Biologic therapies and infections in the daily practice of three Italian rheumatologic units: a prospective, observational study

Clinical Rheumatology

Volumn 36, Issue 2, 2017, Pages 251-260

  Cipriani, Paola ^a   Berardicurti, Onorina ^a   Masedu, Francesco ^a   D’Onofrio, Francesca ^b   Navarini, Luca ^c   Ruscitti, Piero ^a   Maruotti, Nicola ^b   Margiotta, Domenico Paolo Emanuele ^c   Liakouli, Vasiliki ^a   Di Benedetto, Paola ^a   Carubbi, Francesco ^a   Valenti, Marco ^a   Cantatore, Francesco Paolo ^b   Afeltra, Antonella ^c   Giacomelli, Roberto ^a  

^a UNIVERSITY OF L'AQUILA   (Italy)

^b UNIVERSITY OF FOGGIA   (Italy)

^c UNIVERSITY CAMPUS BIO MEDICO   (Italy)

Author keywords

Biological therapies; Infection and arthritis; Rheumatoid arthritis; Serious infection; Spondyloarthropathies; TNF inhibitor

Indexed keywords

ABATACEPT; ADALIMUMAB; ANAKINRA; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; RITUXIMAB; TOCILIZUMAB; ANTIRHEUMATIC AGENT; BIOLOGICAL PRODUCT; TNF PROTEIN, HUMAN; TUMOR NECROSIS FACTOR;

ADULT; ARTICLE; BIOLOGICAL THERAPY; CANDIDA ALBICANS; CLINICAL PRACTICE; COMORBIDITY; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; FEMALE; FOLLOW UP; HUMAN; INFECTION; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MYCOBACTERIUM TUBERCULOSIS; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RHEUMATOLOGY; STAPHYLOCOCCUS AUREUS; STEROID THERAPY; THERAPY; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMPLICATION; ITALY; MIDDLE AGED; MULTICENTER STUDY; MULTIVARIATE ANALYSIS; PROCEDURES; RISK FACTOR; SPONDYLARTHROPATHIES;

ADULT; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFECTION; ITALY; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PROSPECTIVE STUDIES; RHEUMATOLOGY; RISK FACTORS; SPONDYLARTHROPATHIES; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84992387938     PISSN: 07703198     EISSN: 14349949     Source Type: Journal    
DOI: 10.1007/s10067-016-3444-1     Document Type: Article

References (48)

1. Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK et al (2011) Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 16:CD008794
2. Listing J, Gerhold K, Zink A (2013) The risk of infections associated with rheumatoid arthritis, with its comorbidity and treatment. Rheumatology (Oxford) 52:53–61
3. Ruderman EM (2012) Overview of safety of non-biologic and biologic DMARDs. Rheumatology (Oxford) 51:vi37–vi43
4. Singh JA, Cameron C, Noorbaloochi S, Cullis T, Tucker M, Christensen R et al (2015) Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet 18(386):258–265
5. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V (2006) 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 295:2275–2285
6. Leombruno JP, Einarson TR, Keystone EC (2009) The safety of anti-tumour necrosis factor treatments in rheumatoid arthritis: meta and exposure-adjusted pooled analyses of serious adverse events. Ann Rheum Dis 68:1136–1145
7. Salliot C, Dougados M, Gossec L (2009) Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials. Ann Rheum Dis 68:25–32
8. Thompson AE, Rieder SW, Pope JE (2011) Tumor necrosis factor therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis: a meta-analysis of randomized controlled trials. Arthritis Rheum 63:1479–1485
9. Sokka T, Pincus T (2003) Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or American College of Rheumatology criteria for remission. J Rheumatol 30:1138–1146
10. Sokka T, Pincus T (2003) A historical perspective concerning population-based and clinical studies of early arthritis and early rheumatoid arthritis. Clin Exp Rheumatol 21:S5–14
11. Dixon WG, Symmons DP, Lunt M, Watson KD, Hyrich KL, British Society for Rheumatology Biologics Register Control Centre Consortium, AJ S, British Society for Rheumatology Biologics Register (2007) Serious infection following anti-tumor necrosis factor alpha therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum 56:2896–2904
12. Salliot C, Gossec L, Ruyssen-Witrand A, Luc M, Duclos M, Guignard S et al (2007) Infections during tumour necrosis factor-alpha blocker therapy for rheumatic diseases in daily practice: a systematic retrospective study of 709 patients. Rheumatology (Oxford) 46:327–334
13. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd et al (2010) 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 62:2569–2581
14. van der Linden S, Valkenburg HA, Cats A (1984) Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 27:361–368
15. Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, European Study Group on Classification Criteria for Sjögren’s Syndrome et al (2002) Classification criteria for Sjögren’s syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis 61:554–558
16. Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H, CASPAR Study Group (2006) Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 54:2665–2673
17. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM et al (2012) 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 64:625–639
18. Gossec L, Smolen JS, Gaujoux-Viala C, Ash Z, Marzo-Ortega H, van der Heijde D, European League Against Rheumatism et al (2012) European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis 71:4–12
19. Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C et al (2010) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 69:964–975
20. Favalli EG, Desiati F, Atzeni F, Sarzi-Puttini P, Caporali R, Pallavicini FB et al (2009) Serious infections during anti-TNFalpha treatment in rheumatoid arthritis patients. Autoimmun Rev 8:266–273
21. Furst DE, Breedveld FC, Kalden JR, Smolen JS, Antoni CE, Bijlsma JW et al (2002) Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other rheumatic diseases (May 2002). Ann Rheum Dis 61:ii2–ii7
22. Volkmann ER, Rezai S, Tarp S, Woodworth TG, Furst DE (2013) We still don’t know how to taper glucocorticoids in rheumatoid arthritis, and we can do better. J Rheumatol 40(10):1646–1649
23. Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC et al (1997) Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet 350(9074):309–318
24. Tengstrand B, Larsson E, Klareskog L, Hafström I (2007) Randomized withdrawal of long-term prednisolone treatment in rheumatoid arthritis: effects on inflammation and bone mineral density. Scand J Rheumatol 36(5):351–358
25. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM et al (2005) Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 52(11):3381–3390
26. Choy EH, Smith CM, Farewell V, Walker D, Hassell A, Chau L, Scott DL, CARDERA (Combination Anti-Rheumatic Drugs in Early Rheumatoid Arhritis) Trial Group (2008) Factorial randomised controlled trial of glucocorticoids and combination disease modifying drugs in early rheumatoid arthritis. Ann Rheum Dis 67(5):656–663
27. Pincus T, Swearingen CJ, Luta G, Sokka T (2009) Efficacy of prednisone 1-4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial. Ann Rheum Dis 68(11):1715–1720
28. Hickling P, Jacoby RK, Kirwan JR (1998) Joint destruction after glucocorticoids are withdrawn in early rheumatoid arthritis. Arthritis and Rheumatism Council Low Dose Glucocorticoid Study Group. Br J Rheumatol 37(9):930–936
29. Furst DE (2010) The risk of infections with biologic therapies for rheumatoid arthritis. Semin Arthritis Rheum 39:327–346
30. Pincus T, Sokka T (2004) Should contemporary rheumatoid arthritis clinical trials be more like standard patient care and vice versa? Ann Rheum Dis 63:ii32–ii39
31. Strand V, Sokolove J (2009) Randomized controlled trial design in rheumatoid arthritis: the past decade. Arthritis Res Ther 11:205
32. Vieira R, Fonseca R, Pinto JA, Costa L. Infections in an inpatient rheumatology unit: how big is the problem? Acta Reumatol Port 2015
33. Bernatsky S, Hudson M, Suissa S (2007) Anti-rheumatic drug use and risk of serious infections in rheumatoid arthritis. Rheumatology (Oxford) 46:1157–1160
34. Schneeweiss S, Setoguchi S, Weinblatt ME, Katz JN, Avorn J, Sax PE et al (2007) Anti-tumor necrosis factor alpha therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis. Arthritis Rheum 56:1754–1764
35. Dixon WG, Abrahamowicz M, Beauchamp ME, Ray DW, Bernatsky S, Suissa S et al (2012) Immediate and delayed impact of oral glucocorticoid therapy on risk of serious infection in older patients with rheumatoid arthritis: a nested case-control analysis. Ann Rheum Dis 71:1128–1133
36. van der Goes MC, Jacobs JW, Bijlsma JW (2014) The value of glucocorticoid co-therapy in different rheumatic diseases—positive and adverse effects. Arthritis Res Ther 16:S2
37. McMaster A, Ray DW (2008) Drug insight: selective agonists and antagonists of the glucocorticoid receptor. Nat Clin Pract Endocrinol Metab 4:91–101
38. Doran MF, Crowson CS, Pond GR, O’Fallon WM, Gabriel SE (2002) Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum 46(9):2287–2293
39. Sokka T, Kautiainen H, Toloza S, Mäkinen H, Verstappen SM, Lund Hetland M, QUEST-RA Group et al (2007) QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries. Ann Rheum Dis 66:1491–1496
40. Sokka T, Kautiainen H, Pincus T, Toloza S, da Rocha Castelar Pinheiro G, Lazovskis J et al (2009) Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST RA database. Ann Rheum Dis 68:1666–1672
41. Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, Working Group ‘Equity in access to treatment of rheumatoid arthritis in Europe’ et al (2014) Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis 73:198–206
42. Putrik P, Ramiro S, Kvien TK, Sokka T, Uhlig T, Boonen A, Equity in Clinical Eligibility Criteria for RA treatment Working Group (2014) Variations in criteria regulating treatment with reimbursed biologic DMARDs across European countries. Are differences related to country’s wealth? Ann Rheum Dis 73:2010–2021
43. Gvozdenović E, Wolterbeek R, Allaart CF, Brenol C, Dougados M, Emery P et al (2015) Assessment of global disease activity in rheumatoid arthritis by patients and physicians: differences across countries in the METEOR database. J Clin Rheumatol 21:349–354
44. Au K, Reed G, Curtis JR, Kremer JM, Greenberg JD, Strand V, CORRONA Investigators et al (2011) High disease activity is associated with an increased risk of infection in patients with rheumatoid arthritis. Ann Rheum Dis 70:785–791
45. Wallis D, Thavaneswaran A, Haroon N, Ayearst R, Inman RD (2015) Tumour necrosis factor inhibitor therapy and infection risk in axial spondyloarthritis: results from a longitudinal observational cohort. Rheumatology (Oxford) 54:152–156
46. Burmester GR, Panaccione R, Gordon KB, McIlraith MJ, Lacerda AP (2013) 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 72:517–524
47. Cantini F, Niccoli L, Goletti D (2014) Adalimumab, etanercept, infliximab, and the risk of tuberculosis: data from clinical trials, national registries, and postmarketing surveillance. J Rheumatol Suppl 91:47–55
48. Emery P, Gallo G, Boyd H, Morgan CL, Currie CJ, Poole CD et al (2014) Association between disease activity and risk of serious infections in subjects with rheumatoid arthritis treated with etanercept or disease-modifying anti-rheumatic drugs. Clin Exp Rheumatol 32:653–660