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    You are here : Home » MS Research News » Drugs » Rituximab (Rituxan)

    Rituximab (Rituxan)

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    Third PML case reported with Rituximab

    RituxanA case of progressive multifocal leukoencephalopathy (PML) has been reported in a rheumatoid arthritis patient taking rituximab (Rituxan) who had not previously received anti-tumor necrosis factor therapy, according to the FDA and the drug’s manufacturer.

    The case is the third seen with rituximab in rheumatoid arthritis, according to a “Dear Healthcare Professional” letter issued by Genentech. The previous two were seen in patients who had received anti-TNF drugs earlier.

    PML causes inflammation in the brain, which has been fatal in about half of patients. It is caused by reactivation of latent JC virus infection, presumably a result of immune suppression.

    Other biologic drugs targeting immune system components have been linked to PML, as well, including natalizumab (Tysabri) and efalizumab (Raptiva).

    Both those drugs were removed from the U.S. market after cases of PML appeared, although natalizumab was later reintroduced with a strict risk evaluation and mitigation strategy. (See Raptiva Yanked from U.S. Market and Tysabri (natalizumab) Allowed Back to Market with Restrictions)

    “Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations,” Genentech’s letter said. “Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.”

    The most recent case involved a 73-year-old woman who had received two doses of rituximab in February 2009. Symptoms developed four to six months later, Genentech said.

    The woman had also taken leflunomide, hydroxychloroquine, and prednisone — but not anti-TNF drugs such as infliximab (Remicade) or Etanercept (Enbrel).

    The letter did not indicate whether she had survived.

    Genentech said about 100,000 rheumatoid arthritis patients have received rituximab, apparently putting the risk much lower than with natalizumab.

    The risk of PML with natalizumab has been estimated at about one case per 1,000 patients receiving the drug for two years.

    Source: Discuss Pharmacy Copyright 2010 Discuss Pharmacy (11/07/10)

    Rituximab add-on therapy for breakthrough relapsing MS: a 52-week phase II trial

    RituximabAbstract

    OBJECTIVE: B cells and the humoral immune system have been implicated in the pathogenesis of multiple sclerosis (MS). This study sought to evaluate the efficacy, safety, and tolerability of add-on therapy with rituximab, a monoclonal antibody that depletes circulating B cells, in subjects with relapsing MS with breakthrough disease defined by clinical and MRI activity (Class III evidence).

    METHODS: Thirty subjects with a relapse within the past 18 months despite use of an injectable disease-modifying agent, and with at least 1 gadolinium-enhancing (GdE) lesion on any of 3 pretreatment MRIs, received rituximab administered at 375 mg/m(2) weekly x 4 doses. Three monthly posttreatment brain MRI scans were obtained beginning 12 weeks after the first infusion. Multiple Sclerosis Functional Composite (MSFC) and Expanded Disability Status Scale (EDSS) were obtained at baseline and throughout the post-treatment follow-up.

    RESULTS: GdE lesions were reduced after treatment with rituximab, with 74% of posttreatment MRI scans being free of GdE activity compared with 26% free of GdE activity at baseline (p < 0.0001). Median GdE lesions were reduced from 1.0 to 0, and mean number was reduced from 2.81 per month to 0.33 after treatment (88% reduction). MSFC improved as well (p = 0.02). EDSS remained stable.

    CONCLUSION: Rituximab add-on therapy was effective based upon blinded radiologic endpoints in this phase II study. In combination with standard injectable therapies, rituximab was well-tolerated with no serious adverse events. B-cell-modulating therapy remains a potential option for treatment of patients with relapsing MS with an inadequate response to standard injectable therapies.

    CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that add-on rituximab reduces gadolinium-enhancing brain lesions in multiple sclerosis.

    Source: Neurology. 2010 Jun 8;74(23):1860-7. & Pubmed PMID: 20530322

    AAN - Rituximab may be an effective treatment for secondary progressive Multiple Sclerosis

    RituxanTargeting B cells implicated in progressive multiple sclerosis with rituximab (Rituxan) therapy might help patients diagnosed with the disease, according to data from a small study reported here.

    "This study shows that rituximab could be an effective treatment in a subgroup of patients with secondary progressive multiple sclerosis," Carolina Ionete, MD, of the University of Massachusetts Medical School in Worcester, wrote in a poster presentation abstract for the annual meeting of the American Academy of Neurology.

    However, Ionete said that before clinicians begin using the monoclonal antibody in patients with multiple sclerosis, a larger scale study will be required.

    Her study scrutinized outcomes in 10 patients who had documented diagnoses of secondary progressive multiple sclerosis without relapses.

    Rituximab targets CD20, a protein expressed on most B cells -- believed to be part of the cascade of molecular events involved in the inappropriate autoimmune functioning that is the hallmark of multiple sclerosis.

    Ionete and colleagues determined to evaluate the clinical response to rituximab in the treatment of secondary progressive multiple sclerosis in a retrospective study that used chart reviews to identify patients who received rituximab for treatment of secondary progressive multiple sclerosis at the UMass medical center.

    All of the patients were treated with intravenous rituximab 1 gram, repeated in two weeks.

    Five patients received a second cycle of rituximab at six months, and five patients did not receive the second cycle. Of the latter group, two had adverse reactions, two did not respond to treatment, and one has still had less than one year of follow-up.

    Ionete reviewed the patients' neurological examination, Expanded Disability Status Scale (EDSS), 25-foot walk, and modified nine-hole peg test which was performed at baseline, and then at three months, six months and 12 months.

    Magnetic resonance imaging scans which recorded new or enlarged T2 lesions and new T1 gadolinium enhancing lesions were collected at baseline and at 12 months.

    The patients who received the second cycle of rituximab at six months showed mean extended disability status scale improvement. Their mean baseline scores were 5.4 on the EDSS, and those scores improved to 4.4 at 12 months (P=0.0032).

    Ionete also observed improvement in times for the 25-foot walk at month 12 in all five patients who received the second cycle at six months. Four out of five patients showed improvement in the modified nine-hole peg test. The mean time to perform the test at baseline was 17.14 sec, which decreased to 13.94 sec at 12 months.

    The researchers did not see changes in the magnetic resonance imaging activity over the 12 month period in any of the patients.

    Ionete disclosed financial relationships with Bayer Healthcare, Teva Neuroscience, EMD Serono and Biogen Idec.

    Other authors disclosed financial relationships with other industry entities including Berlex and Genentech.
     
    Primary source: American Academy of Neurology

    Source reference:
    Ionete C, et al "Rituximab in secondary progressive multiple sclerosis -- one year follow up" AAN 2010; Abstract P02.147.

    Source: Medpage Today © 2004-2010 MedPage Today, LLC(19/04/10)

    Rituximab in patients with primary progressive multiple sclerosis

    RituximabOBJECTIVE: Rituximab, a monoclonal antibody selectively depleting CD20+ B cells, has demonstrated efficacy in reducing disease activity in relapsing-remitting multiple sclerosis (MS). We evaluated rituximab in adults with primary progressive MS (PPMS) through 96 weeks and safety through 122 weeks.

    METHODS: Using 2:1 randomization, 439 PPMS patients received two 1,000mg intravenous rituximab or placebo infusions every 24 weeks, through 96 weeks (4 courses). The primary endpoint was time to confirmed disease progression (CDP), a prespecified increase in Expanded Disability Status Scale sustained for 12 weeks. Secondary endpoints were change from baseline to week 96 in T2 lesion volume and total brain volume on magnetic resonance imaging scans.

