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Disclosures

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

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Disclosures

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  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 11:587-592, 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. 11:587-592, 2005

  4. Patient Characteristics, Iyer et al BBMT. 11:587-592 (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)

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