By Jill Stein
PHILADELPHIA -- October 23, 2009 -- Tocilizumab, combined with methotrexate, is significantly more effective in producing sustained prevention of joint damage in patients with rheumatoid arthritis (RA) than methotrexate alone, according to 2-year data from a phase 3 study presented here at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
Roy Fleischmann, MD, Metroplex Clinical Research Center, Dallas, Texas, presented the results of the Tocilizumab Safety and the Prevention of Structural Joint Damage (LITHE) study, which assessed the efficacy of the addition of tocilizumab to methotrexate in patients with moderate to severe RA who had responded inadequately to methotrexate.
"Importantly, tocilizumab plus methotrexate continues to inhibit radiographic progression and improve physical function with a clinical effect, as evidenced by improving DAS 28 [Disease Activity Score using 28 joint counts] remission, low disease activity score, and swollen joint count at 2 years and with a manageable safety profile," said Dr. Fleischmann on October 18.
For the trial, patients were randomised to receive tocilizumab plus methotrexate (4 or 8 mg/kg) or placebo plus methotrexate every 4 weeks. Stepwise rescue therapy starting at week 16 was permitted in nonresponders.
After 1 year, patients were required to start on open-label tocilizumab 8 mg/kg unless they had achieved at least a 70% improvement in swollen joint count and total joint count, allowing them to continue the blinded therapy they had received at the end of the first year throughout the second year.
Results at year 2 in 1,190 patients in the intent-to-treat analysis showed that 75% of patients in the low-dose tocilizumab group and 83% of patients in the high-dose group had no progression of joint damage on x-rays versus 66% of patients assigned to methotrexate alone.
The investigators also documented that DAS 28 remission improved over time in tocilizumab-treated patients. At 1 year, 48% of the tocilizumab group had DAS remission versus 65% of patients at 2 years.
Patients reported an improvement in their ability to perform normal daily activities as determined by scores on the widely validated Health Assessment Questionnaire.
Tocilizumab was generally well tolerated.
"The data show that tocilizumab can effectively inhibit the joint damage that is typically seen with rheumatoid arthritis patients and that the results are maintained over time," Dr. Fleischmann said.
[Presentation title: LITHE: Tocilizumab Inhibits Radiographic Progression and Improves Physical Function in Rheumatoid Arthritis (RA) Patients (Pts) at 2 Yrs With Increasing Clinical Efficacy Over Time. Abstract 637]
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