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Upcoming Biologic Agents for the Treatment of Rheumatic Diseases

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Upcoming Biologic Agents for the Treatment of Rheumatic Diseases

from Current Opinion in Rheumatology

B-Cell-Directed Therapies

Rituximab

Rituximab (anti-CD20 antibody) is a monoclonal antibody that selectively

depletes B cells bearing the CD20 surface marker. Depletion of immature,

mature naïve, and memory B cells occurs through antibody-mediated and

complement-mediated cytotoxicity. Plasma cells do not express CD20;

therefore, immunoglobulin levels are not significantly affected by anti-CD20

treatment. This agent has been used widely in the treatment of B-cell

lymphomas and is currently under study for use in human autoimmune diseases,

especially those diseases characterized by autoantibody production.[78, 79*]

Case reports suggest a possible role for rituximab in refractory WG,[80]

SLE-associated hemolytic anemia,[81] idiopathic thrombocytopenic

purpura,[82] and essential mixed cryoglobulinemia.[83] A phase I,

dose-finding trial of rituximab in SLE is currently underway. Rituximab has

also been shown to be surprisingly effective for the treatment of RA. An

open-label trial of rituximab, administered as four weekly infusions, for

active, refractory RA in five subjects resulted in ACR70 and ACR50 responses

in one patient each and ACR20 responses in two other patients, while only

one patient failed to respond. The clinical improvement occurred within 1 to

2 months of treatment and was maintained for 2 to 10 months after

infusion.[84] Another research group treated 22 patients with various doses

of rituximab in combination with cyclophosphamide and/or high-dose

prednisolone.[85] The subjects tolerated the regimen well, and major

responses were seen in subjects receiving higher doses of rituximab.

Subjects who did not receive cyclophosphamide performed poorly compared with

the cyclophosphamide-treated groups. In a phase II, placebo-controlled,

randomized trial of rituximab in RA, subjects with active RA despite

methotrexate were randomized to one of four treatment groups: methotrexate

and placebo, rituximab alone, rituximab and cyclophosphamide, and rituximab

and methotrexate. The rituximab dose was the same in all groups: two 1-g

infusions. All subjects received a course of corticosteroids (a total of 960

mg over 17 days). Interim results found that ACR20 criteria were met by 58%

treated with rituximab alone, 80% receiving rituximab and continuing

methotrexate, and 84% treated with rituximab and cyclophosphamide, but only

33% of those treated with methotrexate and placebo. The primary outcome,

ACR20 response, was measured at 24 weeks.[86**]

http://www.medscape.com/viewarticle/452882_11

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