    RESULTS: Differences in time to CDP between rituximab and placebo did not reach significance (96-week rates: 38.5% placebo, 30.2% rituximab; p = 0.14). From baseline to week 96, rituximab patients had less (p < 0.001) increase in T2 lesion volume; brain volume change was similar (p = 0.62) to placebo. Subgroup analysis showed time to CDP was delayed in rituximab-treated patients aged <51 years (hazard ratio [HR] = 0.52; p = 0.010), those with gadolinium-enhancing lesions (HR = 0.41; p = 0.007), and those aged <51 years with gadolinium-enhancing lesions (HR = 0.33; p = 0.009) compared with placebo.

    Adverse events were comparable between groups; 16.1% of rituximab and 13.6% of placebo patients reported serious events. Serious infections occurred in 4.5% of rituximab and <1.0% of placebo patients. Infusion-related events, predominantly mild to moderate, were more common with rituximab during the first course, and decreased to rates comparable to placebo on successive courses.

    INTERPRETATION: Although time to CDP between groups was not significant, overall subgroup analyses suggest selective B-cell depletion may affect disease progression in younger patients, particularly those with inflammatory lesions. Ann Neurol 2009;66:460-471.

    Hawker K, O'Connor P, Freedman MS, Calabresi PA, Antel J, Simon J, Hauser S, Waubant E, Vollmer T, Panitch H, Zhang J, Chin P, Smith CH; OLYMPUS trial groupOther investigators who participated in the OLYMPUS Trial Group are listed in the Appendix on page xxx..

    Department of Neurology, The Ohio State University Medical Center, Columbus, OH.

    Source: Pubmed PMID: 19847908 (28/10/09)

    Rituximab may lead to oft-fatal viral brain infection

    Rituxan

    Scientists are concerned that the popular cancer drug, rituximab, may increase a person's chances of acquiring an often fatal viral brain infection, known as progressive multifocal leukoencephalitis (PML), which attacks the brain's white matter.

    The worries about this possible harmful effect of rituximab emerged after MRI brain scans and biopsies were conducted on a 57-year-old lawyer in New York and an 83-year-old woman in Chicago, both of whom had been taking the drug before they developed the brain infection.

    The two patients are currently part of a new study from the Northwestern University Feinberg School of Medicine RADAR project, an international consortium of physicians that collaborate to identify adverse reactions to medications and devices, which is being led by Dr. Charles Bennett.

    Knowing more about the suggested link between rituximab and PML is important because, besides its use as a cancer drug, this medicine is also used for treating rheumatoid arthritis, multiple sclerosis, lupus erythematosus and autoimmune anaemias.

    Bennett has revealed that, from 1997 to 2008, as many as 57 patients with anemia, rheumatoid arthritis or lymphoma developed the fatal brain disease after taking rituximab.

    They died an average of two months after being diagnosed, he said.

    "Rituximab is one of the most prominent drugs in a new class called monoclonal antibodies. It's now the third monoclonal antibody that is associated with PML," added Bennett.

    The researcher points out that the brain infection is often overlooked and undiagnosed because it is so subtle at first.

    "People may think it's early Alzheimer's disease or depression. Many of these patients have cancer and when they die, people assume it's the cancer that killed them," he said.

    He admitted that it was yet to be found out how rituximab is connected to the brain virus and who might be at risk.

    Bennett said that the study results illustrate a need for caution in prescribing rituximab.

    "The drug has tremendous usefulness in lymphoma, but as its use expands to diseases that are not cancer, we might have to reconsider the risk benefit. Some cancer patients take this drug chronically for non-fatal chronic leukemia where the risk-benefit calculations differ from lymphoma," he said.

    He suggested if people on rituximab develop any strange neurological symptoms like forgetfulness, disorientation or mood changes, their doctors should be alerted.

    A research article on the study has been published in the journal Blood.

    Source: AndhraNews.net © 2000-2009 AndhraNews.net (19/05/09)

    Rituxan fails to slow Primary Progressive Multiple Sclerosis

    Rituxan, a top-selling drug from Genentech Inc. and Biogen Idec Inc., failed to slow the course of the most severe form of multiple sclerosis in a large study, the companies said.

