Roche's RoActemra® (Tocilizumab) Shows Long-Term Efficacy In Monotherapy And Also Benefits In Early Rheumatoid Arthritis

Date: Jun-14-2013Roche (SIX: RO, ROG; OTCQX: RHHBY) have announced data from two phase III studies using RoActemra in patients with rheumatoid arthritis (RA): the long-term extension (LTE) follow up of the AMBITION study demonstrated long-term efficacy of RoActemra without methotrexate (MTX); and the FUNCTION study showed the clinical benefits of the medicine, alone or in combination with MTX, when used to treat patients with early RA.1,2 These studies are being presented at the 2013 European League Against Rheumatism (EULAR) Congress.

Results from the AMBITION LTE study showed that long-term treatment with RoActemra alone (monotherapy) showed long-term efficacy in people with RA who, at the time of entering the study, had never received MTX or had not received it in the preceding six months.1 High remission rates and improvements in disease activity lasted up to 4.6 years. This was shown in people who achieved a 50 percent reduction in their swollen and tender joints at week 24 and who continued treatment with RoActemra without MTX.1

The FUNCTION study explored treatment with RoActemra alone or in combination with MTX in people with early RA who had not previously been treated with MTX, a setting in which biologics, such as RoActemra, are not commonly used.3 The study showed that RoActemra (8 mg/kg) when used with or without MTX was superior to MTX alone in achieving disease remission in people at week 24 (as measured by DAS28





RoActemra therapy has an established safety profile as demonstrated in over 125,691 patient years. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, elevated blood pressure, and increased liver enzymes. The serious adverse reactions reported in clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis.14

A copy of the Summary of Product Characteristics is available at http://emc.medicines.org.uk

About AMBITION LTE

The post hoc exploratory analysis evaluated the efficacy and safety of patients randomised to RoActemra (8 mg/kg) monotherapy in AMBITION who entered the long-term extension (LTE) study. Upon entry to the long-term extension study, DMARDs including MTX, were added in 43 percent of patients (n=104) who did not achieve a 50 percent reduction in swollen joint count (SJC) and tender joint count (TJC) from baseline. Fifty-seven percent of patients (n=139) remained on RoActemra without MTX.1

Results from the efficacy analysis over the extended trial period showed that 65 percent of these 139 patients (n=90) remained on monotherapy until week 240. Of these:

- The number of patients achieving remission continued to increase or were maintained over time, with 66.7 percent of patients achieving remission, as measured by DAS28ACTEMRA outside of Europe, is the first humanised interleukin-6 (IL-6) receptor agonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).14 The extensive clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. In addition, the phase IV ADACTA study showed that that this treatment without MTX was superior to monotherapy with Humira in reducing signs and symptoms of RA in MTX-intolerant patients or patients for whom MTX treatment was considered ineffective or inappropriate.15 The overall safety profile of both medications was consistent with previously reported data.15

RoActemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older and is part of a co-development agreement with Chugai Pharmaceutical Co. It has been approved in Japan since April 2005 for Castleman's disease, followed by approvals for RA, sJIA and pJIA in 2008. The treatment is approved in the European Union, and several other countries, including the United States, China, India, Brazil, Switzerland and Australia.

View drug information on Actemra.
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