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Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate at 1 year: The LITHE study
Arthritis & Rheumatism, 11/29/2010
Kremer JL et al. –The objective of this study was to assess the efficacy and safety of tocilizumab plus methotrexate (MTX) versus MTX alone in preventing structural joint damage and improving physical function and disease activity in patients with moderate to severe rheumatoid arthritis and inadequate responses to MTX. The findings of this study show that tocilizumab plus MTX results in greater inhibition of joint damage and improvement of physical function than does MTX alone. Tocilizumab has a well-characterized safety profile.
Methods- 1196 patients enrolled in placebo-controlled, double-blind, randomized, 2-year trial
- Patients received tocilizumab (8 or 4 mg/kg) or placebo every 4 weeks plus MTX
- Rescue treatment available from week 16
- Year 1 results presented
- Mean change in total Genant-modified Sharp score was 0.29 or 0.34 with tocilizumab 8 or 4 mg/kg plus MTX versus 1.13 with placebo plus MTX (P < 0.0001, both comparisons)
- Analysis of variance of the area under the curve for change from baseline in Health Assessment Questionnaire–Disability Index showed greater decreases with tocilizumab 8 and 4 mg/kg (–144.06 and –128.37 U) than with placebo (–58.11 U; P < 0.0001, both comparisons)
- Proportions of patients with American College of Rheumatology 20%, 50%, and 70% improvement and with Disease Activity Score in 28 joints (DAS28) remission higher with tocilizumab 8 mg/kg than with placebo (P < 0.0001, all comparisons)
- Safety profile of tocilizumab consistent with those of previous studies
- Infections were most common adverse and serious adverse events
