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Canakinumab: A Review of Its Use in the Management of Systemic Juvenile Idiopathic Arthritis

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Abstract

Subcutaneous canakinumab (Ilaris®) is a human monoclonal anti-human interleukin (IL)-1β antibody of the immunoglobulin G1/κ isotype that binds with high affinity and specificity to human IL-1β, blocking its interaction with IL-1 receptors. It is approved in the EU as monotherapy or in combination with methotrexate for the treatment of patients aged ≥2 years with active systemic juvenile idiopathic arthritis (SJIA) who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids. In the USA, it is indicated for the treatment of patients aged ≥2 years with active SJIA. In two placebo-controlled, multinational, phase III studies in patients aged 2–19 years with SJIA, canakinumab rapidly reduced disease activity, permitted the tapering of glucocorticoid therapy and delayed the time to disease flare. The efficacy of canakinumab was sustained at a median follow-up of 49 weeks in an ongoing extension study. In clinical studies, canakinumab had an acceptable tolerability profile that was comparable with that observed in patients with cryopyrin-associated periodic syndromes. In general, adverse events were mild or moderate in intensity, with nasopharyngitis, cough, pyrexia, vomiting, diarrhoea and upper respiratory tract infection the most frequently reported treatment-emergent adverse events. Thus, current evidence suggests subcutaneous canakinumab extends the treatment options currently available for patients aged ≥2 years with SJIA.

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References

  1. Prakken B, Albani S, Martini A. Juvenile idiopathic arthritis. Lancet. 2011;377(9783):2138–49.

    Article  PubMed  Google Scholar 

  2. Gurion R, Lehman TJA, Moorthy LN. Systemic arthritis in children: a review of clinical presentation and treatment. Int J Inflam. 2012;2012(271569).

  3. Gowdie PJ, Tse SML. Juvenile idiopathic arthritis. Pediatr Clin N Am. 2012;59(2):301–27.

    Article  Google Scholar 

  4. DeWitt EM, Kimura Y, Beukelman T, et al. Consensus treatment plans for new-onset systemic juvenile idiopathic arthritis. Arthritis Care Res. 2012;64(7):1001–10.

    CAS  Google Scholar 

  5. Vannucci G, Cantarini L, Giani T, et al. Glucocorticoids in the management of systemic juvenile idiopathic arthritis. Paediatr Drugs. 2013;15(5):343–9.

    Article  PubMed  Google Scholar 

  6. Chakraborty A, Tannenbaum S, Rordorf C, et al. Pharmacokinetic and pharmacodynamic properties of canakinumab, a human anti-interleukin-1β monoclonal antibody. Clin Pharmacokinet. 2012;51(6):e1–18.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  7. European Medicines Agency. Ilaris (canakinumab): summary of product characteristics. 2014. http://www.ema.europa.eu/ema/. Accessed 16 March 2015.

  8. Curran MP. Canakinumab. BioDrugs. 2012;26:53–9.

    Article  CAS  Google Scholar 

  9. European Medicines Agency. Ilaris (canakinumab): assessment report. 2013. http://www.ema.europa.eu/ema/. Accessed 16 March 2015.

  10. Novartis Pharmaceuticals Corporation. ILARIS (canakinumab) injection for subcutaneous use: prescribing information. 2013. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed 16 March 2015.

  11. Wulffraat N, Brunner HI, Ruperto N, et al. Analysis of biomarkers in systemic juvenile idiopathic arthritis patients on canakinumab therapy (abstract no. 761). Arthritis Rheum. 2012;64(10 Suppl.):S328.

    Google Scholar 

  12. Nirmala NR, Wulffraat N, Brunner H, et al. Characterization of changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy (abstract no. 1692). Arthritis Rheum. 2013;65(10 Suppl.):S716.

    Google Scholar 

  13. Ruperto N, Brunner HI, Quartier P, et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367(25):2396–406.

    Article  CAS  PubMed  Google Scholar 

  14. Brunner H, Quartier P, Constantin T, et al. Canakinumab in the treatment of systemic juvenile idiopathic arthritis: results from a 12-week pooled post-hoc analysis for efficacy (abstract no. 270). Arthritis Rheum. 2013;65(10 Suppl.):S112–3.

