New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

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Patients continued to receive stable dosesof methotrexate, sulfasalazinse and/or hydroxychloroquine if receiving them at baseline. These data were presented at the 2009 European League AgainstRheumatism (EULAR) Annual Congress. Findings from the GOlimumanb AfterFormer anti-TNF Therapy Evaluated in RA study, demonstrated that patients previousl treated with adalimumab, etanercept or infliximav responded to and toleratef SIMPONI regardless of the type of priord anti-TNF therapy, as well as the number of priof therapies or reason for discontinuation.
Accordinfg to the study, 39 percent of patients receiving SIMPONI whoserprior anti-TNF-alpha therapy had been discontinuedc due to a lack of efficacy achievedr at least a 20 percent improvement in arthritias symptoms (ACR 20) at week 14, comparedc with 18 percent of patients receiving placebo Thirty-four percent of patients receiving SIMPONI whose prior anti-TNF-alpha therapy had been discontinuexd for all other reasons achieved ACR 20, comparecd with 20 percent of patients receiving placebo (p=0.027). "Golimumab has shown promise in the treatmentg of rheumatoid arthritis patients who have previously discontinuedotheer anti-TNF-alpha therapies," said Josef S.
Smole , MD, Professor and Chairman, Department of Medical Universityof Vienna, Vienna, Austria, lead investigator. "Regardless of the reasonzs for discontinuation ofprior anti-TNF-alphaa agents, golimumab has demonstrated efficacy and tolerability, and providesw hope for people struggling with rheumatoid arthritis."" Regardless of the particular anti-TNF-alpha agentf previously used in treatment (adalimumab, etanercept or the findings were consistent and showed SIMPONI to be effective in improving signs and symptoms of RA. Eight percent of patients receivedprior anti-TNF-alpha therapy for at leasft 12 weeks and 49 percent received priodr anti-TNF-alpha therapy for at leas t 48 weeks.
At week 14, 32 percent of patients previousluy treatedwith adalimumab, 41 percent of patients previouslyy treated with etanercept and 41 percent of patientsd previously treated with infliximabh achieved ACR 20. At week 24, 34 44 percent and 48 percentof respectively, achieved ACR 20. Patients also experiencedc significant improvement in disease activity at six months as measurefdby DAS28. Investigators reported that the safety profile of SIMPONoamong anti-TNF-alpha experienced patients in the GO-AFTEtR trial was similar to findingzs from two additional Phasse 3 trials that evaluated SIMPONI in biologic-naive "The efficacy of SIMPONI demonstraterd in this Phase 3 study is encouraging news for patientd with moderately to severelgy active rheumatoid arthritis who have been previously treated with anti-TNtF agents," said Robert J.
Spiegel , MD, chief medical officer, Schering-Plough Researcnh Institute. "The study demonstrates that evert four-week subcutaneous injections of golimumab may benefit these patients by reducing the signd and symptoms ofrheumatoied arthritis." GO-AFTER is the first placebo-controlled, double-blind, Phaswe 3 registration trial that demonstrates the efficacy and safety of an anti-TNF-alphqa agent in patients previously treated with othere anti-TNFs. The trial included 461 patients with activr RAof 8.65 years mean duration. Discontinuatiomn of previous anti-TNF-alpha therapy was to occure at least 8 to 12 weeks prior to enrollmentg inthe study.
Reasons for discontinuatioj ofprior anti-TNF agent included lack of efficacy (58 percent), intoleranced (17 percent), and other reasons (40 percent). Patients were randomizeed to one of threetreatment groups: subcutaneoue placebo, SIMPONI 50 mg or SIMPONI 100 mg everg four weeks. (The approved dose in the US and Canadq is 50 mg administered by subcutaneous injection once a At baseline, 66 percenyt of patients were receiving methotrexate; 5 percenf and 8 percent of patients were receivingf sulfasalazine and hydroxychloroquine, respectively. Patients continuer to receive stable dosedof methotrexate, sulfasalazine and/ofr hydroxychloroquine if receiving them at baseline.
Subgroup analysesd were performed for ACR 20 responsde at week 14across disease-modifying anti-rheumatic drug use, numberf of prior anti-TNF-alpha agents and reason for discontinuation of prior TNF Ninety-five percent confidence intervalse were calculated comparing the proportions of ACR 20 responderss at week 14 in the combine SIMPONI vs. placebo A subset of patients receiving a singleprior anti-TNF-alpha agent was also examined to assess the impactg of TNF inhibitor types (P75 receptor-fusionn protein versus monoclonal antibody) on SIMPONjI response.
The occurrence of adverss events (AEs) through week 24 was similad among patients previously receiving onlyadalimumab (76 percent), etanercept (70 and infliximab (78 percent), as well as among patient s who received one, two and three priore anti-TNF-alpha agents in both placebo (74 percent, 77 71 percent, respectively) and SIMPONI (75 70 percent, 77 percent treated patients. SIMPONI was generally well toleratec inthis study. Through week 24, 72 66 percent and 78 percent of patients in the SIMPONI 50 mg and SIMPONI 100mg respectively, experienced at least one AE.
