Treatment with biological drugs in special situations (pregnancy, lactation, vaccination and surgery)


Authors: P. Němec
Authors‘ workplace: Revmatologická ambulance, II. interní klinika, FN u sv. Anny v Brně a Lékařská fakulta Masarykovy univerzity, Brno
Published in: Čes. Revmatol., 19, 2011, No. 2, p. 95-100.
Category: Posts from Congress

Overview

With the growing number of patients treated with biological drugs an increasing number of circumstances occur that have to be dealt with, such as pregnancy, lactation, vaccination or surgical procedure. This article analyzes current available information and gives recommendations how to proceed in these special situations. The text adds some new and more detailed information to recently published Recommendations of the Czech Society of Rheumatology on safety of biological treatment.

Key words:
safety, biological treatment, pregnancy, surgical procedure, vaccination, breast-feeding.


Sources

1. Mahadevan U, Terdiman JP, Aron J, Jacobsohn S, Turek P. Infliximab and semen quality in men with inflammatory bowel disease. Inflamm Bowel Dis 2005; 11: 395-9.

2. Vasiliauskas EA, Church JA, Silverman N, Barry M, Targan SR, Dubinsky MC. Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol 2006; 4: 1255-8.

3. Įstensen M, Lockshin M, Doria A, Valesini G, Meroni P, Gordon C, et al. Update on safety during pregnancy of biological agents and some immunosuppressive anti-rheumatic drugs. Rheumatology (Oxford) 2008; 47 Suppl3: iii28-31.

4. Vinet E, Pineau C, Gordon C, Clarke AE, Bernatsky S. Biologie therapy and pregnancy outcomes in women with rheumatic diseases. Arthritis Rheum 2009; 61: 587-92.

5. Carter JD, Valeriano J, Vasey FB. Tumor necrosis factor-alpha inhibition and VATER association: a causal relationship. J Rheumatol 2006; 33: 1014-7.

6. Carter JD, Ladhani A, Ricca LR, Valeriano J, Vasey FB. A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the Food and Drug Administration database. J Rheumatol 2009; 36: 635-41.

7. Koren G, Inoue M. Do tumor necrosis factor inhibitors cause malformations in humans? J Rheumatol 2009; 36: 465-6.

8. Įstensen M, Förger F. Management of RA medications in pregnant patients. Nat Rev Rheumatol 2009; 5: 382-90.

9. Pham T, Claudepierre P, Constantin A, Fautrel B, Gossec L, Gottenberg JE et al. Abatacept therapy and safety management. Joint Bone Spine 2009; 76 Suppl1: S3-S55.

10. Įstensen M, Eigenmann GO. Etanercept in breast milk. J Rheumatol 2004; 31: 1017-8.

11. Furst DE, Keystone EC, Kirkham B, Kavanaugh A, Fleischmann R, Mease P et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2008. Ann Rheum Dis 2008; 67 (Suppl 3): iii2-25.

12. Furst DE, Keystone EC, Winthrop K, Dörner T, Van Vollenhoven R, Breedveld FC et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2009. Ann Rheum Dis 2009; 69 (Suppl 1): i2-29.

13. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, 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: 2275-85.

14. Šléglová 0, Mareček Z, Urbánek P, Pavelka K. Bezpečnost podání anti-TNF alfa léčby u revmatických pacientů s chronickou hepatitidou B nebo C. Čes Revmatol 2007; 15: 105-111.

15. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologie disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008; 59: 762-84.

16. Duchet-Niedziolka P, Launay O, Coutsinos Z, Ajana F, Arlet P, Barrou B et al. Vaccination in adults with auto-immune disease and/or drug related immune deficiency: results ofthe GEVACCIM Delphi survey. Vaccine 2009; 27: 1523-9.

17. Duchet-Niedziolka P, Coutsinos Z, Hanslik T, Launay O. Anti-TNFalpha therapy and vaccination of adults. Joint Bone Spine 2007; 74: 563-5.

18. Herron A, Dettleff G, Hixon B, Brandwin L, Ortbals D, Hornick R, Hahn B. Influenza vaccination in patients with rheumatic diseases. Safety and efficacy. JAMA 1979; 242(1): 53-6.

19. Chalmers A, Scheifele D, Patterson C, Williams D, Weber J, Shuckett R, Teufel A. Immunization of patients with rheumatoid arthritis against influenza: a study of vaccine safety and immunogenicity. J Rheumatol 1994; 21(7): 1203-6.

