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« Reply #30 on: June 16, 2008, 01:08:16 pm »

New drug for rheumatoid arthritis
June 16, 2008


A new "smart" drug could save thousands of rheumatoid arthritis patients from years of worsening pain and disability, research has shown.

Tocilizumab is being hailed as a major breakthrough in combating the crippling auto-immune disease which attacks the joints.

Rheumatoid arthritis (RA) is the biggest cause of disability in the UK, affecting 420,000 people in England and Wales alone.

Trial results show that the new drug is nearly three times more effective at halting progression of the disease than the standard therapy given to most patients.

There is also evidence that it can help difficult to manage patients with more advanced disease whose treatment options are running out.

Tocilizumab is not yet licensed for use in Europe or the UK, but is expected to be launched in Britain within six months.

The drug is a laboratory-made antibody that targets a biological signalling pathway linked to inflammation and RA.

It represents a step forward from MabThera, another antibody drug for rheumatoid arthritis, which is only available to late-stage patients who have ceased to respond to other therapies.

Both drugs are from the stable of pharmaceutical giants Roche, which collaborated with the Japanese company Chugai Pharma to develop tocilizumab.

Data from two clinical trials of the new drug were presented at the annual meeting of the European League Against Rheumatism (EULAR) in Paris.

Press Association
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« Reply #31 on: July 28, 2008, 11:06:26 am »

July 28, 2008
Roche Holding (other-otc: RHHBY.PK - news - people ) AG's drug Actemra appears to help adults with rheumatoid arthritis, U.S. drug reviewers said in a summary released Friday ahead of a key meeting on the product.

Abnormal liver enzymes were relatively common but most cases were mild to moderate, Food and Drug Administration staff said. The drug's effects on liver enzymes and blood fats known as lipids were not associated with health problems in the clinical trials, the summary said.

The FDA staff said they would ask an advisory panel that meets Tuesday whether the benefits of Actemra, which Roche (other-otc: RHHBY.PK - news - people ) bills as a potential blockbuster, outweigh known and potential risks and whether the intravenous drug should be approved.

The risk of infections appeared similar to other drugs that suppress the immune system, the FDA reviewers said.

Cancer was reported in some Actemra patients but the rate seemed consistent with the expected level for people with rheumatoid arthritis, they added.

Gastrointestinal perforations "may be slightly elevated" but were "uncommon," the reviewers said.

Roche shares gained 3.5 percent in Swiss trading.

The company is seeking FDA approval to sell Actemra for adults with moderate to severe rheumatoid arthritis.

Actemra is sold in Japan by Roche's partner Chugai Pharmaceutical Co Ltd but has yet to reach the market in the United States or Europe.

Known generically as tocilizumab, the drug works differently than other drugs on the market. It blocks interleukin-6 (IL-6), a protein involved in inflammation.

"The clinical trial experience has been extensive, but may not capture the full extent of safety concerns that may arise with long-term IL-6 inhibition," the FDA staff said.

Roche, in a separate summary, said Actemra was "generally well tolerated" and the potential side effects were "recognizable, reversible and usually not treatment-limiting."

Rheumatoid arthritis, or RA, is a joint inflammation that causes pain, stiffness, swelling and joint damage. More than 21 million people worldwide, including 2.5 million Americans, are estimated to have the disease, Roche said.

In company-funded studies, more patients treated with Actemra reported at least a 20 percent improvement in symptoms after 24 weeks of treatment. About 26 percent of placebo patients saw that level of benefit, compared with 59 percent treated with the highest Actemra dose. Patients in the studies also were given older drugs for the disease.

"Treatment with tocilizumab appears to be effective for patients with moderate to severely active RA," the FDA staff wrote.

The FDA will make the final decision on whether to approve Actemra in the coming months after hearing the advisory panel's recommendation. The agency usually clears drugs that win support from one of its panels of outside advisors.

The drugs widely used now for treating rheumatoid arthritis block tumor necrosis factor (TNF), another protein linked with inflammation. These drugs sharply improve treatment for the disease but up to 40 percent of patients do not adequately respond to them, Roche said.

The TNF drugs in use now include Abbott Laboratories (nyse: ABT - news - people ) Inc's Humira and Enbrel, sold by Amgen Inc (nasdaq: AMGN - news - people ) and Wyeth . Both drugs had more than $3 billion each in 2007 sales. (Reporting by Lisa Richwine; Editing by Tim Dobbyn and Gerald E. McCormick)


source :www.Forbes.com

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« Reply #32 on: July 31, 2008, 04:19:52 pm »

New Survey Findings Reveal Emotional and Physical Toll of Rheumatoid Arthritis and the Advancement of Treatment Through 'Generations'

    Survey Results Capture Perspectives of People Living with Rheumatoid
  Arthritis and Physicians Treating the Condition over a Span of 30 Years

/PRNewswire/ --
Emotional and physical limitations are significant challenges cited by people diagnosed with
rheumatoid arthritis (RA), according to the results released today from two new, groundbreaking parallel surveys. According to the GeneRAtions(TM)
surveys -- one of which includes feedback from more than 1,000 people
living with RA and a second that polled more than 300 physicians
specializing in the treatment of RA -- people with RA felt sad or depressed
because of their disease an average of 25 days in three months and had
difficulty with normal daily activities for 31 days in the same time
period.(1) The surveys form the basis of a new disease awareness
initiative, GeneRAtions, which is focused on increasing understanding of RA
through the perspectives of varying "RA generations" -- people who have
lived with or physicians who have treated RA for different lengths of time
over a 30-year span.

    "It's difficult to explain to people, even as a former Olympic athlete,
why I sometimes struggle because of my RA. Many people don't understand how
great the mental and physical challenges can be when living with this
condition," said Joy Fawcett, Olympic gold medalist and retired member of
the U.S. Women's Soccer Team, who has been living with RA for more than a
decade, and is a spokesperson for the GeneRAtions program, developed by
Centocor, Inc. "I'm fortunate that in the 10 years since my diagnosis,
education and treatment for the disease have improved, but we need to
continue this momentum."

