title: Sparing effect by montelukast treatment for chronic graft versus host disease: a pilot study.
abstract: BACKGROUND
  Chronic graft versus host disease (GvHD) is a major complication after allogeneic stem cell transplantation (SCT), which is usually progression from acute GvHD. Chronic GvHD is the main cause of severe morbidity and mortality in long-term survivors after SCT. The cysteinyl leukotrienes (cysLTs) and eosinophils play an important role in the pathogenesis of GvHD, which is the rationale for the combined use of montelukast (Mk) in the treatment of this illness.
  
  
  METHODS
  Mk was administrated to 19 eligible patients with refractory chronic GvHD, in addition to their standard immunosuppressive regimens. Mk was given orally (10 mg once daily) for a mean period of 10 months (range, 2-21 months). Organ-specific response was determined by the new scoring criteria established by the National Institutes of Health consensus project.
  
  
  RESULTS
  Based on organ involvements endpoints, overall response to the combined therapy with Mk was observed in 15 of 19 (79%) patients. Significant improvement of skin liver and gastrointestinal was observed in 53%, 62%, and 46%, respectively. Generally, Mk was notably beneficial in milder stages of GvHD, which lead to earlier withdrawal of other immunosuppressive agents. Side effects of Mk administration were not documented, nor were cases of relapse of the basic disease.
  
  
  CONCLUSIONS
  Our preliminary prospective investigation supports the potential efficacy of Mk as a safe and toxicity-sparing supplement to standard therapy for patients with chronic GvHD. Future clinical studies are necessary to establish the optimal dose of Mk and its role in the symptomatic and prophylactic treatment of acute and chronic GvHD.
authors.affiliation: Department of Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah Hebrew University Medical Center, Jerusalem, Israel. reuvenor@hadassah.org.il
authors.forename: Reuven
authors.initials: R
authors.lastname: Or
authors.forename: Benjamin
authors.initials: B
authors.lastname: Gesundheit
authors.forename: Igor
authors.initials: I
authors.lastname: Resnick
authors.forename: Menachem
authors.initials: M
authors.lastname: Bitan
authors.forename: Amar
authors.initials: A
authors.lastname: Avraham
authors.forename: Meytal
authors.initials: M
authors.lastname: Avgil
authors.forename: Zadok
authors.initials: Z
authors.lastname: Sacks
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Shapira
mesh_terms: D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002908:Chronic Disease; D003521:Cyclopropanes; D005260:Female; D006086:Graft vs Host Disease / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012189:Retrospective Studies; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast