134
Views
0
CrossRef citations to date
0
Altmetric
Original Research

The safety of canakinumab in systemic juvenile idiopathic arthritis and autoinflammatory diseases in pediatric patients: a multicenter study

, ORCID Icon, , , , , , , , , , , , , , , , , , , & ORCID Icon show all
Pages 1299-1306 | Received 07 Jun 2023, Accepted 07 Nov 2023, Published online: 17 Nov 2023

References

  • Dinarello CA, Simon A, van der Meer JW. Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases. Nat Rev Drug Discov. 2012;11(8):633–652. doi: 10.1038/nrd3800
  • Ozen S, Demirkaya E, Erer B, et al. EULAR recommendations for the management of familial Mediterranean fever. Ann Rheum Dis. 2016;75(4):644–651. doi: 10.1136/annrheumdis-2015-208690
  • De Benedetti F, Gattorno M, Anton J, et al. Canakinumab for the treatment of autoinflammatory recurrent fever syndromes. N Engl J Med. 2018 17;378(20):1908–1919. doi: 10.1056/NEJMoa1706314
  • Buckley LF, Viscusi MM, Van Tassell BW, et al. Interleukin-1 blockade for the treatment of pericarditis. Eur Heart J Cardiovasc Pharmacother. 2018 1;4(1):46–53. doi: 10.1093/ehjcvp/pvx018
  • Pascual V, Allantaz F, Arce E, et al. Role of interleukin-1 (IL-1) in the pathogenesis of systemic onset juvenile idiopathic arthritis and clinical response to IL-1 blockade. J Exp Med. 2005 2;201(9):1479–1486. doi: 10.1084/jem.20050473
  • Quartier P, Allantaz F, Cimaz R, et al. A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). Ann Rheum Dis. 2011;70(5):747–754. doi: 10.1136/ard.2010.134254
  • Ruperto N, Brunner HI, Quartier P, et al. PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 20;367(25):2396–2406. doi: 10.1056/NEJMoa1205099
  • De Benedetti F, Brunner HI, Ruperto N, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367(25):2385–2395. doi: 10.1056/nejmoa1112802
  • Yokota S, Imagawa T, Mori M, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 22;371(9617):998–1006. doi: 10.1016/S0140-6736(08)60454-7
  • Nigrovic PA. Review: is there a window of opportunity for treatment of systemic juvenile idiopathic arthritis? Arthritis & rheumat. 2014;66(6):1405–1413. doi: 10.1002/art.38615
  • Mellins ED, Macaubas C, Grom AA. Pathogenesis of systemic juvenile idiopathic arthritis: some answers, more questions. Nat Rev Rheumatol. 2011 7;7(7):416–426. doi: 10.1038/nrrheum.2011.68
  • Sözeri B, Sönmez HE, Karadağ ŞG, et al. The feasibility of withdrawing canakinumab in paediatric colchicine-resistant familial Mediterranean fever patients. Clin Exp Rheumatol. 2021 39;Suppl 132(5):118–123. doi: 10.55563/clinexprheumatol/ef5llq
  • Öztürk K, Coşkuner T, Baglan E, et al. Real-life data from the largest Pediatric familial Mediterranean fever cohort. Front Pediatr. 2022 Jan 20;9:805919.
  • Ravelli A, Magni-Manzoni S, Pistorio A, et al. Preliminary diagnostic guidelines for macrophage activation syndrome complicating systemic juvenile idiopathic arthritis. J Pediatr. 2005;146(5):598–604. doi: 10.1016/j.jpeds.2004.12.016
  • Yokota S, Imagawa T, Nishikomori R, et al. Long-term safety and efficacy of canakinumab in cryopyrin-associated periodic syndrome: results from an open-label, phase III pivotal study in Japanese patients. Clin Exp Rheumatol. 2017;35108(6):19–26.
  • Başaran Ö, Kavuncu S, Güven A, et al. Familial Mediterranean fever associated with optic neuritis, successfully treated with anti-interleukin 1 agents. Turk J Pediatr. 2016;58(3):327–330. doi: 10.24953/turkjped.2016.03.018
  • Sendogan DO, Saritas H, Kumru G, et al. Outcomes of canakinumab treatment in recipients of kidney transplant with familial Mediterranean fever: a case series. Transplant Proc. 2019;51(7):2292–2294. doi: 10.1016/j.transproceed.2019.03.049