    The findings make Rituxan at least the sixth unsuccessful attempt to treat primary-progressive MS, or PPMS. In the U.S., about 35,000 to 40,000 people have primary-progressive MS, out of roughly 350,000 to 400,000 total MS patients.

    There are no approved treatments for PPMS. Genentech and Biogen had hoped that Rituxan -- which is approved for blood cancer and rheumatoid arthritis -- might become the first such treatment. The drug costs about $20,820 a year at the dosage used.

    But in the companies' study, which followed 439 patients for 96 weeks, Rituxan didn't significantly slow the course of the disease, which gradually robs patients of motor function and causes tremors, tingling and fatigue. Secondary results -- like whether Rituxan improved MRI scans of patients' brains -- weren't released.

    "We are disappointed in the outcome of the primary endpoint, but not surprised given the significant clinical challenges presented by PPMS," said Hal Barron, chief medical officer at Genentech, in a statement.

    In a smaller study last year, Rituxan slowed down the less-severe form of MS, which has several approved drugs, including Biogen's Avonex and Tysabri. The companies have disagreed over what to do next. The matter is subject to an arbitration hearing this summer.

    Rituxan is being studied in lupus, another immune-system disease with few treatment options. Genentech has said results may be released within a few weeks.

    Source: The Wall Street Journal Copyright © 2008 Dow Jones & Company, Inc. (15/04/08)

    Cancer drug slows multiple sclerosis progression

    Two shots of the cancer drug Rituxan given two weeks apart slowed the progression of multiple sclerosis for nearly a year, researchers have reported.

    And Rituxan appears to be twice as effective as first-line treatments for MS, which reduce the number of relapses by about a third, the researchers said.

    "It's quite remarkable that the effect was sustained for 48 weeks with just a single course of therapy," said Dr. Stephen Hauser of the University of California at San Francisco, who worked on the study published in the New England Journal of Medicine.

    Multiple sclerosis, which affects as many as 350,000 people in the United States and 2 million worldwide, is apparently caused when the immune system attacks and breaks down the insulation surrounding cells that make up the brain and spinal cord.

    MS symptoms may include blurred vision, loss of balance, poor coordination, extreme fatigue, paralysis and blindness. There is no cure.

    Although no head-to-head comparison has been done, Hauser said Rituxan appears to work better than existing therapies.

    His team tested patients with the relapsing-remitting form of the disease, in which symptoms wax and wane over many years, making it difficult to gauge whether a treatment is really working. They make up about half the patients with MS.

    To assess the progress of the Rituxan treatments, they used magnetic resonance imaging, or MRI, scans to see damage to the nervous system.

    "What was so surprising here is that the effect on MS inflammatory measures was so fast," Hauser said.

    The number of lesions they could see dropped immediately after the two shots.

    Within 12 weeks, there were almost no old or new lesions, while the number of lesions on volunteers who received placebo shots tended to stay the same or increase in number.

    But the drug was not as good at preventing relapses.

    After 48 weeks, 20 percent of the 69 Rituxan recipients had suffered a relapse. That was still much better than the 35 patients who got placebo injections and had a relapse rate of 40 percent.

    CONCERN VOICED
    Rituxan, known generically as rituximab, is made by the biotechnology companies Genentech Inc. and Biogen Idec Inc., which sponsored the study.

    It is approved for non-Hodgkin's lymphoma and rheumatoid arthritis and sold by Roche AG as MabThera outside the United States, Japan and Canada.

    Hauser expressed concern that, based on the new results, doctors may begin using the drug on their MS patients even though it has not been approved for that use.

    "This trial was not designed to assess long-term safety or to detect uncommon adverse events," the researchers wrote.

    "It would be a tragedy if the drug were to get dinged because of a side effect in a patient that shouldn't have received the drug," he said.

    The research has also given doctors a better idea of what causes MS, according to Hauser. Rituxan is a monoclonal antibody, a genetically engineered immune system protein, that attacks immune cells called B cells.

    "This study has taught us that B cells are absolutely essential to the genesis of inflammatory attacks in multiple sclerosis," Hauser said.

