Roche and Chugai’s investigational RoActemra® (tocilizumab) subcutaneous formulation shows comparable long-term efficacy and tolerability to the intravenous formulation in rheumatoid arthritis

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the long-term use of RoActemra (tocilizumab) subcutaneous (SC) formulation (49 weeks) has comparable efficacy to the use of intravenous (IV) formulation, according to the SUMMACTA study. In addition, long-term efficacy and reduced progression of joint damage over 48 weeks was demonstrated in the BREVACTA study. Both SC phase-3 clinical trials also showed that the adverse event profile was consistent with previous findings.These new data were released at the 2013 American College of Rheumatology Annual Meeting in San Diego, California.

“These data show that RoActemra can continue to deliver meaningful improvements for people living with rheumatoid arthritis over the long-term regardless of how it is delivered,” said Prof.Dr. Gerd Burmester, Clinical Rheumatologist at the Charité Universitätsmedizin, Berlin. “The convenience of subcutaneous administration gives people with rheumatoid arthritis a time-saving treatment option of a self-administered injection, and may mean less time being treated and more time getting on with what matters to them.”

Rheumatoid arthritis (RA) is an autoimmune disease estimated to affect up to 70 million people worldwide. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.4 RA patients are often treated with a number of medicines, combining protein-based biologic therapies with methotrexate, the most common disease modifying antirheumatic drug (DMARD).

Biologic therapies, like RoActemra, are used to help people affected by RA to control symptoms of the disease, slow RA progression and prevent further joint damage. Approximately one in three patients treated with a biologic treatment, such as RoActemra, receive it as monotherapy, largely due to intolerance to methotrexate.

In the BREVACTA study, the efficacy of RoActemra SC given every two weeks was maintained from week 24 to 48, in terms of the proportion of patients with ACR20/50/70* responses, in DAS28** remission and with a clinically meaningful improvement in physical function. Moreover, mean reduction in radiographic progression of structural joint damage was also maintained from week 24 to 48. The safety profile also remained stable with longer-term use to Week 48.

The SUMMACTA study demonstrated that efficacy rates for patients continuing on RoActemra SC given every week are maintained over 49 weeks and remain comparable to RoActemra IV, as shown at week 24. The week 49 cumulative safety profiles of patients on RoActemra SC were consistent with week 24 data and with RoActemra IV. The efficacy and safety profile of patients who switched from RoActemra IV to RoActemra SC and vice versa, was similar to patients who remained on RoActemra SC or RoActemra IV throughout the study with the exception of injection site reactions for SC.