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Considerations for special patient populations

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Biologics for the Treatment of Rheumatoid Arthritis
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Abstract

Patients with rheumatoid arthritis (RA) often experience marked spontaneous improvement during pregnancy. This classical clinical observation, documented already by Philip Hench in the 1930s [1], has been confirmed in several studies [2, 3]. Fortunately therefore the difficulties of treating RA are sometimes – but not always – alleviated at a time when safety considerations must take into account not only the patient but also her child. Nevertheless, most patients with RA do need some form of treatment during pregnancy [3]. Moreover, patients with RA who are considering pregnancy do rightfully wish to plan ahead and be informed of the potential consequences of antirheumatic treatments in the case that a pregnancy might ensue.

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References

  1. Hench PS. The ameliorating effect of pregnancy on chronic atropic (infectious, rheumatoid) arthritis, fibrositis and intermittent hydrarthrosis. Proc Staff Meet Mayo Clin. 1938;13:161-167.

    Google Scholar 

  2. Ostensen M, Villiger PM. The remission of rheumatoid arthritis during pregnancy. Semin Immunopathol. 2007;29:185-191.

    Google Scholar 

  3. de Man YA, Dolhain RJ, van de Geijn FE, et al. Disease activity of rheumatoid arthritis during pregnancy: results from a nationwide prospective study. Arthritis Rheum. 2008;59:1241-1248.

    Google Scholar 

  4. Chakravarty E, Clowse ME, Pushparajah DS, et al. Family planning and pregnancy issues for women with systemic inflammatory diseases: patient and physician perspectives. BMJ Open. 2014;4:e004081.

    Google Scholar 

  5. Makol A, Wright K, Amin S. Rheumatoid arthritis and pregnancy: safety considerations in pharmacological management. Drugs. 2011;71:1973-1987.

    Google Scholar 

  6. Treacy G. Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody. Hum Exp Toxicol. 2000;19:226-228.

    Google Scholar 

  7. Martin PL, Oneda S, Treacy G. Effects of an anti-TNF-alpha monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol. 2007;58:138-149.

    Google Scholar 

  8. Williams M, Chakravarty EF. Rheumatoid arthritis and pregnancy: impediments to optimal management of both biologic use before, during and after pregnancy. Curr Opin Rheumatol. 2014;26:341-346.

    Google Scholar 

  9. Vasiliauskas EA, Church JA, Silverman N, et al. Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol. 2006;4:1255-1258.

    Google Scholar 

  10. Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11:286-292.

    Google Scholar 

  11. Hassid B, Mahadevan U. The use of biologic therapy in pregnancy: a gastroenterologist’s perspective. Curr Opin Rheumatol. 2014;26:347-353.

    Google Scholar 

  12. Katz JA, Antoni C, Keenan GF, Smith DE, Jacobs SJ, Lichtenstein GR. Outcome of pregnancy in women receiving infliximab for the treatment of Crohn’s disease and rheumatoid arthritis. Am J Gastroenterol. 2004;99:2385-2392.

    Google Scholar 

  13. Hyrich KL, Symmons DP, Watson KD, Silman AJ. Pregnancy outcome in women who were exposed to anti-tumor necrosis factor agents: results from a national population register. Arthritis Rheum. 2006;54:2701-2702.

    Google Scholar 

  14. Carter JD, Ladhani A, Ricca LR, et al. A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the Food and Drug Administration database. J Rheumatol. 2009; 36(3): 635-41.

    Google Scholar 

  15. Diav-Citrin O, Otcheretianski-Volodarsky A, Shechtman S, Ornoy A. Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: a prospective, comparative, observational study. Reprod Toxicol. 2014; 43: 78-84.

    Google Scholar 

  16. Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infection and mortality in patients with Crohn‘s disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol. 2012;107:1409-1422.

    Google Scholar 

  17. Chambers C, Johnson DL, Luo Y, et al. Pregnancy outcome in women treated with adalimumab for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2014;66:S361.

