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Tocilizumab improves function, QOL in patients with RA who respond inadequately to conventional DMARDs, researchers report

Wednesday, December 12 2007 | Comments
Evidence Grade 0 What's This?
Targeted inhibition of interleukin-6 signaling with tocilizumab can improve quality of life and function in patients with rheumatoid arthritis who have an inadequate response to a range of disease-modifying antirheumatic drugs, study data indicate.

To investigate the effects of tocilizumab on disability among patients with treatment-refractory RA, researchers conducted a parallel-group, double-blind study known as TOWARD, in which 1,216 patients with moderate to severe RA who had an inadequate response to previous DMARD therapy were randomized to continue receiving stable doses of DMARDs with the addition of intravenous tocilizumab 8 mg/kg (n=803) or placebo (n=413) every 4 weeks for 24 weeks.

At the end of the study, mean scores on the Health Assessment Questionnaire-Disability Index (HAQ-DI) improved significantly more from baseline among the tocilizumab-treated patients than among those in the placebo group (P<.0001). When HAQ-DI scores were stratified as "improved" or "unchanged" (based on a minimal clinically important difference of =<-0.25, rather than the conventional threshold of -0.22), a greater proportion of patients in the tocilizumab group than in the placebo group were classified as improved, the authors noted.

Both treatment groups showed improvement in the mental and physical component scores of the Short Form-36 health survey, although the greatest improvements were among the tocilizumab-treated patients (mean changes from baseline at week 24: tocilizumab vs placebo, P<.0001). While improvements were apparent for all domain scores in the tocilizumab group, the greatest numerical change was in the domain of bodily pain.

Additionally, the patients in the tocilizumab group experienced a clinically meaningful mean change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue scale scores of >=4 points as early as week 4, compared with week 20 for the patients in the placebo group.

"The TOWARD study demonstrates that tocilizumab treatment is effective in combination with a wide range of DMARDs and leads to clinically meaningful improvements in the patient's function and health-related QOL, representing a promising treatment for patients with RA with inadequate response to conventional DMARDs," the authors concluded, noting that between-group differences were apparent as early as the first scheduled assessment for each parameter. (Gomez-Reino JJ, et al. Poster 522.)

This information concerns a use that has not been approved by the Food and Drug Administration.

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