20. Fomin I, Caspi D, Levy V, Varsano N, Shalev Y, Paran D, Levartovsky D, Litinsky I, Kaufman I, Wigler I, Mendelson E, Elkayam O. Vaccination against influenza in rheumatoid arthritis: the effect of disease modifying drugs, including TNF alpha blockers. Ann Rheum Dis 2006; 65(2): 191-4.

21. Kaine JL, Kivitz AJ, Birbara C, Luo AY. Immune responses following administration of influenza and pneumococcal vaccines to patients with rheumatoid arthritis receiving adalimumab. J Rheumatol 2007; 34(2): 272-9.

22. Kubota T, Nii T, Nanki T, Kohsaka H, Harigai M, Komano Y, Sugihara T, Nonomura Y, Hirose W, Nagasaka K, Sakurai T, Miyasaka N. Anti-tumor necrosis factor therapy does not diminish the immune response to influenza vaccine in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2007; 17(6): 531-3.

23. Oren S, Mandelboim M, Braun-Moscovici Y, Paran D, Ablin J, Litinsky I, et al. Vaccination against influenza in patients with rheumatoid arthritis: the effect of rituximab on the humoral response. Ann Rheum Dis 2008; 67: 937-41.

24. Bingham CO 3rd, Looney RJ, Deodhar A, Halsey N, Greenwald M, Codding C, Trzaskoma B, Martin F, Agarwal S, Kelman A. Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum 2010; 62(1): 64-74.

25. van Assen S, Holvast A, Benne CA, Posthumus MD, van Leeuwen MA, Voskuyl AE, Blom M, Risselada AP, de Haan A, Westra J, Kallenberg CG, Bijl M. Humoral responses after influenza vaccination are severely reduced in patients with rheumatoid arthritis treated with rituximab. Arthritis Rheum 2010; 62(1): 75-81.

26. Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther 2007; 9: R38.

27. Wilson MG, Kelley K, Thornhill TS. Infection as a complication of total knee-replacement arthroplasty. Risk factors and treatment in sixty-seven cases. J Bone Joint Surg Am 1991; 72(6): 878-83.

28. Bhattacharyya T, Iorio R, Healy WL. Rate of and risk factors for acute inpatient mortality after orthopaedic surgery. J Bone Joint Surg Am 2002; 84-A (4): 562-72.

29. Blom AW, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Infection after total hip arthroplasty. The Avon experience. J Bone Joint Surg Br 2003; 85(7): 956-9.

30. Scanzello CR, Figgie MP, Nestor BJ, Goodman SM. Perioperative management of medications used in the treatment of rheumatoid arthritis. HSS J 2006; 2: 141-7.

31. Pham T, Claudepierre P, Deprez X, Fautrel B, Goupille P, Hilliquin P et al. Clinical tool guide elaborated by the Club Rhumatismes et Inflammations (CRI), section of the French Society of Rheumatology (Société Francaise de Rhumatologie, SFR). Joint Bone Spine 2005; 72 (Suppl1): S1-58.

32. Giles JT, Bartlett SJ, Gelber AC, Nanda S, Fontaine K, Ruffing V, Bathon JM. Tumor necrosis factor inhibitor therapy and risk of serious postoperative orthopedic infection in rheumatoid arthritis. Arthritis Rheum 2006; 55(2): 333-7.

33. den Broeder AA, Creemers MC, Fransen J, de Jong E, de Rooij DJ, Wymenga A, et al. Risk factors for surgical site infections and other complications in elective surgery in patients with rheumatoid arthritis with special attention for anti-tumor necrosis factor: a large retrospective study. J Rheumatol 2007; 34: 689-95.

34. Ciantar M, Adlam DM. Treatment with infliximab: Implications in oral surgery? A case report. Br J Oral Maxillofac Surg 2007; 45: 507-10.

35. Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol 2009; 19(4): 351-7.

36. Hirao M, Hashimoto J, Tsuboi H, Nampei A, Nakahara H, Yoshio N, et al. Laboratory and febrile features after joint surgery in patients with rheumatoid arthritis treated with tocilizumab. Ann Rheum Dis 2009; 68: 654-7.

37. Vencovský J. a výbor České revmatologické společnosti. Bezpečnost biologické léčby – doporučení České revmatologické společnosti. Čes Revmatol 2009; 17(3): 146-60.

Labels
Dermatology & STDs Paediatric rheumatology Rheumatology
Login
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account