    Source: guardian.co.uk © Guardian News and Media Limited 2008 (14/02/08)

    Rituximab in Adults With Relapsing-Remitting Multiple Sclerosis
    A single course of rituximab is safe and well tolerated, and compared with placebo, significantly reduces magnetic resonance imaging (MRI) and clinical evidence of inflammatory activity in patients with relapsing-remitting multiple sclerosis (RRMS), according to a multicenter, randomized, placebo-controlled, phase 2 trial.

    The findings were presented here on October 13 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

    "For a decade or more, people have mostly looked at treatment that affects T cells in MS, although within the past 10 years there has actually been increased interest in B cells and their products," said principal investigator Emmanuelle Waubant, MD, PhD, Associate Professor of Neurology, Department of Neurology, University of California at San Francisco, San Francisco, California.

    Past research has shown that the action of the genetically-engineered chimeric monoclonal anti-CD20 antibody rituximab, in its depletion of pre-B and B cells via binding to their CD20 antigen, could provide an alternative approach in the modulation of MS pathophysiology.

    "So this is a proof-of-concept study, to determine whether, in human MS, targeting B cells has an impact on the course of the disease," Dr. Waubant said. The design aim was to evaluate the safety and efficacy of a single treatment cycle of rituximab over 48 weeks in patients with RRMS.

    Study subjects were 18 to 55 years old and had a confirmed diagnosis of MS, at least one relapse in the previous year, and an expanded disability status scale (EDSS) score of 0 to 5. They were excluded if they had secondary progressive, primary progressive or progressive-relapsing MS, and patients who had received various previous treatments were also excluded.

    The 104 patients with RRMS enrolled were randomized to placebo (n = 35; mean age, 41.5 years; male, 17.1%) or rituximab 1,000 mg IV infusion on days 1 and 15 (n = 69; mean age, 39.6 years; male, 24.6%).

    The primary endpoint was the total number of Gd-enhancing T1 brain lesions on serial MRI scans at weeks 12, 16, 20 and 24. A series of exploratory efficacy outcome measures were used as secondary endpoints: proportion of patients relapsing; annualized relapse rate; total number of new Gd-enhancing T1 lesions; and annualized relapse rate and T2 lesion volume change.

    Baseline clinical characteristics between placebo and rituximab treatment groups were essentially the same with respect to number of relapses in the previous year (about 75% of patients had one relapse), mean EDSS score (2.7 vs 2.8, respectively), MS therapy in the previous 2 years (generally glatiramer acetate, interferon beta-1a and methylprednisone), and lesion counts and volumes.

    When compared with the placebo group, rituximab treatment satisfied the primary endpoint, with a significant 91% reduction in mean total Gd-enhancing lesion counts at weeks 12, 16, 20 and 24 (5.5 vs 0.5, respectively; P <.001). Significance was reached at week 12 (P =.003) and continued through the full 48 weeks of monitoring (P <.0001).

    For the secondary endpoints, rituximab significantly reduced the number of new Gd-enhancing lesions at weeks 12, 16, 20 and 24, as compared with placebo (P <.001). From week 12, rituximab significantly reduced the number of new Gd-enhancing lesions at each assessment (P =.002 to <.001).

    Rituximab treatment also showed a trend in these patients towards lower annualized relapse rates that reached significance compared with placebo by week 24 (0.84 vs 0.37, respectively; P =.04), although this significance did not carry through to week 48.

    For the safety assessments, while all other safety aspects examined were the same across the treatment groups, after the first infusion there were significantly greater infusion-associated adverse events with rituximab than placebo (78.3% vs 40.0%, respectively). However, this effect was reversed after the second infusion (40.0% vs. 20.9%, respectively).

    Overall, rituximab was safe, well tolerated and efficacious through the full 48 weeks of followup.

