Long-term safety – part 2/2
30. Ryan C et al. Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events. A Meta-analysis of Randomized Controlled Trials. J Am Med Assoc 2011;306:864–71.
31. Tzellos T, Kyrgidis A, Zouboulis CC. Re-evaluation of the risk for major adverse cardiovascular events in patients treated with anti-IL-12/23 biological agents for chronic plaque psoriasis: a meta- analysis of randomized controlled trials. J Eur Acad Dermatol Venereol 2012;27(5):622–7.
32. Burmester GR et al. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. Ann Rheum Dis [Internet]. 2013;72(4):517–24.
33. Garcia-Doval I et al. The Psonet Network. Systemic psoriasis therapy shows high between-countries variation. A sign of unwarranted variation? Cross-sectional analysis of baseline data from the Psonet registries. Br J Dermatol 2013;169(3):710–4.
34. Rivera Ret al. Miembros del grupo BIOBADADERM. BIOBADADERM, the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology: first report. Actas Dermosifiliogr 2011;102:132–41. [Article in Spanish].
35. Dixon WG et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis 2010;69(3):522–8.
36. Tubach F et al. Research Axed on Tolerance of Biotherapies Group. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum 2009;60:1884–94.
37. Le Blay P et al. Risk of malignancy including non-melanoma skin cancers with anti-tumor necrosis factor therapy in patients with rheumatoid arthritis: meta-analysis of registries and systematic review of long-term extension studies. Clin Exp Rheumatol 2012;30:756–64.
38. Winthrop KL et al. Association between the initiation of anti-tumor necrosis factor therapy and the risk of herpes zoster. J Am Med Assoc 2013;309:887–95.
39. National Institute for Health and Care Excellence. Psoriasis: The assessment and management of psoriasis. 2012;CG153. London: National Institute for Health and Care Excellence.
40. Hsu S et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol 2012;148(1):95–102.
41. Abramson A, Menter A, Perrillo R. Psoriasis, hepatitis B, and the tumor necrosis factor-alpha inhibitory agents: a review and recommendations for management. J Am Acad Dermatol 2012;67(6):1349–61.
42. Viganò M et al. Anti-TNF drugs in patients with hepatitis B or C virus infection: safety and clinical management. Exp Opin Biol Ther 2012;12(2): 193–207.
43. Manzano-Alonso ML, Castellano-Tortajada G. Reactivation of hepatitis B virus infection after cytotoxic chemotherapy or immunosuppressive therapy. World J Gastroenterol 2011;17(12):1531–7.
44. Strangfeld A et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF- alpha agents. J Am Med Assoc 2009;301(7): 737–44.
45. Mercer LK et al. The influence of anti-TNF therapy upon incidence of keratinocyte skin cancer in patients with rheumatoid arthritis: longitudinal results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2012;71(6): 869–74.
46. Dixon WG Influence of anti-tumor necrosis factor therapy on cancer incidence in patients with rheumatoid arthritis who have had a prior malignancy: results from the British Society for Rheumatology Biologics Register. Arthritis Care Res 2010;62(6):755–63.
47. Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study. Arthritis Rheum 2007;56(9):2886–95.
48. Kotlyar DS et al. A systematic review of factors that contribute to hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2011;9(1):36–41.e1.
49. Leombruno JP, Einarson TR, Keystone EC. The safety of anti-tumour necrosis factor treatments in rheumatoid arthritis: meta and exposure-adjusted pooled analyses of serious adverse events. Ann Rheum Dis 2009;68(7):1136–45.
50. Gartlehner G et al. The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis. J Rheumatol 2006;33(12):2398–408.
51. Lozeron P, Denier C, Lacroix C, Adams D. Long-term course of demyelinating neuropathies occurring during tumor necrosis factor-alpha- blocker therapy. Arch Neurol 2009;66(4):490–7.
52. Seror R et al. Pattern of demyelination occurring during anti-TNF-a therapy: a French national survey. Rheumatology 2013;52(5):868–74.
53. Ghabril M et al. Liver Injury From Tumor Necrosis Factor-a Antagonists: Analysis of Thirty-four Cases. Clin Gastroenterol Hepatol 2013;11(5):558–564.e3.
54. Coffin CS, Fraser HF, Panaccione R, Ghosh S. Liver diseases associated with anti-tumor necrosis factor-alpha (TNF-a) use for inflammatory bowel disease. Inflamm Bowel Dis 2011;17(1):479–84.
55. Bessissow T Review article: non-malignant haematological complications of anti-tumour necrosis factor alpha therapy. Aliment Pharmacol Ther 2012;36(4):312–23.
56. Brunasso AMG, Massone C. Thrombocytopenia associated with the use of anti-tumor necrosis factor-alpha agents for psoriasis. J Am Acad
57. Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nature reviews. Gastroenterol Hepatol 2012;9(9):496–503.
58. Cullen G, Kroshinsky D, Cheifetz AS, Korzenik JR. Psoriasis associated with anti-tumour necrosis factor therapy in inflammatory bowel disease: a new series and a review of 120 cases from the literature. Aliment Pharmacol Ther 2011;34(11- 12):1318–27.
59. Collamer AN, Battafarano DF. Psoriatic skin lesions induced by tumor necrosis factor antagonist therapy: clinical features and possible immunopathogenesis. Semin Arthritis Rheum 2010;40(3):233–40.
60. Moustou A-E et al. Cutaneous side effects of anti-tumor necrosis factor biologic therapy: a clinical review. J Am Acad Dermatol 2009;61(3):486–504.
61. Wetter DA, Davis MDP. Lupus-like syndrome attributable to anti-tumor necrosis factor alpha therapy in 14 patients during an 8-year period at Mayo Clinic. Mayo Clinic Proc 2009;84(11): 979–84.
62. Williams EL, Gadola S, Edwards CJ. Anti-TNF- induced lupus. Rheumatology 2009;48(7):716–20.
63. Costa MF, Said NR, Zimmermann B. Drug-induced lupus due to anti-tumor necrosis factor alpha agents. Semin Arthritis Rheum 2008;37(6):381–7.
64. Tyring S et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007;143(6):719–26.
65. Pariser DM et al. Integrated safety analysis: Short- and long-term safety profiles of etanercept in patients with psoriasis. J Amer Acad Dermatol 2011;1–12.
66. Menter A et al. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Amer Acad Dermatol 2010;63(3):448–56.
67. Papoutsaki M et al. The impact of methodological approaches for presenting long-term clinical data on estimates of efficacy in psoriasis illustrated by three-year treatment data on infliximab. Dermatology 2010;221 Suppl (suppl 1):43–7.
68. Esposito M et al. Survival rate of anti-TNF alpha treatments for psoriasis in routine dermatological practice: a multicenter observational study. Br J Dermatol 2013;169(3):666–72.
69. Kimball AB et al. OBSERVE-5 interim analysis: An observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Amer Acad Dermatol 2013;68(5):756–64.
70. Remicade Summary of Product Characteristics, August 2013.
71. Enbrel Summary of Product Characteristics, October 2013.
72. Humira Summary of Product Characteristics, September 2013.
73. Stelara Summary of Product Characteristics, September 2013.
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