Canakinumab allows discontinuation of corticosteroids in patients with SJIA

June 13, 2013

Study findings first presented today at EULAR 2013, the Annual Congress of the European League Against Rheumatism, demonstrate the efficacy of canakinumab at tapering corticosteroid (CS) use in patients with SJIA.

Successful CS tapering was achieved within 20 weeks in almost half of patients (44.5%, p<0.0001); at the end of the tapering phase, the CS-free patients had active arthritis in fewer joints, a lower physician's global assessment of disease activity and a less limited range of motion.

JIA is a chronic arthritis occurring in 1 in every 1,000 children; SJIA is a subset occurring in 10%-20% of cases, involving the body as a whole and impacting small joints such as hands, wrists, knees and . In addition the autoimmune process that devastates the joints can also impact the heart, liver and .

(CS) are a mainstay of therapy for SJIA however due to well-known long term side effects – including increased blood pressure and , increased risk of infections, (which can worsen or trigger diabetes) and osteoporosis – reduction of CS dose is desirable.

Dr Nicola Ruperto, lead author of the study speaking on behalf of the Paediatric Rheumatology International Trials Organisation said, "in addition to the evident efficacy of canakinumab in the treatment of SJIA, we now have additional evidence of its value in successfully tapering corticosteroid use. Any reductions that can be made in CS use will have significant long-term for children suffering from SJIA."

A total of 72% (92/128) patients using CS at baseline entered the CS-tapering phase, 44.5% (57/128) qualified as CS-tapering successes (primary endpoint). At the end of the CS-tapering phase 42/128 (33%) patients were CS-free and 24/128 (19%) had a CS dose ≤0.2 mg/kg/day (a secondary endpoint). The 42 patients achieving CS-free status vs. CS users at baseline (n=128) were older (median 9 years versus 8) and with a lower number of active joints and lower number of joints with limitation on motion (median 7 vs. 11, and 5.5 vs. 10).

Interleukin-1β (IL-1β) is a key driver in the of SJIA. Canakinumab, a selective fully human anti-IL-1β monoclonal antibody, has been shown to be efficacious in the treatment of SJIA.3

In this Phase III clinical trial, patients (2-19 years of age) with active SJIA received subcutaneous injections of canakinumab (4mg/kg to 300 mg max) every four weeks during the maximum 20-week CS-tapering phase. CS tapering was initiated during this phase when at least an adapted ACR50* was achieved and there was no fever.

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More information: *JIA ACR50 response is defined as an improvement of at least 50% from the baseline assessments in any three of six core outcome variables, with no more than one of the remaining variables deteriorating by more than 30%. The JIA core outcome variables are: active joint count, limitation of motion joint count, physician global assessment of disease activity, patient/parent global assessment of patient's overall well-being, Childhood Health Assessment Questionnaire (CHAQ), and acute-phase reactant level (CRP). The JIA ACR criteria was adapted to include the absence of fever due to SJIA in the 7 days prior to ACR measurement

1.Ruperto N et al., Baseline characteristics of patients with active systemic JIA successfully discontinuing corticosteroid while receiving canakinumab: secondary analysis from a pivotal Phase 3 trial [abstract]. EULAR Annual European Congress of Rheumatology; 12-15 June 2013; Madrid, Spain. Abstract nr. OP0136

2.Cassidy, J.T., and R.E. Petty. 2001. Textbook of Pediatric Rheumatology. W.B. Saunders, Philadelphia, PA. 976 pp.

3.Ruperto N. et al. Two Randomized Trials of Canakinumab in Systemic Juvenile Idiopathic Arthritis. N Engl J Med. 2012;367:2396-406.

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