title: Development of cockroach immunotherapy by the Inner-City Asthma Consortium.
abstract: BACKGROUND
  Cockroach allergy is a key contributor to asthma morbidity in children living in urban environments.
  
  
  OBJECTIVE
  We sought to document immune responses to cockroach allergen and provide direction for the development of immunotherapy for cockroach allergy.
  
  
  METHODS
  Four pilot studies were conducted: (1) an open-label study to assess the safety of cockroach sublingual immunotherapy (SLIT) in adults and children; (2) a randomized, double-blind biomarker study of cockroach SLIT versus placebo in adults; (3) a randomized, double-blind biomarker study of 2 doses of cockroach SLIT versus placebo in children; and (4) an open-label safety and biomarker study of cockroach subcutaneous immunotherapy (SCIT) in adults.
  
  
  RESULTS
  The adult SLIT trial (n = 54; age, 18-54 years) found a significantly greater increase in cockroach-specific IgE levels between the active and placebo groups (geometric mean ratio, 1.92; P < .0001) and a trend toward increased cockroach-specific IgG4 levels in actively treated subjects (P = .09) but no evidence of functional blocking antibody response. The pediatric SLIT trial (n = 99; age, 5-17 years) found significant differences in IgE, IgG, and IgG4 responses between both active groups and the placebo group but no consistent differences between the high- and low-dose groups. In the SCIT study the treatment resulted in significant changes from baseline in cockroach IgE, IgG4, and blocking antibody levels. The safety profile of cockroach immunotherapy was reassuring in all studies.
  
  
  CONCLUSIONS
  The administration of cockroach allergen by means of SCIT is immunologically more active than SLIT, especially with regard to IgG4 levels and blocking antibody responses. No safety concerns were raised in any age group. These pilot studies suggest that immunotherapy with cockroach allergen is more likely to be effective with SCIT.
authors.affiliation: Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md. Electronic address: rwood@jhmi.edu.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wood
authors.affiliation: Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
authors.forename: Alkis
authors.initials: A
authors.lastname: Togias
authors.affiliation: Rho Federal Systems Division, Chapel Hill, NC.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Wildfire
authors.affiliation: Rho Federal Systems Division, Chapel Hill, NC.
authors.forename: Cynthia M
authors.initials: CM
authors.lastname: Visness
authors.affiliation: Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Matsui
authors.affiliation: Departments of Medicine and Pediatrics, University of Texas Southwestern Medical School, Dallas, Tex.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Gruchalla
authors.affiliation: Department of Pediatrics, Cincinnati Children's Hospital, Cincinnati, Ohio.
authors.forename: Gurjit
authors.initials: G
authors.lastname: Hershey
authors.affiliation: National Jewish Health and University of Colorado Denver School of Medicine, Denver, Colo.
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Liu
authors.affiliation: Department of Medicine, Boston University School of Medicine, Boston, Mass.
authors.forename: George T
authors.initials: GT
authors.lastname: O'Connor
authors.affiliation: Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: Pongracic
authors.affiliation: Department of Medicine, Henry Ford Health System, Detroit, Mich.
authors.forename: Edward
authors.initials: E
authors.lastname: Zoratti
authors.affiliation: Department of Medicine, Boston University School of Medicine, Boston, Mass.
authors.forename: Frederic
authors.initials: F
authors.lastname: Little
authors.affiliation: Department of Medicine, Boston University School of Medicine, Boston, Mass.
authors.forename: Mark
authors.initials: M
authors.lastname: Granada
authors.affiliation: Rho Federal Systems Division, Chapel Hill, NC.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Kennedy
authors.affiliation: Imperial College, London, United Kingdom.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Durham
authors.affiliation: Imperial College, London, United Kingdom.
authors.forename: Mohamed H
authors.initials: MH
authors.lastname: Shamji
authors.affiliation: Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.
authors.forename: William W
authors.initials: WW
authors.lastname: Busse
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000818:Animals; D001249:Asthma / Q000209:etiology*; D002648:Child; D002675:Child, Preschool; D003058:Cockroaches / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D006801:Humans; D006967:Hypersensitivity / Q000628:therapy*; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008875:Middle Aged; D010865:Pilot Projects
chemical_list: D007074:Immunoglobulin G; D007073:Immunoglobulin E
keywords: Cockroach; immunotherapy; inner city asthma; subcutaneous immunotherapy; sublingual immunotherapy