Preview

Current Pediatrics

Advanced search

Efficacy of Pneumococcal Polysaccharide Conjugate Vaccine (13-valent, Adsorbed) in Patients with Systemic Juvenile Idiopathic Arthritis Treated with Genetically Engineered Biologic Drugs (Tocilizumab or Canakinumab): Prospective Cohort Study

https://doi.org/10.15690/vsp.v19i3.2114

Abstract

Background. Immunological potency of 13-valent pneumococcal vaccine (PCV-13) in children with systemic juvenile idiopathic arthritis (SJIA) is still unstudied. Estimates of the genetically engineered biologic drugs (GEBD) effects on pneumococcal vaccination results also remain controversial.

Objective. The aim of the study was to explore the PCV-13 efficacy in patients with SJIA and who is on treatment with monoclonal antibodies against interleukin 6 receptor (tocilizumab) and interleukin 8 receptor beta (canakinumab).

Methods. The study included patients under the age of 18 with SJIA in remission or active form of disease vaccinated with PCV-13. The vaccine was administered in single dose of 0.5 ml intramuscularly in patients on treatment with GEBD or 3 weeks before GEBD administration for the first time (for patients with active disease). Vaccination was considered effective at achievement of the minimum protective level of antibodies to capsular polysaccharide of pneumococcus (anti-SPP IgG; ≥ 7 U/ml) or increase of anti-SPP IgG level ≥ 2 times in 4 weeks after vaccination. The anti-SPP IgG levels were measured with enzyme immunoassay.

Results. The study included 53 patients (27 girls) in remission of SJIA and 25 (16 girls) in active disease. Median age was 13.3 and 10.8 years respectively. Tocilizumab/canakinumab was administrated in 43/10 and 18/7 patients respectively. Minimum significant anti-SPP IgG level and two-fold increase in anti-SPP IgG level were recorded in 49/53 (92%) and 32/53 (60%) patients with SJIA in remission, as well as in 22/25 (88%) and 18/25 (72%) patients in active disease respectively. PCV-13 immunological potency in patients with SJIA in remission and in active disease (in those who were initially administrated and who did not receive GEBD) did not differ.

Conclusion. PCV-13 vaccination allows to achieve protective antibodies level in most of the patients with SJIA in children population regardless of the disease stage and the history of GEBD administration.

About the Authors

Ekaterina I. Alexeeva
National Medical Research Center for Children's Health; Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Moscow
Disclosure of interest: Ekaterina I. Alexeeva — receiving research grants from pharmaceutical companies Roche, Pfizer, Centocor, Novartis.


Dariya D. Vankova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Tatyana M. Dvoryakovskaya
National Medical Research Center for Children's Health; Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Moscow
Disclosure of interest: Tatyana M. Dvoryakovskaya — receiving research grants from pharmaceutical companies Roche, Pfizer.


Ksenia B. Isaeva
National Medical Research Center for Children's Health
Russian Federation
Moscow


Rina V. Denisova
National Medical Research Center for Children's Health
Russian Federation
Moscow
Disclosure of interest:

Rina V. Denisova — receiving research grants from pharmaceutical companies Roche, Centocor, Novartis.

Other authors confirmed the absence of a reportable conflict of interests.



Anna V. Mamutova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Aleksandra M. Chomakhidze
National Medical Research Center for Children's Health
Russian Federation
Moscow


Tatyana V. Radygina
National Medical Research Center for Children's Health
Russian Federation
Moscow


Irina V. Zubkova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Natalia E. Tkachenko
National Medical Research Center for Children's Health
Russian Federation
Moscow


Anna N. Fetisova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Olga L. Lomakina
National Medical Research Center for Children's Health
Russian Federation
Moscow


Yanina O. Orlova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Mariya K. Kurdup
National Medical Research Center for Children's Health
Russian Federation
Moscow


Marina S. Gautier
National Medical Research Center for Children's Health
Russian Federation
Moscow


Elizaveta A. Krekhova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Meyri S. Shingarova
National Medical Research Center for Children's Health
Russian Federation
Moscow


Olga P. Galkina
National Medical Research Center for Children's Health
Russian Federation
Moscow


References

1. Gattorno M. Autoinflammatory diseases in children. Current Pediatrics. 2014;13(2):55–64. (In Russ). doi: 10.15690/vsp.v13i2.973.

2. Yunosheskij artrit s sistemnym nachalom. Klinicheskie rekomendatsii [Internet]. Moscow: Soyuz pediatrov Rossii; 2016. (In Russ). Доступно по: http://cr.rosminzdrav.ru/#!/recomend/58. Ссылка активна на 12.02.2019.

