EFFICIENCY AND SAFETY OF HUMAN MONOCLONAL ANTIBODIES TO TNF-Α IN CHILDREN WITH JUVENILE IDIOPATHIC ARTHRITIS IN PRIMARY AND SECONDARY INEFFECTIVENESS OF OTHER BIOLOGICALS

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Abstract

Purpose: To evaluate the safety and efficiency of adalimumab in children with severe refractory JIA with primary  inefficiency,  partial effect or loss of the effectiveness of other biologicals. Patients and methods: The article presents the results of the retrospective observational study of the efficacy and safety of adalimumab in 68 patients aged 10 (3, 17) years with various embodiments of JIA , with the primary inefficiency or partial or loss of the effectiveness of other biologicals. JIA diagnosis established on the basis of criteria ILAR (International League of Associations for Rheumatology).
Results: Efficacy was assessed during 1 year in 68 and  2 years -  in 56 patients . At the 24th week we observed the  improvement by criteria AKR in 100 , 91 and 74 % of patients , respectively, and at the 52 th week - in 100 , 96 and 90 % , respectively. Inactive disease status was recorded in 55.8, 66,1 and 98.2 % of study participants after  6 months, 1 and 2 years, respectively. Remission was achieved in 55.8 and 96.4 % of patients after 1 and 2 years of observation, respectively. Conclusions: Adalimumab was effective and well tolerated by patients with primary inefficiency, partial and  loss of efficiency of other biologicals. In clinical practice, patients with non-systemic JIA transition to the second TNF-α blocker can restore the biological effect of the first drug without increasing the frequency of infectious AEs.


About the authors

E. I. Alexeeva

Scientific Center of Children’s Health, Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation

Author for correspondence.
Email: alekatya@ya.ru
PhD, professor, Head of the Pediatric Faculty of I.M. Sechenov First MSMU, Head of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-02-97 Russian Federation

A. A. Baranov

Scientific Center of Children’s Health, Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation

Email: baranov@nczd.ru
academician of RAMS and RAS, PhD, professor, Director of SCCH of RAMS, Head of the Pediatric department with course of Pediatric Rheumatology of I.M. Sechenov First. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-30-87 Russian Federation

E. V. Mitenko

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: el.mitenko@yandex.ru
research scientist of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

T. M. Bzarova

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: bzarova@nczd.ru
MD, senior research scientist of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

S. I. Valieva

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: valieva@nczd.ru
MD, senior research scientist of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

R. V. Denisova

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: denisovarv@yandex.ru
MD, senior research scientist of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

K. B. Isaeva

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: isaeva-kseniya@yandex.ru
MD, pediatrician of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

E. G. Chistyakova

Scientific Center of Children’s Health, Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation

Email: chistyakova@nczd.ru
MD, leading research scientist of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

T. V. Sleptsova

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: tatyanasl08@mail.ru
MD, research scientist of the Rheumatologic Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-14-94 Russian Federation

N. I. Taibulatov

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: taibulatov@nczd.ru
MD, Head of the Department of Remedial Treatment of Children with musculoskeletal disorders of RI of Preventive Pediatrics and Remedial Treatment of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-03-69 Russian Federation

E. I. Zelikovich

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: alekatya@ya.ru
PhD, Head of the X-ray Computed Tomography Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499) 134-13-62 Russian Federation

G. V. Kurilenkov

Scientific Center of Children’s Health, Moscow, Russian Federation

Email: alekatya@ya.ru
MD, leading research scientist of the X-ray Computed Tomography Department of SCCH of RAMS. Address: build. 1, 2, Lomonosovskii Avenue, Moscow, RF, 119991; tel.: +7 (499)134-13-62 Russian Federation

