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The LITHE trial, a two-year study with planned analyses at Week 24, Week 52 and Week 104 enrolled patients who had an inadequate clinical response to methotrexate (MTX). ACTEMRA/RoACTEMRA 8 mg/kg or placebo were given every 4 weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly). Nearly 400 patients were randomised to each treatment group. After Week 52, all patients could receive open-label treatment with ACTEMRA/RoACTEMRA 8 mg/kg. Of the patients who completed the study who were originally randomised to placebo plus MTX, 86% received open-label ACTEMRA/RoACTEMRA 8 mg/kg in Year 2.

The primary endpoint at Week 24 was the proportion of patients who achieved an ACR20 response. At Week 52 and Week 104 the co-primary endpoints were prevention of joint damage and improvement in physical function. Inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score. At the end of the 48-week study period, patients who met the inclusion criteria could continue in an ongoing, long-term, open-label follow-up study.

The results of the LITHE study can be found in the Efficacy and Safety and Tolerability sections of the website.

Reference:
1. RoACTEMRA® (tocilizumab) Summary of Product Characteristics. Roche Registration Limited. June 2010. 2. European Medicines Agency. European Public Assessment Report: RoActemra (EMEA/H-C-955). 2009.