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Publication Detail
Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis: a randomized, double-blind, placebo-controlled, dose-escalation trial
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Choy EH, Isenberg DA, Garrood T, Farrow S, Ioannou Y, Bird H, Cheung N, Williams B, Hazleman B, Price R, Yoshizaki K, Nishimoto N, Kishimoto T, Panayi GS
  • Publication date:
    12/2002
  • Pagination:
    3143, 3150
  • Journal:
    Arthritis and Rheumatism
  • Volume:
    46
  • Issue:
    12
  • Print ISSN:
    0004-3591
  • Keywords:
    activity, Acute-Phase Reaction, administration & dosage, adult, ADVERSE, adverse effects, adverse events, Aged, American, analysis, Analysis of Variance, anti-interleukin-6, antibodies, Antibodies, Monoclonal, Antibody, Arthritis, Arthritis, Rheumatoid, As, benefit, C REACTIVE PROTEIN, C-Reactive Protein, C-REACTIVE-PROTEIN, clinical, Clinical trial, CLINICAL-TRIAL, COHORT, Cohort Studies, COMMON, CONTROLLED TRIAL, corticosteroid, CRITERIA, demographic, DIARRHEA, difference, disease, dose, Dose-Response Relationship, Drug, DOUBLE BLIND, DOUBLE-BLIND, Double-Blind Method, DRUG, drug therapy, EFFICACY, END, EVENTS, FEATURES, Female, function, groups, Half-Life, IL-6, IM, immunology, improved, IMPROVEMENT, INHIBIT, inhibition, Injections, Intravenous, Interleukin 6, Interleukin-6, INTRAVENOUS, LA, Male, Methods, Middle Age, MONOCLONAL ANTIBODIES, MONOCLONAL ANTIBODY, MONOCLONAL-ANTIBODIES, MONOCLONAL-ANTIBODY, multiple, Other, Patient, patients, Pharmacokinetics, physiopathology, PLACEBO, Placebos, PROTEIN, randomized, RANDOMIZED CONTROLLED TRIAL, Receptor, recombinant, REGIMEN, Research, response, response criteria, Result, Rheumatoid arthritis, RHEUMATOID-ARTHRITIS, Rheumatology, Safety, SCORES, sedimentation, SIGNS, SINGLE, Support, Non-U.S.Gov't, SYMPTOM, SYMPTOMS, therapeutic, therapeutic use, TIME, treatment, Treatment Outcome, Treatments, TRIAL, VALUES
  • Notes:
    UI - 22370292 DA - 20021216 IS - 0004-3591 LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial RN - 0 (Antibodies, Monoclonal) RN - 0 (Interleukin-6) RN - 0 (Placebos) SB - AIM SB - IM
Abstract
OBJECTIVE: To investigate the safety and efficacy of MRA, a recombinant human anti-interleukin-6 (anti-IL-6) receptor monoclonal antibody of the IgG1 subclass that inhibits the function of IL-6, in patients with established rheumatoid arthritis (RA). METHODS: A randomized, double-blind, placebo-controlled, dose-escalation trial was conducted in 45 patients with active RA, as defined by the American College of Rheumatology (ACR) revised criteria. Patients were sequentially allocated to receive a single intravenous dose of either 0.1, 1, 5, or 10 mg/kg of MRA or placebo. The primary efficacy end point was meeting the ACR 20% response criteria at week 2 after treatment. RESULTS: Demographic features were similar between treatment groups. At week 2, a significant treatment difference was observed between the 5 mg/kg of MRA and placebo, with 5 patients (55.6%) in the MRA cohort and none in the placebo cohort achieving ACR 20% improvement. There was no statistically significant difference in the ACR 20% response between the other 3 MRA cohorts and placebo at week 2. The mean disease activity score at week 2 in those who received 5 mg/kg and 10 mg/kg of MRA was 4.8 and 4.7 (P < 0.001 and P < 0.001 by analysis of variance), respectively. These mean scores were statistically significantly lower than those in the 0.1- and 1-mg/kg MRA and the placebo cohorts (6.4, 6.2, and 7.0, respectively). The erythrocyte sedimentation rate and C-reactive protein values fell significantly in the 5- and 10-mg/kg MRA cohorts and normalized 2 weeks after treatment. Seventeen patients (5, 4, 6, 2, and 0 patients in the placebo, 0.1-, 1-, 5-, and 10-mg/kg MRA cohorts, respectively) required corticosteroid or disease-modifying antirheumatic drug treatment because of active disease before study end. They were regarded as nonresponders from the time they received these treatments. Diarrhea was the most common adverse event, occurring in 8% of patients. Seven patients (15.6%) reported a severe adverse event (3, 1, 2, and 2 patients in the placebo, 0.1-, 1-, and 10-mg/kg MRA cohorts). There were no serious adverse events that were thought to be related to the study drug. CONCLUSION: This is the first randomized controlled trial showing that inhibition of IL-6 significantly improved the signs and symptoms of RA and normalized the acute-phase reactants. Further research with multiple dosing is necessary to define the most appropriate therapeutic regimen of MRA in RA
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