Roche’s Phase III Actemra Study Achieves Goal

25 May 2009 (Last Updated May 25th, 2009 18:30)

Swiss drugmaker Roche has declared that new two-year data from the LITHE (TociLIzumab Safety and The Prevention of Structural Joint Damage) study demonstrated the effectiveness of its Actemra (tocilizumab) drug in inhibiting structural damage to joints in patients with rheumatoid arthritis.

Swiss drugmaker Roche has declared that new two-year data from the LITHE (TociLIzumab Safety and The Prevention of Structural Joint Damage) study demonstrated the effectiveness of its Actemra (tocilizumab) drug in inhibiting structural damage to joints in patients with rheumatoid arthritis.

LITHE was the fifth international Phase III study in the extensive Actemra clinical development programme and showed that a greater proportion of patients treated with Actemra, in combination with the current standard therapy methotrexate, witnessed an improved physical function during 24 months of treatment as compared to patients receiving placebo plus methotrexate.

The drug improved patients' ability to perform normal daily activities, as measured by the Health Assessment Questionnaire Disability Index.

The outcome was determined by X-ray evidence of the progression of bone erosion and narrowing of joint spaces.

Roche Global Medical Director, Autoimmunity, Kenneth Bahrt said that the study proves the drug's long-term benefits.

"We are extremely pleased by these two-year LITHE data as they confirm the previous study findings, and also suggest that the effect of Actemra actually improves over time," he said.

In the study, Actemra was usually well tolerated and the overall safety profile after two years of treatment with the drug was consistent with previously reported data.

Roche said that full data from this two-year study will be submitted to the US Food and Drug Administration.