Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

Remicade Rapidly Reduces Signs And Symptoms Of Rheumatoid Arthritis SAN DIEGO, CA -- Nov. 9, 1998 -- Centocor, Inc.’s Remicade (infliximab), the first monoclonal antibody under investigation for rheumatoid arthritis, reduced signs and symptoms of the painful and chronic joint condition by 52 percent in patients receiving the drug compared to 20 percent of those on placebo. Results were highly significant over a 30-week timeframe compared to placebo. In the study, Remicade was well tolerated and side effects were minimal. A summary of the 30-week, Phase III clinical trial, also known as ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), was presented here today at the American College of Rheumatology meeting and will be presented again in greater detail on Thursday. "All patients in this study had advanced disease, which makes these results even more noteworthy," said Peter Lipsky, M.D., a principal investigator for Remicade and director, Harold C. Simmons Arthritis Research Center, University of Texas Southwestern Medical Center at Dallas. "The 3 mg/kg infusion every eight weeks provided comparable benefits to patients who received higher doses of the drug." Fifty-two percent of all patients treated with Remicade, compared to 20 percent of patients receiving placebo, experienced a reduction in signs and symptoms of rheumatoid arthritis as measured by ACR 20, a standard assessment of disease activity and a primary endpoint of the study. ACR 20 represents a 20 percent reduction in the number of tender and swollen joint counts, as well as other criteria including physician and patient global assessments and a laboratory marker of inflammation and pain. Two other key assessments, ACR 50 and ACR 70, represent 50 percent and 70 percent reductions in these same benchmarks, respectively. The study presented today also demonstrated that: -- Twenty-eight percent of patients treated with Remicade achieved an ACR 50 response at 30 weeks compared to five percent of those on placebo; -- Twelve percent of patients treated with Remicade achieved an ACR 70 response at 30 weeks compared to zero percent of those receiving placebo; -- Swollen joints were reduced by 57 percent from baseline in patients who received Remicade compared to 20 percent of those on placebo; -- Tender joint counts were reduced by 61 percent from baseline in patients who received Remicade compared to 26 percent of those on placebo; -- Significant improvements were also achieved in other disease parameters, including disability, pain, patient and physician global assessments and laboratory measures of disease activity. The ATTRACT trial was a double-blind, placebo-controlled, randomised clinical trial of 428 patients at 34 clinical sites in North America and Europe. It was designed to evaluate the efficacy and safety of Remicade in combination with methotrexate in patients with active rheumatoid arthritis despite treatment with methotrexate. Other objectives of the trial included determining the most appropriate dose and dosing interval for Remicade treatment. In the study, patients were randomised to one of the following treatment arms: Placebo and methotrexate infusion every four weeks; 3 mg/kg of Remicade and methotrexate infused every four weeks; 3 mg/kg of Remicade and methotrexate infused every eight weeks; 10 mg/kg of Remicade and methotrexate infused every four weeks; or 10 mg/kg of Remicade and methotrexate infused every eight weeks. The 3 mg/kg infusion every eight weeks provided optimal results in the trial and consistent benefits were seen in all patient groups treated with Remicade compared to placebo. Patients enrolled in the ATTRACT trial were characterised as having disease that was particularly difficult to manage. The median duration of disease in trial patients was 8.4 years and the majority of patients were on methotrexate therapy for three or more years. More than a third of all patients had previous joint surgery and approximately half were classified as functional class and/or anatomical stage III or IV, which indicates progressive and advanced disease. The majority of patients responding to treatment with Remicade did so within two weeks of infusion and virtually all responding patients (approximately 90 percent) did so within six weeks. Dr. Lipsky believes the rapid onset of action for Remicade will be welcome news to patients suffering from rheumatoid arthritis and the physicians who treat them. "Patients with rheumatoid arthritis are often in chronic pain because of inflammation in the joints," Dr. Lipsky said. "Rapid onset of action is crucial to patient and physician acceptance of the product once it is available." The most common adverse events included upper respiratory tract infection, headache, nausea, sinusitis, rash and cough. There was no increased incidence of serious adverse events (11 percent with Remicade versus 16 percent with placebo) or serious infections (four percent with Remicade versus six percent with placebo). The incidence of infusion reactions was also low in Remicade patients compared to those receiving placebo (five percent with Remicade versus two percent with placebo). The ATTRACT trial will continue for another 18 months to evaluate the long-term use of REMICADE in patients with rheumatoid arthritis. E-mail this page to a friend or colleague! To print, use this version