    The GeneRAtions surveys, conducted by Manhattan Research and supported
by Centocor, Inc., are the first to provide new insights into the physical,
emotional and social effects -- including the impact of RA on
relationships, work, and overall daily living -- of a debilitating disease
that affects 1.3 million Americans. The survey results also highlight
changes in physicians' approaches to treating RA over the past 30 years,
the progress that has been made in managing the disease, particularly
because of important treatment advances in the past decade, as well as
patient and physician perspectives about the future of treatment. Key
findings revealed that:

    -- More than 90 percent of people with RA surveyed reported that their
disease interfered with their work in the last three months, illustrating
how RA can impede many facets of people's lives.(2)

    -- Physicians surveyed rated limitations on physical activities as the
most restrictive consequence of RA for their patients.(3)

    -- More than half of patients surveyed agreed that the public does not
understand the difference between RA, a chronic autoimmune disorder, and
osteoarthritis, which results from wear and tear on the joints.(4)

    -- Two out of three of all patients surveyed believed that friends and
family underestimate the impact of RA. More than half of all respondents
felt that their doctors do not fully understand the impact of RA on their
patients. (5,6)

    -- While nearly three out of five RA patients are satisfied with their
physician's ability to effectively treat their RA with current therapies,
more than 80 percent are looking forward to the future for new innovative
options. (7,8)

    Comprehensive survey findings, as well as testimonials from people
living with RA and physicians sharing their own personal experiences
related to the disease, are available on the program website,
http://www.RAGeneRAtions.com.

    "The specialty of rheumatology has made tremendous strides over the
last 30 years when my father, also a rheumatologist, was practicing and
aspirin was the standard treatment. Today the standard treatment for people
living with moderate to severe rheumatoid arthritis includes disease
modifying anti- rheumatic drugs (DMARDs) and biologic therapies that
inhibit specific proteins like tumor necrosis factor (TNF)," said Hayes
Wilson, MD, Chief of Rheumatology, Piedmont Hospital, Atlanta, Georgia.
"Initiatives like GeneRAtions will bring awareness to this serious illness
which can affect entire families; and in turn, may give rheumatologists the
opportunity to prevent the debilitating effects of RA."

    "Findings from the GeneRAtions surveys provide interesting perspectives
relative to both patient and physician insights," said Seth D. Ginsberg,
Co- Founder and President, CreakyJoints, an arthritis advocacy group. "We
are pleased to note the progress made so far in education and treatment and
will continue our efforts to increase awareness of RA and improve patients'
quality of life."

    About the GeneRAtions Surveys

    The GeneRAtions surveys, completed in the first half of 2008, were
fielded via one-time online inquiries of 1,050 RA patients and 307
practicing rheumatologists and primary care physicians specializing in the
care of patients with RA. The population was wholly examined and further
sub-segmented by the length of time RA patients had been diagnosed or time
that physicians had been practicing. Specific subsets consisted of
individuals living with RA or a physician practicing for 10 years or less,
11-20 years, and 21 years or more. Each of the survey's generational
breakouts revealed the differences or similarities in experiences that
people living with RA can have depending on the amount of time living with
the disease since diagnosis or the amount of time a physician has been
practicing and caring for patients with RA.


    About Rheumatoid Arthritis

    Rheumatoid arthritis (RA) is a chronic and debilitating disease that
affects approximately 1.3 million people in the United States. Signs and
symptoms of RA include pain, stiffness and motion restriction in multiple
joints. Because RA is a progressive disease, it can cause permanent joint
deformity and severe disability if not diagnosed early or if initial
treatment is delayed. RA can occur at any age, but is most common in adults
30-50 years old and is two-to-three times more prevalent in women than in
men. The cause of RA is unknown, although genetic factors may contribute to
the disease.

    About Manhattan Research

    Manhattan Research, LLC, is a marketing information and services firm
that helps healthcare and life sciences organizations adapt, prosper, and
explore opportunities in the networked economy. Manhattan Research's focus
is on healthcare business trends, seeking to understand the impact and
forces that will change the competitive landscape and the long-term effects
on organizational structure, customer behavior and competitive strategy.
Manhattan Research's clients include global pharmaceutical companies, non-
profit health companies, health plans and agencies.

    About CreakyJoints

    CreakyJoints is an online community for people of all ages with
arthritis who want to live their lives despite their condition. It provides
a place to find out more about arthritis-related conditions and treatment
options based on what other people in the arthritis community are saying.
The site also provides resources including message boards, clinical trial
information, podcasts, stories or commentary about arthritis-related
topics, and more. More information about CreakyJoints is available at
http://www.creakyjoints.org.

    About Centocor

    Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives.

    The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. More information about Centocor is available
at http://www.centocor.com.

    (1) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide
121

    (2) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide
31

    (3) Manhattan Research 2007 Rheumatologist Study, Years in Practice
Reference Deck, Slide 72


    (4) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide 147
    (5) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide 144
    (6) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide 142
    (7) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide 28
    (8) Manhattan Research 2007 Rheumatoid Arthritis Patient Study, Slide 104


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« Reply #33 on: September 29, 2008, 03:21:43 pm »

VGX Pharmaceuticals Commences Follow-on Phase I Study for Novel Oral Anti-Inflammatory Drug Targeting Rheumatoid Arthritis and Type 1 Diabetes


VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study. VGX-1027 is an orally active, small molecule compound that has shown preclinical efficacy against various inflammatory diseases including rheumatoid arthritis (RA) and Type 1 diabetes (T1D).

VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines responsible for the damaging effects of inflammatory diseases. Preclinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. They have also demonstrated the product’s efficacy in animal models for several diseases including RA, T1D, colitis, and uveitis. Its mechanism of action includes the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.

Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 million people suffer from rheumatoid arthritis. An additional 1 million Americans suffer from type 1 diabetes, which is fatal if untreated.

Several blockbuster therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug market. However, these agents require parenteral (e.g. such as intravenous) delivery. There are few treatment options available for T1D patients other than insulin, which requires daily injections. VGX-1027 is being investigated as an oral therapeutic.

