Firm plans 2012 filing for IL-1 beta-targeting antibody against childhood autoimmune disease.
Treating systemic juvenile idiopathic arthritis (SJIA) using Novartis’ IL-1 beta-targeting monoclonal antibody therapy ACZ885 (canakinumab) significantly increases the likelihood that patients with the rare autoinflammatory disease will remain symptom free, according to pivotal Phase III study data. Novartis says it plans to file for regulatory approval of the drug as a treatment for SJIA later this year.
ACZ885 is already approved under brand name Ilaris® in the EU, U.S., Japan, and other countries for the treatment of adults and children with the autoinflammatory disorder cryopyrin-associated periodic syndrome (CAPS). The reported Phase III SJIA trial, involving 177 patients between the ages of 2 and 20 years, showed that 62% of participants treated with ACZ885 maintained an inactive disease status at the end of the placebo-controlled portion of the study, compared with just 32% of patients who were switched to placebo after an initial ACZ885 treatment period.
Canakinumab treatment in addition more than halved the percentage of patients who experienced a new flare during the placebo-controlled part of the trial, and allowed 45% of participants to reduce their steroid use within 28 weeks of starting treatment in the first phase of the trial, which comprised an open-label active treatment period. A third of SJIA patients treated using ACZ885 were able to completely discontinue corticosteroid therapy.
Novartis separately reported positive data from an ongoing Phase II study evaluating canakinumab in TNF-receptor associated periodic syndrome (TRAPS), another rare, inherited auto-inflammatory disease that can affect both children and adults. In this study 90% of TRAPS patients treated using ACZ885 experienced clinical remission after just a week of treatment, and after two weeks 95% of patients had achieved a complete or almost complete response, which could be maintained with monthly dosing.
ACZ885 is in addition being studied in other inflammatory diseases including gouty arthritis and cardiovascular disease.