CHERISH trial demonstrates efficacy of tocilizumab in juvenile idiopathic arthritis

(Press-News.org) Madrid, Spain, 12 June 2013: A new study presented today at EULAR 2013, the Annual Congress of the European League Against Rheumatism shows that tocilizumab is efficacious and leads to a sustained clinically meaningful improvement in children with polyarticular Juvenile Idiopathic Arthritis (pcJIA).

Tocilizumab is a humanized recombinant antibody, which blocks the receptors where interleukin-6 (IL-6) attaches to the surface of cells. When IL-6 is unable to attach to these cells, they are prevented from driving inflammation. Elevated serum and joint fluid IL-6 levels have been shown to be associated with disease activity in patients with pcJIA.1

"JIA is a chronic arthritis occurring in 1 in every 1,000 children. With no known cause, it can lead to joint damage and permanent disability. These data show that tocilizumab rapidly improves signs and symptoms of pcJIA, with meaningful clinical responses maintained in a large proportion of patients at week 40," said lead author Dr. Fabrizio De Benedetti of the IRCCS Ospedale Pediatrico Bambino Gesu, Rome.

Speaking on behalf of the Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG), who had overseen this study, Dr. De Benedetti concluded that "these data suggest that tocilizumab is going to be a novel biologic part of the therapeutic armamentarium for pcJIA."

CHERISH is a two-year, 3-part trial being conducted at 58 centres across 15 countries. Patients aged 2-17 years were included in the study if they had active pcJIA for at least 6 months and had failed to respond to methotrexate (a cornerstone of therapy worldwide for this condition).

Part 1 of the study was a 16-week open-label phase in which 188 patients received tocilizumab every four weeks. The 166 patients who achieved at least a 30% improvement in symptoms and signs of pcJIA (an JIA ACR30* response) went on to part 2, which was a 24-week study in which patients were randomised to continue on the same dose of tocilizumab or to receive placebo. Part 3 is an ongoing open-label study.

For the primary end point of ACR30 flare, fewer patients in the tocilizumab group than in the placebo group experienced a flare by week 40 (25.6% vs. 48.1%) and JIA ACR30/50/70* responses were significantly higher with tocilizumab than placebo, with as many as 65% of the children attaining an ACR70 response.

Dosing of tocilizumab was based on the patient's body weight (BW): with a BW ≥30 kg, the dose was 8 mg/kg [n=119]; with a BW END