    Google Scholar 

  18. Oussalah A, Bigard MA, Peyrin-Biroulet L. Certolizumab use in pregnancy. Gut. 2009;58:608.

    Google Scholar 

  19. Nielsen OH, Loftus EV Jr, Jess T. Safety of TNF-alpha inhibitors during IBD pregnancy: a systematic review. BMC Med. 2013;11:174.

    Google Scholar 

  20. Marchioni RM, Lichtenstein GR. Tumor necrosis factor-alpha inhibitor therapy and fetal risk: a systematic literature review. World J Gastroenterol. 2013;19:2591-2602.

    Google Scholar 

  21. Cheent K, Nolan J, Shariq S, et al. Case Report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn’s disease. J Crohns Colitis. 2010;4:603-615.

    Google Scholar 

  22. Berger CT, Recher M, Steiner U, Hauser TM. A patient‘s wish: anakinra in pregnancy. Ann Rheum Dis. 2009;68:1794-1795.

    Google Scholar 

  23. Fischer-Betz R, Specker C, Schneider M. Successful outcome of two pregnancies in patients with adult-onset Still’s disease treated with IL-1 receptor antagonist (anakinra). Clin Exp Rheumatol. 2011;29:1021-1023.

    Google Scholar 

  24. Klink DT, van Elburg RM, Schreurs MW, van Well GT. Rituximab administration in third trimester of pregnancy suppresses neonatal B-cell development. Clin Dev Immunol. 2008;2008:271363.

    Google Scholar 

  25. Friedrichs B, Tiemann M, Salwender H, et al. The effects of rituximab treatment during pregnancy on a neonate. Haematologica. 2006;91:1426-1427.

    Google Scholar 

  26. Chakravarty EF, Murray ER, Kelman A, Farmer P. Pregnancy outcomes after maternal exposure to rituximab. Blood. 2011;117:1499-1506.

    Google Scholar 

  27. Rubbert-Roth A, Goupille PM, Moosavi S, Hou A. First experiences with pregnancies in RA patients receiving tocilizumab therapy. Arthritis Rheum. 2010;62:Suppl 10:384.

    Google Scholar 

  28. Murashima A, Watanabe N, Ozawa N, Saito H, Yamaguchi K. Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: drug levels in maternal serum, cord blood, breast milk and the infant’s serum. Ann Rheum Dis. 2009;68:1793-1794.

    Google Scholar 

  29. Kane S, Ford J, Cohen R, Wagner C. Absence of infliximab in infants and breast milk from nursing mothers receiving therapy for Crohn’s disease before and after delivery. J Clin Gastroenterol. 2009;43:613-616.

    Google Scholar 

  30. Ben-Horin S, Yavzori M, Katz L, et al. Adalimumab level in breast milk of a nursing mother. Clin Gastroenterol Hepatol. 2010;8:475-476.

    Google Scholar 

  31. Nelson JL, Ostensen M. Pregnancy and rheumatoid arthritis. Rheum Dis Clin North Am. 1997;23:195-212.

    Google Scholar 

  32. Barrett JH, Brennan P, Fiddler M, Silman AJ. Does rheumatoid arthritis remit during pregnancy and relapse postpartum? Results from a nationwide study in the United Kingdom performed prospectively from late pregnancy. Arthritis Rheum. 1999;42:1219-1227.

    Google Scholar 

  33. Villiger PM, Caliezi G, Cottin V, et al. Effects of TNF antagonists on sperm characteristics in patients with spondyloarthritis. Ann Rheum Dis. 2010;69:1842-1844.

    Google Scholar 

  34. Paschou S, Voulgari PV, Vrabie IG, et al. Fertility and reproduction in male patients with ankylosing spondylitis treated with infliximab. J Rheumatol. 2009;36:351-354.

    Google Scholar 

  35. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369:767-778.

    Google Scholar 

  36. Kahn PJ. Juvenile idiopathic arthritis - what the clinician needs to know. Bull Hosp Jt Dis (2013). 2013;71:194-199.

    Google Scholar 

  37. Stoll ML, Cron RQ. Treatment of juvenile idiopathic arthritis: a revolution in care. Pediatr Rheumatol Online J. 2014;12:13.

    Google Scholar 

  38. Smith EM, Foster HE, Beresford MW. The development and assessment of biological treatments for children. Br J Clin Pharmacol. 2015;79:379-394.

