Novartis’ SJIA study meets endpoints


Novartis’ ACZ885 (canakinumab) has met both of its primary endpoints in Phase III studies for the treatment of active systemic juvenile idiopathic arthritis (SJIA) treatment, the company has said.

Data showed that ACZ885 allowed nearly half (45%) of children with SJIA to reduce their use of steroids within 28 weeks and that patients were nearly three times less likely to suffer a new flare.

David Epstein, Head of the Pharmaceuticals Division of Novartis, says the data demonstrates “the significant benefits that ACZ885 may provide”.

The results of the trial, along with data from a second pivotal study, are planned to form the basis for worldwide regulatory submissions next year.

A total of 177 patients between the ages of 1 and 19 years with active SJIA were enrolled in the study. The primary endpoints were to assess if ACZ885 allows tapering of steroids in at least 25% of SJIA patients and demonstrates that time to flare is extended with ACZ885 versus placebo.

Only 27% of ACZ885-treated patients experienced a new flare, compared to three-quarters of patients on placebo.

“These data are very welcome because nearly half of ACZ885-treated patients were able to reduce their steroid use during the study, potentially helping decrease the impact that these drugs can have on this young population,” said Dr Nico Wulffraat, one of the study investigators and pediatric immunologist at Wilhelmina Children’s Hospital, University Medical Center in Utrecht, The Netherlands.

SJIA is the most serious form of childhood arthritis affecting less than one child per 100,000. Traditional therapies used to treat the condition only partially mitigate symptoms but do not usually prevent long-term damage. Long-term steroid use can also contribute to slowed growth, delayed puberty and reduced bone density.

Under the brand name Ilaris, ACZ885 is already approved in more than 50 countries, including the EU, US, Switzerland and Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). It is also being studies for use in other diseases which cause inflammation.