  • Alpa M, Roccatello D. Canakinumab as rescue therapy in familial Mediterranean fever refractory to conventional treatment. Drug Des Devel Ther. 2015 17;9:1983–1987. doi: 10.2147/DDDT.S69117
  • Laskari K, Boura P, Dalekos GN, et al. Longterm beneficial effect of canakinumab in colchicine-resistant familial Mediterranean fever. J Rheumatol. 2017;44(1):102–109. doi: 10.3899/jrheum.160518
  • Meinzer U, Quartier P, Alexandra JF, et al. Interleukin-1 targeting drugs in familial Mediterranean fever: a case series and a review of the literature. Semin Arthritis Rheum. 2011;41(2):265–271. doi: 10.1016/j.semarthrit.2010.11.003
  • Yasuda R, Mizuochi T, Kitamura M, et al. Canakinumab eliminates resistant familial Mediterranean fever in a Japanese girl. Pediatr Int. 2019;61(11):1173–1174. doi: 10.1111/ped.13968
  • Eren Akarcan S, Dogantan S, Karaca E, et al. Successful management of colchicine resistant familial Mediterranean fever patients with a standardized canakinumab treatment protocol: a case series and literature review. Rheumatol Int. 2020;40(1):161–168. doi: 10.1007/s00296-019-04366-w
  • Cetin P, Sari I, Sozeri B, et al. Efficacy of interleukin-1 targeting treatments in patients with familial Mediterranean fever. Inflammation. 2015;38(1):27–31. doi: 10.1007/s10753-014-0004-1
  • Kucuksahin O, Yildizgoren MT, Ilgen U, et al. Anti-interleukin-1 treatment in 26 patients with refractory familial Mediterranean fever. Mod Rheumatol. 2017 Mar;27(2):350–355. doi: 10.1080/14397595.2016.1194510
  • Yildirim T, Yilmaz R, Uzerk Kibar M, et al. Canakinumab treatment in renal transplant recipients with familial Mediterranean fever. J Nephrol. 2018;31(3):453–455. doi: 10.1007/s40620-018-0475-5
  • Yazılıtaş F, Aydoğ Ö, Özlü SG, et al. Canakinumab treatment in children with familial Mediterranean fever: report from a single center. Rheumatol Int. 2018;38(5):879–885. doi: 10.1007/s00296-018-3993-5
  • Trabulus S, Korkmaz M, Kaya E, et al. Canakinumab treatment in kidney transplant recipients with AA amyloidosis due to familial Mediterranean fever. Clin Transplant. 2018;32(8):e13345. doi: 10.1111/ctr.13345
  • Babaoglu H, Varan O, Kucuk H, et al. Effectiveness of canakinumab in colchicine- and anakinra-resistant or -intolerant adult familial Mediterranean fever patients: a single-center real-life study. J Clin Rheumatol. 2020;26(1):7–13. doi: 10.1097/RHU.0000000000000873
  • Gülez N, Makay B, Sözeri B. Long-term effectiveness and safety of canakinumab in pediatric familial Mediterranean fever patients. Mod Rheumatol. 2020;30(1):166–171. doi: 10.1080/14397595.2018.1559488
  • Gül A, Ozdogan H, Erer B, et al. Efficacy and safety of canakinumab in adolescents and adults with colchicine-resistant familial Mediterranean fever. Arthritis Res Ther. 2015 4;17(1):243. doi: 10.1186/s13075-015-0765-4
  • Kisla Ekinci RM, Balci S, Bisgin A, et al. Renal amyloidosis in deficiency of Adenosine Deaminase 2: successful experience WithCanakinumab. Pediatrics. 2018;142(5):e20180948. doi: 10.1542/peds.2018-0948
  • Berdeli A, Ö Ş, Talay G. Treatment of familial Mediterranean fever with canakinumab in patients who are unresponsive to colchicine. Eur J Rheumatol. 2019 1;6(2):85–88. doi: 10.5152/eurjrheum.2019.18190
  • Brik R, Butbul-Aviel Y, Lubin S, et al. Canakinumab for the treatment of children with colchicine-resistant familial Mediterranean fever: a 6-month open-label, single-arm pilot study. Arthritis & rheumat. 2014;66(11):3241–3243. doi: 10.1002/art.38777
