Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens

被引：7

作者：

Gupta, Sudhir ^{[1
]}

DeAngelo, James ^{[2
]}

Melamed, Isaac ^{[3
]}

Walter, Jolan E. E. ^{[4
]}

Kobayashi, Ai-Lan ^{[5
]}

Bridges, Tracy ^{[6
]}

Sublett, J. Wesley ^{[7
]}

Bernstein, Jonathan A. A. ^{[8
]}

Koterba, Alan ^{[9
]}

Manning, Michael ^{[10
]}

Maltese, Joanna ^{[11
]}

Hoeller, Sonja ^{[12
]}

Turpel-Kantor, Eva ^{[12
]}

Kreuwel, Huub ^{[11
]}

Kobayashi, Roger H. H. ^{[13
]}

机构：

[1] Univ Calif Irvine, Irvine, CA 92697 USA

[2] Univ Pittsburgh, Pittsburgh, PA USA

[3] IMMUNOe Res Ctr, Centennial, CO USA

[4] Univ S Florida, St Petersburg, FL USA

[5] Midland Pediat, Papillion, NE USA

[6] Allergy & Asthma Clin Georgia, Albany, GA USA

[7] Family Allergy & Asthma, Louisville, KY USA

[8] Univ Cincinnati, Cincinnati, OH USA

[9] Allergy Associates, North Palm Beach, FL USA

[10] Med Res Arizona, Scottsdale, AZ USA

[11] Octapharma USA Inc, Paramus, NJ USA

[12] Octapharma AG, Vienna, Austria

[13] Univ Calif Los Angeles, Los Angeles, CA USA

来源：

JOURNAL OF CLINICAL IMMUNOLOGY | 2023年 / 43卷 / 06期

关键词：

Subcutaneous immunoglobulin (SCIG); Primary immunodeficiency disease; Cutaquig; High infusion volume; High infusion rate; Every other week dosing; Biweekly dosing; PRIMARY ANTIBODY DEFICIENCIES; IGG REPLACEMENT THERAPY; INTRAVENOUS IMMUNOGLOBULIN; GAMMA-GLOBULIN; HOME; HYPOGAMMAGLOBULINEMIA;

D O I：

10.1007/s10875-023-01509-4

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

PurposeTo achieve reductions in infusion time, infusion sites, and frequency, a prospective, open-label, multicenter, Phase 3 study evaluated the safety, efficacy, and tolerability of subcutaneous immunoglobulin (SCIG) 16.5% (Cutaquig (R), Octapharma) at enhanced infusion regimens.MethodsThree separate cohorts received SCIG 16.5% evaluating volume, rate, and frequency: Cohort 1) volume assessment/site: up to a maximum 100 mL/site; Cohort 2) infusion flow rate/site: up to a maximum of 100 mL/hr/site or the maximum flow rate achievable by the tubing; Cohort 3) infusion frequency: every other week at twice the patient's weekly dose.ResultsFor Cohort 1 (n = 15), the maximum realized volume per site was 108 mL/site, exceeding the currently labeled (US) maximum (up to 40 mL/site for adults). In Cohort 2 (n = 15), the maximum realized infusion flow rate was 67.5 mL/hr/site which is also higher than the labeled (US) maximum (up to 52 mL/hr/site). In Cohort 3 (n = 34), the mean total trough levels for every other week dosing demonstrated equivalency to weekly dosing (p value = 0.0017). All regimens were well tolerated. There were no serious bacterial infections (SBIs). Most patients had mild (23.4%) or moderate (56.3%) adverse events. The majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens and reported that switching to SCIG 16.5% was easy.ConclusionsSCIG 16.5% (Cutaquig (R)), infusions are efficacious, safe, and well tolerated with reduced infusion time, fewer infusion sites, and reduced frequency. Further, the majority of patients found the new infusion regimens to be better or somewhat better than their previous regimens.

引用

页码：1414 / 1425

页数：12

共 29 条

[1] Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study [J].