  15. Wulffraat NM, Ruperto N, Brunner HI, et al. Response to canakinumab treatment is maintained in systemic juvenile idiopathic arthritis patients (abstract no. 931). Arthritis Rheumatol. 2014;66(10 Suppl):S413–4.

  16. Ruperto N, Brunner H, Constantin T, 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 no. OP0136). Ann Rheum Dis. 2013;72(Suppl. 3):97.

    Article  Google Scholar 

  17. Schneider R, Brunner HI, Ruperto N, et al. Marked improvement in patient reported outcomes of children with active systemic juvenile idiopathic arthritis with canakinumab treatment: results of the phase III program (abstract no. 269). Arthritis Rheum. 2013;65(10 Suppl.):S111–2.

  18. Wulffraat N, Kallinich T, McCann L, et al. Changes in health-related quality of life in systemic juvenile idiopathic arthritis patients after single dose of canakinumab (abstract no. THU0328). Ann Rheum Dis. 2012;71(Suppl. 3):266.

    Article  Google Scholar 

  19. Brunner HI, Ruperto N, Koné-Paut I, et al. An exploratory analysis of predictors of response from 12-weeks of canakinumab therapy in patients with active systemic juvenile idiopathic arthritis (abstract no. 930). Arthritis Rheumatol. 2014;66(Suppl. 10):S413.

    Google Scholar 

  20. Ruperto N, Quartier P, Wulffraat N, et al. A phase II, multicenter, open-label study evaluating dosing and preliminary safety and efficacy of canakinumab in systemic juvenile idiopathic arthritis with active systemic features. Arthritis Rheum. 2012;64(2):557–67.

    Article  CAS  PubMed  Google Scholar 

  21. Xiong Y, Wang W, Ebling W, et al. Exposure-response modelling of canakinumab in the avoidance of flares in children with systemic juvenile idiopathic arthritis (abstract no. 2029). Arthritis Rheum. 2013;65(10 Suppl.):S865–6.

  22. Kimura Y, Weiss JE, Haroldson KL, et al. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res. 2013;65(5):745–52.

    Article  CAS  Google Scholar 

  23. Levi M, Dumortier T, Ruperto N, et al. A pharmacometric based analysis of the occurrence of selected safety events of special interest and canakinumab exposure in systemic juvenile idiopathic arthritis patients (abstract no. 2295). Arthritis Rheumatol. 2014;66(10 Suppl):S1001–2.

  24. Grom AA, Brunner HI, Ruperto N, et al. Canakinumab in systemic juvenile idiopathic arthritis: impact on the rate and clinical presentation of macrophage activation syndrome (abstract no. FRI0528). Ann Rheum Dis. 2014;73(Suppl. 2).

  25. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res. 2013;65(10):1551–63.

    Article  Google Scholar 

  26. Otten MH, Anink J, Spronk S, et al. Efficacy of biological agents in juvenile idiopathic arthritis: a systematic review using indirect comparisons. Ann Rheum Dis. 2013;72(11):1806–12.

    Article  CAS  PubMed  Google Scholar 

  27. Kimura Y, DeWitt EM, Beukelman T, et al. Adding canakinumab to the Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans for systemic juvenile idiopathic arthritis: comment on the article by DeWitt et al. Arthritis Care Res. 2014;66(9):1430–1.

    Article  CAS  Google Scholar 

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit. Sheridan Hoy is a salaried employee of Adis/Springer.

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Correspondence to Sheridan M. Hoy.

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The manuscript was reviewed by: R. Cimaz, Anna Meyer Children’s Hospital, University of Florence, Florence, Italy; S. Saluja, Saran Ashram Hospital, Dayalbagh, Agra, India.

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Hoy, S.M. Canakinumab: A Review of Its Use in the Management of Systemic Juvenile Idiopathic Arthritis. BioDrugs 29, 133–142 (2015). https://doi.org/10.1007/s40259-015-0123-8

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