“VGX looks forward to the results of the MAD studies for VGX-1027. Successful completion of the MAD studies would allow initiation of two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by VGX International," stated Dr. J. Joseph Kim, President and Chief Executive Officer.

About VGX International

More information about VGX International can be found at www.vgxi.com.

SOURCE: press release
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« Reply #34 on: December 09, 2008, 10:26:46 pm »

Optimal dosage and route of administration of methotrexate in rheumatoid arthritis: a systematic review of the literature

K Visser 1* and D van der Heijde 1
1 Leiden University Medical Center, Netherlands

Abstract


Objectives: To systematically review the available literature on the optimal dosage and route of administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA), as an evidence base for generating clinical practice recommendations.

Methods: A systematic literature search was carried out in MEDLINE, EMBASE, Cochrane Library and ACR/EULAR meeting abstracts, searching for randomized controlled trials evaluating various dosages or routes of administration of MTX in RA. Articles that fulfilled predefined inclusion criteria were systematically reviewed and the quality was appraised. Effect sizes (ES) and odds ratios (OR) for clinical, radiological and toxicity outcomes were calculated and directly or indirectly compared between study groups using MTX in different dosages or via different routes.

Results: A total of 38 publications out of 1748 identified references were included in the review. Start doses of 25mg/wk or fast escalation with 5mg/month to 25-30mg/wk were associated with higher clinical ES and more (gastrointestinal) adverse events in comparison with doses of 5-15mg/wk or slow escalation. Starting with 15mg/wk subcutaneous versus oral MTX was associated with higher clinical efficacy, but more withdrawal due to toxicity in early RA. In longstanding RA, however, after failure on 15-20mg/wk orally, a switch to 15mg/wk intramuscular with subsequent dose escalation did not result in increased efficacy.

Conclusions Starting on MTX 15mg/wk orally, escalating with 5mg/month to 25-30mg/wk, or the highest tolerable dose, with a subsequent switch to subcutaneous in case of an insufficient response, seems to be the optimal evidence-based dosing and routing recommendation for MTX in RA.


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« Reply #35 on: March 02, 2009, 11:29:09 am »

Lipid Profiles in Patients with Rheumatoid Arthritis: Mechanisms and the Impact of Treatment


Objective
To describe the impact of rheumatoid arthritis (RA), and its treatment, on lipoprotein levels with potential implications for atherosclerosis.

Methods
A PubMed literature search was undertaken for studies published between 1990 and May 2007, using the search terms “rheumatoid arthritis” AND “lipid” OR “lipoprotein,” and including all relevant drug treatment terms for glucocorticoids, disease-modifying antirheumatic drugs, and biologics.

Results

Patients with RA face an increased risk of developing premature cardiovascular disease and limited ability to modify risk factors, eg, through exercise. RA is associated with an abnormal lipoprotein pattern, principally low levels of high density lipoprotein (HDL) cholesterol. Most treatments for RA tend to improve the atherogenic index (total/HDL cholesterol ratio), with more evidence for biologics in this regard. The improvement in the lipoprotein profile in RA appears to be associated with suppression of inflammation.

Conclusions
Lipid levels should be monitored and managed in patients with RA to minimize the long-term risk of cardiovascular disease. More research is needed to quantify the relationship between systemic inflammation and lipoprotein levels and to determine the impact of specific lipoprotein particles, eg, small dense low-density lipoprotein and subfractions of HDL on long-term risk. Control of inflammation may have an effect on modifying cardiovascular risk.

Director, Centre for Prognosis Studies in the Rheumatic Diseases Professor of Medicine, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.

Department of Medicine, Division of Endocrinology, Toronto General Hospital and University of Toronto, Toronto, Ontario, Canada
Keywords: rheumatoid arthritis; lipids; cardiovascular risk; inflammation; treatment
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« Reply #36 on: March 13, 2009, 11:40:03 am »

Coronary arterial calcification in rheumatoid arthritis: comparison to the multi–ethnic study of atherosclerosis


http://arthritis-research.com/content/pdf/ar2641.pdf
 
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« Reply #37 on: June 03, 2009, 11:32:56 am »

Genes And Smoking Play Role In Rheumatoid Arthritis

June 3, 2009 — Recent genetic studies have revealed several new sites of genes that are risk factors for developing rheumatoid arthritis (RA). The strongest association with anti-citrullinated protein antibody (ACPA)-positive RA (ACPAs are autoantibodies detected in RA that are used as a major diagnostic tool) has been found for the HLA-DRB1 gene, and this site seems to play a central role in susceptibility to the disease in Caucasian populations.


Previous studies have shown a high increase in the risk of ACPA-positive RA associated with smoking in those who have certain variations of the HLA-DRB1 gene. There are several types of such alleles related to a particular amino acid sequence known as shared epitope (SE). ACPAs occur in about 60 percent of RA patients and are closely linked to the presence of SE alleles. In fact, SE alleles are the strongest genetic risk factor for ACPA-positive RA.

Of several environmental factors that predispose people toward developing RA, smoking has been found to be the main risk factor and a strong gene-environment interaction between smoking and SE alleles for ACPA-positive patients has been shown in previous studies in Europe. Results in North America have not been as conclusive, however. A new large population-based study examined the gene-environment interaction between smoking and SE alleles in RA and found that all SE alleles strongly interact with smoking in conferring an increased risk of ACPA-positive RA.

Led by Emeli Lundström of Karolinska Institutet in Stockholm, the study consisted of genetic analysis of 1,319 RA cases and 943 controls in Sweden and included Caucasian smokers and non-smokers. Researchers set out to determine whether all HLA-DRB1 SE alleles demonstrated a similar gene-environment interaction or if the interaction was restricted to a particular DRB1 SE group. A total of 972 cases and 488 controls were SE positive.

"Our data illustrate that regardless of the fine specificity of the SE alleles of DRB1, the interaction between these genetic risk factors and smoking is evident," the authors state.

