"When treating a debilitating disease like RA, it is important to have several treatment options, and we are encouraged by the safety and efficacy data we have seen thus far for golimumab," said Jonathan Kay, MD, Director, Clinical Trials, Rheumatology Unit, Massachusetts General Hospital, Associate Clinical Professor of Medicine, Harvard University School of Medicine and lead study investigator.
Golimumab, developed by Centocor, Inc. and Schering-Plough, is a fully-human anti-TNF-alpha IgG1 monoclonal antibody that targets and neutralizes both the soluble and the membrane-bound form of TNF-alpha. Golimumab is currently being investigated for administration by either subcutaneous (SC) injection or intravenous (IV) infusion.
Data from the study showed that significantly more patients in all groups receiving SC injections of golimumab plus MTX achieved ACR 50 response (marked improvement in arthritis symptoms according to the American College of Rheumatology scoring criteria) versus patients receiving placebo plus MTX. Adults with active RA for at least three months' duration despite MTX therapy were randomized to one of five treatment groups: placebo every two weeks or golimumab 50 or 100 mg every two weeks or every four weeks. All patients received stable doses of MTX of greater than or equal to 10 mg/week. After just 16 weeks of treatment, 62 percent of all patients receiving golimumab (combined golimumab treatment groups) experienced at least 20 percent improvement in arthritis symptoms (ACR 20), compared with 37 percent of placebo-treated patients (P = 0.008). Additionally, at week 16, 31 percent of patients in the combined golimumab treatment groups achieved ACR 50, and 12 percent achieved ACR 70, compared with six percent and zero percent, respectively, of patients in the placebo group. All individual golimumab treatment groups achieved higher ACR 20 response rates than placebo. Golimumab 50 mg every four weeks (63 percent) and golimumab 100 mg every two weeks (79 percent) were statistically significantly more effective than placebo (37 percent) in achieving an ACR 20 response (P = 0.031 and P < 0.001, respectively).
Patients in the golimumab plus MTX treatment group also achieved remission, as assessed by DAS 28, which measures tender and swollen joints, inflammation and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 16 weeks of treatment, 27 percent of patients in the combined group achieved remission as assessed by DAS28 compared with six percent of patients receiving MTX alone (P = 0.007).
Adverse events in the golimumab groups were similar to those in the MTX group. Serious adverse events were reported in eight percent of patients in the combined golimumab group, compared with six percent in the MTX group. No deaths, cases of tuberculosis or other opportunistic infections were reported and serious infections were uncommon. One case each of lung cancer, congestive heart failure, cardiac tamponade, and two cases of pneumonia were reported among patients treated with golimumab.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, progressive disease and research demonstrates that a critical therapeutic window exists within the first two years of disease onset when the rate of radiographic progression of the disease can be "reset." 1,2,3 Radiographic changes occur within two years of disease onset in 50 percent to 70 percent of RA patients.4 The American College of Rheumatology suggests control of disease progression should start early to limit joint damage in RA.3 RA is associated with substantial disability and economic losses, and one study showed that one-third of patients in the United Kingdom who were employed became work-disabled within two years of disease onset.5 Rheumatologic disorders also account for 25 percent of Social Security disability payments in the United States.6
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 and ulcerative colitis.
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, a worldwide manufacturer of healthcare products.
(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 Johnson & Johnson'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(b) of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K are available online at www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson assumes no obligation 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 more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE:
This press release contains certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements related to the potential market for golimumab and the company's strategy. 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, current and future branded, generic or over-the-counter competition and the regulatory process, 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 the company's third quarter 2005 10-Q.
1 Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
2 Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis benefit from early 2nd line therapy: 5 year follow up of a prospective double blind placebo controlled study. J. Rheumatol. 1995;22:2208-2213.
3 American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, 2002 Update.
4 van der Heijde DM. Joint erosions and patients with early rheumatoid arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
5 Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study. Rheumatology. 2000;39:1403-1409.
6 Social Security Disability Insurance Program.