  • Kacar M, Savic S, van der Hilst JCH, et al. The Efficacy, safety and tolerability of canakinumab in the treatment of familial mediterranean fever: a systematic review of the literature. J Inflamm Res. 2020 9;13:141–149. doi: 10.2147/JIR.S206204
  • Walker UA, Tilson HH, Hawkins PN, et al. Long-term safety and effectiveness of canakinumab therapy in patients with cryopyrin-associated periodic syndrome: results from the β-Confident Registry. RMD Open. 2021;7(2):e001663. doi: 10.1136/rmdopen-2021-001663
  • Brogan P, Hofer M, KuemmerleDeschner J, et al. FRI0503 efficacy and safety of canakinumab in patients with cryopyrin associated periodic syndromes: an open-label, phase-III, extension study. Ann Rheum Dis. 2016;75(Suppl 2):620–621. doi: 10.1136/annrheumdis-2016-eular.4865
  • Hosono K, Kato C, Sasajima T. Real-world safety and effectiveness of canakinumab in patients with cryopyrin-associated periodic fever syndrome: a long-term observational study in Japan. Clin Exp Rheumatol. 2022;40(8):1543–1553. doi: 10.55563/clinexprheumatol/pjs6eh
  • Ruperto N, Brunner HI, Quartier P, et al. Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018;77(12):1710–1719. doi: 10.1136/annrheumdis-2018-213150
  • Ridker PM, MacFadyen JG, Thuren T, et al. Effect of interleukin-1β inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo-controlled trial. Lancet. 2017 21;390(10105):1833–1842. doi: 10.1016/S0140-6736(17)32247-X
  • Yamasaki Y, Kubota T, Takei S, et al. A case of cryopyrin-associated periodic fever syndrome during canakinumab administration complicated by inflammatory bowel disease. Clin Rheumatol. 2021;40(1):393–397. doi: 10.1007/s10067-020-05267-1
  • Hügle B, Speth F, Haas JP. Inflammatory bowel disease following anti-interleukin-1-treatment in systemic juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2017 14;15(1):16. doi: 10.1186/s12969-017-0147-3
  • Bamias G, Arseneau KO, Cominelli F. Cytokines and mucosal immunity. Curr Opin Gastroenterol. 2014;30:547–552. doi: 10.1097/mog.0000000000000118
  • Bersudsky M, Luski L, Fishman D, et al. Non-redundant properties of IL-1alpha and IL-1beta during acute colon inflammation in mice. Gut. 2014;63:598–609. doi: 10.1136/gutjnl-2012-303329
  • Sozeri B, Ulu K, Kaya-Akça U, et al. The clinical course of SARS-CoV-2 infection among children with rheumatic disease under biologic therapy: a retrospective and multicenter study. Rheumatol Int. 2022;42(3):469–475. doi: 10.1007/s00296-021-05008-w
  • Ao G, Wang Y, Li A, et al. The effect of canakinumab on clinical outcomes in patients with COVID-19: a meta-analysis. J Infect. 2022;84(6):834–872. doi: 10.1016/j.jinf.2022.03.011
  • De Matteis A, Bracaglia C, PiresMarafon D, et al. Canakinumab in systemic juvenile idiopathic arthritis: real-world data from a retrospective Italian cohort. Rheumatology (Oxford). 2022 11;61(4):1621–1629. doi: 10.1093/rheumatology/keab619
  • Ruperto N, Quartier P, Wulffraat N, et al. Paediatric Rheumatology International clinical trials Organisation. 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):557–567. doi: 10.1002/art.33342
  • Grom AA, Ilowite NT, Pascual V, et al. Rate and clinical presentation of macrophage activation syndrome in patients with systemic juvenile idiopathic arthritis treated with canakinumab. Arthritis & rheumat. 2016;68(1):218–228. doi: 10.1002/art.39407
  • Nishimura K, Hara R, Umebayashi H, et al. Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients. Mod Rheumatol. 2021;31(1):226–234. doi: 10.1080/14397595.2020.1783163

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.