CIMZIA(R) (Certolizumab Pegol) Provides Rapid And Sustained Relief From Signs And Symptoms Of Rheumatoid Arthritis For Two Years

UCB announced results from several Phase III clinical trials evaluating CIMZIA(R) (certolizumab pegol) - the only PEGylated anti-TNF (Tumor Necrosis Factor)
- presented at the American College of Rheumatology (ACR) Annual Scientific
Meeting. Results from the open-label extension study to RAPID 1 met both
co-primary endpoints (American College of Rheumatology (ACR) 20 response(a)
scores at Week 24 and change from baseline in modified Total Sharp Scores
at Week 52). Results also showed that CIMZIA together with methotrexate
(MTX) provided ACR 20 response as early as Week 1 with sustained long-term
benefit in relieving symptoms of rheumatoid arthritis (RA) through 100
weeks.



Another analysis investigating the rapidity of response to CIMZIA as a
monotherapy (FAST 4WARD) and together with MTX (RAPID 1) was presented at
the meeting. Both studies met their primary endpoints (ACR20 response rate
at Week 24) with clinical and statistical significance. The analysis
presented showed that the response to CIMZIA treatment was rapid in both
studies with more than a third (36.7 percent) of patients receiving CIMZIA
as a monotherapy (FAST 4WARD) and nearly a quarter (22.9 percent) of
patients receiving CIMZIA together with MTX (RAPID 1) achieving an ACR20
response within one week, both significantly different from placebo. ACR20
response rates peaked at Week 12 in both studies and were sustained until
the end of the studies (Week 24 in FAST 4WARD; Week 52 in RAPID 1).



"The data show that treatment with CIMZIA in clinical trials produced a
fast and clinically meaningful effect for RA patients over an extended
period of time," said Michael Schiff, M.D., study investigator and Clinical
Professor of Medicine at the University of Colorado School of Medicine.



CIMZIA had a low occurrence of treatment discontinuation due to adverse
events. The most commonly occurring adverse events were headache,
nasopharyngitis, and upper respiratory tract infections. Pooled safety data
from the two main phase III trials showed there was a low incidence of
injection site burning and stinging (n=








Additional data presented focused on the effect of treatment with
CIMZIA together with MTX in quality of life measurements. In RAPID 1,
nearly three-quarters of patients achieved improvements in physical
function when treated with CIMZIA together with MTX, including 72.4 percent
of those initially treated with CIMZIA 200 mg together with MTX or 70.1
percent of those treated with CIMZIA 400 mg together with MTX.



On a 10-point improvement on the Patients Assessment of Arthritis Pain
(PAAP) scale, the data showed an average improvement of 39.1 and 38.1
points for those on CIMZIA 200 mg together with MTX and CIMZIA 400 mg
together with MTX, respectively.



"It is exciting to see that these patients are deriving and maintaining
improvements on multiple levels with continued CIMZIA treatment," noted
Philip Mease, M.D., study investigator at the Seattle Rheumatology
Associates and Director of Rheumatology Research at Swedish Medical Center.
"Reducing pain and discomfort from RA is extremely important, but it is
also noteworthy when patients find treatments that lead to a better overall
quality of life."



In RAPID 1, patients treated with CIMZIA together with MTX reported
gains in additional work and household work days per month and productive
work and household work days per month as early as week 4. Over 6 months,
improvements continued compared to the control group. These improvements
were maintained for up to one year.



Additionally, data presented shows Health Reported Quality of Life
Measurements (HRQoL) approached population norms in the "vitality" and
"mental health" domains. As assessed by the Fatigue Assessment Scale of 1
to 10, patients in the trial also reported a mean reduction in fatigue to
3.1 points at week 100 with CIMZIA together with MTX treatment.



RAPID Clinical Trials Program



The international, multi-center, double-blind placebo-controlled RAPID
(RA PreventIon of structural Damage) clinical trials were designed to
establish the efficacy and tolerability of CIMZIA(R) (certolizumab pegol)
together with methotrexate (MTX) in the treatment of active rheumatoid
arthritis who did not adequately respond to conventional treatment. The
program is comprised of two large, international, multi-center
placebo-controlled studies - RAPID 1 (027) and RAPID 2 (050).