    "We demonstrate a very rapid effect of depletion of B cells on the course of MS, measured by MRI, and clinical course, which suggests that it is probably not an effect that is promoted by interfering with the antibodies or immunoglobulin in MS, but it's more likely to be through B cells and their direct cellular effects on T cells and cytokines," Dr. Waubant indicated.

    Funding for this study was provided by Genentech Inc.

    Source: Presentation title: Safety and Efficacy of Rituximab in Adults With Relapsing-Remitting Multiple Sclerosis: Results of a Phase 2, Placebo-Controlled, Multicentre Trial Through 48 Weeks. Abstract P554 (18/10/07)

    New Drug Reduces Disease Activity In Multiple Sclerosis, Investigation Suggests
    A new drug under investigation shows a reduction in disease activity in multiple sclerosis (MS), according to two studies. The drug reduced disease activity as indicated by MRI scans.

    Both of the studies involved people with the relapsing-remitting form of MS, where symptoms flare up and then subside. By 24 weeks, treatment with the drug rituximab reduced the number of areas of brain damage, or lesions, in people with MS and the number of relapses, or times when symptoms flare up, when compared with placebo.

    Rituximab is a therapeutic antibody that selectively targets and depletes a subset of immune cells called B-cells by targeting a specific protein on their surface.

    "This is the first drug to target B-cells and may represent a potential new treatment strategy for relapsing-remitting MS," said study author Stephen Hauser, MD, of the University of California, San Francisco, and a member of the American Academy of Neurology. "While these are early stage clinical trials, these results are exciting, because the current drugs available for MS are only partially effective in reducing disease activity and preventing exacerbations. New and more effective treatments for MS are sorely needed, especially for people who do not adequately respond to currently available medications. These data are also important because they demonstrate that B-cells, which are the precursors of antibody-producing cells, play an essential role in mediating relapses of MS."

    In the first study, a randomised, placebo-controlled trial, 69 people were given two infusions of rituximab two weeks apart and 35 were given a placebo. The participants were followed for six months. Those given rituximab had approximately 90 percent fewer brain lesions than those given placebo. During the six-month period, 58 percent fewer of those taking the drug had relapses than those taking placebo; 14.5 percent of the rituximab patients experienced at least one relapse during the six-month period, compared to 34.3 percent of the patients receiving a placebo.

    "Treatment with rituximab was generally safe and well-tolerated in the study," Hauser said. With the exception of infusion-associated adverse events, the rates of adverse events and serious adverse events were comparable between those taking rituximab and those taking placebo. Although there were more first infusion-associated adverse events with rituximab, the majority of adverse events resolved with appropriate medical treatment. The overall rates of infection were also comparable with rituximab and placebo.

    In the second study, an uncontrolled open label trial, 26 people received two infusions of rituximab two weeks apart (one course of treatment) and then another treatment course six months later. Patients were followed for a total of at least one year. Though a placebo group was not included in this safety study, brain lesions were reduced by more than 90 percent and the relapse rate was reduced from an average of at least one per patient per year to only a few for the entire group over the year of treatment. Side effects were limited to mild to moderate reactions to the drug infusion, according to study author Amit Bar-Or, MD, of the Montreal Neurological Institute at McGill University in Montreal, Canada, and a member of the American Academy of Neurology.

    Both studies were supported by Genentech, Inc., and Biogen Idec., the companies marketing the drug in the United States. The drug is currently approved for use with certain types of lymphoma and for a moderate to severe form of rheumatoid arthritis; it is not approved for use in multiple sclerosis.

    Rituximab has been associated with fatal infusion reactions, tumor lysis syndrome, progressive multifocal leukoencephalopathy, renal toxicity, and other adverse effects.

    The findings were presented at the American Academy of Neurology's 59th Annual Meeting in Boston, April 28 -- May 5, 2007.

    Source: American Academy of Neurology.(02/05/07)

    Biogen issues alert after 2 Rituxan deaths
    Biogen Idec Inc. said yesterday that two patients using its drug Rituxan have died of a rare brain infection, the same one that shadows its multiple sclerosis treatment Tysabri.

