Disclosures

1
Disclosures

• Philip L. McCarthy Jr. BMT Program Roswell Park
  Cancer Institute, Buffalo, NY
• Participated in Dor Pharma acute
  Graft-versus-Host Disease (GvHD) Phase III study
  examining beclomethasone diproprionate (BDP)
• Involved in the design of future large chronic
  GvHD study
• Asked by BMC Communications Group, LLC if I would
  speak regarding the RPCI experience with BDP
• Paid for travel myself

2
Iyer et al Long-Term Use of Oral Beclomethasone
Dipropionate (BDP) for the Treatment of
Gastrointestinal (GI) Graft-versus-Host Disease
(GvHD). Biology of Blood and Marrow
Transplantation 11587-592, 2005

• Investigational New Drug (IND) application for
  each patient and cross-referenced originally with
  Enteron IND
• RPCI BMT program interest in BDP use long-term
  for chronic GvHD of the GI tract
• Used BDP as capsule from Enteron as well as
  compounded in corn oil and later in capsules
• BDP was used for the treatment of acute and
  chronic GI GvHD that was refractory to front line
  immunosuppressive therapy (calcineurin inhibitor
  and methylprednisolone 1-2 mg/kg/day or
  equivalent) or unable to wean or tolerate
  steroids without a GI GvHD flare
• BDP used as a systemic steroid-sparing agent

3
Patient Results, Iyer et al BBMT. 11587-592,
2005
4
Patient Characteristics, Iyer et al BBMT.
11587-592 (2005)
5
BDP use at RPCI

• Pharmacy-compounded at present
• We would prefer a standardized formulation that
  would allow for upper and lower GI tract exposure
• We have used BDP in over 30 GI GvHD patients with
  a response (decreased immunosuppression) in
  approximately 60 of patients
• Well tolerated in long-term use
• BDP blunts ACTH stimulation test adrenal response
  but does not have the systemic effects of
  standard steroid therapy
• Is this due to the liver first pass effect with
  metabolites that do not result in symptomatic
  adrenal suppression?
• BDP is the only drug added to steroids for
  upfront therapy of acute GvHD that generates a
  superior outcome. Most immunosuppressive drugs
  added to steroids result in worse or equivalent
  outcomes
• BDP is useful therapy for acute GvHD and
  potentially for chronic GI GvHD (to be studied)