Although the molecular mechanisms underlying the risk and interaction of smoking and SE alleles are incompletely understood, there are several possible explanations. One is that long-term exposure to cigarette smoke may accelerate the modification of arginine into citrulline in autoantigens present in the lungs, enhancing an immune response in individuals carrying the SE alleles. Another possibility is that substances present in smoke may trigger the innate immune system to contribute to the development of arthritis. It may also be that an as yet undetermined genetic factor (factors) plays a role or that there is a genetic interaction between the HLA-DRB1 gene and the gene involved in the behavior that includes smoking.

The authors conclude that while SE alleles do not seem to confer an increased risk of ACPA-negative RA either on their own or in combination with smoking, all SE DRB1 alleles strongly interact with smoking in the development of ACPA-positive RA.

Journal reference:

   1. Emeli Lundström, Henrik Källberg, Lars Alfredsson, Lars Klareskog, Leonid Padyukov. Gene-Environment Interaction Between the DRB1 Shared Epitope and Smoking Regarding the Risk of Anti-Citrullinated Protein Antibody-Positive Rheumatoid Arthritis. Arthritis & Rheumatism, June 2009

SOURCE: Science Daily
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« Reply #38 on: June 10, 2009, 03:15:30 am »

Pfizer drug effective in rheumatoid arthritis study

* Oral RA drug significantly better than placebo

* ACR 20 tops placebo at all tested doses

* 5 mg and 10 mg to move on to Phase III testing



June 10,2009
 An experimental oral rheumatoid arthritis drug being developed by Pfizer Inc was significantly more effective than a placebo in a mid-stage clinical trial, according to data to be presented at a medical meeting in Denmark on Thursday.

The drug, given twice daily, was tested at strengths of 3 milligrams, 5 mg, 10 mg and 15 mg and demonstrated a statistically significant response at all doses compared with a placebo, the company said.

Data from a 12-week interim analysis of the six-month study of the drug, CP-690,550, has been used to help select the 5 mg and 10 mg doses for larger Phase III clinical trials, Pfizer said. Phase III is typically the final stage of testing before a new drug is submitted to the U.S. Food and Drug Administration for an approval decision.

The primary goal of the study was an ACR 20 response rate, defined as 20 percent improvement in tender and swollen joints.

At the two highest doses, 75.4 percent of patients achieved ACR 20 response rates compared with 28.8 percent of those in the placebo group. The ACR 20 response was 49 percent at 3 mg and 63.3 percent at 5 mg, according to data to be presented at the European League Against Rheumatism meeting in Copenhagen.

The differences in response rates were seen as early as two weeks into the study, researchers said.

The study involved 384 patients with active rheumatoid arthritis, who had not responded to treatment with another anti-rheumatic drug, such as methotrexate.

CP-690,550 is a so-called JAK-3 inhibitor that works by blocking enzymes involved in inflammatory and autoimmune diseases.

In addition to the ACR 20 primary goal, there were statistically significant ACR 50 responses -- 50 percent improvement -- for the drug at 5 mg, 10 mg and 15 mg, and ACR 70 responses at the two highest doses, compared with placebo, researchers said.

The most common adverse events were mild to moderate urinary tract infection, diarrhea, bronchitis and headaches.

Significant dose-dependent decreases in white blood cells and increases in both good and bad cholesterol were consistent with previous studies of CP-690,550, Pfizer said.
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« Reply #39 on: June 12, 2009, 01:10:39 am »

FDA approves UCB drug for rheumatoid arthritis


Belgian drugmaker UCB says it received federal approval for an injectable drug to treat arthritis.

It enters a competitive market dominated by some of the largest U.S. drugmakers.

The Food and Drug Administration approved the drug Cimzia for moderate to severe rheumatoid arthritis. The injectable medication was previously approved to treat gastrointesinal Crohn's disease last April.

The drug is the fourth drug in its class approved in the U.S. The other three products are multibillion-dollar drugs, including Abbott Laboratories' Humira, Johnson & Johnson's Remicade and Wyeth and Amgen's Enbrel. Enbrel was the biggest seller of the group last year, with sales of $3.4 billion.
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« Reply #40 on: June 13, 2009, 05:29:50 am »

63 Percent Of Rheumatoid Arthritis Patients Suffer Psychiatric Disorders, With Depressive Spectrum Conditions Most Likely

June 12, 2009
 Over half (63%) of patients with rheumatoid arthritis (RA) also suffer from psychiatric disorders, with the majority of these (87%) occurring in the depressive spectrum, according to the results of a new study presented today at EULAR 2009, the Annual Congress of the European League Against Rheumatism in Copenhagen, Denmark. Interestingly, over half (52%) of the patients studied indicated that they had experienced stress events before the onset of their RA.

The study also revealed a number of other interesting findings about the emotional burden of RA:

    * Cognitive dysfunction was diagnosed in 23% of patients, with 16% of this attributed to depression
    * A third (33%) suffered from sleep disorders
    * Those with depression also exhibited more severe RA (measured by X-ray), greater functional insufficiency and pain, as well as having received less aggressive treatment than patients without depression. (No significant differences in age, duration of illness, gender or DAS28* scores were noted between the two groups)
    * Significantly, cognitive impairments were found more often (p=0.02) in patients older than 50 years (39% vs. 9%)
    * The age of the first prednisone intake was significantly higher (p<0.05) in patients with depression compared to those without (48 vs. 30 years)

Dr Tatiana Lisitsyna from the State Institute of Rheumatology RAMS, Russian Federation, who conducted the study, said: "Psychiatric disorders are a very common comorbidity for people with RA, and they tend to be stress-related and associated with disease activity and chronic pain. Evaluating and addressing the mental health of those with RA should be a regular feature of rheumatology practice to improve quality of life and reduce the potentially distressing psychological burden of RA."

In the study, the disease activity of 75 patients with American College of Rheumatology (ACR) defined RA (96% female, median age 52 years (46-55), median disease duration 12 years (4-22) was assessed using DAS28* with a median score of 4.98 (3.71 - 6.4). Median prednisone intake duration was 34 months (3-72) and 80% of patients were taking DMARDs (49% methotrexate; 23% leflunomide). Using the Brief Pain Inventory (BPI) scale to assess pain, 74% were considered to have either severe (7-10 points) or moderate (5-6 points) pain.

