I'm prettty sure someone will post this and since I use Rituxan, I thought I would do it first. Let me add that I'm scheduled for my second set of infusions starting the first week in October and this hasn't impacted that decision at all.
| ROCKVILLE, Md., Sept. 11 -- A rheumatoid arthritis patient treated with rituximab (Rituxan) was diagnosed with progressive multifocal leukoencephalopathy (PML) 18 months after taking the last dose of the agent, and later died, the FDA and drugmakers announced today.
It was the first PML-associated death of a patient taking rituximab for RA, according to Genentech and Biogen Idec in a letter to clinicians. The patient, who developed a JC virus infection leading to PML, had been taking the drug in a long-term safety extension clinical study.
"This case was confounded by the patient's development of oropharyngeal cancer, which was treated with chemotherapy (a platinum-containing regimen) and radiation therapy nine months prior to the development of PML," said the letter.
"The patient had longstanding RA treated with immunosuppressants and a complex medical and rheumatologic history including Sjogren's syndrome and undetectable complement C4 levels. Treatment for RA included methotrexate, steroids, and a TNF antagonist prior to Rituxan therapy, and methotrexate and steroids during and after Rituxan therapy."
Rituxan is approved for RA in combination with methotrexate to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderate to severe active disease who have had an inadequate response to one or more TNF antagonists.
The rituximab label was updated to reflect the PML-associated death.
"Physicians treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations," said the letter. "Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated."
In addition to RA, rituximab is approved for patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (NHL) as a single agent, and for the treatment of previously untreated follicular CD20-positive, B-cell NHL in combination with CVP chemotherapy. Rituximab is indicated for the treatment of nonprogressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, following first-line treatment with CVP chemotherapy.
Rituximab is also indicated for previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. |
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The virus is very common in the general population, infecting 70 to 90 percent of humans; most people acquire JCV in childhood or adolescence [1]. It is found in high concentrations in urban sewage worldwide, leading some researchers to suspect contaminated water as a typical route of infection [2].
Minor genetic variations are found consistently in different geographic areas; thus, genetic analysis of JC virus samples has been useful in tracing the history of human migration [3].
The initial site of infection may be the tonsils [4], or possibly the gastrointestinal tract [2]. The virus then remains latent in the gastrointestinal tract [5] and can also infect epithelial cells in the kidneys, where it continues to reproduce, shedding virus particles in the urine.
I'm fine, better than fine....feeling well and very happy with my choice of Rituxan.
Just my opinion though. People will have to decide whether or not this is an acceptable risk/ benefit ratio for themselves. For me, it's not even close. Rituxan has been a wondeful med for treating my RA and I will continue to use it......