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Use of Subcutaneous IgG in Patients on Concomitant
Anticoagulant and Antiplatelet Therapy
Mark R. Stein,1 Kelly Farnan,1 Danielle Eufrasio,1 Carla Duff, 2 Jerry Hunter,3 Diana Ochoa,4 Marie-Claude
Levasseur,5 Loris Aro,6 Annette Zampelli7
1Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA; 2University of South Florida, Tampa, FL, USA; 3Arizona Allergy Associates, Phoenix, AZ, USA; 4Allergy/Immunology Research Center of North Texas, Dallas, TX, USA; 5University
Health Center, Sainte-Justine Hospital, Montreal, QC, Canada; 6Toronto Allergy Group, Toronto, ON, Canada; 7CSL Behring, LLC, King of Prussia, PA, USA
The International Nursing Group for ImmunodeficienciesOctober 3-6, 2012, Florence, Italy
Disclosures and Acknowledgments
• MRS has served as a speaker, consultant, and/or investigator for Baxter Healthcare Corp, CSL Behring, Merck, and Teva. CD, JH, MCL, and LA are nurse consultants for CSL Behring. DO is a nurse consultant for CSL Behring and has served on an advisory board for Baxter Healthcare. AZ is employed by CSL Behring.
• This presentation was supported by CSL Behring, LLC.
• Medical writing and editorial support was provided by Daniel McCallus, PhD, of Complete Publication Solutions, LLC, and was funded by CSL Behring, LLC.
• Primary or Secondary Immunodeficiency Disease (PIDD/SIDD)– Standard treatment:
• Intravenous immunoglobulin (IVIG)1
• Subcutaneous immunoglobulin (SCIG)1
• High prevalence of thrombotic risks in the general population2
– Many patients with PIDD/SIDD are also prescribed anticoagulant and antiplatelet (AC/AP) drugs for the treatment and prophylaxis of thrombotic, cardiac, and vascular diseases3
– Some disorders associated with PIDD have congenital cardiovascular manifestations that require AC/AP
Introduction
1. Fried AJ and Bonilla FA. Clin Microbiol Rev. 2009;22(3):396-414.2. Heidenreich PA, et al. Circulation. 2011;123(8):933-944.3. Alexander KP and Peterson ED. Circulation. 2010;121(17):1960-1970.
• Rationale– Infusion-site bleeding or bruising at the site of SCIG
administration due to the activity of AC/AP medication was theoretical concern
• Objective– To establish the safety of concomitant SCIG and AC/AP
therapy
Rationale and Objective
Study Design
• Multicenter retrospective chart review of tolerability data
• Patient inclusion criteria:– PIDD or SIDD– Receiving treatment with 20% SCIG
(Hizentra®, CSL Behring, LLC, King of Prussia, PA) or 16% SCIG (Vivaglobin®, CSL Behring, LLC; no longer available in the United States)
– Prescribed concomitant AC/AP medications
Patient Descriptions
26 of the total 33 patients were part of a larger (n=47) retrospective single-center study on safety and efficacy of SCIG in the elderly
Parameter Patients, n (%)N=47
PIDD diagnosis
Hypogammaglobulinemia 29 (61.7)
IgG subclass deficiency or specific antibody deficiency
9 (19.1)
Hypogamma globulinemia and subclass deficiency or specific antibody deficiency or another immunodeficiency
9 (19.1
Medical history
Serious acute bacterial infections 31 (68.1)
Chronic infections 44 (93.6)
Comorbid conditions
COPD 7 (14.9)
Type 1 diabetes 4 (8.5)
Type 2 diabetes 3 (6.4)Stein et al. Postgrad Med. 2011; 123:186-93.
Patient Descriptions Cont.
Parameter Patients, n (%)N=47
Brochodilators/inhaled corticosteroids 29 (61.7)
Proton pump inhibitors 21 (44.7)
Statins/antilipidemics 21 (44.7)
Nasal sprays 17 (36.2)
Antihistamines 16 (34.0)
Diuretics/antihypertensives 16 (34.0)
Antidepressants 11 (23.4)
Bone resorption inhibitors 10 (21.3)
Thyroid hormone 9 (19.1)
Concomitant medication use in the larger study population
Stein et al. Postgrad Med. 2011; 123:186-93.
AC/AP Use: Patient Descriptions
• 33 patients total – 26 from larger single-center in elderly, 7 from other centers
• Age– Median: 70 years– Range: 3−89 years
• AC/AP medications– Included:
• Aspirin, warfarin, clopidogrel, and heparin– Used for:
• Treatment and/or prophylaxis for thrombotic and vascular diseases
– ie, pulmonary embolism, congenital heart disease, chronic atrial fibrillation/flutter
Concomitant AC/AP Medications
• The most common concomitant medication was aspirin (18/33 patients, 55%)
• A large percentage of patients were on warfarin (10/33 patients, 30%)
• Few patients used clopidogrel alone or aspirin combined with either clopidogrel or heparin (5/33 patients, 12%)
Types of concomitant AC/AP medications in patients treated with
SCIG
Patient SCIG Administration Parameters
• SCIG was administered using a variety of different regimens
Mean duration of use, months (range) 22.2 (5−49)
Mean total dose, mg/kg/month 441
Number of sites per infusion 12-3≥4
3219
Method of SCIG AdministrationSyringe PumpPush
303
Site of infusionAbdomenArmThighMultiple body areas
24135
SCIG administration frequency>1X/weekWeeklyEvery 2 weeks
5271
Results
• Local site reactions– Mild, transient, and similar to those previously
described4
• Infusion-site bleeding/bruising: observed in only 1 patient– A 62-year-old white male– Immune thrombocytopenic purpura and SIDD – Receiving aspirin (81 mg/day)– SCIG dose of 710 mg/kg per month via syringe push,
20 mL in 1 site (abdomen), 4 times per week– Reported mild bruising during the first month of SCIG
treatment4. Jolles S, et al. Clin Immunol. 2011;141(1):90-120.
Case Study 1
• 21-year-old female– 16% SCIG dose of 696 mg/kg per month
via syringe push – Concomitant warfarin therapy (5 mg/d) for
treatment of prior pulmonary embolism• First SCIG treatment
– Two 5 mL push injections (2 hours apart), followed by two 10 mL injections (1 hour apart)
– No photo available• Subsequent SCIG treatments
– One 20 mL push injection in one site over 15 minutes
– 3 times per week• Patient outcomes
– No bruising, bleeding, or skin reactions at the infusion site, despite increase in general bruisability since starting warfarin
– After 8 months of well-tolerated SCIG, restarted IVIG for personal reasons
Week 4 Infusion
Week 4 Infusion
Before
After
• 33-year-old female– 16% SCIG dose of 750 mg/kg per month
via syringe push – Concomitant warfarin therapy (alternating
9/10 mg/day) for chronic atrial flutter• First SCIG treatment
– Two 5 mL push injections (2 hours apart), followed by two 10 mL injections (1 hour apart)
• Subsequent SCIG treatments– One 20 mL push injection in one site over
15 minutes– 3 times per week
• Patient outcomes– No bruising, bleeding, or skin reactions at
the infusion site
Before After
First SCIG treatment
Before After
Case Study 2
Week 4 Infusion
Conclusions
•The concurrent use of AC/AP medications in this group of patients with PIDD or SIDD aged 3-89 years did not increase the occurrence of local site complications after 16% SCIG or 20% SCIG treatment.
•In patients with PIDD or SIDD and comorbid cardiovascular or thrombotic disorders treated with AC/AP medications, the use of 16% or 20% SCIG was well tolerated.