Preview

Pediatric pharmacology

Advanced search

SAFETY OF BIOLOGICAL PREPARATIONS AND SMALL MOLECULES. ARE THERE ANY DIFFERENCES?

https://doi.org/10.15690/pf.v10i3.693

Abstract

 A considerable number of biopharmaceuticals have recently been introduced into clinical practice. Their role is becoming more and more important in managing various diseases, including incapacitating and life-threatening diseases. The authors systematically reviewed literary data from 1990 to 2013 dedicated to studying adverse side reactions to medicinal proteins. The authors used international databases to search for publications dedicated to this issue. As a result, this analysis involves studies describing adverse reactions of such biopharmaceuticals as immunosuppressants and antineoplastic agents. Differences between biopharmaceuticals and small molecules in the rate of adverse phenomena, structure and severity of their manifestations are shown. Classification of adverse reactions and possibility of its use in terms of biopharmaceuticals, recommendations and conclusions for the Russian pharmacovigilance system are given.


About the Authors

A. S. Kolbin
Saint Petersburg State University, Russian Federation Regional Drug Safety Monitoring Center, Saint Petersburg, Russian Federation
Russian Federation
PhD, professor at the pharmacology department of the Saint Petersburg State University, head of the Regional Drug Safety Monitoring Center


A. V. Kharchev
Saint Petersburg State Pediatric Medical University, Russian Federation
Russian Federation


References

1. Motola D., De Ponti F., Poluzzi E., Martini N., Rossi P., Silvani M.C. et al. An update on the first decade of the European centralized procedure: how many innovative drugs? Br. J. Clin. Pharmacol. 2006; 62 (5): 610–6.

2. Trusheim M.R., Aitken M.L., Berndt A.R. Characterizing markets for biopharmaceutical innovations: do biologics differ from small molecules? Forum Health Econ. Pol. 2010; 13 (1): 1–45.

3. Available at: www.bio.org.

4. Astakhova A.V., Lepakhin V.K. Federal Center of Drug Safety Monitoring. The role of the risk management system in the prevention of pharmacotherapy complications. Available at: http://www.rspor.ru

5. Available at: http://www.kaloramainformation.com

6. Naldi L. Malignancy concerns with psoriasis treatments using phototherapy, methotrexate, cyclosporin, and biologics: facts and controversies. Clin. Dermatol. 2010; 28 (1): 88–92.

7. Smolen J.S., Landewe R., Breedveld F.C., Dougados M., Emery P., Gaujoux-Viala C. et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann. Rheum. Dis. 2010; 69 (6): 964–975.

8. Pathirana D., Ormerod A.D., Saiag P., Smith C., Spuls P.I., Nast A., Barker J., Bos J.D. et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J. Eur. Acad. Dermatol. Venereol. 2009; 23 (2): 1–70.

9. Singh J., Christensen R., Wells G.A., Suarez-Almazor Maria E., Buchbinder R., Lopez-Olivo Maria A. et al. Biologics for rheumatoid arthritis: an overview of Cochrane reviews. Cochrane Database Syst. Rev. 2009; 4: CD007848.

10. Alonso-Ruiz A., Pijoan J.I., Ansuategui E., Urkaregi A., Calabozo M., Quintana A. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord. 2008; 9: 52.

11. Mazurov V.I. Klinicheskaya revmatologiya. Rukovodstvo dlya prakticheskikh vrachei. 2-e izd. [Manual for Practicing Physicians. 2nd edition] St. Petersburg, Foliant, 2005. 520 p.

12. Available at: http://www.rosoncoweb.ru

13. Aronson J.K. Adverse drug reactions: history, terminology, classification, causality, frequency, preventability. Stephens’ Detection and evaluation of adverse drug reactions. New York, Wiley Ltd, 2011. pp. 1–119.

14. Clark J.B. Mechanisms of adverse drug reactions to biologics. In: Uetrecht J., editor. Adverse drug reactions. Berlin, Springer, 2010. pp. 453–474.

15. Baumann A. Early development of therapeutic biologics: pharmacokinetics. Curr. Drug Metab. 2006; 7 (7): 15–21.

16. Giezen T.J., Mantel-Teeuwisse A.K., Leufkens H.G. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf. 2009; 32 (10): 811–817.

17. Doran M.F., Crowson C.S., Pond G.R., O’Fallon W.M., Gabriel S.E. Predictors of infection in rheumatoid arthritis. Arthritis Rheum. 2002; 46 (9): 2294–2300.

18. Kolbin A.S., Kurylev A.A., Pavlysh A.V., Proskurin M.A., Balykina Yu.E. Scientific analysis of outcomes in oncology. Peculiarities of pharmacoeconomic examination. Med. tekhnol. Otsenka i vybor = Medical technologies. Assessment and selection. 2012; 2 (8): 87–93.

19. Kleijnen S., George E., Goulden S., d’Andon A., Vitre P., Osinska B., Rdzany R., Thirstrup S., Corbacho B. et al. Relative effectiveness assessment of pharmaceuticals: similarities and differences in 29 jurisdictions. Value In Health. 2012; 15: 954–960.

20. Vial T., Descotes J. Immunosuppressive drugs and cancer. Toxicology. 2003; 185 (3): 229–40.

21. Lepakhin V.K., Ushakova E.A., Astakhova A.V. The role of a clinical pharmacologist in the drug therapy safety improvement. Bezopasnost' lekarstv i farmakonadzor = Drug safety and pharmacovigilance. 2008; 1: 5–11.

