title: Alemtuzumab in lung transplantation: an open-label, randomized, prospective single center study.
abstract: Induction therapy with alemtuzumab followed by lower maintenance immunosuppression (IS) has been associated with reduced morbidity and mortality in abdominal and heart transplantation (TX). In the current study, alemtuzumab, in combination with reduced levels of maintenance IS, was compared to thymoglobulin in combination with standard IS. Sixty consecutive patients who underwent lung transplantation (LUTX) at a single center were prospectively randomized in two groups: group A received alemtuzumab in conjunction with reduced doses of tacrolimus, steroids and mycophenolate mofetil. Group B received thymoglobulin in association with standard dose IS. Patient and graft survival, freedom from acute cellular rejection (ACR), lymphocytic bronchiolitis, bronchiolitis obliterans syndrome, kidney function, infectious complications and posttransplant lymphoproliferative disorder were analyzed. Alemtuzumab induction therapy resulted in complete the absence of ACR episodes ≥ A2 within the first year post-TX. The difference to thymoglobulin was significant (alemtuzumab 0 vs. ATG 0.33; p = 0.019). All other factors studied did not show any differences between the two groups. Alemtuzumab induction therapy after LUTX in combination with reduced maintenance IS significantly reduces higher-grade rejection rates. This novel therapeutic agent had no impact on survival, infections rates, kidney function and incidence of malignancies.
authors.affiliation: Department of Thoracic Surgery, Medical University of Vienna, Wien, Austria.
authors.forename: P
authors.initials: P
authors.lastname: Jaksch
authors.forename: J
authors.initials: J
authors.lastname: Ankersmit
authors.forename: A
authors.initials: A
authors.lastname: Scheed
authors.forename: A
authors.initials: A
authors.lastname: Kocher
authors.forename: G
authors.initials: G
authors.lastname: Muraközy
authors.forename: W
authors.initials: W
authors.lastname: Klepetko
authors.forename: G
authors.initials: G
authors.lastname: Lang
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001999:Bronchoscopy; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D016027:Heart Transplantation; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008171:Lung Diseases / Q000601:surgery; D016040:Lung Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab; C512542:thymoglobulin; D009173:Mycophenolic Acid; D016559:Tacrolimus
keywords: Clinical research/practice; immunosuppressive regimens; induction; lung transplantation/pulmonology; lung transplantation: living donor; organ transplantation in general