References

  1. Giannini E.H., Brewer E.J., Kuzmina N. et al. Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children’s Study Group. N. Engl. J. Med. 1992; 326 (16): 1043–1049.
  2. Silverman E., Mouy R., Spiegel L. et al. Leflunomide or methotrexate for juvenile rheumatoid arthritis. N. Engl. J. Med. 2005; 352 (16): 1655–1666.
  3. Woo P., Southwood T.R., Prieur A.M., Dore C.J., Grainger J., David J. et al. Randomized, placebo-controlled, crossover trial of low dose oral methotrexate in children with extended oligoarticular or systemic arthritis. Arthritis Rheum. 2000; 43: 1849–1857.
  4. Takken T., van Der Net J., Helders P.J. Methotrexate for treating juvenile idiopathic arthritis. Cochr. Database Syst. Rev. 2001; 4: CD003129.
  5. Giannini E.H., Cassidy J.T., Brewer E.J. et al. Comparative efficacy and safety of advanced drug therapy in children with juvenile rheumatoid arthritis. Semin. Arthritis Rheum. 1993; 23 (1): 34–46.
  6. van der Bijl A.E., Breedveld F.C., Antoni C.E. et al. Adalimumab (Humira) is effective in treating patients with rheumatoid arthritis who previously failed infliximab [abstract SAT0062]. Ann. Rheum. Dis. 2005; 64 (Suppl. III): 428.
  7. Breda L., Del Torto M., De Sanctis S., Chiarelli F. Biologics in children’s autoimmune disorders: efficacy and safety. Eur. J. Pediatr. 2011; 170:157–167.
  8. Tynjala P., Vahasalo P., Honkanen V. et al. Drug survival of the first and second course of anti-tumour necrosis factor agents in juvenile idiopathic arthritis. Ann. Rheum. Dis. 2009; 68: 552–557.
  9. Otten M.H., Prince F.H., Armbrust W. et al. Effectiveness and safety of a second and third biological agent after failing etanercept in juvenile idiopathic arthritis: results from the Dutch National ABC Register, ARD Online First. Published on June 23, 2012 as 10.1136/annrheumdis-2011-201060.
  10. Feldman M., Brennan P., Maini R. Role of cytokines in rheumatoid arthritis. Ann. Rev. Immunol. 1996; 14: 397–440.
  11. Beutler B. The role of tumor necrosis factor in health and disease. J. Rheumatol. 1999; 26 (Suppl. 57): 16–21.
  12. Emi Aikawa N., de Carvalho J.F., Artur Almeida Silva C Bonfá E. Immunogenicity of anti-TNF-α agents in autoimmune diseases. Clin. Rev. Allerg. Immunol .2010; 38(2–3): 82–89.
  13. Weinblatt M.E., Keystone E.C., Furst D.E., Moreland L.W., Weisman M.H., Birbara C.A. et al. Adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial [published erratum appears in Arthritis Rheum. 2003; 48: 855]. Arthritis Rheum. 2003; 48: 35–45.
  14. Breedveld F.C., Weisman M.H., Kavanaugh A.F., Cohen S.B., Pavelka K., van Vollenhoven R. et al. The PREMIER study: A multicenter, randomized, double blind clinical trial of combination therapy with Adalimumab plus methotrexate versus methotrexate alone or Adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006; 54: 26–37.
  15. Burmester G.R., Manette X. Montecucco C.M., Monteagudo-Sáez I., Malaise M., Tzioufas A.G. et al. Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: The Research in Active Rheumatoid Arthritis (ReAct) trial. Ann. Rheum. Dis. 2007; 66 (6): 732–739.
  16. Bombardieri S., Ruiz A.A., Fardellone P., Geusens P., McKenna F., Unnebrink K. et al. () Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice. Rheumatology. 2007; 46 (7): 1191–1199.
  17. Nicas S.N., Voulgan P.V., Alamanos Y., Papadopoulos C.G., Venetsanopoulou A.I., Georgiadis A.N. et al. Efficacy and safety of switching from infliximab to adalimumab: A comparative controlled study. Ann. Rheum. Dis. 2006; 65: 257–260.
  18. Bennett A.N., Peterson P., Zain A., Grumley J., Panayi G., Kirkham В. Adalimumab in clinical practice. Outcome in 70 rheumatoid arthritis patients, including comparison of patients with and without previous anti-TNF exposure. Rheumatology. 2005; 44: 1026–1031.
  19. Wick M.C., Ernestam S., Lmdblad S., Bratt J., Klareskog L., van Vollenhoven R.F. Adalimumab (Humira) restores clinical response in patients with secondary loss of efficacy from infliximab (Remicade) or etanercept (Enbrel): Results from the STURE registry at Karolinska University Hospital. J. Rheumatol. 2005; 34: 353–358.
  20. Brocq O., Albert C., Roux C., Gerard D., Breuil V., Ziegler L.E. Adalimumab in rheumatoid arthritis after failed infliximab and/or etanercept therapy experience with 18 patients. Joint Bone Spine .2004; 71: 601–603.
