RESEARCH - Safety of biologic therapy in RA and other autoimmune diseases: focus on rituximab

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Semin Arthritis Rheum. 2009 Feb;38(4):265-80.

Safety of biologic therapy in rheumatoid arthritis and other

autoimmune diseases: focus on rituximab.

Fleischmann RM.

University of Texas Southwestern Medical Center, and Metroplex

Clinical Research Center, Dallas, TX 75235-5360, USA.

OBJECTIVES: To review the safety of biologic agents used to treat

rheumatoid arthritis (RA) and other autoimmune diseases, with a focus

on rituximab.

METHODS: Information was gathered from a search of the PubMed database

and from major congress abstract listings through June 2007.

RESULTS: Rituximab is approved for treating RA in patients with an

inadequate response to TNF inhibitors and is under study in other

indications for RA and other autoimmune disorders. The current safety

profile of rituximab in RA is known from Phase II and III studies

conducted preapproval, treating approximately 750 patients, as well as

from long-term extension studies with repeated therapy. Clinical

trials have established that the most common adverse events are

infusion-associated reactions, seen in 29 to 40% of patients, most of

which are mild to moderate and occur following the first rituximab

infusion, with incidence and severity decreasing with subsequent

infusions. Rates of infections and serious infections to date are

within the range expected for RA patients treated with other biologic

agents, but the longer term effects of B-cell depletion and the

effects of repeated treatment on the risk of infections are uncertain.

Information is limited for rituximab safety in other autoimmune

disorders but current data do not suggest that there is a significant

difference in adverse events from that previously reported.

CONCLUSIONS: Rituximab is an important addition to the

rheumatologist's armamentarium for the treatment of difficult RA and

ongoing trials will determine its utility in other indications for RA

and other autoimmune conditions. The true safety profile of rituximab

will emerge as larger numbers of patients are treated in routine

clinical practice.

PMID: 18336874

http://www.ncbi.nlm.nih.gov/pubmed/18336874

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