Rituximab in the Treatment of Patients With Bullous Pemphigoid

Summary

This study will determine the safety of treatment of bullous pemphigoid in patients resistant to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.

Timeline

Start

2005-03

Primary completion

2010-03

Completion

2010-03

Publications

• Background Anolik JH, Campbell D, Felgar RE, Young F, Sanz I, Rosenblatt J, Looney RJ. The relationship of FcgammaRIIIa genotype to degree of B cell depletion by rituximab in the treatment of systemic lupus erythematosus. Arthritis Rheum. 2003 Feb;48(2):455-9. doi: 10.1002/art.10764.
• Background Gupta N, Kavuru S, Patel D, Janson D, Driscoll N, Ahmed S, Rai KR. Rituximab-based chemotherapy for steroid-refractory autoimmune hemolytic anemia of chronic lymphocytic leukemia. Leukemia. 2002 Oct;16(10):2092-5. doi: 10.1038/sj.leu.2402676.
• Background Leandro MJ, Edwards JC, Cambridge G. Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion. Ann Rheum Dis. 2002 Oct;61(10):883-8. doi: 10.1136/ard.61.10.883.
• Background Maloney DG, Grillo-Lopez AJ, Bodkin DJ, White CA, Liles TM, Royston I, Varns C, Rosenberg J, Levy R. IDEC-C2B8: results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J Clin Oncol. 1997 Oct;15(10):3266-74. doi: 10.1200/JCO.1997.15.10.3266.
• Background McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
• Background Pestronk A, Florence J, Miller T, Choksi R, Al-Lozi MT, Levine TD. Treatment of IgM antibody associated polyneuropathies using rituximab. J Neurol Neurosurg Psychiatry. 2003 Apr;74(4):485-9. doi: 10.1136/jnnp.74.4.485.
• Background Piro LD, White CA, Grillo-Lopez AJ, Janakiraman N, Saven A, Beck TM, Varns C, Shuey S, Czuczman M, Lynch JW, Kolitz JE, Jain V. Extended Rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol. 1999 Jun;10(6):655-61. doi: 10.1023/a:1008389119525.
• Background Reff ME, Carner K, Chambers KS, Chinn PC, Leonard JE, Raab R, Newman RA, Hanna N, Anderson DR. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood. 1994 Jan 15;83(2):435-45.
• Background Stasi R, Pagano A, Stipa E, Amadori S. Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura. Blood. 2001 Aug 15;98(4):952-7. doi: 10.1182/blood.v98.4.952.
• Background Stasi R, Stipa E, Forte V, Meo P, Amadori S. Variable patterns of response to rituximab treatment in adults with chronic idiopathic thrombocytopenic purpura. Blood. 2002 May 15;99(10):3872-3. doi: 10.1182/blood-2002-02-0392. No abstract available.
• Background Zaja F, Iacona I, Masolini P, Russo D, Sperotto A, Prosdocimo S, Patriarca F, de Vita S, Regazzi M, Baccarani M, Fanin R. B-cell depletion with rituximab as treatment for immune hemolytic anemia and chronic thrombocytopenia. Haematologica. 2002 Feb;87(2):189-95.
• Background Bernard P, Bedane C, Bonnetblanc JM. Anti-BP180 autoantibodies as a marker of poor prognosis in bullous pemphigoid: a cohort analysis of 94 elderly patients. Br J Dermatol. 1997 May;136(5):694-8.
• Background Cooper HL, Healy E, Theaker JM, Friedmann PS. Treatment of resistant pemphigus vulgaris with an anti-CD20 monoclonal antibody (Rituximab). Clin Exp Dermatol. 2003 Jul;28(4):366-8. doi: 10.1046/j.1365-2230.2003.01283.x.
• Background Diaz LA, Ratrie H 3rd, Saunders WS, Futamura S, Squiquera HL, Anhalt GJ, Giudice GJ. Isolation of a human epidermal cDNA corresponding to the 180-kD autoantigen recognized by bullous pemphigoid and herpes gestationis sera. Immunolocalization of this protein to the hemidesmosome. J Clin Invest. 1990 Oct;86(4):1088-94. doi: 10.1172/JCI114812.
• Background Dupuy A, Viguier M, Bedane C, Cordoliani F, Blaise S, Aucouturier F, Bonnetblanc JM, Morel P, Dubertret L, Bachelez H. Treatment of refractory pemphigus vulgaris with rituximab (anti-CD20 monoclonal antibody). Arch Dermatol. 2004 Jan;140(1):91-6. doi: 10.1001/archderm.140.1.91.