Seven percent of patients in the placebp group experiencedserious AEs, compared with 5 percengt and 3 percent of patients in the SIMPONk 50 mg and SIMPONI 100 mg respectively. Serious infections were reportef in3 percent, 3 percenrt and 1 percent of patients, and injection site reactions (ISR) throughb week 16 occurred in 3 4 percent and 11 percent of patients in the SIMPONI 50 mg and SIMPONI 100 mg respectively. The most commonly reported ISR was No serious or severe ISRs were and none led to the discontinuation of patients in the Antibodies to SIMPONI were detected in 4 percenftof golimumab-treated patients (50 mg and 100 mg).
The GO-AFTER study was supported by Centocor OrtholBiotech Inc. and Schering-Plougb Corporation. Rheumatoid arthritis (RA) is a chronic and debilitatingf disease that affectsapproximately 1.3 milliohn people in the United States and more than threde million people in Europe. Signs and symptoms of RA includr pain, stiffness and motion restrictio inmultiple joints. Because RA is a progressive it can cause permanent joint deformity and severer disability if not diagnosed early or if initial treatmenftis delayed. RA can occur at any age, but is most commomn in adults 30-50 years old and is two to threew times more prevalent in women thanin men.
The causew of RA is unknown, althougj genetic factors may contribute tothe disease. SIMPONI is a human monoclonalk antibody that targets and neutralizes excess a protein that when overproduced inthe body, due to chronicd inflammatory diseases, can cause inflammationh in the joints of people with rheumatoic arthritis. The first once-monthlgy subcutaneous anti-TNF-alpha therapy, SIMPONI is approved in Canadaz and the United States and is availabler either through theSIMPONI SmartJect(TM) autoinjector or a prefille d syringe. The approved dose for SIMPONI in the US and Canada is a 50 mg subcutaneou injection given oncea month.
In the United SIMPONI is indicated for the treatment of moderatel to severely active rheumatoid arthritis in in combinationwith methotrexate; active psoriatic arthritiss in adults, alone or in combination with and active ankylosing spondylitis in adults. In Canada, in combination with methotrexate (MTX), is indicated for reducinb the signs and symptoms in adulft patients with moderately to severelyactive RA; reducing signs and symptoms in adulft patients with moderately to severely active PsA, alonwe or in combination with MTX; and reducinhg signs and symptoms in adult patientsx with active AS who have had an inadequate responsre to conventional therapies.
SIMPONI is also being studie d as an intravenous infusion therapy for the treatmeny of moderately to severely activerheumatoidd arthritis. In March 2008, Centocore Ortho Biotech Inc. and Schering-Plougyh Corporation announced that a Marketing Authorizatio nApplication (MAA) had been submittede to the European Medicines Agency (EMEA) requestiny the approval of SIMPONI as a once-monthly subcutaneouss treatment for adults with RA, PsA and AS. Centocore Ortho Biotech Inc. developed and discovered SIMPONIj and has exclusive marketingh rights to the producft in theUnited States.
Following regulatory approvals, Schering-Plougb will assume exclusive marketing rights outsidew the United States exceptyin Japan, Indonesia and Taiwan, where SIMPONI will be co-marketef by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceuticalo Kabushiki Kaisha; Hong Kong, where SIMPONoI will be exclusively marketed by and China, where SIMPONI will be exclusively marketedr by Xian-Janssen. SIMPONI(TM) is a prescription medicine. can lower your ability to fighyt infections. There are reports of serious infection causedby bacteria, fungi, or viruses that have spread throughout the including tuberculosis (TB) and histoplasmosis. Some of thes infections have been fatal.
Your doctor will test you for TB befordestarting SIMPONI(TM) and will monitor you for signs of TB during treatment. Tell your doctor if you have been in closew contact with peoplewith TB. Tell your doctor if you have been in aregionj (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are You should not start if you have any kind of infection. Tell your doctor if you are prons to or have a historu of infections orhave diabetes.
You should also tell your doctor if you are currentlyg being treated for an infection or if you have or developo any signs of an infectionsuch as: -- sweat, or chills -- muscle aches -- cough -- shortness of breath -- bloodf in phlegm -- weight loss -- red, or painful skin or sorees on your body -- diarrhea or stomachn pain -- burning when you urinate or urinate more than normao -- feel very tired Tell your doctor abou all the medications you take or if you are schedulef to or recently received a vaccine. Reactivation of hepatitis B virusa has been reported in patients who are carriersx of this virus and are taking TNFblocked medicines, such as SIMPONI(TM).
Some of these cases have been Your doctor may do blood tests before and aftef you start treatmentwith SIMPONI(TM). Tell your doctor if you know or thinkj you may be a carrief of hepatitis B virus or if you experience signz of hepatitisB infection, such as: If you take or other TNF blockers, your risk for developingt lymphoma or other cancers may increase. You shoulde tell your doctor if you have had or develop lymphomwa orother cancers. Heart failure can occur or get worser in people who use TNF blockerslike SIMPONI(TM). Your doctoe will monitor you closely if you haveheartr failure.