  21. Haibel H., Rudwaleit M., Listing J., Heldmann F., Wong R.L., Kupper H. et al. Efficacy of Adalimumab in the treatment of axial spondylarthritis without radiographically defined sacroiliitis: Results of a twelve-week randomized, double-blind, placebo-controlled trial followed by an open-label extension up to week fifty-two. Arthritis Rheum. 2008; 58 (7): 1981–1991.
  22. Wijbrandts C.A., Klaasen R., Dijkgraaf M.G., Gerlag D.M., van Eck-Smit B.L., Tak P.P. Bone mineral density in rheumatoid arthritis patients 1 year after Adalimumab therapy: Arrest of bone loss? Ann. Rheum. Dis. 2008; 68 (3): 373–376.
  23. Kimel M., Cifaldi M., Chen N., Revicki D. Adalimumab plus methotrexate improved SF-36 scores and reduced the effect of rheumatoid arthritis (RA) on work activity for patients with early RA. J. Rheumatol. 2008; 35 (2): 206–215.
  24. Lovell D., Ruperto N., Reiff A., Jung L.K., Higgins G., Koné-Paut I., Jones Olcay Y., McIlraith M.J., Andhivarothai N., Kupper H., Giannini E.H., Peterson T., Martini A. Long-term efficacy and safety of adalimumab for up to 6 years in patients with juvenile idiopathic arthritis. Abstract presented at: 75th Annual scientific meeting of the American College of Rheumatology (ACR) and the 46th Annual meeting of the Association of Rheumatology Health Professionals (ARHP). Chicago, IL. USA. 2011. Abstract MIS (7190791).
  25. Lovell D.J. et al OLE DE 038: Long-term efficacy and safety of ADA for up to 6 years in patients with JIA. ACR11. Arthritis Rheum. 2011; 63 (10) (Suppl.): abstract 265.
  26. Breda L., Del Torto M., De Sanctis S., Chiarelli F. Biologics in children’s autoimmune disorders: Efficacy and safety. Eur. J. Pediatr. 2011; 170: 157–167.
  27. Schett G., Coates L.C., Ash Z.R., Finzel S., Conaghan P.G. Structural damage in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: Traditional views, novel insights gained from TNF blockade, and concepts for the future. Arthritis Res. Ther. 2011; 13(Suppl. 1): 4.
  28. Cassidy J.T., Petty R.E., Laxer R.M., Lindsley C.B. Textbook of pediatric rheumatology. 6th ed. Saunders Elsevier, Philadelphia. 2010. 794 p.
  29. Wallace C.A,. Giannini E.H., Huang В., Itert L., Ruperto N., Childhood Arthritis Rheumatology Research Alliance (CARRA), Pediatric Rheumatology Collaborative Study Group (PRCSG) and Paediatric Rheumatology International Trials Organisation (PRINTO), American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis. Arthritis Care Res. 2011; 63: 929–936. doi: 10.1002/acr.20497
  30. Ruperto N., Lovell D.J., Reiff A., Gamir M., Higgins G., Koné-Paut I. et al Long-term efficacy and safety of Adalimumab in 4-12 year old patients with juvenile idiopathic arthritis. Pediatr. Rheumatol. 2011; 9 (Suppl. 1):26.
  31. Lahdenne P., Vahasalo P., Honkanen V. Infliximab or etanercept in the treatment of children with refractory juvenile idiopathic arthritis: An open label study. Ann. Rheum. Dis. 2003; 62: 245–247.
  32. Mariette X. et al. Tumour necrosis factor alpha blocking agents in refractory adult Still's disease: An observational study of 20 cases. Ann. Rheum. Dis. 2005; 64: 262.
  33. Remy A., Avouac J., Gossec L. et al. Clinical relevance of switching to a second tumour necrosis factor-alpha inhibitor after discontinuation of a first tumour necrosis factor-alpha inhibitor in rheumatoid arthritis: a systematic literature review and meta-analysis. Clin. Exp. Rheumatol. 2011; 29: 96–103.
  34. Curtis J.R., Xie F., Chen L. et al. The comparative risk of serious infections among rheumatoid arthritis patients starting or switching biological agents. Ann. Rheum. Dis. 2011; 70:1401–1406.
  35. Sleptsova T., Alexeeva E., Valieva S., Bzarova T., Lisitsyn A., Denisova R., Isayeva K. Efficacy and safety of treatment with infliximab in patients with early and long-standing oligo- and polyarticular juvenile idiopathic arthritis. Abstract in the Annual European Congress of Rheumatology EULAR. Ann. Rheum. Dis. 2010; 69: 639.
  36. Alexeeva E.I., Valieva S.I., Bzarova T.M., Semikina E.L., Isaeva K.B., Lisitsyn A.O., Denisova R.V., Chistyakova E.G. Efficacy and safety of repeat courses of rituximab treatment in patients with severe refractory juvenile idiopathic arthritis. Clin. Rheumatol. 2011; 30 (9): 1163–1172.

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