    In a letter sent to doctors, Biogen and Genentech Inc., which co-markets Rituxan with the Cambridge drug maker, warned that the two patients had contracted fatal progressive multifocal leukoencephalopathy, or PML.

    Both patients were being treated for lupus, a disease in which Rituxan use is still considered experimental.

    The drug is approved only for use in rheumatoid arthritis and non-Hodgkin's lymphoma , a form of blood cancer, but doctors are allowed to prescribe it for other diseases at their discretion.

    In a posting on its website, the Food and Drug Administration said it was looking into the deaths.

    "The FDA is working to gather more information about Rituxan and PML and to strengthen the warnings about PML in the Rituxan product label," the agency said.

    The FDA warned doctors who prescribe Rituxan to be on the lookout for PML symptoms, which include dizziness, difficulty talking, and vision problems.

    The disease, a viral brain infection that is usually fatal, strikes patients with compromised immune systems.

    Last year, Biogen Idec withdrew Tysabri from the market shortly after its introduction, after three cases of PML were reported and two of the patients died. After a Food and Drug Administration hearing, the company brought Tysabri back to the market earlier this year.

    Rituxan is one of the biggest-selling biotechnology drugs in the world, generating $1.8 billion in sales in 2005.

    Biogen Idec recorded $709 million of that revenue, making Rituxan its second-biggest seller, after the multiple sclerosis treatment Avonex. Rituxan was discovered by Biogen Idec.

    In a "Dear Healthcare Provider" letter posted yesterday on Genentech's website, the companies also said 23 cases of PML had been reported in blood-cancer patients taking Rituxan. The label for Rituxan already includes a warning about PML in those cases.

    "This is the first time we've seen it outside the oncology setting," said Biogen Idec spokesman Tim Hunt. "We want to alert the prescribing public that it's been observed."

    Both Rituxan and Tysabri are antibodies, a complex molecule modeled on a component of the human immune system.

    Hunt said Biogen Idec didn't believe there was a link between the PML cases in Tysabri and Rituxan patients.

    "I think the reality is, you see PML with a lot of patient populations," he said.

    Hunt said PML is also seen in cancer and lupus patients not undergoing Rituxan treatment.

    Rituxan is currently in clinical testing on patients with lupus, multiple sclerosis, and cancer. In addition to revising the label, the makers will obtain renewed consent forms from patients currently in Rituxan clinical trials. The patients who died were not in a clinical trial.

    Source: The New York Times © 2006 The New York Times Company(19/12/06)

    Genentech, Biogen say cancer drug helps against MS
    Biotechnology companies Genentech Inc. and Biogen Idec Inc. said on Monday cancer drug Rituxan was successful at treating multiple sclerosis in a midstage trial.

    The Food and Drug Administration originally approved the drug in 1997 for the treatment of cancer. It was developed by Cambridge, Mass-based Biogen and is co-marketed with South San Francisco, Calif-based Genentech in the United States.

    The companies said the treatment reached its primary endpoint in reducing the number of gadolinium enhancing T1 lesions, or indicators of relapsing forms of MS, in a 104-patient study. The clinical trial compared Rituxan to a placebo and took place over 24 weeks.

    Patients involved in the study will be followed for an additional 48 weeks as the companies monitor the long-term safety affects of the treatment.

    Genentech and Biogen Idec said they will continue to analyse the study results and will submit the data for presentation at an upcoming medical meeting.

    "These initial results exceeded our expectations," said Hal Barron, Genentech senior vice president, development, and chief medical officer.

    Source: Yahoo News Copyright © 2006 Reuters Limited. & Kipflinger Forecasts.com © 2006 The Kiplinger Washington Editors, Inc(28/08/06)

    UT Southwestern lead site for study of a new multiple sclerosis drug

    UT Southwestern Medical Center is the lead research site testing a new treatment for a rare form of Multiple Sclerosis.

