LITHE
TociLIzumab safety and THE prevention of structural joint damage
The LITHE trial, a two-year study with planned analyses at Week 24 and Week 52, evaluated 1,196 patients who had an inadequate clinical response to methotrexate (MTX). Doses of 4 or 8 mg/kg of ACTEMRA or placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly). The primary endpoint at Week 24 was the proportion of patients who achieved an ACR20 response. At Week 52 the co-primary endpoints were prevention of joint damage and improvement in physical function.
Summary of results
1190 patients were randomised. Compared with controls treated with placebo plus MTX, patients in the ACTEMRA 8 mg/kg arm plus MTX arm had superior American College of Rheumatology (ACR) 20 (56% vs. 25%), ACR50 (36% vs. 10%) and ACR70 (20% vs. 4%) responses (p<0.0001 for each) and more patients achieved Disease Activity Score (DAS) 28 remission at 1 year (47% vs. 8%; p<0.0001). Patients in the ACTEMRA 8 mg/kg plus MTX arm also showed significantly less progression of joint damage on the total Sharp-Genant score (0.29 vs 1.13) and significantly improved physical function (health assessment questionnaire-disability index [HAQ-DI] score).
ACTEMRA therapy significantly inhibited the progression of structural joint damage, and improved physical function (HAQ-DI) and the signs and symptoms of rheumatoid arthritis (RA), significantly more than control.
Kremer J, et al. Ann Rheum Dis 2009; 68 (Suppl 3):122.