Tell your doctorf right away if you get new or worsenin g symptoms of heart failure like shortness of breat h or swelling of your lower legsor feet. Rarely, peoplde using TNF blockers can have nervous systejm problems such asmultiple sclerosis. Tell your doctor righf away if you have symptoms like vision weakness in your armsor legs, or numbnessa or tingling in any part of your body. Livere problems can happen in peoples usingTNF blockers. Contac t your doctor immediately if you develop symptomas such as feelingvery tired, skin or eyes look poor appetite or vomiting, or pain on the righ side of your stomach. Low blood counts have been seen with peoplwe usingTNF blockers.
If this occurs, your body may not make enoughj blood cells to help fight infections or help stop Your doctor will check your bloodc counts before andduring treatment. Tell your doctor if you have signz suchas fever, bruising, bleeding easily, or paleness. people using TNF blockers havedevelopef lupus-like symptoms. Tell your doctof if you have any symptoms such as a rash on your cheekas or other parts ofthe body, sensitivityh to the sun, new joint or muscle pain, becomingv very tired, chest pain or shortnes s of breath, swelling of the feet, and/or legs. Tell your doctor if you are allergic to rubbedor latex. The needle covee contains dry natural rubber.
Tell your doctor if you have any symptoms of an allergic reaction whiletakingg SIMPONI(TM) such as swollen face, breathing trouble, or chesy pain. Common side effects of include: upper respiratory tract infection, nausea, abnormal livetr tests, redness at site of injection, high bloox pressure, bronchitis, dizziness, sinus flu, runny nose, cold sores, numbness or tingling. You are encouragex to report negative side effects of prescription drugs tothe FDA. Visit , or call The Full Prescribing Information and Medicatiom Guide for SIMPONI will be availableat . About Centocort Ortho Biotech Inc. Centocor Ortho Biotech Inc. redefiness the standard of carein immunology, and oncology.
The company was created when Orth oBiotech Inc. merged into Inc., and Centocor, Inc. was renamed Centocod Ortho Biotech Inc. Built upon a pioneering Centocor OrthoBiotech Inc. harnesses innovations in large-moleculer and small-molecule research to create important newtherapeutic options. Beyond its innovative Centocor Ortho Biotech is at the forefront of developinhg education and public policy initiatives to ensure patientd andtheir families, caregivers, and healthcare professionals have access to the latestf treatment information, support services, and qualituy care. For more information about CentocorOrtho Biotech, visit .
Centocor Ortho Biotech is a wholly-owned subsidiar y of Johnson & Johnson. (This press release contains "forward-lookinyg statements" as defined in the Privated Securities Litigation Reform Actof 1995. These statements are based on current expectations offuturer events. If underlying assumptiones prove inaccurate or unknown risks oruncertainties materialize, actua results could vary materially from Centocot Ortho Biotech Inc. and/or Johnson Johnson's expectations and projections.
Risks and uncertainties include general industry conditions and economic conditions, such as interest rate and currency exchanged rate fluctuations; technological advances and patentw attained by competitors; challenges inherent in new product development, including obtaininbg regulatory approvals; domestic and foreigb health care reforms and governmental laws and regulations; and trends toward healthu care cost containment. A further list and description ofthesew risks, uncertainties and other factors can be found in Exhibift 99 of Johnson Johnson's Annual Report on Form 10-K for the fiscal year endedr December 28, 2008.
Copies of this Form 10-K, as well as subsequentt filings, are available online at , or on requesr from Johnson & Johnson. Neitherd Centocor Ortho Biotech Inc. nor Johnson Johnson undertake to updatdeany forward-looking statements as a resul t of new information or future events or developments.) Schering-Ploughb (headquartered in the US) is an innovation-driven, science-centered global healtg care company. Through its own biopharmaceutical researcjh and collaborationswith partners, Schering-Plough creates therapies that help save and improvs lives around the world.
The company appliea its research-and-development platform to human prescription and consumer products as well as to animahealth products. Schering-Plough's vision is to "Earnh Trust, Every Day" with the doctors, patients, customersa and other stakeholders served by its colleagues aroundsthe world. The company is based in N.J., and its Web site is . SCHERING-PLOUGy DISCLOSURE NOTICE: The information in this press releases includescertain "forward-looking statements" withij the meaning of the Private Securitie Litigation Reform Act of 1995, including statements relating to the potentiall market for SIMPONI.
Forward-looking statements relate to expectationd or forecasts offuture Schering-Plough does not assume the obligation to update any forward-lookingf statement. Many factors could cause actual results to differd materiallyfrom Schering-Plough's forward-looking including market forces, economic factors, product availability, patent and othert intellectual property protection, current and future generic or over-the-counter the regulatory process, and any developments following regulatory among other uncertainties.
For further details about thesde and other factors that may impactythe forward-looking statements, see Schering-Plough's Securities and Exchangs Commission filings, including Item 1A. "Risk Factors " in Schering-Plough's 2009 10-Q, filed May 1, 2009. SOURCE Centoco Ortho Biotech Inc.