    Google Scholar 

  39. Lovell DJ, Giannini EH, Reiff A, et al. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 2003;48:218-226.

    Google Scholar 

  40. Lovell DJ, Ruperto N, Goodman S, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359:810-820.

    Google Scholar 

  41. Ruperto N, Lovell DJ, Cuttica R, et al. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2007;56:3096-3106.

    Google Scholar 

  42. Tynjala P, Vahasalo P, Tarkiainen M, et al. Aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis (ACUTE-JIA): a multicentre randomised open-label clinical trial. Ann Rheum Dis. 2011;70:1605-1612.

    Google Scholar 

  43. Giannini EH, Ilowite NT, Lovell DJ, et al. Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2009;60:2794-2804.

    Google Scholar 

  44. Lehman TJ. Should the Food and Drug Administration warning of malignancy in children receiving tumor necrosis factor alpha blockers change the way we treat children with juvenile idiopathic arthritis? Arthritis Rheum. 2010;62:2183-2184.

    Google Scholar 

  45. Simard JF, Neovius M, Hagelberg S, Askling J. Juvenile idiopathic arthritis and risk of cancer: a nationwide cohort study. Arthritis Rheum. 2010;62:3776-3782.

    Google Scholar 

  46. Horneff G, Foeldvari I, Minden K, et al. Report on malignancies in the German juvenile idiopathic arthritis registry. Rheumatology (Oxford). 2011;50:230-236.

    Google Scholar 

  47. Beukelman T, Haynes K, Curtis JR, et al. Rates of malignancy associated with juvenile idiopathic arthritis and its treatment. Arthritis Rheum. 2012;64:1263-1271.

    Google Scholar 

  48. Ilowite N, Porras O, Reiff A, et al. Anakinra in the treatment of polyarticular-course juvenile rheumatoid arthritis: safety and preliminary efficacy results of a randomized multicenter study. Clin Rheumatol. 2009;28:129-37.

    Google Scholar 

  49. Ruperto N, Lovell DJ, Quartier P, Paz E, et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008;372:383-391.

    Google Scholar 

  50. Brunner HI, Ruperto N, Zuber Z, et al. Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann Rheum Dis. 2014 [Epub ahead of print]; doi: 10.1136/annrheumdis-2014-205351.

    Google Scholar 

  51. Alexeeva EI, Valieva SI, Bzarova TM, et al. Efficacy and safety of repeat courses of rituximab treatment in patients with severe refractory juvenile idiopathic arthritis. Clin Rheumatol. 2011;30:1163-1172.

    Google Scholar 

  52. Jansson AF, Sengler C, Kuemmerle-Deschner J, et al. B cell depletion for autoimmune diseases in paediatric patients. Clin Rheumatol. 2011;30:87-97.

    Google Scholar 

  53. Biester S, Deuter C, Michels H, et al. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007;91:319-324.

    Google Scholar 

  54. Tynjala P, Kotaniemi K, Lindahl P, et al. Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis. Rheumatology (Oxford). 2008;47:339-344.

    Google Scholar 

  55. Simonini G, Taddio A, Cattalini M, et al. Prevention of flare recurrences in childhoodrefractory chronic uveitis: an open-label comparative study of adalimumab versus infliximab. Arthritis Care Res (Hoboken). 2011;63:612-618.

    Google Scholar 

  56. Quartier P, Taupin P, Bourdeaut F, et al. Efficacy of etanercept for the treatment of juvenile idiopathic arthritis according to the onset type. Arthritis Rheum. 2003;48:1093-1101.

    Google Scholar 

  57. Gerloni V, Pontikaki I, Gattinara M, Fantini F. Focus on adverse events of tumour necrosis factor alpha blockade in juvenile idiopathic arthritis in an open monocentric long-term prospective study of 163 patients. Ann Rheum Dis. 2008;67:1145-1152.

    Google Scholar 

  58. Verbsky JW, White AJ. Effective use of the recombinant interleukin 1 receptor antagonist anakinra in therapy resistant systemic onset juvenile rheumatoid arthritis. J Rheumatol. 2004;31:2071-2075.

