title: Inolimomab in steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplantation: retrospective analysis and comparison with other interleukin-2 receptor antibodies.
abstract: BACKGROUND
  The use of monoclonal antibodies against interleukin-2 receptor (IL-2R)-alpha chains could be an effective treatment of acute graft-versus-host disease (GvHD). Experimental model and clinical studies have reported various results.
  
  
  METHODS
  Inolimomab is a murine anti-IL-2R. Eighty-five patients were evaluated retrospectively for the safety and efficacy of inolimomab given for the treatment of steroid-resistant acute GvHD (aGvHD) following allogeneic hematopoietic stem cell transplantation (HSCT). Diseases were immune deficiency, hematological malignancies, or solid tumors. Seventy-six percent of the patients received a myeloablative regimen. The source of HSCT was bone marrow for 45 patients, peripheral blood for 36 patients, and cord blood for 4 patients. Donors were 49 siblings and 36 unrelated. Acute GvHD was diagnosed within a median of 28 days after transplantation (grade II, 26 patients; grade III, 26 patients; grade IV, 33 patients). Inolimomab was administered in the event of steroid-resistant aGvHD with a median dose of 0.468 mg per kg (median period of treatment: 18 days).
  
  
  RESULTS
  Twenty-five complete responses and 29 partial responses (total response rate: 63%) were observed with no side effects. There was no correlation between aGvHD grading and quality of response. Better responses were observed in cutaneous aGvHD. The overall survival probability was 26% (median follow-up: 20 months). Fifty-seven percent of patients died of toxicity related mortality, mostly aGvHD. Response to inolimomab seemed sustained (11% relapse in responders).
  
  
  CONCLUSIONS
  Inolimomab is well-tolerated and effective for severe steroid-resistant aGvHD. The optimum regimen remains to be defined.
authors.affiliation: Unité de transplantation médullaire, Centre Jean Perrin, Clermont-Ferrand, France. Olivier.bay@cjp.fr
authors.forename: Jacques-Olivier
authors.initials: JO
authors.lastname: Bay
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dhédin
authors.forename: Martin
authors.initials: M
authors.lastname: Goerner
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Vannier
authors.forename: Aude
authors.initials: A
authors.lastname: Marie-Cardine
authors.forename: Aspasia
authors.initials: A
authors.lastname: Stamatoullas
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Jouet
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Yakoub-Agha
authors.forename: Reza
authors.initials: R
authors.lastname: Tabrizi
authors.forename: Catherine
authors.initials: C
authors.lastname: Faucher
authors.forename: Jose-Luis
authors.initials: JL
authors.lastname: Diez-Martin
authors.forename: Gomez
authors.initials: G
authors.lastname: Nunez
authors.forename: Rocio
authors.initials: R
authors.lastname: Parody
authors.forename: Noël
authors.initials: N
authors.lastname: Milpied
authors.forename: Helène
authors.initials: H
authors.lastname: Espérou
authors.forename: Frédéric
authors.initials: F
authors.lastname: Garban
authors.forename: Claire
authors.initials: C
authors.lastname: Galambrun
authors.forename: Fabrice
authors.initials: F
authors.lastname: Kwiatkovski
authors.forename: Isabelle
authors.initials: I
authors.lastname: Darlavoix
authors.forename: Amina
authors.initials: A
authors.lastname: Zinaï
authors.forename: Alain
authors.initials: A
authors.lastname: Fischer
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Vernant
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006086:Graft vs Host Disease / Q000276:immunology* / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007167:Immunotherapy; D007223:Infant; D008297:Male; D008875:Middle Aged; D015375:Receptors, Interleukin-2 / Q000276:immunology*; D012189:Retrospective Studies; D015996:Survival Rate; D014184:Transplantation, Homologous
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D015375:Receptors, Interleukin-2; C079843:inolimomab