3. Machado SH, Xavier RM. Safety of tocilizumab in the treatment of juvenile idiopathic arthritis. Expert Opin Drug Saf. 2017;16(4): 493–500. doi: 10.1080/14740338.2017.1303479.

4. Roszkiewicz J, Orczyk K, Smolewska E. Tocilizumab in the treatment of systemic-onset juvenile idiopathic arthritis — singlecentre experience. Reumatologia. 2018;56(5):279–284. doi: 10.5114/reum.2018.79497.

5. Grevich S, Shenoi S. Update on the management of systemic juvenile idiopathic arthritis and role of IL-1 and IL-6 inhibition. Adolesc Health Med Ther. 2017;8:125–135. doi: 10.2147/AHMT. S109495.

6. Bracaglia C, Prencipe G, De Benedetti F. Macrophage activation syndrome: different mechanisms leading to a one clinical syndrome. Pediatr Rheumatol Online J. 2017;15(1):5. doi: 10.1186/s12969-016-0130-4.

7. Davies HD; Committee on infectious diseases. Infectious complications with the use of biologic response modifiers in infants and children. Pediatrics. 2016;138(2):e20161209. doi: 10.1542/peds.2016-1209.

8. van Assen S, Agmon-Levin N, Elkayam O, et al. EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2011;70(3): 414–422. doi: 10.1136/ard.2010.137216.

9. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(5):625–639. doi: 10.1002/acr.21641.

10. Cassidy JT, Petty RE, Laxer RM, Lindsley CB. Textbook of pediatric rheumatology. 6th ed. Philadelphia: Saunders Elsevier; 2011. 794 p.

11. Farmaki E, Kanakoudi-Tsakalidou F, Spoulou V, et al. The effect of anti-TNF treatment on the immunogenicity and safety of the 7-valent conjugate pneumococcal vaccine in children with juvenile idiopathic arthritis. Vaccine. 2010;28(31):5109–5113. doi: 10.1016/j.vaccine.2010.03.080.

12. Aikawa NE, Franca IL, Ribeiro AC, et al. Short and long-term immunogenicity and safety following the 23-valent polysaccharide pneumococcal vaccine in juvenile idiopathic arthritis patients under conventional DMARDs with or without anti-TNF therapy. Vaccine. 2015;33(5):604–609. doi: 10.1016/j.vaccine.2014.12.030.

13. Rakoczi E, Perge B, Vegh E, et al. Evaluation of the immunogenicity of the 13-valent conjugated pneumococcal vaccine in rheumatoid arthritis patients treated with etanercept. Joint Bone Spine 2016;83:675–679. doi: 10.1016/j.jbspin.2015.1.

14. Alexeeva EI, Dvoryakovskaya TM, Denisova RV, et al. Immunization with a pneumococcal polysaccharide vaccine in children with juvenile idiopathic arthritis without systemic manifestations: a prospective study. Current Pediatrics. 2017;16(6):493–501. [In Russ). doi: 10.15690/vsp.v16i6.1822.

15. Nagel J, Saxne T, Geborek P, et al. Treatment with belimumab in systemic lupus erythematosus does not impair antibody response to 13-valent pneumococcal conjugate vaccine. Lupus. 2017;26(10):1072–1081. doi: 10.1177/0961203317695465.

16. Nived P, Nagel J, Saxne T, et al. Immune response to pneumococcal conjugate vaccine in patients with systemic vasculitis receiving standard of care therapy. Vaccine. 2017;35(29); 3639–3646. doi: 10.1016/j.vaccine.2017.05.044.

17. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007; 369(9563):767–778. doi: 10.1016/S0140-6736(07)60363-8.

18. Federal’nye klini cheskie reko mendatsii po okazaniyu meditsinskoi pomoshchi detyam s yuvenil’nym artritom [Internet]. Moscow: Soyuz pediatrov Rossii; 2013. (In Russ). Доступно по: https://minzdrav.gov-murman.ru/documents/poryadki-okazaniya-meditsinskoy-pomoshchi/_kr_ua.pdf. Ссылка активна на 04.07.2020.

19. Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines-proposed replacement of TRS 927, Annex 2, ECBS, 19 to 23 October 2009. Available online: https://www.who.int/biologicals/publications/trs/areas/vaccines/pneumo/en. Accessed on June 01, 2020.