In the year-long RAPID 1 trial, patients randomly received one of three
treatment regimens: 393 patients received CIMZIA 400 mg at weeks 0, 2 and
4, then CIMZIA 200 mg together with MTX every two weeks; 390 patients
received CIMZIA 400 mg together with MTX every 2 weeks; 199 patients
received placebo together with MTX every 2 weeks. RAPID 1 met co-primary
endpoints: ACR20 response rate(a) at week 24 and the change from baseline
in mTSS(b) at week 52. An open-label extension study continued to evaluate
the effects of CIMZIA over two years.



In the six-month RAPID 2 trial, 619 patients randomly received one of
three treatment regimens: 246 patients received CIMZIA 400 mg at weeks O, 2
and 4, then CIMZIA 200 mg together with MTX every two weeks; 246 patients
received CIMZIA 400 mg together with MTX every two weeks; 127 patients
received placebo together with MTX every two weeks.



In all arms of the study, the dose of methotrexate was 10mg per week or
greater. Patients were assessed for improvement in signs and symptoms of
RA. The primary endpoint for the study RAPID 2 was ACR20 responder rate at
week 24.



In both studies, CIMZIA given at a dosage of 200mg every two weeks
produced similar clinical results as a dosage of 400mg every two weeks.



(a) ACR (American College of Rheumatology) response scores measure
improvement in the tender and swollen joint count and also include
assessment of the following five parameters: patient's global assessment,
physician's global assessment, patient's assessment of pain, degree of
disability, and level of acute-phase reactant. ACR20 is achieved when there
is 20% improvement in the tender and swollen joint count as well as a 20%
improvement in at least three of the five parameters. ACR50 & ACR70 are an
extension of these criteria corresponding to a 50% and 70% improvement
respectively. (1)



(b) Modified Total Sharp Scores (mTSS) is a measurement used to assess
changes in bone erosion and joint-space narrowing measured by X-ray. A
smaller change in mTSS reflects less progression of joint damage. (2)



Open-Label Study to RAPID 1 (028)



The Phase III, open-label extension (OLE) study to RAPID 1 is
investigating the long-term efficacy and safety of subcutaneous CIMZIA (400
mg every 2 weeks) together with methotrexate in the treatment of signs and
symptoms and in the prevention of joint damage in patients with active RA.
Patients completing RAPID 1 through 52 weeks (completers), or who were
ACR20 nonresponders at Week 12 (confirmed at Week 14) and were to be
withdrawn from the study at Week 16 (withdrawers), could continue in the
028 study. The open-label extension study continued to evaluate the effects
of CIMZIA over two years.



FAST 4WARD (Study 011)



In the 24-week FAST 4WARD (eFficAcy and Safety of cerTolizumab pegol -
4 Weekly dosAge in RheumatoiD arthritis, Study O11) phase III study, 220
adult patients with active RA who had previously failed at least one
disease-modifying antirheumatic drugs (DMARD) were randomized to receive
either CIMZIA 400 mg subcutaneously every four weeks (n=111) or placebo
(n=109). Patients were assessed for improvement in signs and symptoms of
RA. The primary endpoint of the 011 study was ACR20 responder rate, with
secondary measures including ACR50 and ACR70 responder rates.



About Rheumatoid Arthritis



Rheumatoid arthritis (RA) is a progressive autoimmune disease that
causes chronic inflammation of the joints. It is estimated that five
million people suffer from RA globally, with 0.3 percent to 1 percent of
the population in industrialized countries suffering from RA. It is
estimated that, approximately 1.3 million people in the United States have
RA. Women are three times more likely to be affected than men. Although it
can affect people of all ages, the onset of RA usually occurs between the
ages of 35-55.



Symptoms of RA include joint stiffness, joint pain, inflammation of the
affected areas and an associated reduction in mobility. These symptoms can
be intermittent and vary in severity from patient to patient. In more
severe cases RA can eventually lead to disability. RA patients are also at
a higher risk of developing other conditions, in particular heart disease,
stroke, infections, lung problems and osteoporosis.



