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Blood, 15 July 2006, Vol. 108, No. 2, pp. 756-762.
Prepublished online as a Blood First Edition Paper on March 21, 2006; DOI 10.1182/blood-2006-01-0233.
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TRANSPLANTATION
Rituximab for steroid-refractory chronic graft-versus-host disease
Corey Cutler,
David Miklos,
Haesook T. Kim,
Nathaniel Treister,
Sook-Bin Woo,
Don Bienfang,
Lloyd B. Klickstein,
Jesse Levin,
Katherine Miller,
Carol Reynolds,
Rebecca Macdonell,
Mildred Pasek,
Stephanie J. Lee,
Vincent Ho,
Robert Soiffer,
Joseph H. Antin,
Jerome Ritz, and
Edwin Alyea
From the Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA; the Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA; the Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA; the Department of Ophthalmology, Brigham and Women's Hospital, Boston, MA; the Department of Rheumatology, Brigham and Women's Hospital, Boston, MA; and the Department of Medicine, Stanford University, Palo Alto, CA.
B cells may be implicated in the pathophysiology of chronic graft-versus-host disease (GVHD), as evidenced by antibody production against sex-mismatched, Y chromosome–encoded minor HLA antigens in association with chronic GVHD. We therefore designed a phase 1/2 study of anti–B-cell therapy with rituximab in steroid-refractory chronic GVHD. Twenty-one patients were treated with 38 cycles of rituximab. Rituximab was tolerated well, and toxicity was limited to infectious events. The clinical response rate was 70%, including 2 patients with complete responses. Responses were limited to patients with cutaneous and musculoskeletal manifestations of chronic GVHD and were durable through 1 year after therapy. The median dose of prednisone among treated subjects fell from 40 mg/day to 10 mg/day, 1 year after rituximab therapy (P < .001). A chronic GVHD symptom score improved in the majority of treated patients. Antibody titers against Y chromosome–encoded minor HLA antigens fell and remained low, whereas titers against infectious antigens (EBV, tetanus) remained stable or rose during the treatment period. We conclude that specific anti–B-cell therapy with rituximab may be beneficial for patients with steroidrefractory chronic GVHD. This trial was registered at www.clinicaltrials.gov as #NCT00136396
[ClinicalTrials.gov]
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