title: A novel triple therapy for ITP using high-dose dexamethasone, low-dose rituximab, and cyclosporine (TT4).
abstract: Promising reports of combination immunosuppression with high-dose dexamethasone and rituximab for the treatment of primary immune thrombocytopenia (ITP) have recently emerged. They suggest a potential to further optimize the efficacy of therapy. We investigate the use of a novel combination of conventional therapies in ITP given over 4 weeks. From 2011 to 2014, 20 patients were prospectively enrolled onto a single-arm phase 2b study to describe the safety, efficacy, and tolerability of oral dexamethasone 40 mg for days 1 to 4, oral cyclosporine 2.5 to 3 mg/kg daily for day 1 to 28, and intravenous low-dose rituximab 100 mg for days 7, 14, 21, and 28. There were no therapy-related serious adverse side effects, 6-month response rate was 60%, and treatment was well tolerated. Responders enjoyed relapse-free survivals of 92% and 76%, respectively, at 12 and 24 months. This study highlights the possibility of achieving an enduring remission from 4 weeks of therapy. This study is registered at www.anzctr.org.au (#ANZCTRN12611000015943).
authors.affiliation: St George Clinical School, University of New South Wales, Kogarah, NSW, Australia; and.
authors.forename: Philip Young-Ill
authors.identifier: http://orcid.org/0000-0001-9340-8125
authors.initials: PY
authors.lastname: Choi
authors.affiliation: Department of Haematology, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Fernando
authors.initials: F
authors.lastname: Roncolato
authors.affiliation: Department of Haematology, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Xavier
authors.initials: X
authors.lastname: Badoux
authors.affiliation: Department of Haematology, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Sundra
authors.initials: S
authors.lastname: Ramanathan
authors.affiliation: Department of Haematology, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Shir-Jing
authors.initials: SJ
authors.lastname: Ho
authors.affiliation: St George Clinical School, University of New South Wales, Kogarah, NSW, Australia; and Department of Haematology, St George Hospital, Kogarah, NSW, Australia.
authors.forename: Beng H
authors.initials: BH
authors.lastname: Chong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D016572:Cyclosporine / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D011446:Prospective Studies; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069283:Rituximab; D015996:Survival Rate; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D058846:Antibodies, Monoclonal, Murine-Derived; D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D000069283:Rituximab; D003907:Dexamethasone; D016572:Cyclosporine