As there is currently no cure for RA, treatment goals center on disease
management and controlling symptoms. Treatment is aimed at controlling
disease progression, providing pain relief and reducing swelling,
preventing joint damage and deformity and maintaining function of the
affected joints to prevent disability.



Traditional treatments for RA include nonsteroidal anti-inflammatory
drugs (NSAIDs), corticosteroids and disease-modifying antirheumatic drugs
(DMARDs), with biological therapies a more recent addition. Anti-TNF
(TNF-alpha; Tumor Necrosis Factor) therapies are specific types of
biological therapies which have been used in patients with RA. They may be
given alone but are usually given in combination with methotrexate or
another immunosuppressant. They work by inhibiting the action of TNF-alpha,
an inflammatory mediator, either directly or indirectly responsible for
damaging the joint.



About CIMZIA(R) (certolizumab pegol)



CIMZIA is the only PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA
has a high affinity for human TNF-alpha, selectively neutralizing the
pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha
has emerged as a major target of basic research and clinical investigation.
This cytokine plays a key role in mediating pathological inflammation, and
excess TNF-alpha production has been directly implicated in a wide variety
of diseases.



UCB submitted a Marketing Authorisation Application to the European
Medicines Agency in June 2008 requesting the approval of CIMZIA as a
subcutaneous treatment for adults with moderate to severe active RA. The US
Food and Drug Administration (FDA) has approved CIMZIA (certolizumab
pegol), for reducing signs and symptoms of Crohn's disease and maintaining
clinical response in adult patients with moderate to severe active disease
who have an inadequate response to conventional therapy. CIMZIA was
approved in Switzerland for the induction of a clinical response and for
the maintenance of a clinical response and remission in patients with
active Crohn's disease who have not responded adequately to conventional
treatment. CIMZIA is currently under review by the FDA for the treatment of
adult patients with active rheumatoid arthritis (RA). CIMZIA is a
registered trademark of UCB PHARMA S.A. Please visit ucb-group for
full prescribing information for CIMZIA.



Tuberculosis (frequently disseminated or extrapulmonary at clinical
presentation), invasive fungal infections, and other opportunistic
infections, have been observed in patients receiving CIMZIA. Some of these
infections have been fatal. Anti-tuberculosis treatment of patients with
latent tuberculosis infection reduces the risk of reactivation in patients
receiving treatment with TNF blockers such as CIMZIA. However, active
tuberculosis has developed in patients receiving CIMZIA whose tuberculin
test was negative. Evaluate patients for tuberculosis risk factors and test
for latent tuberculosis infection prior to initiating CIMZIA and during
therapy. Initiate treatment of latent tuberculosis infection prior to
therapy with CIMZIA. Monitor patients receiving CIMZIA for signs and
symptoms of active tuberculosis, including patients who tested negative for
latent tuberculosis infection. Consider anti-tuberculosis therapy prior to
initiation of CIMZIA in patients with a past history of latent or active
tuberculosis in whom an adequate course of treatment cannot be confirmed.



Serious infections, sepsis, and cases of opportunistic infections,
including fatalities, have been reported in patients receiving TNF
blockers, including CIMZIA. Infections have been reported in patients
receiving CIMZIA alone or in conjunction with immunosuppressive agents. Do
not initiate treatment with CIMZIA in patients with active infections,
including chronic or localized infections. Patients who develop a new
infection while undergoing treatment with CIMZIA should be monitored
closely. Discontinue administration of CIMZIA if a patient develops a
serious infection. Exercise caution when considering the use of CIMZIA in
patients with a history of recurrent infection, concomitant
immunosuppressive therapy, or underlying conditions that may predispose
them to infections, or patients who have resided in regions where
tuberculosis and histoplasmosis are endemic.



Use of TNF blockers, including CIMZIA may increase the risk of
reactivation of hepatitis B virus (HBV) in patients who are chronic
carriers of this virus. Some cases have been fatal. Evaluate patients at
risk for HBV infection for prior evidence of HBV infection before
initiating CIMZIA therapy. Exercise caution in prescribing CIMZIA for
patients identified as carriers of HBV. Patients who are carriers of HBV
and require treatment with CIMZIA should be closely monitored for clinical
and laboratory signs of active HBV infection throughout therapy and for
several months following termination of therapy. In patients who develop
HBV reactivation, discontinue CIMZIA and initiate effective anti-viral
therapy with appropriate supportive treatment.