Psychiatric disorders were diagnosed in accordance with the ICD-10 (International Classification of Disease) scale, and other psychiatric and psychological scales used included: the Hospital Anxiety and Depression Scale for screening, the Hamilton Anxiety Rating Scale and the Montgomery-Asberg Depression Rating Scale. Projective psychological methods were employed for evaluation of cognitive function.

* DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual's RA is. It assesses number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR, a blood marker of inflammation), and the patient's 'global assessment of global health'. A higher score indicates more active disease.



European League Against Rheumatism (2009, June 12). 63 Percent Of Rheumatoid Arthritis Patients Suffer Psychiatric Disorders, With Depressive Spectrum Conditions Most Likely. ScienceDaily. Retrieved June 13, 2009, from http://www.sciencedaily.com­ /releases/2009/06/090612092737.htm
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« Reply #41 on: June 20, 2009, 04:08:32 am »

A new drug has raised hopes for recovery in cases of severe rheumatoid arthritis.

The drug, MabThera (rituximab), is already used as an aggressive treatment for various forms of cancer, but it has now been found to have a significant effect in long term use for those with moderate to severe rheumatoid arthritis.

According to a study done by the European League Against Rheumatism, just under half of those given a one year treatment improved drastically, with others improving slightly. About 1/5 of the patients showed no improvement, showing the need for more research to be done in order to make the drug more effective.

“It has shown good results and we are beginning to target individual therapies at individual patients,” Professor Paul Emery, a researcher from the University of Leeds, was quoted as saying.

If able to created more targeted regimens from MabThera, it could offer the first real hope for significant improvement over time in the case of rheumatoid arthritis, a condition that effects millions all over the world every year.

As it is a drug that targets the immune system, thought to be a leading cause of rheumatoid arthritis, finding a way to break it down and create a more specific medication is possible and likely. Further trials are currently being conducted.
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« Reply #42 on: August 05, 2009, 02:27:17 am »

FDA: Rheumatoid Arthritis Drugs Raise Cancer Risks for Kids
August 5, 2009

The list of warnings for a popular class of medicines that treats rheumatoid arthritis, Crohn’s and other autoimmune diseases continues to grow.

The drugs will now include a boxed warning about the risk of cancer in children and adolescents, the FDA said today.

The agency said its analysis of showed an increased risk of cancer, with cases occurring after an average of 30 months of treatment. The FDA said it’s working with the manufacturers to “explore new ways to further define the risk of cancer” in children and adolescents.

The medicines, which include J&J’s Remicade and Simponi, Amgen and Wyeth’s Enbrel, Abbott’s Humira and UCB’s Cimzia, must already warn against a potentially deadly fungal infection, histoplasmosis.

The drugs work by inhibiting a protein called tumor necrosis factor. Among other functions, TNF plays a role in programmed cell death, so it makes sense that blocking TNF could theoretically raise the risk of cancer, which is uncontrolled cell growth.
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« Reply #43 on: August 28, 2009, 09:00:39 am »



Bristol-Myers Squibb's Orencia Gets Wider Labeling Approval From FDA


8/27/2009

Drug maker Bristol-Myers Squibb Co. (BMY), Wednesday said the U.S. FDA approved a broader labeling for its rheumatoid arthritis drug, Orencia, to include patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration. Orencia was initially approved in the treatment of moderate-to-severe rheumatoid arthritis patients who did not respond to other drugs.

The broader labeling approval was based on clinical data from the Abatacept study that showed Orencia helped patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration. The U.S. FDA approved on August 25 the addition of data from the AGREE trial.

Bristol-Myers said data indicated that Orencia can inhibit radiographic progression of RA and can improve physical function and health-related quality of life in addition to relieving pain, swelling and fatigue.

The Abatacept study to Gauge Remission and Joint Damage Progression in Methotrexate-Naïve Patients with Early Erosive Rheumatoid Arthritis, known as AGREE trial, showed 41% of patients with Orencia plus methotrexate achieved a DAS28-CRP score of less than 2.6 at 12 months, compared to 23% with those taking methotrexate plus placebo.

DAS28-CRP is a combined index that measures the disease activity in patients with rheumatoid arthritis, with a DAS28-CRP score of less than 2.6 indicating a low level of disease activity.

Bristol-Myers Squibb also said that additional measures of improvement of signs and symptoms in RA patients were reported at 1 year as per the AGREE study.

Safety experience in the AGREE study was consistent with the Orencia rheumatoid arthritis clinical studies currently included in the prescribing information. The most serious adverse reactions were serious infections observed in 3.0% of patients treated with Orencia and 1.9% of patients treated with placebo. Malignancies were observed in 1.3% of patients treated with Orencia and 1.1% of patients treated with placebo.

The most frequent adverse events occurring in greater than or equal to 10% of patients treated with Orencia were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

The Abatacept study comprised an active-controlled clinical trial in methotrexate-naïve patients with moderate-to-severe rheumatoid arthritis of less than two years disease duration.

RA is a systemic, chronic, autoimmune disease characterized by inflammated joints, causing damage with chronic pain, stiffness, swelling and fatigue. It limits range of motion and results in loss of shape and alignment of joints. The condition is more common in women than in men.


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« Reply #44 on: October 22, 2009, 08:49:50 am »

FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis
Tue Oct 20, 2009


An important assay usedto aid in the diagnosis of rheumatoid arthritis (RA) will soon be available on Abbott's ARCHITECT immunoassay analyzers.  The FDA has granted 510(k)
clearance for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to run on the world class systems.


Many patients with RA develop an immune response against proteins containing
citrulline long before they present symptoms of the disease.  Studies show
detecting the level of these antibodies earlier in the disease continuum, in
conjunction with other clinical information, is critical to the early
diagnosis of the disease. The American College of Rheumatology treatment
guidelines for RA recommends early diagnosis of the disease and timely
introduction of therapies to prevent potentially irreversible joint damage.


The assay was developed by Axis-Shield to run on Abbott's ARCHITECT i1000SR
and i2000SR systems.  The anti-CCP assay is already approved and available on
the Abbott ARCHITECT outside the United States.  


