Safety of synthetic and biological DMARDs: A systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 73, Issue 3, 2014, Pages 529-535

  Ramiro, Sofia ^a,b   Gaujoux Viala, Cécile ^c   Nam, Jackie L ^d,e   Smolen, Josef S ^f,g   Buch, Maya ^d,e   Gossec, Laure ^h   Van Der Heijde, Désirée ⁱ   Winthrop, Kevin ^j   Landewé, Robert ^a,k  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b HOSPITAL GARCIA DE ORTA   (Portugal)

^c NÎMES UNIVERSITY HOSPITAL   (France)

^d UNIVERSITY OF LEEDS   (United Kingdom)

^e LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

^f MEDICAL UNIVERSITY OF VIENNA   (Austria)

^g Hietzing Hospital Vienna   (Austria)

^h SORBONNE UNIVERSITÉ   (France)

ⁱ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^j OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^k Sittard Geleen Heerlen   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTI-TNF; DMARDS (BIOLOGIC); DMARDS (SYNTHETIC); OUTCOMES RESEARCH; RHEUMATOID ARTHRITIS;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; EVIDENCE-BASED MEDICINE; HUMANS; NEOPLASMS; OPPORTUNISTIC INFECTIONS; PRACTICE GUIDELINES AS TOPIC; RISK ASSESSMENT; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84893803131     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-204575     Document Type: Article

References (75)