22. Giezen T.J., Mantel-Teeuwisse A.K., Meyboom R.H., Sabine M.J.M. Straus, Hubert G.M. Leufkens, Toine C.G. Egberts. Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase. Drug Saf. 2010; 33 (10): 865–878.

23. Giezen T.J., Mantel-Teeuwisse A.K., Straus S.M., Huub Schellekens, Hubert G. M. Leufkens, Antoine C. G. Egberts. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA. 2008; 300 (16): 1887–1896.

24. Bongartz T., Sutton A.J., Sweeting M.J., Buchan I., Matteson E.L., Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006; 295 (19): 2275–2285.

25. Available at: http://www.fda.gov

26. Khraishi M. Comparative overview of safety of the biologics in rheumatoid arthritis. J. Rheumatol. Suppl. 2009; 82: 25–32.

27. Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin. Ther. 2002; 24 (11): 1720.

28. Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol. Dial. Transplant. 2005; 20 (6): 3–9.

29. Locatelli F., Del Vecchio L., Pozzoni P. Pure red-cell aplasia «epidemic» — mystery completely revealed? Perit. Dial. Int. 2007; 27 (2): 303–307.

30. Salliot C., Dougados M., Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials. Ann. Rheum. Dis. 2009; 68 (1): 25–32.

31. Keane J., Gershon S., Wise R.P. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N. Engl. J. Med. 2001; 345 (15): 1098–1104.

32. Slifman N.R., Gershon S.K., Lee J.H., Edwards E.T, Braun M.M. Listeria monocytogenes infection as a complication of treatment with tumor necrosis factor alpha-neutralizing agents. Arthritis Rheum. 2003; 48 (2): 319–324.

33. Dixon W.G., Watson K., Lunt M., Hyrich K.L., Silman A.J. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2006; 54 (8): 2368–2376.

34. Schneeweiss S., Setoguchi S., Weinblatt M.E., Katz J.N., Avorn J., Sax P.E., Levin R., Solomon D.H. Anti-tumor necrosis factor alpha therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis. Arthritis Rheum. 2007; 56 (6): 1754–1764.

35. Curtis J.R., Patkar N., Xie A., Martin C., Allison J.J., Saag M., Shatin D., Saag K.G. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum. 2007; 56 (4): 1125–1133.

36. Suwannalai P., Auethavekiat P., Udomsubpayakul U. The infectious profiles of anti-tumor necrosis factor agents in a Thai population: a retrospective study a the university-based hospital. Int. J. Rheum. Dis. 2009; 12 (2): 118–124.

37. Strangfeld A., Listing J., Herzer P., Liebhaber A., Rockwitz K., Richter C. et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA. 2009; 301 (7): 737–744.

38. Ebbers H.C., Al-Temimi E., Moors E.H., Mantel-Teeuwisse A.K., Schellekens H., Leufkens H.G. Differences between postauthorization adverse drug reactions of biopharmaceuticals and small molecules. BioDrugs. 2013. DOI 10.1007/s40259-013-0012-y.

39. Lasser K.E., Allen P.D., Woolhandler S.J., Himmelstein D.U., Wolfe S.M., Bor D.H. Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002; 287 (17): 2215–2220.

40. Crommelin D.J., Storm G., Verrijk R., de Leede L., Jiskoot W., Hennink W.E. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int. J. Pharm. 2003; 266 (1–2): 3–16.

41. Schellekens H. How similar do ‘biosimilars’ need to be? Nat. Biotechnol. 2004; 22 (11): 1357–1359.

42. Brennan F.R., Shaw L., Wing M.G., Robinson C. Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the challenges. Mol. Biotechnol. 2004; 27 (1): 59–74.

43. Ferner R.E., Aronson J.K. EIDOS: a mechanistic classification of adverse drug effects. Drug Saf. 2010; 33 (1): 15–23.

44. Pichler W.J. Adverse side-effects to biological agents. Allergy. 2006; 61 (8): 912–920.

45. Shankar G., Pendley C., Stein K.E. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 2007; 25 (5): 555–561.

46. Hausmann O.V., Seitz M., Villiger P.M. The complex clinical picture of side effects to biologicals. Med. Clin. North Am. 2010; 94 (4): 791–804.

47. Zemkovа M., Jebavн L., Kotlаrovа J., Jiri Vlcek, Ronald H.B. Meyboom. The spectrum and types of adverse side effects to biological immune modulators: a proposal for new classification Folia Biol. (Praha). 2007; 53 (4): 146–155.

48. Kolbin A.C., Burbello A.T., Zagorodnikova K.A. Pharmacovigilance in the Russian Federation and the united Europe in the setting of the new directive of the European Union. Will there be changes? Remedium = Remedium. 2012; 8 (186): 8–14.

49. Fitt H. The new pharmacovigilance legislation: an EMA perspective. — IPA Conference Reinforcing patient safety in Europe, 2011. Available at: www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/WC500107888.pdf (accessed: 05.07.12).

50. The European Parliament and the Council of the European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [online]. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF (accessed: 05.07.12).

51. Mellstedt H., Niederwieser D., Ludwig H. The challenge of biosimilars. Ann. Oncol. 2008; 19 (3): 411–419.

52. Zuсiga L., Calvo B. Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiol. Drug Saf. 2010; 19 (7): 661–669.


Review

For citations:


Kolbin A.S., Kharchev A.V. SAFETY OF BIOLOGICAL PREPARATIONS AND SMALL MOLECULES. ARE THERE ANY DIFFERENCES? Pediatric pharmacology. 2013;10(3):17-25. https://doi.org/10.15690/pf.v10i3.693

Views: 756


ISSN 1727-5776 (Print)
ISSN 2500-3089 (Online)