"The approval of the anti-CCP assay for use on the ARCHITECT provides an
important tool for physicians to aid in the early diagnosis of RA.  We are
pleased to add this assay to the existing panel of autoimmune disease
biomarker assays currently available on the ARCHITECT and clinical chemistry
platforms as we underscore Abbott's continued commitment to the area of
immunology," said Michael Warmuth, senior vice president, diagnostics, Abbott.



Important Product Usage and Safety Information
The ARCHITECT Anti-CCP assay is a chemiluminescent microparticle immunoassay
(CMIA) for the semi-quantitative determination of the lgG class of
autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum
or plasma on the ARCHITECT i System.  Detection of anti-CCP antibodies is used
as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in
conjunction with other clinical information.  This product is for in vitro
diagnostic use only.  Use of this product requires the handling of human
specimens, and it is recommended that all human-sourced materials be
considered potentially infectious.  This product contains sodium azide, and
both the material and its container should be disposed of safely.  Assay
specific information is presented in the assay package insert which can be
accessed at www.abbottdiagnostics.com once the product is available.
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« Reply #45 on: November 13, 2009, 02:22:04 pm »

UAB, Huntsville scientists look to unlock rheumatoid arthritis clues

November 13, 2009

Dr. S. Louis Bridges Jr., head of clinical immunology and rheumatology at UAB, and Gwendolyn Johnson, a longtime rheumatoid arthritis patient, share a desire to find ways to better diagnose and treat the debilitating illness. (The Birmingham News/Beverly Taylor)The University of Alabama at Birmingham will lead a five-year, $4.4 million effort to search for genetic links to rheumatoid arthritis in African-Americans.

  This study will use the power of research called genomics to search for genetic needles in a haystack. Although they're focusing on African-Americans, what the researchers learn could aid all sufferers from rheumatoid arthritis, they say.

  UAB's Dr. S. Louis Bridges Jr. and colleagues have the largest collection of blood samples from African-Americans with rheumatoid arthritis in the nation through a National Institutes of Health-sponsored registry. From the blood, scientists can extract DNA, the starting material for the gene hunt.   

  A major partner in the study is the HudsonAlpha Institute for Biotechnology in Huntsville, headed by Dr. Richard Myers, formerly of Stanford University. Myers has identified genes involved in several inherited diseases, and his genome center contributed about 11 percent of the DNA sequence for the Human Genome project.

  Why look for genetic links to a disease?

  If you can find them, said Bridges and HudsonAlpha faculty investigator Devin Absher, you can identify genes that maybe involved in causing the disease, or that may protect against the disease. Basic research into these genes can help show how the disease works, and may lead to information to aid diagnosis or treatment. In other words, they are clues that can help solve the mystery of a debilitating illness.

  About 30 percent of the risk of getting rheumatoid arthritis is genetic, Bridges said. Previous genome studies with Europeans and Asians have found about 20 to 25 genes involved in the genetic risk.

  Bridges expects to find some differences in African-Americans, compared to the other two groups.

  His study begins with a simple question: "Are you African-American?" Only those who say yes are included.

  Since African-Americans have about 5 to 15 percent European genes, the UAB study will also include some ancestry genetic markers.

  The entire study will search through separate DNA samples from 1,600 African-Americans with rheumatoid arthritis and 1,600 African-Americans who don't have the disease. That latter group serves as the "control" in the gene hunt.

  Since people get two copies of each gene, one from their mother and one from their father, the hunt has to look at each pair of genes in the human DNA, known as minor and major alleles.

  "What we look for is a minor allele with a large difference in between controls and patients," Bridges said. "If you found that, you would have a possible new genetic risk factor associated with rheumatoid arthritis, possibly specific to African-Americans."

The steps of the research show the amazing complexity -- and potential power -- of this kind of genetic hunt.

  For every single person in the study, Myers and Absher will search about one million places on the genome, checking which alleles they have. Alleles are distinguished by a difference in a single base of DNA, a marker spot nicknamed a "snip" for SNP, or "single nucleotide polymorphism."

  SNPs are identified on a microarray, similar in size to a 1-inch-by-3-inch microscope slide. Each array has millions of tiny glass beads with different SNP DNAs attached. Each SNP is able to bind with single-strand copies of a patient's DNA.

  Since the 1 million SNPs are each tested about 15 times, the array actually has about 15 million beads on each slide, Absher said. The extremely expensive microarrays are built using some of the technology used in electronic chip manufacturing.

  Through a series of chemical tricks, minor and major alleles will show up as different glowing colors -- red and green -- when the three-day automated steps of the DNA binding are finished. If a patient has one minor and one major allele, the spot will glow yellow.

  Each microarray is scanned by a machine, and computers analyze the results, looking for sites that differ between rheumatoid arthritis patients and the controls.

  But the SNP is not a gene -- it's merely a mapping marker along the DNA. The gene or genes in question may be nearby, and that will involve a further hunt.

  The gene hunt will have two phases.

  The first microarrays will be used to analyze 800 patients and 800 controls. This filters out the vast majority of DNA sites that have no relation to rheumatoid arthritis.

  Then, Absher said, the most promising 16,000 to 20,000 SNPs identified in the first hunt will be retested with DNA from an additional 800 patients and 800 controls. Scientists will also look for differences among rheumatoid arthritis patients who have bone erosion at their joints and those who don't, and those who suffer a loss of bone density and those who don't.

  At the end of this testing, 1 million possible sites may be reduced to just 10 to 15 that truly have a relationship to rheumatoid arthritis.

  At that point, the hunt for particular genes can begin.

  Bridges' search for genetic links to rheumatoid arthritis is just the second funded grant that involves collaboration between HudsonAlpha and UAB, but there are also about six to 10 pilot collaborations going on.

  "There's a new project proposed every few weeks," Absher said. "Our connections with UAB are pretty strong, and are getting stronger."


