New Magnetic Resonance Imaging (MRI) Data Show Efficacy of SIMPONI® in Treatment of Rheumatoid Arthritis

/PRNewswire/ -- Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI® (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate. Changes in disease activity were measured using the Rheumatoid Arthritis MRI Scoring (RAMRIS) system, which assesses three components: synovitis, bone edema (osteitis) and bone erosions. Changes in RAMRIS scores were observed as early as week 12 and continued through week 24. These data were presented at the largest rheumatology medical meeting in the United States.

"MRI assessment has previously been demonstrated to show greater sensitivity than x-ray in detecting changes in inflammation and the structural integrity of the bone. The findings from a randomized controlled trial with a large number of patients show the value of this diagnostic tool in its ability to monitor disease progression" said Dr. Paul Emery, head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds and lead study investigator. "The ultimate goals of inhibiting joint damage are to both reduce the symptoms that patients with RA experience and also to preserve patients' functional ability (which is correlated with early structural changes). These findings present important new information for rheumatologists and further support the substantial efficacy SIMPONI demonstrated in multiple Phase 3 registration trials in the treatment of this chronic disease."

Investigators reported that at week 24 of the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study, patients with RA receiving SIMPONI 50 mg plus methotrexate showed significant improvements in synovitis, bone edema and bone erosions [-2.2 (P = 0.011), -2.5 ( p <0.001) and -0.7 (p = 0.016), respectively], compared with patients receiving placebo plus methotrexate (-1.0, -0.3 and -0.2, respectively).

In a second study, GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD), patients receiving SIMPONI 50 mg plus methotrexate experienced significant improvements in synovitis and bone edema [-1.9 (p < 0.001) and -2.6 (p < 0.001), respectively] at week 24 when compared with the placebo plus methotrexate group (-0.4 and 0.7, respectively). Minimal changes in bone erosion across all treatment groups (mean change ranging from -1.1 to 0.4) precluded the adequate evaluation of the effects of SIMPONI on bone erosion, which is consistent with previously published radiographic data.

In September 2010, Centocor Ortho Biotech Inc. announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI physician label to include inhibiting the progression of structural damage in the treatment of moderately to severely active RA.

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UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

/PRNewswire/ UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia(R), the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia(R) can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered.

In clinical trials with Cimzia(R), together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia(R), together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p<0.001).

"The approval of Cimzia(R) for moderate to severe rheumatoid arthritis in the U.S. is a major milestone for UCB, and most importantly, for people seeking a new treatment option to manage this debilitating condition," said Roch Doliveux, Chief Executive Officer of UCB. "UCB is committed to developing new therapies, such as Cimzia(R), to help meet the needs of patients living with rheumatoid arthritis and other immune diseases. I am also proud of our partnership with OXO(R) and of the fact that RA patients were directly involved in the design and development of our new prefilled syringe, which is designed to make self-administration easy for people living with rheumatoid arthritis."

The new prefilled Cimzia(R) syringe is now also available for subcutaneous self-administration to U.S. patients with moderate to severe Crohn's disease who have had an inadequate response to conventional therapy.

The FDA approval is based on UCB's comprehensive clinical program, including data from four multi-center placebo-controlled phase III trials, involving more than 2 300 patients with RA and over 4 000 patient-years experience. Cimzia(R) has been studied at dosing intervals of two or four weeks, and administered together with MTX or as monotherapy.

In the pivotal clinical trials, reported serious adverse reactions were infections including tuberculosis and malignancies including lymphoma. The most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data show there was a low incidence of injection site pain (<2%) and a low level of discontinuations due to adverse events (5%).

"People with RA have pain and swelling of joints with stiffness and fatigue which makes it difficult for them to perform many activities of daily living, sometimes making it a struggle to even get out of bed," said Roy Fleischmann, MD, Clinical Professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center in Dallas. "With the approval of Cimzia(R), I now have another alternative to offer my patients in an easy-to-use treatment that improves quality of life and inhibits structural damage."

It is estimated that 5 million people suffer from RA globally. In the United States alone, an estimated 1.3 million people have the disease. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 35-55 years of age.

Forward-looking statements

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.

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New Research Shows Promise for Finding A Cure for Rheumatoid Arthritis

PRNewswire/ -- For the first time during its unprecedented initiative to find a cure for rheumatoid arthritis, the American College of Rheumatology Research and Education Foundation is releasing new information acquired from research funded by the Within Our Reach: Finding a Cure for Rheumatoid Arthritis campaign.

Doctors and scientists from across the nation are utilizing more than $12 million in grants awarded by the ACR REF to investigate critical issues including early detection of RA, novel treatment pathways as well as improved patient-provider interaction and patient care. While research is still underway, the REF is encouraged by the progress made thus far and is pleased to announce the new and promising knowledge which RA researchers will continue to build upon as studies continue.

"The REF is committed to funding RA research that is not being done elsewhere, and supporting scientists and doctors who are most prepared and motivated to work on finding a cure," said Dr. Leslie J. Crofford, president of the REF. "The quality and value of the studies in progress is evidence that the Within Our Reach campaign to is critical and must continue."

Viewed as one of the most disabling types of arthritis, RA affects nearly 1.3 million Americans. But, because of rapidly advancing research into the fundamentals of inflammation, the outlook for those suffering from RA has improved dramatically over the past 25 years. Recent advances in treatment have made it possible to stop, or at least slow the progression of joint damage. Additionally, new therapies that target inflammation are being developed.

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