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Shift in Patterns in Previous Immunoglobulin Therapy Use in Patients Prescribed 20% Subcutaneous Immunoglobulin
AB156 Abstracts
550
MONDAY
The Spectrum of Primary Immunodeficiency Diseases in A Saudi Tertiary Care Hospital Over Two Years Bandar Al-Saud, MD1,2, S. Al-Muhsen, MD3,4, A. Al-Ghonaium, MD1, S. Al Gazlan, MD5, H. Al-Dhekri, MD3, R. Arnaout, MD3, A. AlSeraihy, MD6, N. Elsayed7, M. Shoukri, PhD8, J. Afzal, MD9, H. Al-Mousa, MD2,3; 1King Faisal Specialist Hospital & Research Center, 2Alfaisal University, College of Medicine, 3Pediatric, King Faisal Specialist Hospital & Research Center, 4King Saud University, College of Medicine, Riyadh, Saudi Arabia, 5Madicine,King Faisal Specialist Hospital & Research Center, 6 Pediatric Hematology/Oncology King Faisal Specialist Hospital & Research Center, 7Nursing Affairs, King Faisal Specialist Hospital & Research Center, 8Biostatistics, Epidemiology & Scientific Computing King Faisal Specialist Hospital & Research Center, 9Biostatistics, Epidemiology & Scientific Computing, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia. RATIONALE: Primary immunodeficiencies (PID) are a group of heterogeneous diseases with more then 200 type described. Databases worldwide show geographical variation. METHODS: Data captured form interviews and a retrospective chart review for all PID patients managed at King Faisal Specialist Hospital & Research Center (KFSHRC) from May 2010 to April 2012(ongoing). A software was designed for data entry. Microsoft SQL Server was used to develop and administer the database. RESULTS: 357 cases encountered (54% male and 46% female).age range: <1 to 45 years. Consanguinity in 76 %. 205 patients of combined B & T-cell defect (T- B+ SCID 9, T-B-SCID 51, ADA 7, PNP 3, Reticular dysgenesis 3, Omenn Syndrome 12, CID 7, SCID NOS 37, Hyper IgM syndrome 18, MHC II deficiency 42, Hyper IgE Syndrome 16). Predominantly antibody defect in 55 patients (CVID 26, Agammaglobulinemia 10, and Hypogammaglobulinemia 19). 21 patients in other well defined PID (Wiskott Aldrich syndrome 12, DiGeorge Syndrome 3, Ataxia Telangeictasia 4, ICF 1, Dyskeratosis congenital 1). 23 with Immune Dysregulation (Chediak Higashi 7, Griscelli Syndrome 15, EBV related LPS 1). 37 patients had phagocytic defect (Chronic Granulomatous Disease 26, leukocyte adhesion deficiency 11). 16 patients with complement deficiencies (HAE 14, C5 deficiency 2). 178 patients underwent hematopoietic stem cell transplantation (HSCT) (143allogenic & 35cord). 10 patients died (5 SCID, 1 CID, 2 MHCII deficiency,1 Griscelli syndrome and 1 Dyskeratosis congenital). CONCLUSIONS: The high incidence and the pattern of PIDs with higher percentage of combined B & T-cell defects could be due to the genetic backgrounds and the higher consanguinity in the Saudi population.
551
Shift in Patterns in Previous Immunoglobulin Therapy Use in Patients Prescribed 20% Subcutaneous Immunoglobulin Marc Botteman, MSc1, Art Zbrozek2, Ann Bullinger, PharmD3, Alan P. Baptist, MD, MPH4; 1Pharmerit International, Bethesda, MD, 2CSL Behring LLC, King of Prussia, PA, 3CSL Behring, King of Prussia, PA, 4 University of Michigan, Division of Allergy, Ann Arbor, MI. RATIONALE: The product label for HizentraÒ (CSL Behring), a 20% subcutaneous immunoglobulin (SCIG) therapy for patients with primary immunodeficiency disease (PIDD), specifies that a 1.53 dose conversion factor is used when changing from the intravenous immunoglobulin (IVIG) dose to Hizentra. Prior reports calculated the resulting cost implications, however, existence of patients without previous IVIG use was not considered. Our objective was to analyze the trends in previous therapies in patients treated with Hizentra to address the validity of cost considerations. METHODS: A retrospective analysis was conducted of IMS Health database claims from patients with PIDD prescribed Hizentra during October 2010 (market launch) and December 2011 (most recent data available). RESULTS: In October 2010, 43 patients had a Hizentra prescription. Of _10 months). 41.4% of these patients, 41 were newly transitioned (Hizentra < new Hizentra patients transitioned from IVIG therapy, 39.1% transitioned
J ALLERGY CLIN IMMUNOL FEBRUARY 2013
from other SCIG therapy, and 19.5% had no previous IgG therapy. In December 2011, 447 patients had a Hizentra prescription, 184 of whom were newly transitioned. In contrast to the October 2010 data, the percentage of new Hizentra patients who transitioned from IVIG dropped by half to 19.0%. 35.4% transitioned from other SCIG therapy and 45.6% of newly transitioned patients had no previous IgG therapy. CONCLUSIONS: This study suggests that currently less than 20% of patients receiving Hizentra have received previous IVIG therapy. Nearly 50% started Hizentra without any previous IgG therapy, and should decrease concerns about costs of therapy.
