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News Release - October 27, 2008
One-Year Data Show Golimumab Improved Signs and Symptoms In Patients with Psoriatic Arthritis In Phase 3 StudyNew Findings Also Demonstrate Treatment Results in Improvements in Physical Function and Health-Related Quality of Life
SAN FRANCISCO, Oct. 27 -- (Healthcare Sales & Marketing Network) -- More than half of patients receiving every four week subcutaneous injections of golimumab (CNTO 148) 50 mg and 100 mg, an investigational therapy, experienced sustained improvements in the joint and skin symptoms of active psoriatic arthritis through six months with results sustained through one year. Golimumab-treated patients also experienced improvements in health-related quality of life (HRQOL) in the placebo-controlled portion of the study (through week 24) along with the substantial improvements in physical function and arthritis and psoriasis components of the disease. These findings were presented at the American College of Rheumatology (ACR) annual meeting.
"These results demonstrate long-term efficacy of every four week dosing with golimumab in improving physical symptoms and functional ability as well as improving quality of life," said Arthur Kavanaugh, M.D., Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "The sustained effects of golimumab as demonstrated in these study findings are encouraging for both the physicians treating this condition and for the many patients living with this potentially debilitating disease."
In the study, Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL), 52 percent and 61 percent of patients receiving golimumab 50 mg and 100 mg, respectively, achieved at least 20 percent improvement in arthritis signs and symptoms as measured by American College of Rheumatology (ACR 20) response compared with 12 percent of patients receiving placebo (P < 0.001) at week 24. Through one year, 78 percent of patients continuing in the golimumab 50 mg group and 74 percent of patients continuing in the golimumab 100 mg group achieved ACR 20 response. Improvements were also observed in ACR 50 and ACR 70 measures within the same timeframes. Thirty-two percent and 38 percent of patients receiving golimumab 50 mg and 100 mg, respectively, achieved ACR 50 at week 24 compared with 4 percent of patients receiving placebo (P < 0.001). Fifty-seven percent and 53 percent of patients continuing in the respective golimumab dosing groups achieved ACR 50 response through one year. ACR 70 was achieved by 19 percent and 21 percent of patients receiving golimumab 50 mg and 100 mg, respectively, at 24 weeks compared to 1 percent of patients receiving placebo (P < 0.001). These results were sustained through one year with 43 percent of patients receiving golimumab 50 mg and 31 percent of patients receiving golimumab 100 mg achieving ACR 70.
The majority of patients treated with golimumab every four weeks experienced improvements in disease activity as measured by good or moderate Disease Activity Score 28 (DAS 28) response. At week 24, 64 percent and 78 percent of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS 28 responders, compared with 24 percent of patients receiving placebo (P < 0.001). At one year, 93 percent and 86 percent of patients continuing to receive golimumab 50 mg and 100 mg, respectively, were DAS 28 responders.
Golimumab-treated patients also experienced substantial and sustained improvements in psoriatic skin disease through one year. Patients with greater than 3 percent Body Surface Area (BSA) psoriasis skin involvement at baseline were evaluated for Psoriatic Area and Severity Index (PASI) responses. At week 24, 56 percent of patients treated with golimumab 50 mg and 66 percent of patients treated with golimumab 100 mg achieved at least 75 percent improvement in PASI (PASI 75), compared with 1.4 percent of patients receiving placebo (P < 0.001). At one year, 62 percent and 69 percent of patients continuing in the golimumab 50 mg and 100 mg dose groups, respectively, achieved PASI 75.
Improvements in Physical Function and Health-Related Quality of Life
In addition to improvements in signs and symptoms of psoriatic arthritis, patients receiving every four week dosing with golimumab also experienced clinically meaningful (increase of at least 0.3) improvement in physical function, as measured by the Health Assessment Questionnaire (HAQ). HAQ assesses the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living.) At week 24, patients treated with golimumab 50 mg and 100 mg had a mean improvement of 0.33 and 0.39 score, respectively, as compared to placebo patients worsening by a mean of 0.01 score (P < 0.001). At one year, the mean improvements were 0.49 in patients continuing to receive golimumab 50 mg and 0.45 in patients continuing to receive golimumab 100 mg.
"These findings show golimumab to be promising in improving multiple aspects of psoriatic arthritis, including key areas such as physical function and productivity," said Philip Mease, M.D., Seattle Rheumatology Associates, and Swedish Medical Center, Seattle, and lead study investigator. "The results demonstrate that the effectiveness of golimumab extends beyond the categories of signs and symptoms and improved the lives of patients and those who care for them as measured through this analysis."
