Counseling Points - December 2008 - (Page 6)

significantly more patients in both golimumab plus methotrexate cohorts (61.3%) achieved an ACR20 response at 16 weeks compared with the placebo-plusmethotrexate group (37.1%, P=0.010).7 Individuals who received golimumab demonstrated a clinical response as early as week 2 of the study, which was maintained over 52 weeks.7 Across the study population, 85.3% of placebo patients and 86.1% of golimumab patients experienced adverse effects. Most side effects reported were mild or moderate in nature and included nausea, headache, injection-site swelling, and worsening of RA disease activity. Serious adverse events occurred in 8.8% of combined golimumab groups compared with 5.9% in the placebo group. Pneumonia was the most common serious adverse event and occurred in three golimumab patients.7 although infusion reactions are still a concern. The most frequently reported infusion-related events of ocrelizumab include headache, nausea, chills, pyrexia, and dizziness. Ocrelizumab is also being studied as a treatment for lupus, MS, and hematological cancer.1,2 Ofatumumab Ofatumumab is an infusional fully human anti-CD20 antibody manufactured by Genmab and GlaxoSmithKline. It depletes B cells that express CD20, but does so by binding to a different epitope (a localized region on the surface of CD20) than rituximab.1,9 In a phase-2 study of 224 RA patients, the three infusional doses of ofatumumab (300 mg, 700 mg, and 1,000 mg) tested all demonstrated efficacy versus placebo as measured by ACR20 responses. 9 Patients are currently being recruited for several other phase-2 and phase-3 studies for IV and subcutaneous administration of ofatumumab. The compound is also being tested in MS, and, not surprisingly, non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, which are all known B-cell diseases.1,4 Anti-CD20 Drugs B cells initiate and contribute to the inflammatory process of RA by disrupting antigen presentation by T cells and promoting the expression of pro-inflammatory cytokines and autoantibodies.3 CD20 is an antigen that is present on B cells and thought to play a pivotal role in B-cell activation and proliferation.8 Rituximab was the first B-celldepleting agent approved for RA in 2006; it is a chimeric monoclonal antibody that binds complement and induces antibody-dependent cellular cytotoxicity, effectively depleting CD20-expressing B cells.8 Recent clinical trials also have evaluated new agents that bind to CD20. Ocrelizumab A second-generation rituximab-like compound, ocrelizumab is a humanized anti-CD20 monoclonal antibody being developed by Genentech, Biogen Idec, Roche, and, Chugai.1,2 It is given as a single infusion every 6 months and promotes rapid B-cell depletion. Because ocreliziumab works on a slightly different epitope than rituximab, its cytotoxicity profile is decreased and provides better overall B-cell reduction. It has a shorter infusion time than other infusible DMARDs and appears to be fairly well tolerated, B-Lymphocyte Stimulator (BLyS) Inhibitors BLyS is a member of the TNF family that plays a crucial role in maintaining normal B-cell development and homeostasis.1-4 In diseases such as systemic lupus erythematosus (SLE) and RA, as well as other autoimmune disorders, elevated levels of this cytokine are thought to cause production of autoantibodies. Additionally, when overexpressed, BLyS causes B-cell proliferation and immunoglobulin secretion. In RA, BLyS is found in the synovial fluid of joints and is associated with elevated rheumatoid factor (RF) values.1-4 Atacicept Atacicept is a BLyS inhibitor being developed by Merck that is being studied as a treatment for RA. This drug is a recombinant fusion protein that binds to and neutralizes National IV Nurses Day—January 25, 2009 Since 1980, National IV Nurses Day has been designated to recognize the dedication of infusion nurses in their roles in advancing the delivery of quality infusion therapy, promoting research and education, and continually improving outcomes for intravenous therapy patients. The next National IV Nurses Day will be celebrated on January 25, 2009. Many local INS chapters will offer networking and educational opportunities, such as presentations on a variety of topics, including rheumatic diseases. To find out if a local chapter near you is sponsoring upcoming IV Nurses Day activities, please contact your local INS Board Liaison. COUNSELING POINTS™ 6

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Counseling Points - December 2008

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