1. Smolen JS, van der Heijde D, Machold KP, et al. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis 2014;73:3-5.
2. Zink A, Askling J, Dixon WG, et al. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009;68:1240-6.
3. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492-509.
4. Nam J, Ramiro S, Gaujoux-Viala C, et al. Efficacy of biological DMARDs-a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 2014;73:516-28.
5. Gaujoux-Viala C, Nam J, Ramiro S, et al. Efficacy of conventional synthetic DMARDs, glucocorticoids and tofacitinib-a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis 2014;73:510-15.
6. Hoes JN, Jacobs JW, Boers M, et al. EULAR evidence-based recommendations on the management of systemic glucocorticoid therapy in rheumatic diseases. Ann Rheum Dis 2007;66:1560-7. (Pubitemid 350205441)
7. Duru N, van der Goes MC, Jacobs JW, et al. EULAR evidence-based and consensus-based recommendations on the management of medium to high-dose glucocorticoid therapy in rheumatic diseases. Ann Rheum Dis 2013;72:1905-13.
8. Da Silva JA, Jacobs JW, Kirwan JR, et al. Safety of low dose glucocorticoid treatment in rheumatoid arthritis: published evidence and prospective trial data. Ann Rheum Dis 2006;65:285-93. (Pubitemid 43268214)
9. Sackett D, WS R, Rosenberg W, et al. Evidence-based medicine: how to practice and teach EBM. London: Churchill Livingstone, 1997.
10. Hayden JA, Cote P, Bombardier C. Evaluation of the quality of prognosis studies in systematic reviews. Ann Intern Med 2006;144:427-37. (Pubitemid 46768164)
11. Galloway JB, Hyrich KL, Mercer LK, et al. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology 2011;50:124-31.
12. Greenberg JD, Reed G, Kremer JM, et al. Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry. Ann Rheum Dis 2010;69:380-6.
13. Grijalva CG, Chen L, Delzell E, et al. Initiation of tumor necrosis factor-alpha antagonists and the risk of hospitalization for infection in patients with autoimmune diseases. JAMA 2011;306:2331-9.
14. Grijalva CG, Kaltenbach L, Arbogast PG, et al. Initiation of rheumatoid arthritis treatments and the risk of serious infections. Rheumatology 2010;49:82-90.
15. Komano Y, Tanaka M, Nanki T, et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011;38:1258-64.
16. Sakai R, Komano Y, Tanaka M, et al. Time-dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritis. Arthritis Care Res 2012;64:1125-34.
17. Strangfeld A, Eveslage M, Schneider M, et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient? Ann Rheum Dis 2011;70:1914-20.
18. Lane MA, McDonald JR, Zeringue AL, et al. TNF-alpha antagonist use and risk of hospitalization for infection in a national cohort of veterans with rheumatoid arthritis. Medicine 2011;90:139-45.
19. Galloway JB, Hyrich KL, Mercer LK, et al. The risk of serious infections in patients receiving anakinra for rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Rheumatology 2011;50:1341-2.
20. Galloway JB, Mercer LK, Moseley A, et al. Risk of skin and soft tissue infections (including shingles) in patients exposed to anti-tumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2013;72:229-34.
21. McDonald JR, Zeringue AL, Caplan L, et al. Herpes zoster risk factors in a national cohort of veterans with rheumatoid arthritis. Clin Infect Dis 2009;48:1364-71.
22. Strangfeld A, Listing J, Herzer P, et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents. JAMA 2009;301:737-44.
23. Garcia-Doval I, Perez-Zafrilla B, Descalzo MA, et al. Incidence and risk of hospitalisation due to shingles and chickenpox in patients with rheumatic diseases treated with TNF antagonists. Ann Rheum Dis 2010;69:1751-5.
24. Winthrop KL, Baddley JW, Chen L, et al. Association between the initiation of anti-tumor necrosis factor therapy and the risk of herpes zoster. JAMA 2013;309:887-95.
25. Dixon WG, Hyrich KL, Watson KD, 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;69:522-8.
26. Tam LS, Leung CC, Ying SK, et al. Risk of tuberculosis in patients with rheumatoid arthritis in Hong Kong-the role of TNF blockers in an area of high tuberculosis burden. Clin Exp Rheumatol 2010;28:679-85.
27. Tubach F, Salmon D, Ravaud P, et al. 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.
28. Winthrop KL, Baxter R, Liu L, et al. Mycobacterial diseases and antitumour necrosis factor therapy in USA. Ann Rheum Dis 2013;72:37-42.
29. Galloway JB, Hyrich KL, Mercer LK, et al. Risk of septic arthritis in patients with rheumatoid arthritis and the effect of anti-TNF therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2011;70:1810-14.
30. Pena-Sagredo JL, Farinas MC, Perez-Zafrilla B, et al. Non-typhi Salmonella infection in patients with rheumatic diseases on TNF-alpha antagonist therapy. Clin Exp Rheumatol 2009;27:920-5.
31. Curtis JR, Xie F, Chen L, et al. The comparative risk of serious infections among rheumatoid arthritis patients starting or switching biological agents. Ann Rheum Dis 2011;70:1401-6.
32. Nguyen-Khoa BA, Goehring EL Jr, Alexander KA, et al. Risk of significant infection in rheumatoid arthritis patients switching anti-tumor necrosis factor-alpha drugs. Semin Arthritis Rheum 2012;42:119-26.
33. Askling J, van Vollenhoven RF, Granath F, et al. Cancer risk in patients with rheumatoid arthritis treated with anti-tumor necrosis factor alpha therapies: does the risk change with the time since start of treatment? Arthritis Rheum 2009;60:3180-9.
34. Carmona L, Abasolo L, Descalzo MA, et al. Cancer in patients with rheumatic diseases exposed to TNF antagonists. Semin Arthritis Rheum 2011;41:71-80.
35. Haynes K, Beukelman T, Curtis JR, et al. Tumor necrosis factor alpha inhibitor therapy and cancer risk in chronic immune-mediated diseases. Arthritis Rheum 2013;65:48-58.
36. Pallavicini FB, Caporali R, Sarzi-Puttini P, et al. Tumour necrosis factor antagonist therapy and cancer development: analysis of the LORHEN registry. Autoimmun Rev 2010;9:175-80.
37. Strangfeld A, Hierse F, Rau R, et al. Risk of incident or recurrent malignancies among patients with rheumatoid arthritis exposed to biologic therapy in the German biologics register RABBIT. Arthritis Res Ther 2010;12:R5.
38. Dixon WG, Watson KD, Lunt M, et al. 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;62:755-63.
