A phase II study of rituximab in RA patients following haematopoietic stem cell transplantation

July 7, 2004

Bone Marrow Transplant. 2004 Jul 5 [Epub ahead of print]

A phase II study of Rituximab in rheumatoid arthritis patients with

recurrent disease following haematopoietic stem cell transplantation.

J, Ma D, Will R, Cannell P, Handel M, Milliken S.

1Haematology Department, St s Hospital, Sydney, NSW, Australia.

Summary:Haematopoietic stem cell transplantation (HSCT) has been used

recently as an effective therapy in patients with resistant rheumatoid

arthritis (RA). Although disease control occurs in the majority of

cases, recurrence is common, often coinciding with B-cell

reconstitution. We hypothesized that Rituximab, a monoclonal anti-CD20

antibody, would have activity in this group of patients. We treated 10

RA patients (8F:2M, median age 46.5 years), who had recurrent disease

post HSCT. All patients received two doses of Rituximab 1 g, 2 weeks

apart with no major adverse sequelae and were followed for 12 months. A

total of eight out of 10 patients experienced major clinical responses

as measured by the American College of Rheumatology (ACR) criteria, with

50-70% improvement in disease parameters. Responses were equivalent to

previous responses attained with HSCT. Disease responses were maximal at

4-8 months post Rituximab and correlated with B-cell lymphopenia and a

reduction of rheumatoid factor titre. Disease recurrence occurred in 6/9

responders within 12 months and four patients were subsequently

retreated, with major responses again attained. This study provides

further evidence that B-cell depletion leads to a significant

improvement in disease activity in patients with severe RA and provides

data for future trials of HSCT and Rituximab therapy.Bone Marrow

Transplantation advance online publication, 5 July 2004;

doi:10.1038/sj.bmt.1704570

PMID: 15235579

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