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« Reply #46 on: November 09, 2010, 04:09:23 pm »

First Phase 3 Trial, Tasocitinib (CP-690,550), an Oral JAK Inhibitor, Administered as Monotherapy, Reduces Signs and Symptoms of Active Rheumatoid Arthritis and Improves Physical Function


Tasocitinib Demonstrates Sustained Efficacy at 24 Months in Phase 2/3 Open Label Extension Study


Nov. 7, 2010  Pfizer Inc. (NYSE: PFE) today announced results of ORAL Solo (1045), a Phase 3 study that showed tasocitinib (CP-690,550), an investigational, novel, oral JAK inhibitor, administered as monotherapy met two primary endpoints, demonstrating a statistically significant reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) and improvement in physical function as measured by ACR20 response rates and mean change in HAQ-DI, respectively, versus placebo at three months. For a third primary endpoint, the rate of DAS28-4(ESR) <2.6, a measure of disease remission, treatment with tasocitinib resulted in a numerically greater, but not statistically significant difference from placebo at three months.


In ORAL Solo, a similar frequency of adverse events was seen across all treatment groups. Serious adverse events were reported in 4.1 percent of patients. Additionally, decreases in neutrophil count and hemoglobin and an increase in cholesterol occurred by month three. These changes tended to stabilize thereafter. No new safety signals were detected.

"We are encouraged by the statistically significant and clinically meaningful improvements we observed in a proportion of patients treated with tasocitinib monotherapy in ORAL Solo," said Roy Fleischmann, MD, Clinical Professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center in Dallas.  "Further research into additional treatment options for patients with moderately to severely active RA is important, and we look forward to seeing the results of the additional Phase 3 ORAL trials of tasocitinib."

ORAL Sequel (1024), an open label, follow-up Phase 2/3 study, had safety findings consistent with the global Phase 2 RA clinical program and showed sustained efficacy over 24 months when tasocitinib was administered as monotherapy or in combination with methotrexate.

Results of both studies will be presented at the American College of Rheumatology (ACR) Annual Meeting in Atlanta this week.

ORAL Solo (1045): Trial Design and Results

ORAL Solo was a six-month, double-blind, placebo-controlled study of 611 randomized patients. Patients with moderately to severely active RA who had an inadequate response to at least one disease- modifying antirheumatic drug (DMARD) received tasocitinib 5 mg or 10 mg monotherapy or placebo twice a day. After three months of treatment, patients randomized to the placebo group began receiving tasocitinib 5 mg or 10 mg in a blinded manner. Primary efficacy endpoints were ACR20 response rates (20 percent improvement from baseline in the American College of Rheumatology scale), mean change in HAQ-DI (Health Assessment Questionnaire Disability Index) and DAS (Disease Activity Score) 28-4(ESR) (DAS28) <2.6, all at month three. Secondary endpoints included ACR50/70 response rates and mean change in DAS28.


ACR20/50/70, HAQ-DI and DAS28 measurements showed both a dose effect and improvement over time.  ACR20 showed separation from placebo by week two, the first time point measured after baseline.

The safety findings in ORAL Solo were consistent with those observed in the global Phase 2 RA clinical program. In months 0-3 and months 3-6 of the study, respectively, 54.1 percent and 40.0 percent of patients had adverse events (AEs) and 2.1 percent and 1.0 percent discontinued due to these AEs, with similar frequency across groups. Twenty five patients (4.1 percent) had serious AEs and serious infections were reported in six patients during the total six months of the study. Among patients treated with tasocitinib, there were statistically significant decreases in neutrophil count, statistically significant increases in LDL and HDL cholesterol and not statistically significant changes in hemoglobin levels.  These changes were seen at month three and were stable thereafter. During the course of the study, few patients had transaminase elevations distributed across all groups.

ORAL Sequel (1024): Trial Design and Results

ORAL Sequel is an ongoing Phase 2/3 study designed to evaluate the long-term safety and efficacy of tasocitinib 5 mg or 10 mg twice daily in the treatment of moderately to severely active RA in patients who have participated in a prior randomized study of tasocitinib and then rolled over to this open label extension study. The primary endpoints are laboratory safety data and AE reports.  Secondary endpoints include ACR20/50/70 response rates and mean change in DAS28 and HAQ-DI.

Safety and efficacy were evaluated over 24 months in 1,070 patients, and compared between patients who received tasocitinib monotherapy and tasocitinib in combination with methotrexate.

ACR response rates showed a trend for improvement over time (month 1-24) with similar ACR20 response rates in tasocitinib monotherapy and tasocitinib on background methotrexate groups at month 24.  The mean DAS28 and HAQ-DI scores also improved compared to baseline and remained consistent over time.

No new safety signals emerged in ORAL Sequel. For all patients, the most frequent AEs were bronchitis, upper respiratory infection and urinary tract infection. 6.3 percent of patients discontinued from the study due to AEs. The most frequently reported class of serious AEs was infections (n=34, 18.1 percent) with an incidence rate of 2.62/100 patient-years of tasocitinib treatment. There were two cases of TB; one disseminated TB, which occurred in the background methotrexate group, and one case that was reported two months after discontinuation of tasocitinib. The increases seen in mean total cholesterol, LDL, hemoglobin, serum creatinine and transaminases and the decrease seen in mean absolute neutrophil counts from baseline during the first 6-12 weeks in the prior randomized studies did not progress during the two years in ORAL Sequel.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects 1.3 million people in the U.S. and approximately one percent of the adult population worldwide.

About Tasocitinib

Tasocitinib is a novel, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease- modifying therapy for RA.  Unlike current therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tasocitinib takes a novel approach, targeting the intracellular signaling pathways that operate as hubs in the inflammatory cytokine network.

Pfizer is studying tasocitinib in one of the largest clinical programs of its kind, evaluating more than 4,000 RA patients. The Phase 3 ORAL Trials clinical program includes six studies with more than 350 locations in 35 countries worldwide (www.ORALtrials.com).

