Long-Term Tocilizumab Therapy Results in Increased Response Rates in Patients With RA: Presented at ACR/ARHP
By Liz Meszaros
PHILADELPHIA -- October 19, 2009 -- Tocilizumab is effective and results in a greater proportion of patients achieving beneficial outcomes in the long-term treatment of patients with rheumatoid arthritis (RA), according to data presented at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
Tocilizumab is a humanised monoclonal antibody that works to inhibit interleukin (IL)-6 receptor binding, and thus prevents IL-6-mediated proinflammatory activity. Previous trials have demonstrated the safety and efficacy of tocilizumab in over 4,000 patients, and postapproval programs have started in several countries.
Researchers analysed outcomes from patients who received 1 or more doses of tocilizumab in several randomised, controlled studies, as well as long-term, open-label extension studies. They also included patients who received 1 or more doses of tocilizumab in the Tocilizumab Safety and the Prevention of Structural Joint Damage (LITHE) study, which was a 2-year controlled phase 3 study with 3-year follow-up.
For analysis, patients were divided into 3 groups: inadequate responders to disease-modifying antirheumatic drugs (DMARD-IR) patients, inadequate responders to anti-tumour necrosis factor (TNF-IR) patients, and monotherapy patients who had not failed methotrexate. Outcomes were assessed every 12 weeks from initial tocilizumab dosage, and data were gathered for a maximum of 180 weeks.
Of the 3,986 patients included in the analysis, 4% discontinued therapy due to insufficient therapeutic response, while 14% discontinued due to safety. At 96 weeks, data were available for 2,173 patients. The results were presented here on October 18.
Clinically significant improvements in ACR core components were achieved with tocilizumab treatment in all groups at week 96. Proportions of patients who achieved 0 swollen joint count and 0 tender joint count were 40.4% and 25.1%, respectively, in the never-exposed or never-failed methotrexate groups, 22.9% and 14.8% in the anti-TNF-IR group, respectively, and 35.7% and 26.7% in the DMARD-IR group, respectively.
At this time, Health Assessment Questionnaire Disability Index scores of 0 were seen in 15% of patients in the DMARD-IR group, 8% of those in the anti-TNF-IR group, and in 23% of those in the methotrexate group.
“Response rates to therapy with tocilizumab, with or without concomitant DMARD, were maintained or continued to improve with increasing duration of treatment,” noted Josef S. Smolen, MD, Medical University of Vienna, Vienna, Austria. “The number of DMARD-IR patients achieving low disease activity or DAS28 [Disease Activity Score using 28 joint counts] remission continuously increased up to week 84 or week 72, respectively, of follow-up.”
“Overall, this analysis shows that during long-term treatment with tocilizumab, the number of patients responding and the magnitude of patient response increased beyond 24 weeks,” concluded Dr. Smolen.
[Presentation title: Long-Term Efficacy of Tocilizumab Rheumatoid Arthritis for Up to 3.5 Years. Abstract 413]
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