    Called "primary progressive" this type of MS affects about 15 percent of patients with the neurodegenerative disease. "There really hasn't been a lot of research or treatment options for patients with this form of MS," said Dr. Kathleen Hawker, assistant professor of neurology, who is heading up the clinical investigation. UT Southwestern researchers are testing Rituxan – a therapeutic monoclonal antibody approved by the Food and Drug Administration in 1997 for treating some forms of cancer. "It's an exciting study and the patients are really enthusiastic about this," Dr. Hawker said.

    The primary progressive form of MS is characterized by a slow, steady onset, usually beginning with walking difficulties and steadily worsening with motor dysfunctions and increased disability. People with primary progressive MS don't respond as well to traditional drug therapies as patients with other, more common forms of the disease, such as relapsing and remitting MS. Because of this, many people with primary progressive MS have higher incidences of debilitating physical side effects. Many need walkers or wheelchairs.

    "Rituxan works on a component of the immune system called B-cells," Dr. Hawker said. "The drug depletes B-cells and has been used to treat other autoimmune diseases such as lupus." As the lead testing site, UT Southwestern doctors in the MS Program and Clinical Center were involved in developing the protocol, choosing subsequent sites and overseeing the research. There are 61 sites in the United States and 11 in Canada currently working on the two-year trial. Total enrollment will be 435 people, with 15 at UT Southwestern. Patients throughout the region are participating in the study, which still has openings available for those who meet the criteria.

    People with primary progressive MS usually are in their 40s or 50s, and men and women have an equal risk of developing the disease. Fewer brain lesions are present on a magnetic resonance imaging screening with this form of MS as well, making it more difficult to diagnose, Dr. Hawker said. New patients in the study receive lab work, an electrocardiogram to check their heart, magnetic resonance imaging, spinal tap, and a physical and neurological exam prior to receiving the first dose of the drug. Patients who can participate in this placebo-controlled study are given infusion treatments that take a full day. Dr. Hawker said positive outcomes for patients during the study would mark a breakthrough for treatment of primary progressive MS.

    Source: University of Texas Southwestern Medical Center (09/01/06)

    Breakthrough for MS
    Multiple sclerosis can leave its victims unable to move and in constant pain. It's an autoimmune disease that wrecks havoc on the central nervous system. In some cases, no treatment works. Now, a new therapy stops the disease's progression and gets patients out of bed and back on their feet.

    On her 40th birthday, Andra Litman was taken down a path unthinkable. "Unless you're in this body, I don't know how you can begin to imagine," she says.

    Doctors diagnosed this artist, attorney, and mother of two with multiple sclerosis, a disease that left her unable to even turn over in bed. Then she started a new treatment. She was out of a wheelchair and on her feet in one month.

    Olaf Stuve, M.D., Ph.DNeurologist Olaf Stuve, M.D., Ph.D., says the cancer drug rituximab (Rituxan) is the first treatment to target the B cells in patients with MS, and it could be the first effective treatment for patients when nothing else works.

    "The response to the Rituxan in those patients were really dramatic, in terms of not only stopping disease progression, but really helping the patient to recover some of the neurological function," Dr. Stuve, of UT Southwestern Medical Center in Dallas, tells Ivanhoe.

    Instead of a daily or weekly injection, rituximab requires two infusions every six months. White spots, or lesions on a patient's brain before treatment, are hallmarks of MS. After treatment, they are gone.

    Dr. Stuve says, "I think it will be a very effective therapy and probably more effective than what we have available at this time."

    Litman says, "The first thought every morning when I woke up for four years was, 'Is it a shot night?'" Now, she can tune her thoughts to what matters most.

    Since rituximab only targets one aspect of the immune system, it poses fewer side effects than standard treatments. Dr. Stuve is just beginning a study on using rituximab to treat primary-progressive MS (PPMS), a specific form that affects 10 percent of patients and for which there are no effective treatments.

    Source: Copyright © 2006 Ivanhoe Broadcast News, Inc.(06/01/06)

    © Multiple Sclerosis Resource Centre

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