Patients in both golimumab groups experienced improvements in HRQOL as measured by the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short form (SF)-36 questionnaire. SF-36 assesses well- being in patients along eight domains of health status, including physical functioning, pain, vitality, social functioning, psychological functioning, general health perceptions, and role limitations due to physical and emotional problems.
At week 14, patients receiving golimumab 50 mg and 100 mg achieved a mean change of 6.53 and 7.85 scores, respectively, in PCS compared with a mean change of 0.63 among patients receiving placebo (P < 0.001). At six months, these results improved to mean changes of 7.42 and 8.22 in the respective treatment groups, compared with a mean improvement of 0.67 in the placebo group (P < 0.001). Also at week 14, patients receiving golimumab 50 mg achieved a mean change of 2.79 in MCS, while patients receiving golimumab 100 mg achieved a mean change of 3.56, compared with a mean change of 0.40 in patients treated with placebo (P < 0.05). At six months, patients receiving golimumab 50 mg and 100 mg achieved a mean change of 3.37 and 4.29, respectively, compared with 0.60 in placebo-treated patients (P < 0.05).
Self-reported productivity was measured on a Visual Analog Scale (VAS), a tool used to assess the patients' daily productivity at work, school or home. Patients receiving golimumab 50 mg and 100 mg experienced improvements in self-reported productivity, both at 16 and 24 weeks, while patients receiving placebo reported no change in their productivity at 16 weeks and a decrease in productivity at 24 weeks. Additionally, caregivers of golimumab-treated patients experienced a reduction of time lost from work through week 24, compared with caregivers of patients treated with placebo.
Nail, Enthesitis and Dactylitis Response
In patients with nail involvement or enthesitis at baseline, both golimumab treatment groups experienced improvements in psoriatic nail changes and enthesitis, as measured by the Nail Psoriasis Severity Index (NAPSI) and the psoriatic arthritis-modified Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), respectively. In patients with dactylitis at baseline, both golimumab dose groups also experienced improvements in dactylitis, though the changes were not statistically significant with the 50 mg dose. Enthesitis, an inflammation of a tendon, ligament or joint capsule insertion to the bone, and dactylitis, a swelling of digits in the hands or feet, are estimated to affect more than one-third of people with psoriatic arthritis.
The Biologics License Application (BLA) and Marketing Authorization Application (MAA) for golimumab were submitted earlier in the year and are currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), respectively. The filings are based on the extensive clinical development program for golimumab, including data from five pivotal Phase 3 trials in rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis.
About the GO-REVEAL Trial
The GO-REVEAL trial involved 405 adults with psoriatic arthritis. Subjects with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 centimeters in diameter were randomly assigned to receive subcutaneous injections of placebo or golimumab (50 or 100 mg) at week 0 and every 4 weeks thereafter through the end of the study. At week 16, patients with inadequate arthritis response were switched to golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg (patients originally receiving golimumab 50 mg). At week 24 all placebo patients crossed over to active treatment with golimumab 50 mg. The primary endpoint was ACR 20 response at week 14 for combined golimumab groups and individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, 2 percent of golimumab-treated patients experienced serious adverse events (SAE) compared with 6 percent of patients in the placebo group. Injection site reactions (ISR) occurred in 5 percent of patients receiving golimumab and 3 percent of patients receiving placebo. One case of prostate cancer and 2 cases of basal cell carcinoma were reported in golimumab-treated patients. Through week 52, 5 percent of golimumab-treated patients experienced SAEs and no tuberculosis or opportunistic infections were reported. Between weeks 24 and 52, one colon and one small cell lung cancer were reported. The small cell lung cancer patient died; another patient died in a climbing accident. Through one year, golimumab had a similar safety profile to the first 6 months.
Anti-TNF therapies have been associated with serious and sometimes fatal risks including the risk of tuberculosis and other serious infections, malignancies, heart failure, central nervous system disorders, reactivation of hepatitis B and other serious events.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.
Golimumab, the next-generation human anti-TNF-alpha monoclonal antibody from Centocor Inc. and Schering-Plough Corporation, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as an every four-week subcutaneous injection and an intravenous (IV) infusion therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Centocor does not undertake to update any forward-looking statements as a result of new information or future events or developments.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for Golimumab. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 8.01 of Schering-Plough's Form 8-K filed October 21, 2008.
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