During controlled and open-labeled portions of CIMZIA studies of
Crohn's disease and other investigational uses, malignancies were observed
at a rate (95% confidence interval) of 0.6 (0.4, 0.8) per 100 patient-years
among 4,650 CIMZIA-treated patients verses a rate of 0.6 (0.2, 1.7) per 100
patient-years among 1,319 placebo-treated patients. The size of the control
group and limited duration of the controlled portions of the studies
preclude the ability to draw firm conclusions. In studies of CIMZIA for
Crohn's disease and other investigational uses, there was one case of
lymphoma among 2,657 CIMZIA-treated patients and one case of Hodgkin
lymphoma among 1,319 placebo-treated patients. The potential role of TNF
blocker therapy in the development of malignancies is not known.



Symptoms compatible with hypersensitivity reactions, including
angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have
been reported rarely following CIMZIA administration. If such reactions
occur, discontinue further administration of CIMZIA and institute
appropriate therapy.



Use of TNF blockers, including CIMZIA, has been associated with rare
cases of new onset or exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease. Rare cases of neurological disorders,
including seizure disorder, optic neuritis, and peripheral neuropathy have
been reported in patients treated with CIMZIA; the causal relationship to
CIMZIA remains unclear. Exercise caution in considering the use of CIMZIA
in patients with these disorders.



Rare reports of pancytopenia, including aplastic anemia, have been
reported with TNF blockers. Medically significant cytopenia (e.g.,
leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported
with CIMZIA. The causal relationship of these events to CIMZIA remains
unclear. Advise all patients to seek immediate medical attention if they
develop signs and symptoms suggestive of blood dyscrasias or infection
(e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA.
Consider discontinuation of CIMZIA therapy in patients with confirmed
significant hematologic abnormalities.



Serious infections were seen in clinical studies with concurrent use of
anakinra (an interleukin-1 antagonist) and another TNF blocker, with no
added benefit. Therefore, the combination of CIMZIA and anakinra is not
recommended.



Interference with certain coagulation assays has been detected in
patients treated with CIMZIA. There is no evidence that CIMZIA therapy has
an effect on in vivo coagulation.



Cases of worsening congestive heart failure (CHF) and new onset CHF
have been reported with TNF blockers. CIMZIA has not been formally studied
in patients with CHF. Exercise caution when using CIMZIA in patients who
have heart failure and monitor them carefully.



Treatment with CIMZIA may result in the formation of autoantibodies
and, rarely, in the development of a lupus-like syndrome. Discontinue
treatment if symptoms of lupus-like syndrome develop.



Do not administer live vaccines or attenuated vaccines concurrently
with CIMZIA.



In controlled Crohn's clinical trials, the most common adverse events
that occurred in greater than or equal to 5% of CIMZIA patients (n=620) and
more frequently than with placebo (n=614) were upper respiratory infection
(20% CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo),
and arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who
discontinued treatment due to adverse reactions in the controlled clinical
studies was 8% for CIMZIA and 7% for placebo.



CIMZIA should be administered by a healthcare professional.



About UCB



UCB, Brussels, Belgium (ucb-group) is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialization of innovative medicines with a focus on the fields of
central nervous system and immunology disorders. Employing around 12 000
people in over 40 countries, UCB achieved revenue of 3.6 billion euro in
2007. UCB is listed on Euronext Brussels (symbol: UCB). UCB's North
American headquarters is located in Atlanta, Ga.



Forward Looking statement



This press release contains forward-looking statements based on current
plans, estimates and beliefs of management. Such statements are subject to
risks and uncertainties that may cause actual results to be materially
different from those that may be implied by such forward-looking statements
contained in this press release. Important factors that could result in
such differences include: changes in general economic, business and
competitive conditions, effects of future judicial decisions, changes in
regulation, exchange rate fluctuations and hiring and retention of its
employees.


