ACTEMRA Inhibited Progression Of Joint Damage In RA Patients Demonstrated
One-year data from a two-year Phase III study demonstrated that ACTEMRA (tocilizumab) significantly inhibited the progression of structural joint damage in patients with rheumatoid arthritis (RA). Late-breaking results from the LITHE study will be featured as an oral presentation during the American College of Rheumatology (ACR) Annual Scientific Meeting (October 24-28) in San Francisco. Fourteen additional abstracts, which evaluate ACTEMRA, a novel interleukin-6 (IL-6) receptor inhibitor, in patients with moderately to severely active RA, will also be presented during the meeting.
"The LITHE study demonstrated that treatment with ACTEMRA inhibited structural joint damage, which is a major cause of disability and loss of physical function for RA patients," said Joel Kremer, M.D., investigator in the LITHE study and Director of Research at The Center for Rheumatology in Albany, New York. "It is critical to stop joint damage as quickly as possible to avoid joint deformity and to help patients maintain their quality of life."
In the study, the mean change in the combined Genant-modified Sharp score(1), which assesses progression of both joint erosion and joint space narrowing, was lower among ACTEMRA (8 mg/kg and 4 mg/kg) plus methotrexate-treated patients versus methotrexate plus placebo-treated patients (0.3, 0.3 versus 1.1, respectively; p<0.001). In addition, the study showed that 85 percent and 81 percent of patients treated with ACTEMRA (8 mg/kg or 4 mg/kg, respectively) experienced no progression of either joint erosion or joint space narrowing, as measured by the Genant-modified Sharp score, compared with 67 percent of patients treated with placebo plus methotrexate.
Importantly, data from the LITHE study also showed that patients treated with ACTEMRA (8 mg/kg or 4 mg/kg) plus methotrexate experienced a reduction in disease signs and symptoms at one year compared with patients treated with placebo plus methotrexate. At 52 weeks, 56 percent, 36 percent and 20 percent of RA patients treated with ACTEMRA 8 mg/kg plus methotrexate achieved ACR20, ACR50 and ACR70(2), respectively, and 47 percent, 29 percent and 16 percent of patients in the ACTEMRA 4 mg/kg arm achieved these ACR scores, respectively. In contrast, 25 percent, 10 percent and 4 percent of patients in the control group achieved ACR20, ACR50 and ACR70, respectively. Disease remission (DAS28 <2.6)(3) was demonstrated in 47 percent and 30 percent of patients treated with ACTEMRA 8 mg/kg and 4 mg/kg, respectively, at week 52 compared with 8 percent of patients treated with placebo plus methotrexate.
"We've seen in previous studies that patients treated with ACTEMRA experienced an improvement in the signs and symptoms of RA and achieved remission according to the DAS28 criteria more often than with DMARDs," said Kenneth Bahrt, M.D., Global Medical Director, Autoimmunity, Roche. "The LITHE study not only confirmed these data, but for the first time demonstrated that ACTEMRA also significantly inhibited the progression of structural joint damage in patients with RA."