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MILOTA, Tomas, Marketa BLOOMFIELD, Pavlina KRALICKOVA, Dalibor JILEK, Vitezslav NOVAK, Jiří LITZMAN, Helena POSOVA, Lucie MRAZOVA, Jana POLONIOVA, Miroslav PRUCHA, Pavel ROZSIVAL, Vlasta RAUSCHOVA, Gunnar PHILIPP and Anna SEDIVA. Czech Hizentra Noninterventional Study With Rapid Push: Efficacy, Safety, Tolerability, and Convenience of Therapy With 20% Subcutaneous Immunoglobulin. Clinical Therapeutics. BRIDGEWATER: Elsevier, 2019, vol. 41, No 11, p. 2231-2238. ISSN 0149-2918. Available from: https://dx.doi.org/10.1016/j.clinthera.2019.08.013.

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TY  - JOUR
ID  - 1604796
AU  - Milota, Tomas - Bloomfield, Marketa - Kralickova, Pavlina - Jilek, Dalibor - Novak, Vitezslav - Litzman, Jiří - Posova, Helena - Mrazova, Lucie - Poloniova, Jana - Prucha, Miroslav - Rozsival, Pavel - Rauschova, Vlasta - Philipp, Gunnar - Sediva, Anna
PY  - 2019
TI  - Czech Hizentra Noninterventional Study With Rapid Push: Efficacy, Safety, Tolerability, and Convenience of Therapy With 20% Subcutaneous Immunoglobulin
JF  - Clinical Therapeutics
VL  - 41
IS  - 11
SP  - 2231-2238
EP  - 2231-2238
PB  - Elsevier
SN  - 01492918
KW  - Nonmedical switch
KW  - Primary antibody deficiency
KW  - Rapid push
KW  - Subcutaneous immunoglobulin replacement therapy
KW  - Treatment satisfaction
UR  - http://dx.doi.org/10.1016/j.clinthera.2019.08.013
L2  - http://dx.doi.org/10.1016/j.clinthera.2019.08.013
N2  - Purpose: Immunoglobulin substitution therapy is an essential therapeutic approach for patients with primary antibody deficiencies. Different methods of administration, including intravenous immunoglobulin (WIG) 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 WIG or SCIG and rapid push as a new way to administer SCIG. CHHINSTRAP is the first Phase W, 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 WIG 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 WIG 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 WIG. Moreover, our study found a high level of safety of 20% SCIG rapid push, which was comparable to other preparations and application methods. (C) 2019 Elsevier Inc. All rights reserved.
ER  -

Basic information
Original name	Czech Hizentra Noninterventional Study With Rapid Push: Efficacy, Safety, Tolerability, and Convenience of Therapy With 20% Subcutaneous Immunoglobulin
Authors	MILOTA, Tomas (203 Czech Republic, guarantor), Marketa BLOOMFIELD (203 Czech Republic), Pavlina KRALICKOVA (203 Czech Republic), Dalibor JILEK (203 Czech Republic), Vitezslav NOVAK (203 Czech Republic), Jiří LITZMAN (203 Czech Republic, belonging to the institution), Helena POSOVA (203 Czech Republic), Lucie MRAZOVA (203 Czech Republic), Jana POLONIOVA (203 Czech Republic), Miroslav PRUCHA (203 Czech Republic), Pavel ROZSIVAL (203 Czech Republic), Vlasta RAUSCHOVA (203 Czech Republic), Gunnar PHILIPP (203 Czech Republic) and Anna SEDIVA (203 Czech Republic).
Edition	Clinical Therapeutics, BRIDGEWATER, Elsevier, 2019, 0149-2918.

Other information
Original language	English
Type of outcome	Article in a journal
Field of Study	30104 Pharmacology and pharmacy
Country of publisher	United States of America
Confidentiality degree	is not subject to a state or trade secret
WWW	URL
Impact factor	Impact factor: 3.119
RIV identification code	RIV/00216224:14110/19:00112432
Organization unit	Faculty of Medicine
Doi	http://dx.doi.org/10.1016/j.clinthera.2019.08.013
UT WoS	000503107700004
Keywords in English	Nonmedical switch; Primary antibody deficiency; Rapid push; Subcutaneous immunoglobulin replacement therapy; Treatment satisfaction
Tags	14110114, rivok
Tags	International impact, Reviewed
Changed by	Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 16/1/2020 07:22.

Abstract
Purpose: Immunoglobulin substitution therapy is an essential therapeutic approach for patients with primary antibody deficiencies. Different methods of administration, including intravenous immunoglobulin (WIG) 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 WIG or SCIG and rapid push as a new way to administer SCIG. CHHINSTRAP is the first Phase W, 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 WIG 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 WIG 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 WIG. Moreover, our study found a high level of safety of 20% SCIG rapid push, which was comparable to other preparations and application methods. (C) 2019 Elsevier Inc. All rights reserved.

Abstract

Purpose: Immunoglobulin substitution therapy is an essential therapeutic approach for patients with primary antibody deficiencies. Different methods of administration, including intravenous immunoglobulin (WIG) 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 WIG or SCIG and rapid push as a new way to administer SCIG. CHHINSTRAP is the first Phase W, 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 WIG 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 WIG 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 WIG. Moreover, our study found a high level of safety of 20% SCIG rapid push, which was comparable to other preparations and application methods. (C) 2019 Elsevier Inc. All rights reserved.