UCB

ucb-group

Thiarabine Demonstrates A Reduction Of Both Inflammatory And Erosive Disease Parameters In Rheumatoid Arthritis

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) announced new preclinical data demonstrating that thiarabine shows remarkable efficacy in the prevention and treatment of rheumatoid arthritis (RA). In a well-established animal model for RA, an exceptional restoration of joint structure was observed in the studies, which were conducted at Wayne State University School of Medicine and at Southern Research Institute.


As a therapeutic treatment of established disease, thiarabine demonstrated a highly significant, dose-dependent amelioration of arthritis. Thiarabine treatment resulted in a broad inhibition of disease pathology, with reduction of both inflammatory and erosive disease parameters, as well as protection from loss of cartilage matrix proteins. When used as a preventative treatment, thiarabine blocked the development of joint disease at the 60 mg/kg/day dose level and exhibited a significant reduction in disease incidence and severity at 20 mg/kg/day.


In a therapeutic study comparing thiarabine to methotrexate, a commonly used clinical drug for RA treatment, high resolution 3-D images from an X-ray microtomograph were used along with histological scoring to evaluate joint and bone destruction. Thiarabine demonstrated statistically significant anti-arthritic efficacy comparable to that of methotrexate. "The images from X-ray microtomography present a compelling visual representation of diseased vs. treated limbs" commented David Nowotnik, Senior Vice President Research and Development. "We are delighted with the results of the preclinical study which demonstrate a real benefit to the use of thiarabine in RA."


"Our current development focus for thiarabine is for the treatment of hematological cancers," stated Jeffrey B. Davis, President & CEO. "But, we believe these new RA data provide compelling evidence that Thiarabine should be developed for rheumatoid arthritis as well."


Thiarabine is a next generation nucleoside analogue that Access has licensed from Southern Research. It has been in two Phase 1/2 solid tumor trials and was shown to have significant anti-tumor activity. Access is now working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and other indications. "The IND for thiarabine has been transferred to Access and we have a supply of clinical-grade material." continued Dr. Nowotnik. "We should be able to start the study shortly after FDA clearance of the protocol and drug recertification."















Access is actively seeking co-development partners for all applications of Thiarabine.


About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.


This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access' plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.


Source: Access Pharmaceuticals, Inc

Progression Slowed And Symptoms Of Knee Osteoarthritis Relieved By Chondroitin

Osteoarthritis (OA) causes disability and is a major public health problem. A new study examined the effect of chondroitins 4 and 6 sulfate (CS) on OA progression and symptoms. CS, unlike other chondroitin sulfate products sold as dietary supplements in the U.S., has been approved as a prescription symptomatic slow acting drug for OA in many European countries. The study was published in the February issue of Arthritis & Rheumatism.



Led by Andre Kahan of the University of Paris Descartes in Paris, the randomized, double-blind, placebo-controlled study involved 622 patients with OA from France, Belgium, Switzerland, Austria and the U.S. Patients had knee X-rays at the time of enrollment and at 12, 18 and 24 months. The X-rays were evaluated for joint space loss and patients were also assessed for OA symptoms and pain.



The results showed that "long-term administration of CS over 2 years can prevent joint structure degradation in patients with knee OA," the authors state. Joint space loss was significantly reduced in the CS group, fewer patients had progression of joint space width, and CS reduced pain in those taking it compared to the placebo group. CS was well-tolerated and there were no significant differences in the frequency of adverse events between the two groups.



The study showed that there was faster improvement regarding pain during the first year in the CS group compared to the placebo group. This may be due to the fact that all of the patients had pain symptoms, so the effect of CS was more noticeable early on. Since those who took a placebo also had decreased pain in the first year, it may also be due to the natural course of the disease. The authors note that the study involved CS, which is used as a prescription drug and that the results cannot be generalized to other chondroitin sulfate products or compounds, such as those available in the form of dietary supplements.



The decrease in joint space loss shown in this and another recent study involving 300 patients, suggests better outcomes for OA patients, according to the authors. They conclude: "Further studies with longer followup and different outcome criteria are warranted to assess whether the beneficial structural changes associated with CS demonstrated in our study are predictive of improvement in the long-term clinical progression of OA."







