COPENHAGEN – The interleukin (IL)-6 receptor inhibitor tocilizumab (ActemraR) combined with methotrexate is more effective than methotrexate monotherapy in inhibiting the progression of structural joint damage in rheumatoid arthritis patients, according to results released at the 10th Annual Congress of the European League Against Rheumatism (EULAR) 2009.

Joel Kremer, MD, Research Director at the Center for Rheumatology in Albany, New York, and co-workers examined the efficacy of adding tocilizumab to methotrexate in patients who had an inadequate response to methotrexate. The two-year, phase 3 LITHE (Tocilizumab Safety and The Prevention of Structural Joint Damage) trial was conducted in more than 1,200 patients in 15 countries.

Patients received stable doses of methotrexate with tocilizumab (4 mg/kg or 8 mg/kg) or placebo (control) every four weeks and could receive blinded rescue therapy starting at week 16.

Interim results at 52 weeks showed disease remission, demonstrated by DAS28 less than 2.6, in 30 percent of tocilizumab patients on the 4 mg/kg dose and 47 percent of patients on the tocilizumab 8 mg/kg dose versus eight percent of placebo-treated patients.

Both tocilizumab cohorts also had a significant inhibition in the progression of structural joint damage as measured by the change in the mean Genant -modified Total Sharp Score versus patients assigned to methotrexate plus placebo (0.29, 0.34, and 1.1, respectively, p less than 0.001). In addition, there were significantly more patients in the tocilizumab groups with no radiographic progression whatsoever from baseline versus control, (p≤0.0001.) Most tocilizumab-treated patients had significantly more improvement in their physical function than control patients.

“Inhibiting rheumatoid arthritis from progressing further by achieving disease remission provides real-life benefits to patients while at the same time helping them maintain day-to day function,”‘ Dr. Kremer, who is the study’s principal investigator, said in a news release. “The study also demonstrated the efficacy of tocilizumab, even in patients with a relatively long disease duration, which suggests that it may be an effective treatment option for many rheumatoid arthritis patients.”

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03(at)gmail.com