A phase II study of Rituximab in rheumatoid arthritis patients with recurrent disease following haematopoietic stem cell transplantation.

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Bone Marrow Transplant. 2004 Jul 5

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 [PubMed - as supplied by publisher]