RoACTEMRA: New hope for children with systemic Juvenile Idiopathic Arthritis

June 29th, 2010

First presentation of TENDER study demonstrates RoACTEMRA’s strong efficacy in this severe childhood condition with no currently licensed treatment

Roche announced that new data being presented at the European League Against Rheumatism (EULAR) congress demonstrates that RoACTEMRA (known as ACTEMRA outside Europe) is highly effective in improving the signs and symptoms of systemic Juvenile Idiopathic Arthritis (sJIA), a severe childhood arthritis, where there are no currently licensed treatments. RoACTEMRA is also well tolerated in children with sJIA having a safety profile similar to adults with RA.

Data from the phase III TENDER studyi showed that, following three months’ treatment with RoACTEMRA, 85 percent of patients achieved 30 percent improvement (JIA ACR30*) in the signs and symptoms of sJIA and absence of fever, a primary characteristic of sJIA, compared to 24 percent of patients receiving placebo. Further data showed 70 percent achieved JIA ACR70 and 37 percent achieved ACR90. In addition to the significant improvement in JIA ACR response nearly two thirds were free of rash after three months.

“There is a critical need for new therapies for children suffering from the debilitating and life-threatening effects of sJIA, and these data represent an exciting breakthrough”, commented Hal Barron, M.D, Head of Global Development and Chief Medical Officer for Roche. “RoACTEMRA’s striking efficacy confirms a major advance in the treatment of this disease. It promises to have a significant impact in the life of these young children.”

sJIA is characterised by chronic arthritis accompanied by intermittent fever, skin rash, anaemia, enlargement of the liver and/or spleen and inflammation of the lining of the heart and/or lungs.ii The peak age of onset of sJIA is between 18 months and two yearsiii,iv although persistence of the disease into adulthood does occur.

Its disease course is variable and in the most severe cases, up to two thirds of patients have chronic and persistent arthritis and approximately half of these will develop significant disabilityv,vi It has the worst long term prognosis of all childhood arthritis subtypes, accounting for almost two-thirds of all deaths among children with arthritis, with an overall mortality rate estimated to be between two to four percent.vii There are no approved therapies for sJIA and current treatment consists of high dose corticosteroids to control systemic symptoms. However, these do not improve the long-term prognosis and their use is accompanied by severe side effects.ii

The TENDER study findings reflect previous Japanese studiesviii,ix which demonstrated that RoACTEMRA is well tolerated and effective in children with sJIA who could not tolerate, or showed inadequate response to systemic corticosteroids and immunosuppressants. No new major safety signals were observed and the adverse event profile was similar to adult RA studies and as expected for this patient population.

RoACTEMRA inhibits the activity of interleukin-6 (IL-6), a contributor to the major features of sJIA including chronic synovial inflammation, articular cartilage damage, fever, anaemia, growth impairment and osteoporosis.x Commenting on IL-6 as a treatment approach, Hal Barron said: “RoACTEMRA’s efficacy in treating these symptoms provides further evidence of the pivotal role of IL-6 in mediating joint inflammation and the detrimental systemic effects of chronic inflammatory diseases.”

RoACTEMRA is already approved in the EU, US and other countries for adult RA, a disease also associated with elevated levels of IL-6 and systemic symptoms such as fatigue, anaemia and fever. Studies in RA have demonstrated RoACTEMRA’s strong efficacy and safety, with consistently high remission rates across all patient types and inhibition of structural joint damage.xii In addition it is the only product to have proven superiority to methotrexate in monotherapy in ACR20, ACR50 and ACR70 responses at six months, in adult RA.xiii

This entry was posted on Tuesday, June 29th, 2010 at 5:17 pm |

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