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| |  Tocilizumab Tops Methotrexate Monotherapy in Rheumatoid Arthritis Patient-Reported Outcomes: Presented at EULAR By Jill Stein PARIS -- June 16, 2008 -- Tocilizumab monotherapy appears to result in better patient-reported outcomes compared with methotrexate monotherapy, among patients with active rheumatoid arthritis (RA) who responded to previous methotrexate or biologic treatment. These findings, from the 24-week, phase 3 Actemra Versus Methotrexate Double-Blind Investigative Trial in Monotherapy (AMBITION) trial were presented here on June 13 at EULAR 2008, the Annual Congress of the European Union League Against Rheumatism. Anthony Sebba, MD, Arthritis Research of Florida Inc., Palm Harbor, Florida, and coworkers compared the effects of monotherapy with tocilizumab and methotrexate on health and physical functioning at 24 weeks of treatment in 572 patients with moderate to severe active RA. Tocilizumab is a humanised anti-interleukin (IL)-6 receptor (IL-6R) monoclonal antibody that binds to both membrane-expressed and soluble IL-6R, disrupting signalling by IL-6 and the IL-6/IL-6R complex. Subjects were randomised to either tocilizumab 8 mg/kg every 4 weeks or to an escalating methotrexate dose of 7.5 to 20 mg weekly. Baseline demographic and clinical characteristics were similar between treatment groups. The results showed that tocilizumab was superior to methotrexate, with a higher proportion of patients achieving American College of Rheumatology 20%, 50%, and 70% responses and Disease Activity Score 28 remission at week 24, Dr. Sebba said. At 24 weeks, larger mean changes in Health Assessment Questionnaire-Disability Index scores were seen in the tocilizumab group than in the methotrexate group (-0.73 vs -0.55). This was higher than the minimal clinically important difference (MCID) of -0.22. Improvements were seen in both groups at week 24 in the Short Form-36 health survey (SF-36) physical component (PCS) and mental component (MCS) scores. However, a larger improvement occurred in the tocilizumab group (PCS, 10.0 vs 8.4; MCS, 7.2 vs 5.5; MCID, 2.5-5.0). An improvement in SF-36 score was apparent as early as week 8, and tocilizumab-treated patients had larger mean improvements than methotrexate in the individual domain scores of the SF-36. Importantly, greater mean increases in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score were observed for patients in the tocilizumab arm compared with the methotrexate arm (9.2 vs 6.5; MCID, 4.0) at week 24, with improvements in the tocilizumab arm seen as early as week 4. "Fatigue is a substantial problem for rheumatoid arthritis patients and the improvements observed with tocilizumab on the FACIT-Fatigue score are likely to be of considerable clinical benefit in patients overall," the authors wrote in their poster presentation. They concluded that the improvements in all patient-reported outcomes seen with tocilizumab were consistently greater than with methotrexate monotherapy. Funding for the study was provided by Roche.
[Presentation title: Tocilizumab Monotherapy Improves Quality of Life Compared With Methotrexate Monotherapy in Patients With Rheumatoid Arthritis: The Ambition Study. Abstract FRI0174]
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