Article: " Long-Term Effects of Chondroitins 4 and 6 Sulfate on Knee Osteoarthritis," Andre Kahan, Daniel Uebelhart, Florent De Vathaire, Pierre Delmas, Jean-Yves Reginster, Arthritis & Rheumatism, February 2009.



Source: Sean Wagner


Wiley-Blackwell

Roche Comment On NICE Anti-TNF Inhibitor Sequencing FAD

Following the widespread media coverage regarding the NICE FAD on the sequencing
of anti-TNF inhibitors, Roche want to reassure patients with rheumatoid arthritis and
rheumatology health professionals that they will continue to benefit from access to
effective treatment with MabThera (rituximab), following the use of one anti-TNF, for this
debilitating disease.



MabThera has proven to be clinically effective for patients who cannot tolerate or do not
respond to an anti-TNF inhibitor and as per NICE's recommendations, provides such
patients with a vital and cost effective treatment option.



The money that will be released by not cycling to a second anti-TNF would be available
to be used to give new hope to thousands of patients, suffering from rheumatoid arthritis,
who currently don't have access to any biologic treatment, including MabThera, on the
NHS.



It is the fundamental belief of Roche that every eligible patient should benefit from the
best available treatment for their disease and wholly support patient choice.



References:

1- NICE -FAD Adalimumab, Etanercept and Infliximab for the treatment of rheumatoid arthritis after failure of
a previous TNF inhibitor. July 2008


Source:

Teva Dawson

roche

Alcohol Consumption Lowers Risk Of Rheumatoid Arthritis

Alcohol consumption has been linked with a decrease in risk of
developing rheumatoid arthritis, according to an article released on
June 5, 2008 in the BMJ specialist journal Annals of the
Rheumatic Diseases.



Arthritis is a disease that involves damage to the joints of the body.
Rheumatoid arthritis is specifically a type of damage caused by
autoimmune attack resulting in inflammation of the protective
cartilage. It commonly affects multiple joints at once, and can result
in severe deformation of the joints themselves.



More than 2,750 subjects were examined in two separate studies
regarding various environmental and genetic risk factors for rheumatoid
arthritis. These included survey questions about lifestyle,
specifically, how much they smoked and drank. Separately, blood samples
were taken and examined for genetic risk factors. Nearly half of the
participants (1650 subjects) suffered from
rheumatoid arthritis, and their non-arthritic counterparts were
similarly distributed in terms of sex, age, and residential location.



Drinking alcohol was associated with a significantly lower risk of
developing rheumatoid arthritis. In face, it was found that the more
alcohol a subject consumed, the better their chances were to escape
this disease. The top one quarter of regular drinkers were 50% less
likely to develop the disease in comparison with the half of the
population drinking the least. This effect was true for both males and
females. However, it was more pronounced in subjects who already
carried risk factors for the disease. Among the other factors examined,
smoking has already been shown to increase the risk of rheumatoid
arthritis -- this was confirmed and magnified by genetic risk
factors.? 



According to the authors, this strengthens the idea that lifestyle
factors are of great importance in the development of this disease.
Other researchers have also observed this connection between alcohol
arthritis prevention. Additionally, this is similar to other studies
linking alcohol consumption to a reduced risk of other inflammatory
processes including cardiovascular disease. They note that, despite
these new results, giving up smoking is still this disease's single
most effective preventative measure.



Alcohol consumption is associated with decreased risk of
rheumatoid
arthritis: results from two Scandinavian case-control studies

H Kallberg, S Jacobsen, C Bengtsson, M Pedersen, L Padyukov, P Garred,
M Frisch, E W Karlson, L Klareskog, L Alfredsson

Online
First Ann Rheum Dis

10.1136/ard.2007.086314

Click Here For Journal



Written by Anna Sophia McKenney

CombinatoRx'S Synavive (CRx-102) Maintains Efficacy Throughout 12 Month Phase 2 Knee OA Extension Trial

CombinatoRx, Incorporated (NASDAQ: CRXX) announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive™ (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial. These findings further support the core study data, which was presented at EULAR in June 2009, in which knee OA efficacy was observed early in treatment and sustained throughout the three month core study in all WOMAC measurement subscales including pain, physical function and stiffness. Synavive is a novel dissociated glucocorticoid product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and is being developed as a uniquely engineered oral, once-daily formulation.