20. Alekseeva YeI, Lomakina OL, Valieva SI, et al. Features of the drug therapy of children with systemic juvenile idiopathic arthritis: analysis results of the All-russian register of the Union of pediatricians of Russia. Current Pediatrics. 2016;15(1):59-67. (In Russ). doi: 10.15690/vsp.v15i1.1500.

21. Guideline on clinical evaluation of vaccines. EMEA/CHMP/VWP/164653/05 Rev. 1. Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinicalevaluation-vaccines-revision-1_en.pdf. Accessed on June 30, 2020.

22. Voysey M, Sadarangani M, Pollard AJ, Fanshawe TR. Com puting threshold antibody levels of protection in vaccine clinical trials: An assessment of methodological bias. PLoS One. 2018;13(9): e0202517. doi: 10.1371/journal.pone.0202517.

23. Harris JG, Maletta KI, Ren B, Olson JC. Improving Pneumococcal Vaccination Rate in the Pediatric Rheumatology Clinic. Pediatrics. 2015;136(3):e681–686. doi: 10.1542/peds.2014-2512.

24. Nikityuk NF, Glushchenko VA, Panin IV. Scientific and methodical approaches to organizing and conducting immunization in patients with health disorders. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(1):35–42. (In Russ). doi: 10.30895/2221-996X-2016-16-1-35-42.

25. Bingham CO, Rizzo W, Kivitz A, et al. Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA). Ann Rheum Dis. 2014;74(5):818–822. doi: 10.1136/annrheumdis-2013-204427.

26. Hua C, Barnetche T, Combe B, et al. Effect of methotrexate, antitumor necrosis factor α, and rituximab on the immune response to influenza and pneumococcal vaccines in patients with rheumatoid arthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2014;66(7):1016–1026. doi: 10.1002/acr.22246.

27. Mori S, Ueki Y, Akeda Y, et al. Pneumococcal polysaccharide vaccination in rheumatoid arthritis patients receiving tocilizumab therapy. Ann Rheum Dis. 2013;72(8):1362–1366. doi: 10.1136/annrheumdis-2012-202658.

28. Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010;59(34): 1102–1106.

29. Greenberg RN, Gurtman A, Frenck RW, et al. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60–64 years of age. Vaccine. 2014;32(20): 2364–2374. doi: 10.1016/j.vaccine.2014.02.002.

30. Jackson LA, Gurtman A, van Cleeff M, et al. Influence of initial vaccination with 13-valent pneumococcal conjugate vaccine or 23-valent pneumococcal polysaccharide vaccine on anti-pneumococcal responses following subsequent pneumococcal vaccination

31. in adults 50 years and older. Vaccine. 2013;31(35):3594–3602. doi: 10.1016/j.vaccine.2013.04.084.

32. Lesprit P, Pedrono G, Molina J-M. Immunological efficacy of a prime-boost pneumococcal vaccination in HIV-infected adults. AIDS. 2007;21(18):2425–2434. doi: 10.1097/QAD.0b013e3282887e91.

33. Nguyen MTT, Lindegaard H, Hendricks O, et al. Initial serological response after prime-boost pneumococcal vaccination in rheumatoid arthritis patients: results of a randomized controlled trial. J Rheumatol. 2017;44(12):1794–803. doi: 10.3899/jrheum.161407

34. Jaeger VK, Hoffman HM, van der Poll T, et al. Safety of vaccinations in patients with cryopyrin-associated periodic syndromes: a prospective registry based study. Rheumatology (Oxford). 2017;56(9):1484–1491. doi: 10.1093/rheumatology/kex185.

35. Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020; 79(1):39–52. doi: 10.1136/annrheumdis-2019-215882.


Review

For citations:


Alexeeva E.I., Vankova D.D., Dvoryakovskaya T.M., Isaeva K.B., Denisova R.V., Mamutova A.V., Chomakhidze A.M., Radygina T.V., Zubkova I.V., Tkachenko N.E., Fetisova A.N., Lomakina O.L., Orlova Ya.O., Kurdup M.K., Gautier M.S., Krekhova E.A., Shingarova M.S., Galkina O.P. Efficacy of Pneumococcal Polysaccharide Conjugate Vaccine (13-valent, Adsorbed) in Patients with Systemic Juvenile Idiopathic Arthritis Treated with Genetically Engineered Biologic Drugs (Tocilizumab or Canakinumab): Prospective Cohort Study. Current Pediatrics. 2020;19(3):190-199. https://doi.org/10.15690/vsp.v19i3.2114

Views: 1155


ISSN 1682-5527 (Print)
ISSN 1682-5535 (Online)