Weekly Subcutaneous Efalizumab for the Treatment of Steroid Refractory Graft-Versus-Host Disease of the Skin and Liver

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of acute or chronic cutaneous graft-versus-host disease (GVHD), as
evidenced by an erythematous maculopapular rash which is felt to be clinically
consistent with GVHD

- Pathologic findings from skin biopsy consistent with GVHD

- Sclerodermatous skin changes may be present but will not by themselves be
considered adequate for study enrollment

- Patients with concurrent hepatic GVHD are eligible

- Patients with liver dysfunction are encouraged but not required to undergo
hepatic biopsy in order to document that liver injury is the result of GVHD

- Patients with a pretreatment serum bilirubin ≥ 2.0 mg/dL and biopsy-confirmed
cutaneous GVHD will be assumed to demonstrate hepatic GVHD if no other cause for
the bilirubin elevation can be identified

- Underwent allogeneic hematopoietic stem cell transplantation (peripheral blood stem
cells and/or bone marrow, regardless of the degree of HLA matching) ≥ 30 days prior
to study enrollment

- Steroid refractory disease, defined by 1 of the following criteria:

- Worsening skin or liver disease despite 1 week of treatment with the equivalent
of 1 mg/kg of methylprednisolone

- Failed to achieve a 50% reduction in the body surface area involved by GVHD or a
50% reduction in the total serum bilirubin after 4 weeks of treatment with the
equivalent of at least 0.5 mg/kg of methylprednisolone

- Requires the equivalent of at least 0.5 mg/kg of methylprednisolone to maintain
a response after 8 weeks of steroid therapy

- Progression of cutaneous or hepatic GVHD after a prior history of treatment with
at least 8 weeks of corticosteroids now requiring the reintroduction of
corticosteroids (the equivalent of greater than 10 mg/day of methylprednisolone)

- Not improving or progressing on alternative immunosuppressive agents after prior
steroid refractoriness had been established

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Absolute neutrophil count (ANC) > 1,000/μL

- Platelet count ≥ 20,000/μL

- Serum creatinine ≤ 3.0 mg/dL

- No HIV infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 2 terminal half-lives since prior and no concurrent infliximab, daclizumab,
etanercept, rituximab, antithymocyte globulin (ATG), or denileukin diftitox