Overview of safety of non-biologic and biologic DMARDs

Rheumatology (United Kingdom)

Volumn 51, Issue SUPPL. 6, 2012, Pages

  Ruderman, Eric M ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Biologic DMARDs; Herpes zoster; Infection; Latent tuberculosis screening; Methotrexate; Non melanoma skin cancer; Rheumatoid arthritis; Safety; Vaccination

Indexed keywords

ABATACEPT; ADALIMUMAB; ANTIBIOTIC AGENT; BCG VACCINE; CERTOLIZUMAB PEGOL; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GOLIMUMAB; HERPES VACCINE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INFLIXIMAB; INFLUENZA VACCINE; METHOTREXATE; PNEUMOCOCCUS VACCINE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; TOCILIZUMAB; TUMOR NECROSIS FACTOR INHIBITOR;

ARTICLE; BACTERIAL INFECTION; CARDIOVASCULAR DISEASE; CHILDHOOD CANCER; CLINICAL TRIAL (TOPIC); COCCIDIOIDOMYCOSIS; COLON CROHN DISEASE; COMORBIDITY; CONGESTIVE HEART FAILURE; CYTOPENIA; DEMYELINATING DISEASE; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DISEASE ASSOCIATION; DISEASE EXACERBATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG PACKAGING; DRUG SAFETY; DRUG TOLERABILITY; ENZYME BLOOD LEVEL; HERPES ZOSTER; HISTOPLASMOSIS; HUMAN; INFECTION; INJECTION SITE DISCOMFORT; LATENT TUBERCULOSIS; LEGIONNAIRE DISEASE; LEUKOPENIA; LISTERIOSIS; LIVER CANCER; LIVER TOXICITY; LUNG INFECTION; META ANALYSIS (TOPIC); MYCOSIS; NAUSEA; NON MELANOMA SKIN CANCER; OPPORTUNISTIC INFECTION; PATIENT MONITORING; PNEUMOCYSTIS PNEUMONIA; PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; RETINA INJURY; RHEUMATOID ARTHRITIS; RISK FACTOR; SCREENING; SIDE EFFECT; SYSTEMATIC REVIEW (TOPIC); T CELL LYMPHOMA; TUBERCULIN TEST;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL AGENTS; HUMANS; OPPORTUNISTIC INFECTIONS; REGISTRIES; RISK FACTORS; TREATMENT OUTCOME;

EID: 84870864817     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/kes283     Document Type: Article

References (55)

1. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum 2002;46: 2287-93.
2. Saag KG, Teng GG, Patkar NM et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008;59: 762-84.
3. Chakravarty K, McDonald H, Pullar T et al. BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists. Rheumatology 2008;47: 924-5.
4. Tilling L, Townsend S, David J. Methotrexate and hepatic toxicity in rheumatoid arthritis and psoriatic arthritis. Clin Drug Investig 2006;26:55-62.
5. Alarcon GS, Kremer JM, Macaluso M et al. Risk factors for methotrexate-induced lung injury in patients with rheumatoid arthritis. A multicenter, case-control study. Methotrexate-Lung Study Group. Ann Intern Med 1997; 127:356-64.
6. Sathi N, Chikura B, Kaushik VV, Wiswell R, Dawson JK. How common is methotrexate pneumonitis? A large prospective study investigates. Clin Rheumatol 2011;31: 79-83.
7. van der Veen MJ, van der Heide A, Kruize AA, Bijlsma JW. Infection rate and use of antibiotics in patients with rheumatoid arthritis treated with methotrexate. Ann Rheum Dis 1994;53:224-8.
8. 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.
9. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002;46:2294-300.
10. Osiri M, Shea B, Robinson V et al. Leflunomide for treating rheumatoid arthritis. Cochrane Database Syst Rev 2003;1: CD002047.
11. Curtis JR, Beukelman T, Onofrei A et al. Elevated liver enzyme tests among patients with rheumatoid arthritis or psoriatic arthritis treated with methotrexate and/or leflunomide. Ann Rheum Dis 2010;69:43-7.
12. Kremer JM, Genovese MC, Cannon GW et al. Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 2002;137: 726-33.
13. Marmor MF, Kellner U, Lai TY, Lyons JS, Mieler WF. Revised recommendations on screening for chloroquine and hydroxychloroquine retinopathy. Ophthalmology 2011;118:415-22.
14. Bingham CO 3rd, Looney RJ, Deodhar A et al. Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum 2010;62:64-74.
15. 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
16. 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.
17. 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.
18. Askling J, Fored CM, Brandt L et al. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis 2007;66:1339-44.
19. Au K, Reed G, Curtis JR et al. High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis 2011;70:785-91.
20. Wolfe F, Caplan L, Michaud K. Treatment for rheumatoid arthritis and the risk of hospitalization for pneumonia: associations with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum 2006;54:628-34.
21. Fleischmann R, Baumgartner SW, Weisman MH, Liu T, White B, Peloso P. Long term safety of etanercept in elderly subjects with rheumatic diseases. Ann Rheum Dis 2006;65:379-84.
22. Keane J, Gershon S, Wise RP et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001;345: 1098-104.
23. 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.
24. Gomez-Reino JJ, Carmona L, Valverde VR, Mola EM, Montero MD. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum 2003;48: 2122-7.
25. Carmona L, Gomez-Reino JJ, Rodriguez-Valverde V et al. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum 2005; 52:1766-72.
26. BTS recommendations for assessing risk and for managing Mycobacterium tuberculosis infection and disease in patients due to start anti-TNF-alpha treatment. Thorax, 2005;60:800-5.
27. Fuchs I, Avnon L, Freud T, Abu-Shakra M. Repeated tuberculin skin testing following therapy with TNF-alpha inhibitors. Clin Rheumatol 2009;28:167-72.
28. Winthrop KL, Chang E, Yamashita S, Iademarco MF, LoBue PA. Nontuberculous mycobacteria infections and anti-tumor necrosis factor-alpha therapy. Emerg Infect Dis 2009;15:1556-61.
29. 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.
30. 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.
31. Carroll MB, Bond MI. Use of tumor necrosis factor-alpha inhibitors in patients with chronic hepatitis B infection. Semin Arthritis Rheum 2008;38:208-17.
32. Baecklund E, Iliadou A, Askling J et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthritis Rheum 2006;54:692-701.
33. Setoguchi S, Solomon DH, Weinblatt ME et al. Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis. Arthritis Rheum 2006;54: 2757-64.
34. 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.
35. Mackey AC, Green L, Leptak C, Avigan M. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease: update. J Pediatr Gastroenterol Nutr 2009;48:386-8.
36. Dixon WG, Watson KD, Lunt M, Mercer LK, Hyrich KL, Symmons DP. 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.
37. Mariette X, Matucci-Cerinic M, Pavelka K et al. Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis. Ann Rheum Dis 2011;70:1895-904.
38. Amari W, Zeringue AL, McDonald JR, Caplan L, Eisen SA, Ranganathan P. Risk of non-melanoma skin cancer in a national cohort of veterans with rheumatoid arthritis. Rheumatology 2011;50:1431-9.
39. Chung ES, Packer M, Lo KH, Fasanmade AA, Willerson JT. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure: results of the anti-TNF therapy against congestive heart failure (ATTACH) trial. Circulation 2003;107:3133-40.
40. Mohan N, Edwards ET, Cupps TR et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides. Arthritis Rheum 2001;44: 2862-9.
41. Smolen J, Landewe RB, Mease P et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis 2009;68:797-804.
42. 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;68:25-32.
43. Hoshi D, Nakajima A, Inoue E et al. Incidence of serious respiratory infections in patients with rheumatoid arthritis treated with tocilizumab. Mod Rheumatol 2011;22:122-7.
44. van Vollenhoven R, Keystone E, Furie R, Blesch A, Wang C, Curtis JR. Gastrointestinal safety in patients with rheumatoid arthritis treated with tocilizumab: data from Roche clinical trials. Philadelphia: American College of Rheumatology 2009.
45. Weinblatt M, Combe B, Covucci A, Aranda R, Becker JC, Keystone E. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: a one-year randomized, placebo-controlled study. Arthritis Rheum 2006;54: 2807-16.
46. Bigbee CL, Gonchoroff DG, Vratsanos G, Nadler SG, Haggerty HG, Flynn JL. Abatacept treatment does not exacerbate chronic Mycobacterium tuberculosis infection in mice. Arthritis Rheum 2007;56:2557-65.
47. Simon TA, Smitten AL, Franklin J et al. Malignancies in the rheumatoid arthritis abatacept clinical development programme: an epidemiological assessment. Ann Rheum Dis 2009;68:1819-26.
48. Keystone E, Fleischmann R, Emery P et al. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum 2007;56:3896-908.
49. Carson KR, Evens AM, Richey EA et al. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the research on adverse drug events and reports project. Blood 2009;113:4834-40.
50. 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.
51. Dixon WG, Watson KD, Lunt M, Hyrich KL, Silman AJ, Symmons DP. Reduction in the incidence of myocardial infarction in patients with rheumatoid arthritis who respond to anti-tumor necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 2007; 56:2905-12.
52. Jacobsson LT, Turesson C, Gulfe A et al. Treatment with tumor necrosis factor blockers is associated with a lower incidence of first cardiovascular events in patients with rheumatoid arthritis. J Rheumatol 2005;32:1213-8.
53. Micha R, Imamura F, Wyler von Ballmoos M et al. Systematic review and meta-analysis of methotrexate use and risk of cardiovascular disease. Am J Cardiol 2011; 108:1362-70.
54. Dixon WG, Hyrich KL, Watson KD, Lunt M, Symmons DP. 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.
55. Mikuls TR, Fay BT, Michaud K et al. Associations of disease activity and treatments with mortality in men with rheumatoid arthritis: results from the VARA registry. Rheumatology 2011;50:101-9.