    Google Scholar 

  59. Pascual V, Allantaz F, Arce E, Punaro M, Banchereau J. 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;201:1479-1486.

    Google Scholar 

  60. Nigrovic PA, Mannion M, Prince FH, et al. Anakinra as first-line disease-modifying therapy in systemic juvenile idiopathic arthritis: report of forty-six patients from an international multicenter series. Arthritis Rheum. 2011;63:545-555.

    Google Scholar 

  61. Ruperto N, Brunner HI, Quartier P, et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367:2396-2406.

    Google Scholar 

  62. Ruperto N, Quartier P, Wulffraat N, et al. 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;64:557-567.

    Google Scholar 

  63. Lovell DJ, Giannini EH, Reiff AO, et al. Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis. Arthritis Rheum. 2013;65:2486-2496.

    Google Scholar 

  64. De Benedetti F, Brunner HI, Ruperto N, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367:2385-2395.

    Google Scholar 

  65. Lahaye C, Tatar Z, Dubost JJ, Soubrier M. Overview of biologic treatments in the elderly. Joint Bone Spine. 2014 [Epub ahead of print]; doi:10.1016/j.jbspin.2014.10.012.

    Google Scholar 

  66. Payet S, Soubrier M, Perrodeau E, et al. Efficacy and safety of rituximab in elderly patients with rheumatoid arthritis enrolled in a French Society of Rheumatology registry. Arthritis Care Res (Hoboken). 2014;66:1289-1295.

    Google Scholar 

  67. Koller MD, Aletaha D, Funovits J, et al. Response of elderly patients with rheumatoid arthritis to methotrexate or TNF inhibitors compared with younger patients. Rheumatology (Oxford). 2009;48:1575-1580.

    Google Scholar 

  68. Esposito M, Giunta A, Mazzotta A, et al. Efficacy and safety of subcutaneous anti-tumor necrosis factor-alpha agents, etanercept and adalimumab, in elderly patients affected by psoriasis and psoriatic arthritis: an observational long-term study. Dermatology. 2012;225:312-319.

    Google Scholar 

  69. Fleischmann RM, Baumgartner SW, Tindall EA, et al. Response to etanercept (Enbrel) in elderly patients with rheumatoid arthritis: a retrospective analysis of clinical trial results. J Rheumatol. 2003;30:691-696.

    Google Scholar 

  70. Fleischmann R, Baumgartner SW, Weisman MH,et al. Long term safety of etanercept in elderly subjects with rheumatic diseases. Ann Rheum Dis. 2006;65:379-384.

    Google Scholar 

  71. Fleischmann R, Iqbal I. Risk: benefit profile of etanercept in elderly patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. Drugs Aging. 2007;24:239-254.

    Google Scholar 

  72. Militello G, Xia A, Stevens SR, Van Voorhees AS. Etanercept for the treatment of psoriasis in the elderly. J Am Acad Dermatol. 2006;55:517-519.

    Google Scholar 

  73. Schiff MH, Yu EB, Weinblatt ME, et al. Long-term experience with etanercept in the treatment of rheumatoid arthritis in elderly and younger patients: patient-reported outcomes from multiple controlled and open-label extension studies. Drugs Aging. 2006;23:167-178.

    Google Scholar 

  74. Lurati A, Marrazza M, Angela K, Scarpellini M. Safety of etanercept in elderly subjects with rheumatoid arthritis. Biologics. 2010;4:1-4.

    Google Scholar 

  75. Chevillotte-Maillard H, Ornetti P, Mistrih R, et al. Survival and safety of treatment with infliximab in the elderly population. Rheumatology (Oxford). 2005;44:695-696.

    Google Scholar 

  76. Pers YM, Schaub R, Constant E, et al. Efficacy and safety of tocilizumab in elderly patients with rheumatoid arthritis. Joint Bone Spine. 2015;82:25-30.

    Google Scholar 

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van Vollenhoven, R.F. (2016). Considerations for special patient populations. In: Biologics for the Treatment of Rheumatoid Arthritis. Adis, Cham. https://doi.org/10.1007/978-3-319-13108-5_9

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