According to a new randomized trial, adding rituximab to a standard immunosuppressive regimen failed to increase the overall response rate for patients with lupus nephritis.

Currently, the treatments available for nephritis have proven inadequate, and almost half of patients with systemic lupus erythematosus end up developing nephritis.

According to Brad H. Rovin, MD, Ohio State University in Columbus, and colleagues, the at one year, the rates of combined complete and partial response for patients receiving rituximab and those with the placebo were 56.9% and 45.8%.

The majority of the difference between the two groups was in the partial response rates. These response rates were 30.6% and 15.3%, according to investigators who reported this in April’s Arthritis & Rheumatism.

There were 144 patients with class 3 or 4 nephritis enrolled in a one year study randomizing them to mycophenolate mofetil (CellCept) in doses up to 3g per day plus oral prednisone. For the first 16 days, prednisone was given up to 60mg per day, and then weaned below 10mg per day.

For patients who were randomized to rituximab, they received 1g intravenously on days 1 and 15, and then again at weeks 24 and 26. The investigators conducted a second assessment at week 78, for post-treatment effects.

The complete response rates were seen in 26.4% of the rituximab group and 30.6% in the placebo group after 52 weeks of treatment. Of the two groups, respectively no response was seen in 43.1% and 54.2%.

For the partial responders, one patient receiving the placebo and seven patients receiving the rituximab had complete resolution of proteinuria. At 1 year the responses were generally similar between the groups, and complete or partial response in proteinuria was seen in 56.9% of the placebo patients and 66.7% of the rituximab group.

Six months later, the rituximab group’s proteinuria response rate rose to 73.6%, however the level in the placebo patients stayed at the same level.

The researchers found that this study suggests “a longer duration of observation may be necessary to understand the full impact of rituximab therapy.”

Serious adverse events were higher in the placebo group (743.3 per 100 patient years compared to 42.9 in the rituximab group). Two deaths did occur in the group of patients treated with rituximab, however neither were considered treatment related.

Researchers concluded that there is a need for further examination of the potential role for rituximab in certain subsets of patients with lupus nephritis.

Source:

Rovin B, et al "Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the lupus nephritis assessment with rituximab study" Arthritis Rheum 2012; 64: 1215-1226.

The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).

Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Omontys is administered as a once-a-month injection.

“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”

Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.

The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension) and joint, back, leg or arm pain (arthralgia).

Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.

The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data.

Omontys is marketed by Affymax Inc. of Palo Alto, Calif.

Source: FDA Press Release

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