In addition to maintaining efficacy for the Synavive-treatment group, placebo-treated subjects in the core study also experienced statistically significant improvements in all WOMAC measurement subscales upon crossing over to Synavive in the extension trial. Importantly, no treatment-related increase in glucocorticoid associated adverse events were observed in Synavive-treated subjects.


"Synavive appears to be well-tolerated and efficacious in reducing the signs and symptoms of knee OA over a 3 to 12-month period," said Robert Forrester, Interim President and CEO of CombinatoRx. "These findings support the knee OA core study results and supplement the positive hand OA core study data, providing an attractive risk/benefit ratio warranting further development of Synavive in inflammatory conditions such as osteoarthritis and rheumatoid arthritis".


Highlights of the data include:



-- Synavive activity in knee OA, which was observed early in the core study, was sustained over a 12-month period in the extension trial.


-- Placebo-treated patients in the core study experienced statistically significant improvements in all WOMAC measurement subscales, including pain, physical function and stiffness, upon crossing over to Synavive treatment in the extension trial.


-- Synavive safety was assessed through 12 months of treatment:


- No treatment-related serious adverse events were reported.

- No treatment-related increase in glucocorticoid-associated adverse events such as glucose levels, glaucoma, cataracts, infections, weight gain, bone loss or fractures were observed.


About Synavive (CRx-102)


Synavive is a novel dissociated glucocorticoid product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and is being developed as a uniquely engineered formulation. Synavive is thought to act through a novel multi-target mechanism of action in which dipyridamole synergistically and selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities by inhibiting key cell mediators of inflammation. In prior proof-of-concept clinical trials, Synavive demonstrated a powerful anti-inflammatory effect and rapid onset of action in patients with osteoarthritis and rheumatoid arthritis and was generally well-tolerated. Synavive is in Phase 2 clinical development for the treatment of immuno-inflammatory conditions.


Source

CombinatoRx

To Avoid Stomach Upset In Arthritis Patients, Drug Combination More Effective

UCLA/VA researchers found that for arthritis patients, taking a combination of two drugs may be most effective in protecting against stomach upset called dyspepsia, which is a side effect of common pain medications.



Published this week in The American Journal of Medicine, the study showed that for arthritis patients, taking an anti-inflammatory drug like Naproxen with an acid-reducing drug like Prevacid may prove more effective than taking a Cox-2 inhibitor like Celecoxib alone for protecting against stomach upset.



More than 15 million Americans suffer from chronic arthritis, including osteoarthritis and rheumatoid arthritis. According to researchers, non-steroidal anti-inflammatory drugs (NSAIDS) are the most commonly used medications for these conditions, but often cause gastrointestinal discomfort known as dyspepsia.



"Dyspepsia can be a major problem for patients, causing stomach upset symptoms such as nausea, bloating, gas and belching," said Dr. Brennan M.R. Spiegel, study author and director, UCLA/VA Center for Outcomes Research and Education (CORE). "These symptoms are far more common than more serious side effects like ulcers or bleeding."



Researchers found that compared to taking an over-the-counter anti-inflammatory by itself, a Cox-2 inhibitor taken alone reduced dyspepsia occurrence by 12 percent. An anti-inflammatory taken with an acid-reducing drug together, however, lowered incidence of dyspepsia by 66 percent.



"The drug combination was significantly more effective in reducing dyspepsia and may prove to be the preferred treatment for arthritis patients at high risk for stomach problems," said Spiegel, assistant professor of medicine, David Geffen School of Medicine at UCLA and Veterans Affairs Greater Los Angeles Healthcare System.



The study involved a systematic review of clinical trial findings in medical literature and then researchers conducted a more sensitive meta-analysis of the results.







The study is funded by TAP Pharmaceuticals Products, Inc., manufacturer of lansoprazole, a proton pump inhibitor, which is marketed under the brand name Prevacid. Spiegel is also a consultant for TAP.



In addition to Spiegel, other researchers include Mary Farid, DO; Dr. Gareth S. Dulai; Dr. Ian M. Gralnek and Dr. Fasiha Kanwal.



Contact: Rachel Champeau

University of California - Los Angeles



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