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Ilaris response maintained over 5 years in patients with JIA
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Patients receiving the interleukin-1 inhibitor canakinumab for systemic juvenile idiopathic arthritis maintained or improved their response to the drug over 5 years, with no new long-term safety concerns, according to findings published in the Annals of the Rheumatic Diseases.
“IL-1 plays a key role in the pathogenesis of [systemic] JIA,” Nicolino Ruperto, MD, MPH, of the Giannina Gaslini Institute, and colleagues wrote. “Several reports have suggested that inhibition of IL-1 provides clinical benefit in [systemic] JIA. Canakinumab is a fully human monoclonal antibody that selectively binds to IL-1, inactivating its downstream signaling cascade. Previous phase 2-3 trials have demonstrated the efficacy and safety of canakinumab in patients with [systemic] JIA.”
To analyze the long-term efficacy and safety of canakinumab (Ilaris, Novartis) among patients with systemic JIA, Ruperto and colleagues conducted a long-term extension study of 144 children, aged 2 to 19 years with confirmed diagnoses and active features, who had participated in the two previously reported phase 3 studies. Participants were followed for an additional 5 years between July 2009 and December 2014, with efficacy assessments performed every 3 months.
The researchers measured efficacy using the adapted JIA American College of Rheumatology (aJIA-ACR) criteria, the Juvenile Arthritis Disease Activity Score (JADAS) and the ACR clinical remission on medication criteria (CRACR). Safety and tolerability were defined in terms of adverse events and serious adverse events, as well as laboratory assessments from initial injection to the last available observation. Of the 144 patients enrolled in the extension, 75 were included in the final analysis after 69 discontinued treatment. Among the discontinued cases, 15 were due to adverse events and 36 were because of a lack of therapeutic response.
According to Ruperto and colleagues, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively, at 2 years. In addition, CRACR was achieved by 20% of participants at 6 months, and 32% at 2 years. JADAS low disease activity score was demonstrated by 49% of participants at 2 years. These efficacy results were maintained for up to 5 years, the researchers wrote.
Of the 177 patients who had been enrolled in the core phase 3 study, 128 were receiving glucocorticoids. Among those patients, 15.6% discontinued the steroid hormones and 22% tapered to 0.15mg/kg per day. Seven patients discontinued canakinumab due to clinical remission. Serious adverse events included 13 cases of macrophage activation syndrome. No deaths or new safety findings were observed, the researchers wrote.
“Response to canakinumab treatment was sustained or improved up to 5 years in patients with [systemic] JIA with active systemic features and arthritis and was associated with glucocorticoid discontinuation,” Ruperto and colleagues wrote. “Early response seemed to be a predictive factor of long-term outcome enabling physicians to incorporate in their decision-making the time to response in the consideration of changing canakinumab to another treatment. No new safety findings were observed on long-term use of canakinumab.” – by Jason Laday
Disclosure: Ruperto reports consulting and speaking fees from AbbVie, Ablynx, Amgen, AstraZeneca, Baxalta Biosimilars, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli-Lilly, EMD Serono, Gilead Sciences, Janssen, MedImmune, Novartis, Pfizer, R-Pharm, Roche, Sanofi, Servier and Takeda. In addition, he is an employee of the Giannina Gaslini Institute, a public hospital that has received contributions from Bristol-Myers Squibb, Hoffman-La Roche, Janssen, Novartis, Pfizer and Sobi for the coordination activity of the PRINTO network. Please see the study for all other authors’ relevant financial disclosures.
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