• Background Giudice GJ, Liu Z, Diaz LA. An animal model of bullous pemphigoid: what can it teach us? Proc Assoc Am Physicians. 1995 Jul;107(2):237-41.
• Background Goebeler M, Herzog S, Brocker EB, Zillikens D. Rapid response of treatment-resistant pemphigus foliaceus to the anti-CD20 antibody rituximab. Br J Dermatol. 2003 Oct;149(4):899-901. doi: 10.1046/j.1365-2133.2003.05580.x. No abstract available.
• Background Herrmann G, Hunzelmann N, Engert A. Treatment of pemphigus vulgaris with anti-CD20 monoclonal antibody (rituximab). Br J Dermatol. 2003 Mar;148(3):602-3. doi: 10.1046/j.1365-2133.2003.05209_10.x. No abstract available.
• Background Khumalo NP, Murrell DF, Wojnarowska F, Kirtschig G. A systematic review of treatments for bullous pemphigoid. Arch Dermatol. 2002 Mar;138(3):385-9. doi: 10.1001/archderm.138.3.385.
• Background Korman NJ. Bullous pemphigoid. The latest in diagnosis, prognosis, and therapy. Arch Dermatol. 1998 Sep;134(9):1137-41. doi: 10.1001/archderm.134.9.1137. No abstract available.
• Background Liu Z, Diaz LA, Troy JL, Taylor AF, Emery DJ, Fairley JA, Giudice GJ. A passive transfer model of the organ-specific autoimmune disease, bullous pemphigoid, using antibodies generated against the hemidesmosomal antigen, BP180. J Clin Invest. 1993 Nov;92(5):2480-8. doi: 10.1172/JCI116856.
• Background Nousari HC, Anhalt GJ. Pemphigus and bullous pemphigoid. Lancet. 1999 Aug 21;354(9179):667-72. doi: 10.1016/S0140-6736(99)03007-X.
• Background Roujeau JC, Lok C, Bastuji-Garin S, Mhalla S, Enginger V, Bernard P. High risk of death in elderly patients with extensive bullous pemphigoid. Arch Dermatol. 1998 Apr;134(4):465-9. doi: 10.1001/archderm.134.4.465.
• Background Rzany B, Partscht K, Jung M, Kippes W, Mecking D, Baima B, Prudlo C, Pawelczyk B, Messmer EM, Schuhmann M, Sinkgraven R, Buchner L, Budinger L, Pfeiffer C, Sticherling M, Hertl M, Kaiser HW, Meurer M, Zillikens D, Messer G. Risk factors for lethal outcome in patients with bullous pemphigoid: low serum albumin level, high dosage of glucocorticosteroids, and old age. Arch Dermatol. 2002 Jul;138(7):903-8. doi: 10.1001/archderm.138.7.903.
• Background Salopek TG, Logsetty S, Tredget EE. Anti-CD20 chimeric monoclonal antibody (rituximab) for the treatment of recalcitrant, life-threatening pemphigus vulgaris with implications in the pathogenesis of the disorder. J Am Acad Dermatol. 2002 Nov;47(5):785-8. doi: 10.1067/mjd.2002.126273.
• Background Stanley JR, Hawley-Nelson P, Yuspa SH, Shevach EM, Katz SI. Characterization of bullous pemphigoid antigen: a unique basement membrane protein of stratified squamous epithelia. Cell. 1981 Jun;24(3):897-903. doi: 10.1016/0092-8674(81)90115-x. No abstract available.
• Background Szabolcs P, Reese M, Yancey KB, Hall RP, Kurtzberg J. Combination treatment of bullous pemphigoid with anti-CD20 and anti-CD25 antibodies in a patient with chronic graft-versus-host disease. Bone Marrow Transplant. 2002 Sep;30(5):327-9. doi: 10.1038/sj.bmt.1703654.
• Background Venning VA, Wojnarowska F. Lack of predictive factors for the clinical course of bullous pemphigoid. J Am Acad Dermatol. 1992 Apr;26(4):585-9. doi: 10.1016/0190-9622(92)70085-t.
• Background Gault MH, Purchase L. Would decreased aluminum ingestion reduce the incidence of Alzheimer's disease? CMAJ. 1992 Sep 15;147(6):845-7. No abstract available.
• Background Wojnarowska F, Kirtschig G, Highet AS, Venning VA, Khumalo NP; British Association of Dermatologists. Guidelines for the management of bullous pemphigoid. Br J Dermatol. 2002 Aug;147(2):214-21. doi: 10.1046/j.1365-2133.2002.04835.x.

Drugs

Indications