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Immunologists' Attitudes On "Wear-off" Effects of IgG Replacement Therapy for Primary Immunodeficiency Disease (PIDD) Patients Mark Ballow, MD, FAAAAI1, Ann Bullinger, PharmD2, Elyse A. Murphy, RN3, Melvin Berger, MD, PhD, FAAAAI4; 1SUNY Buffalo, Sarasota, FL, 2CSL Behring, King of Prussia, PA, 3CSL Behring, Vienna, VA, 4CSL Behring, LLC, King of Prussia, PA. RATIONALE: In a 2002 Immune Deficiency Foundation survey, 67% of PIDD patients reported that they could ‘‘feel their IVIG wearing off before the next dose was due’’. We surveyed expert immunologists’ opinions of the prevalence of ‘‘wear-off effects’’ in their practices and how they manage patients experiencing wear-off effects. METHODS: A survey about IgG treatment was sent to 13 immunologists across the USA, who collectively treat nearly 2000 PIDD patients with IgG replacement therapy. RESULTS: When asked what % of the patients in their practices on IVIG ‘‘report a wear-off effect’’, 73% of the immunologists chose 1-25%, 18% chose 26-50% and 9% chose 51-75%. In contrast, in response to the same question about patients on subcutaneous IgG, 64% chose ‘‘none’’, and 36% chose 1-25%. None of the immunologists selected a choice higher than 25% with SCIG. When asked how they manage patients with wear-off effect symptoms, 36% selected ‘‘increase the dose of IVIG’’, 46% selected ‘‘decrease the time between IVIG doses’’, and 55% selected ‘‘recommend SCIG’’ (some selected more than one response). None of the immunologists chose: ‘‘No change in therapy’’. CONCLUSIONS: Expert immunologists, prescribing IgG replacement therapy for an average of 152 PIDD patients each, answered that the percentage of patients on the IV route of IgG therapy who report ‘‘wear-off effects’’ is significantly higher than the percentage of patients on subcutaneous therapy who report such effects. Fifty-five % of the immunologists reported that they recommend subcutaneous therapy as a way of managing ‘‘wear-off’’ effects in PIDD patients on IVIG therapy.
550
MONDAY
The Spectrum of Primary Immunodeficiency Diseases in A Saudi Tertiary Care Hospital Over Two Years Bandar Al-Saud, MD1,2, S. Al-Muhsen, MD3,4, A. Al-Ghonaium, MD1, S. Al Gazlan, MD5, H. Al-Dhekri, MD3, R. Arnaout, MD3, A. AlSeraihy, MD6, N. Elsayed7, M. Shoukri, PhD8, J. Afzal, MD9, H. Al-Mousa, MD2,3; 1King Faisal Specialist Hospital & Research Center, 2Alfaisal University, College of Medicine, 3Pediatric, King Faisal Specialist Hospital & Research Center, 4King Saud University, College of Medicine, Riyadh, Saudi Arabia, 5Madicine,King Faisal Specialist Hospital & Research Center, 6 Pediatric Hematology/Oncology King Faisal Specialist Hospital & Research Center, 7Nursing Affairs, King Faisal Specialist Hospital & Research Center, 8Biostatistics, Epidemiology & Scientific Computing King Faisal Specialist Hospital & Research Center, 9Biostatistics, Epidemiology & Scientific Computing, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia. RATIONALE: Primary immunodeficiencies (PID) are a group of heterogeneous diseases with more then 200 type described. Databases worldwide show geographical variation. METHODS: Data captured form interviews and a retrospective chart review for all PID patients managed at King Faisal Specialist Hospital & Research Center (KFSHRC) from May 2010 to April 2012(ongoing). A software was designed for data entry. Microsoft SQL Server was used to develop and administer the database. RESULTS: 357 cases encountered (54% male and 46% female).age range: <1 to 45 years. Consanguinity in 76 %. 205 patients of combined B & T-cell defect (T- B+ SCID 9, T-B-SCID 51, ADA 7, PNP 3, Reticular dysgenesis 3, Omenn Syndrome 12, CID 7, SCID NOS 37, Hyper IgM syndrome 18, MHC II deficiency 42, Hyper IgE Syndrome 16). Predominantly antibody defect in 55 patients (CVID 26, Agammaglobulinemia 10, and Hypogammaglobulinemia 19). 21 patients in other well defined PID (Wiskott Aldrich syndrome 12, DiGeorge Syndrome 3, Ataxia Telangeictasia 4, ICF 1, Dyskeratosis congenital 1). 23 with Immune Dysregulation (Chediak Higashi 7, Griscelli Syndrome 15, EBV related LPS 1). 37 patients had phagocytic defect (Chronic Granulomatous Disease 26, leukocyte adhesion deficiency 11). 16 patients with complement deficiencies (HAE 14, C5 deficiency 2). 178 patients underwent hematopoietic stem cell transplantation (HSCT) (143allogenic & 35cord). 10 patients died (5 SCID, 1 CID, 2 MHCII deficiency,1 Griscelli syndrome and 1 Dyskeratosis congenital). CONCLUSIONS: The high incidence and the pattern of PIDs with higher percentage of combined B & T-cell defects could be due to the genetic backgrounds and the higher consanguinity in the Saudi population.