39. Askling J, Baecklund E, Granath F, et al. Anti-tumour necrosis factor therapy in rheumatoid arthritis and risk of malignant lymphomas: relative risks and time trends in the Swedish Biologics Register. Ann Rheum Dis 2009;68:648-53.
40. Mariette X, Tubach F, Bagheri H, et al. Lymphoma in patients treated with anti-TNF: results of the 3-year prospective French RATIO registry. Ann Rheum Dis 2010;69:400-8.
41. Amari W, Zeringue AL, McDonald JR, et al. Risk of non-melanoma skin cancer in a national cohort of veterans with rheumatoid arthritis. Rheumatology 2011;50:1431-9.
42. Mercer LK, Green AC, Galloway JB, 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;71:869-74.
43. Raaschou P, Simard JF, Holmqvist M, et al. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma: nationwide population based prospective cohort study from Sweden. BMJ 2013;346:f1939.
44. Strangfeld A, Hyrich K, Askling J, et al. Detection and evaluation of a drug safety signal concerning pancreatic cancer: lessons from a joint approach of three European biologics registers. Rheumatology 2011;50:146-51.
45. Dixon WG, Hyrich KL, Watson KD, et al. Influence of anti-TNF therapy on mortality in patients with rheumatoid arthritis-associated interstitial lung disease: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2010;69:1086-91.
46. Herrinton LJ, Liu L, Chen L, et al. Association between anti-TNF-alpha therapy and all-cause mortality. Pharmacoepidemiol Drug Saf 2012;21:1311-20.
47. Lunt M, Watson KD, Dixon WG, et al. No evidence of association between anti-tumor necrosis factor treatment and mortality in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 2010;62:3145-53.
48. Simard JF, Neovius M, Askling J, et al. Mortality rates in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: drug-specific comparisons in the Swedish Biologics Register. Arthritis Rheum 2012;64:3502-10.
49. Thyagarajan V, Norman H, Alexander KA, et al. Risk of mortality, fatal infection, and fatal malignancy related to use of anti-tumor necrosis factor-alpha biologics by rheumatoid arthritis patients. Semin Arthritis Rheum 2012;42:223-33.
50. Arkema EV, van Vollenhoven RF, Askling J, et al. Incidence of progressive multifocal leukoencephalopathy in patients with rheumatoid arthritis: a national population-based study. Ann Rheum Dis 2012;71:1865-7.
51. Bernatsky S, Renoux C, Suissa S. Demyelinating events in rheumatoid arthritis after drug exposures. Ann Rheum Dis 2010;69:1691-3.
52. Winthrop KL, Chen L, Fraunfelder FW, et al. Initiation of anti-TNF therapy and the risk of optic neuritis: from the safety assessment of biologic ThERapy (SABER) Study. Am J Ophthalmol 2013;155:183-9 e1.
53. Greenberg JD, Kremer JM, Curtis JR, et al. Tumour necrosis factor antagonist use and associated risk reduction of cardiovascular events among patients with rheumatoid arthritis. Ann Rheum Dis 2011;70:576-82.
54. Ljung L, Simard JF, Jacobsson L, et al. Treatment with tumor necrosis factor inhibitors and the risk of acute coronary syndromes in early rheumatoid arthritis. Arthritis Rheum 2012;64:42-52.
55. Curtis JR, Xie F, Chen L, et al. The incidence of gastrointestinal perforations among rheumatoid arthritis patients. Arthritis Rheum 2011;63:346-51.
56. Curtis JR, Lanas A, John A, et al. Factors associated with gastrointestinal perforation in a cohort of patients with rheumatoid arthritis. Arthritis Care Res 2012;64:1819-28.
57. Davies R, Galloway JB, Watson KD, et al. Venous thrombotic events are not increased in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2011;70:1831-4.
58. Sokolove J, Strand V, Greenberg JD, et al. Risk of elevated liver enzymes associated with TNF inhibitor utilisation in patients with rheumatoid arthritis. Ann Rheum Dis 2010;69:1612-17.
59. Harrison MJ, Dixon WG, Watson KD, et al. Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-tumour necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis 2009;68:209-15.
60. Dixon WG, Kezouh A, Bernatsky S, et al. The influence of systemic glucocorticoid therapy upon the risk of non-serious infection in older patients with rheumatoid arthritis: a nested case-control study. Ann Rheum Dis 2011;70:956-60.
61. Doran MF, Crowson CS, Pond GR, et al. Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002;46:2294-300.
62. Brassard P, Lowe AM, Bernatsky S, et al. Rheumatoid arthritis, its treatments, and the risk of tuberculosis in Quebec, Canada. Arthritis Rheum 2009;61:300-4.
63. Mercer LK, Davies R, Galloway JB, et al. Risk of cancer in patients receiving non-biologic disease-modifying therapy for rheumatoid arthritis compared with the UK general population. Rheumatology 2013;52:91-8.
64. Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2011;(2): CD008794.
65. Bongartz T, Sutton AJ, Sweeting MJ, et al. 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. (Pubitemid 43736578)
66. Dixon WG, Carmona L, Finckh A, et al. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis 2010;69:1596-602.
67. Koike T, Harigai M, Inokuma S, et al. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol 2009;36:898-906.
68. Koike T, Harigai M, Inokuma S, et al. Postmarketing surveillance of tocilizumab for rheumatoid arthritis in Japan: interim analysis of 3881 patients. Ann Rheum Dis 2011;70:2148-51.
69. Koike T, Harigai M, Ishiguro N, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol 2012;22:498-508.
70. Morel JDM, Cantagrel A, Combe B, et al. Prospective follow-up of tocilizumab treatment in 1100 patients with refractory rheumatoid arthritis: tolerance data from the french registry regate (registry-roactemra). Ann Rheum Dis 2013;72:456.
71. Hishitani Y, Ogata A, Shima Y, et al. Retention of tocilizumab and anti-tumour necrosis factor drugs in the treatment of rheumatoid arthritis. Scand J Rheumatol 2013;42:253-9.
72. Horak P, Skacelova M, Hejduk K, et al. Abatacept and its use in the treatment of rheumatoid arthritis (RA) in the Czech Republic-data from the ATTRA registry. Clin Rheumatol 2013;32:1451-8.
73. Gottenberg JE, Ravaud P, Bardin T, et al. Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum 2010;62:2625-32.
74. Godot S, Gottenberg JE, Paternotte S, et al. Safety of surgery after rituximab therapy in 133 patients with rheumatoid arthritis: data from the AutoImmunity and Rituximab registry. Arthritis Care Res 2013. doi: 10.1002/acr.22056 [Epub ahead of print 10 Jun 2013]
75. Rakieh C, Conaghan PG. Tofacitinib for treatment of rheumatoid arthritis. Adv Ther 2013;30:713-26.