Another Lupus Nephritis study: paving the way for another FDA approved drug for lupus, I hope!

About six months ago, I blogged about a new study for lupus nephritis, which was designed to explore the efficacy of an immunosuppressant drug developed by a Canadian-based pharma company. I was so excited because for the duration of the study, you could remain on Cellcept. Unfortunately, I was ineligible for participation, due to my distance from a testing site, but I hope some of you were able to take part. I'm up for just about anything, as long as I have my beloved Cellcept running through my veins! 

This month, I am pleased to announce yet another lupus nephritis research effort which allows its participants to remain on Cellcept, this time from the folks at Genentech. They have announced the initiation of a Phase II clinical trial investigating the use of Gazyva (obinutuzumab) in patients with lupus nephritis. Details from the press release are below: 

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The aim of the this study is to compare the efficacy and safety of Obinutuzumab plus Mycophenolate, MMF, (also known as Cellcept), with Placebo plus MMF in Class III and IV patients with proliferative lupus nephritis. Lupus nephritis affects approximately 3 out of every 10,000 people. Up to 60% of lupus patients will develop lupus nephritis. (As a member of that 60% who developed lupus nephritis, I am thrilled at the R&D surge in this specific area!

“Lupus nephritis is a serious disease and if not controlled, lupus nephritis can lead to kidney failure,” said Brad Rovin, MD, Head, Division of Nephrology, Ohio State University at The Ohio State University Medical Center. “It is our hope that this trial will demonstrate that obinutuzumab is an efficient and safe treatment option for patients with lupus nephritis.”

Obinutuzumab is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia.

“The initiation of this clinical trial reinforces Genentech’s commitment to finding a treatment for patients with rare diseases, such as lupus nephritis,” said Jeffrey Siegel, MD, Senior Group Medical Director of Immunology, Genentech.

Facts about Lupus Nephritis:
·         The body’s immune system targets it own body tissues with lupus. Lupus nephritis happens when lupus involves the kidneys.
·         For many, the first noticeable symptom of lupus nephritis is the swelling of the legs, ankles and feet, however, the disease may be “silent” and not cause any symptoms. 
·         Kidney damage from lupus can be mild or severe and cause damage to the glomeruli or the filtering units of the kidney.
·         If both kidneys fail, people with lupus nephritis may need dialysis.         
·         About 90 percent of people diagnosed with lupus are women.

Obinutuzumab is currently approved, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia. Visit http://www.gene.com/download/pdf/gazyva_prescribing.pdf for full prescribing information.

Comments

Hannah Eunice said…
I have lupus nephritis. I would love to hear about new medications that would help treat it while staying on cellcept and tapering my prednisone without the risk of always having the protein in my kidney spike up.

Hannah
http://floraful.blogspot.com
BrynnClark said…
Having lupus nephritis, myself...I'm very much interested in following the journey of this through the FDA approval process. As a Canadian, I can assure you that that biggest highlight we've had in pharmaceutical process was the introduction through our own safety approvals for Benlysta, back in 2011 (http://www.huffingtonpost.ca/2011/07/12/benlysta-approval-canada-lupus_n_896542.html) It seems that we follow in the footsteps of other approvals, elsewhere in the world, even when our own Canadian-based companies craft the medications! Frustrating, at best. We also have had issues with insurance coverages, given the percentages of patients who may benefit versus not, from the medications. How is the coverage for these medications in the U.S.? I will definitely be following up any updates you may have in the future as this progresses. Fingers and toes crossed!! *but not my eyes...I'd fall down-go-boom* ;) ~Brynn
Sara Gorman said…
Agreed! I'll continue to share updates as I get them. Thx for stopping by!