Pfizer is also studying orally administered tasocitinib in psoriasis, inflammatory bowel disease (Crohn's disease and ulcerative colitis) and organ transplant, and topical tasocitinib in both psoriasis and dry eye.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life.  We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products.  Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.  Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.  For more than 150 years, Pfizer has worked to make a difference for all who rely on us.  To learn more about our commitments, please visit us at www.pfizer.com

DISCLOSURE NOTICE: The information contained in this release is as of November 7, 2010.  Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product in development, tasocitinib, including its potential benefits as a treatment for rheumatoid arthritis, certain other diseases and solid organ transplant that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for tasocitinib as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

 
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« Reply #47 on: December 29, 2010, 05:32:41 pm »

http://www.MyRAFitKit.com
Your RA Fit Kit enables you to:

Design your own fitness program around the joints your RA affects
Choose from three levels of exercise intensity
Modify exercises to protect your
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« Reply #48 on: January 14, 2011, 10:32:18 am »

FDA Green Lights New Indication for RA Drug

By Cole Petrochko
Published: January 06, 2011

WASHINGTON -- The FDA expanded the indication of the rheumatoid arthritis drug tocilizumab (Actemra) to inhibit and slow structural joint damage, improve physical function, and treat severely active rheumatoid arthritis in combination with methotrexate.

The new indication's approval was based on phase III data from the TociLIzumab Safety and THE Prevention of Structural Joint Damage (LITHE) study.

The LITHE study measured prevention of structural joint damage and improvement of physical function of 1,196 patients across 15 countries with moderate to severe RA and inadequate response to methotrexate.

Patients were randomized to tocilizumab 4 mg/kg or 8 mg/kg at one infusion every four weeks along with methotrexate, or to methotrexate and placebo.

After 12 months, patients in the 4 mg/kg group showed slowed structural damage progression (defined as a <75% inhibition compared with the control group), while those in the 8 mg/kg group showed inhibited damage progression (defined as >75% inhibition).

Genant-modified Sharp Scores -- a 14-point measure of bone damage -- for patients at 52 weeks were, on average, 0.25, 0.33, and 1.17 for the 8 mg/kg, 4 mg/kg, and placebo groups respectively. Higher scores reflect larger amounts of bone damage. By week 104, damage scores changed to an average 0.34 and 0.47 from baseline in the 8 mg/kg and 4 mg/kg groups.

Improvement of physical function was measured through self-report. Some 63% and 60% of patients in the 8 mg/kg and 4 mg/kg groups reported improvement of physical function at 52 weeks, versus 53% in the placebo group.

Additionally, major clinical response -- measured through an ACR 70 response over a continuous 24-week period -- occurred in 7% of the 8 mg/kg group and 4% of the 4 mg/kg group, versus 1% in the placebo group.

The drug first received FDA approval in January 2010 to treat moderate to severe active RA in adult patients following an inadequate response to one or more tumor necrosis factor antagonist therapies. It was approved for use alone or with methotrexate or other disease-modifying anti-rheumatic drugs.

Adverse events include infection -- including tuberculosis and other bacterial, fungal, and viral infections -- stomach and intestinal perforation, changes in blood test results, hepatitis B infection in virus carriers, nervous system problems, hypersensitive reactions, upper respiratory tract infection, headache, and hypertension.

Patients should not take tocilizumab if they are pregnant or plan on becoming pregnant.

Tocilizumab is manufactured by Roche subsidiary Genentech.
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« Reply #49 on: January 30, 2011, 09:16:09 am »

http://www.actemra.com/hcp/about-actemra/mechanism-of-action.aspx?p=P000986&s=S0536&f=F000487&cid=act_we_F009000_P009007&utm_source=MDL&utm_medium=TL&utm_campaign=HCP
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
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« Reply #50 on: March 07, 2011, 12:00:01 pm »

Pfizer Announces Primary Endpoints Met In Second Phase 3 Clinical Trial Of Tofacitinib (CP-690,550) In Patients With Active Rheumatoid Arthritis
Detailed Results to be Submitted to Future Scientific Meeting

NEW YORK--(BUSINESS WIRE)--Mar 4, 2011 - Pfizer Inc. (NYSE:PFE) today announced that the ORAL Sync Phase 3 study (A3921046) of tofacitinib (development code: CP-690,550), formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor, being studied in moderate-to-severe rheumatoid arthritis (RA), met its primary endpoints by showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.6 at six months. The safety profile of tofacitinib was consistent with that seen previously in the clinical program, and no new safety signal was detected. A full analysis of efficacy and safety data will be submitted to a future scientific meeting.

About ORAL Sync

ORAL Sync evaluated the efficacy and safety of tofacitinib doses 5 mg and 10 mg given twice daily compared to placebo in patients with moderately to severely active RA who had a previous inadequate response to a DMARD and who continued to receive background traditional DMARD therapy throughout the study.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.3 million people in the U.S. 1 and 1 percent of the adult population worldwide.2

About Tofacitinib

Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. More than 4,000 RA patients have been treated with tofacitinib in clinical trials to date. Unlike current therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach, targeting the intracellular signaling pathways that operate as hubs in the inflammatory cytokine network.

The Phase 3 ORAL Trials clinical program includes six studies with more than 350 locations in 35 countries worldwide. For more information, visit www.ORALtrials.com.

Pfizer is also studying orally administered tofacitinib in psoriasis, inflammatory bowel disease (Crohn's disease and ulcerative colitis) and renal transplant, and topical tofacitinib in both psoriasis and dry eye disease.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of March 4, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product in development, tofacitinib, including its potential benefits as a treatment for rheumatoid arthritis, certain other diseases and renal transplant, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for tofacitinib as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.

1 Arthritis Today. “What is Rheumatoid Arthritis.” Accessed 24 February 2011. Available at: http://www.arthritistoday.org/conditions/rheumatoid-arthritis/all-about-ra/what-is-ra.php.
2 Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009; 11(Suppl 1): S1.Published online 2009 April 6. doi: 10.1186/ar2662.
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I look normal, as I have an "Invisible Illness". You can not catch it, you can not see it. It's called Lupus.My body is attacking itself on the inside.
www.LupusMCTD.com Represents:
1) We are patients helping researchers build a future for the lives of others...
2) Where HOPE is a WORK In Progress
3) Pay It Forward~Giving Back To The Future Lupus/MCTD Patients
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