551
Shift in Patterns in Previous Immunoglobulin Therapy Use in Patients Prescribed 20% Subcutaneous Immunoglobulin Marc Botteman, MSc1, Art Zbrozek2, Ann Bullinger, PharmD3, Alan P. Baptist, MD, MPH4; 1Pharmerit International, Bethesda, MD, 2CSL Behring LLC, King of Prussia, PA, 3CSL Behring, King of Prussia, PA, 4 University of Michigan, Division of Allergy, Ann Arbor, MI. RATIONALE: The product label for HizentraÒ (CSL Behring), a 20% subcutaneous immunoglobulin (SCIG) therapy for patients with primary immunodeficiency disease (PIDD), specifies that a 1.53 dose conversion factor is used when changing from the intravenous immunoglobulin (IVIG) dose to Hizentra. Prior reports calculated the resulting cost implications, however, existence of patients without previous IVIG use was not considered. Our objective was to analyze the trends in previous therapies in patients treated with Hizentra to address the validity of cost considerations. METHODS: A retrospective analysis was conducted of IMS Health database claims from patients with PIDD prescribed Hizentra during October 2010 (market launch) and December 2011 (most recent data available). RESULTS: In October 2010, 43 patients had a Hizentra prescription. Of _10 months). 41.4% of these patients, 41 were newly transitioned (Hizentra < new Hizentra patients transitioned from IVIG therapy, 39.1% transitioned
J ALLERGY CLIN IMMUNOL FEBRUARY 2013
from other SCIG therapy, and 19.5% had no previous IgG therapy. In December 2011, 447 patients had a Hizentra prescription, 184 of whom were newly transitioned. In contrast to the October 2010 data, the percentage of new Hizentra patients who transitioned from IVIG dropped by half to 19.0%. 35.4% transitioned from other SCIG therapy and 45.6% of newly transitioned patients had no previous IgG therapy. CONCLUSIONS: This study suggests that currently less than 20% of patients receiving Hizentra have received previous IVIG therapy. Nearly 50% started Hizentra without any previous IgG therapy, and should decrease concerns about costs of therapy.
552
Immunologists' Attitudes On "Wear-off" Effects of IgG Replacement Therapy for Primary Immunodeficiency Disease (PIDD) Patients Mark Ballow, MD, FAAAAI1, Ann Bullinger, PharmD2, Elyse A. Murphy, RN3, Melvin Berger, MD, PhD, FAAAAI4; 1SUNY Buffalo, Sarasota, FL, 2CSL Behring, King of Prussia, PA, 3CSL Behring, Vienna, VA, 4CSL Behring, LLC, King of Prussia, PA. RATIONALE: In a 2002 Immune Deficiency Foundation survey, 67% of PIDD patients reported that they could ‘‘feel their IVIG wearing off before the next dose was due’’. We surveyed expert immunologists’ opinions of the prevalence of ‘‘wear-off effects’’ in their practices and how they manage patients experiencing wear-off effects. METHODS: A survey about IgG treatment was sent to 13 immunologists across the USA, who collectively treat nearly 2000 PIDD patients with IgG replacement therapy. RESULTS: When asked what % of the patients in their practices on IVIG ‘‘report a wear-off effect’’, 73% of the immunologists chose 1-25%, 18% chose 26-50% and 9% chose 51-75%. In contrast, in response to the same question about patients on subcutaneous IgG, 64% chose ‘‘none’’, and 36% chose 1-25%. None of the immunologists selected a choice higher than 25% with SCIG. When asked how they manage patients with wear-off effect symptoms, 36% selected ‘‘increase the dose of IVIG’’, 46% selected ‘‘decrease the time between IVIG doses’’, and 55% selected ‘‘recommend SCIG’’ (some selected more than one response). None of the immunologists chose: ‘‘No change in therapy’’. CONCLUSIONS: Expert immunologists, prescribing IgG replacement therapy for an average of 152 PIDD patients each, answered that the percentage of patients on the IV route of IgG therapy who report ‘‘wear-off effects’’ is significantly higher than the percentage of patients on subcutaneous therapy who report such effects. Fifty-five % of the immunologists reported that they recommend subcutaneous therapy as a way of managing ‘‘wear-off’’ effects in PIDD patients on IVIG therapy.