 12 months during 5 consecutive visits. The results indicate that patients switched from previous IVIG or SCIG preparations had significantly higher serum trough IgG levels and a lower incidence of infections and related events, such as hospital admissions or consumption of antibiotics. These findings were also reflected in gradually increasing convenience of use and overall satisfaction reported by patients. Apart from duration of application, no differences were found between patients previously receiving SCIG or IVIG. Moreover, our study found a high level of safety of 20% SCIG rapid push, which was comparable to other preparations and application methods. IMPLICATIONS: On the basis of the results of CHHINSTRAP study, we conclude that 20% SCIG is a tolerable and effective immunoglobulin preparation, representing a new therapeutic approach in patients with primary antibody deficiencies. Its efficacy and tolerability have been found in patients on nonmedical switch from previous treatment with IVIG or SCIG.
Authors: Bas M Smits; Ilona Kleine Budde; Esther de Vries; Ineke J M Ten Berge; Robbert G M Bredius; Marcel van Deuren; Jaap T van Dissel; Pauline M Ellerbroek; Michiel van der Flier; P Martin van Hagen; Chris Nieuwhof; Bram Rutgers; Lieke E A M Sanders; Anna Simon; Taco W Kuijpers; Joris M van Montfrans Journal: J Clin Immunol Date: 2020-11-18 Impact factor: 8.317
Authors: Juthaporn Cowan; Vincent R Bonagura; Patricia L Lugar; Paul J Maglione; Niraj C Patel; Donald C Vinh; Jutta H Hofmann; Michaela Praus; Mikhail A Rojavin Journal: J Clin Immunol Date: 2020-10-06 Impact factor: 8.317