Serious infection risk after 1 year between patients with rheumatoid arthritis treated with rituximab or with a second TNFi after initial TNFi failure: Results from The British Society for Rheumatology Biologics Register for Rheumatoid Arthritis

Rheumatology (United Kingdom)

Volumn 57, Issue 9, 2018, Pages 1533-1540

  Silva Fernández, Lucía ^a,c   De Cock, Diederik ^c   Lunt, Mark ^c   Low, Audrey S ^c   Watson, Kath D ^c   Symmons, Deborah P M ^b,c   Hyrich, Kimme L ^b,c  

^a Universidad de La Coruña   (Spain)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

Observational cohort; Rituximab; Safety of biologics; Second line biologic treatment; Serious infections; TNF inhibitors

Indexed keywords

ADALIMUMAB; ANTIBIOTIC AGENT; CERTOLIZUMAB PEGOL; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; RITUXIMAB; STEROID; TUMOR NECROSIS FACTOR INHIBITOR; ANTIRHEUMATIC AGENT; TNF PROTEIN, HUMAN; TUMOR NECROSIS FACTOR;

ABDOMINAL INFECTION; ADULT; ANTIBIOTIC THERAPY; ARTICLE; BACTEREMIA; BACTERIAL INFECTION; BIOLOGICAL THERAPY; BONE AND JOINT INFECTIONS; CENTRAL NERVOUS SYSTEM INFECTION; COHORT ANALYSIS; CONTROLLED STUDY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; EYE INFECTION; EYELID DISEASE; FEMALE; FOLLOW UP; GASTROINTESTINAL INFECTION; HAZARD RATIO; HOSPITALIZATION; HUMAN; INFECTION; INFECTION RISK; INFLUENZA; LEGIONNAIRE DISEASE; LISTERIOSIS; LONG TERM EXPOSURE; LOWER RESPIRATORY TRACT INFECTION; LUNG INFECTION; LUNG MYCOSIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MYOSITIS; NECROTIZING ENTEROCOLITIS; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROBABILITY; PROPENSITY SCORE; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SEPSIS; SERIOUS INFECTION; SOFT TISSUE INFECTION; SPINAL CORD INFECTION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIREMIA; VIRUS INFECTION; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; MEDICAL SOCIETY; MORBIDITY; MULTICENTER STUDY; REGISTER; TIME FACTOR; TREATMENT OUTCOME; TRENDS; UNITED KINGDOM;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; MORBIDITY; PROSPECTIVE STUDIES; REGISTRIES; RITUXIMAB; SOCIETIES, MEDICAL; TIME FACTORS; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA; UNITED KINGDOM;

EID: 85052588666     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/kex304     Document Type: Article

References (31)

1. Cohen SB, Emery P, Greenwald MW et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum 2006;54:2793806.
2. Edwards JC, Szczepanski L, Szechinski J et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. New Engl J Med 2004;350:257281.
3. Emery P, Fleischmann R, Filipowicz-Sosnowska A et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 2006;54:1390400.
4. Kelesidis T, Daikos G, Boumpas D, Tsiodras S. Does rituximab increase the incidence of infectious complications? A narrative review. Int J Infect Dis 2011;15:e216.
5. van Vollenhoven RF, Emery P, Bingham CO 3rd et al. Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients. Ann Rheum Dis 2013;72:1496502.
6. van Vollenhoven RF, Fleischmann RM, Furst DE, Lacey S, Lehane PB. Longterm safety of rituximab: final report of the rheumatoid arthritis global clinical trial program over 11 years. J Rheumatol 2015;42:17616.
7. 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;62:6474.
8. Emery P, Deodhar A, Rigby WF et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis 2010;69:162935.
9. Rubbert-Roth A, Tak PP, Zerbini C et al. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology 2010;49:168393.
10. Tak PP, Rigby WF, Rubbert-Roth A et al. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis 2011;70:3946.
11. Porter D, van Melckebeke J, Dale J et al. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial. Lancet 2016;388:23947.
12. Mariette X, Gottenberg JE, Ravaud P, Combe B. Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries. Rheumatology 2011;50:2229.
13. Hyrich KL, Watson KD, Isenberg DA, Symmons DP, Register BSRB. The British Society for Rheumatology Biologics Register: 6 years on. Rheumatology 2008;47:14413.
14. Ledingham J, Deighton C; British Society for Rheumatology Standards, Guidelines and Audit Working Group. Update on the British Society for Rheumatology guidelines for prescribing TNFalpha blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001). Rheumatology 2005;44:15763.
15. Prevoo ML, van't Hof MA, Kuper HH et al. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:448.
16. Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 1983;26:134653.
17. Kirwan JR, Reeback JS. Stanford Health Assessment Questionnaire modified to assess disability in British patients with rheumatoid arthritis. Br J Rheumatol 1986;25:2069.
18. Teng YK, Huizinga TW, van Laar JM. Targeted therapies in rheumatoid arthritis: focus on rituximab. Biologics 2007;1:32533.
19. Curtis LH, Hammill BG, Eisenstein EL, Kramer JM, Anstrom KJ. Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases. Med Care 2007;45(10 Suppl 2):S1037.
20. Lanini S, Molloy AC, Fine PE et al. Risk of infection in patients with lymphoma receiving rituximab: systematic review and meta-analysis. BMC Med 2011;9:36.
21. Aksoy S, Dizdar O, Hayran M, Harputluoglu H. Infectious complications of rituximab in patients with lymphoma during maintenance therapy: a systematic review and meta-analysis. Leuk Lymphoma 2009;50:35765.
22. Bredemeier M, Campos GG, de Oliveira FK. Updated systematic review and meta-analysis of randomized controlled trials comparing low- versus high-dose rituximab for rheumatoid arthritis. Clin Rheumatol 2015;34:18015.
23. 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;46:228793.
24. Brinkman IH, van de Laar MA, Jansen TL, van Roon EN. The potential risk of infections during (prolonged) rituximab therapy in rheumatoid arthritis. Expert Opin Drug Saf 2011;10:71526.
25. Aaltonen KJ, Joensuu JT, Virkki L et al. Rates of serious infections and malignancies among patients with rheumatoid arthritis receiving either tumor necrosis factor inhibitor or rituximab therapy. J Rheumatol 2015;42:3728.
26. NICE. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. https://wwwniceorguk/guidance/ta195 (1 September 2015, date last accessed).
27. Hyrich KL, Lunt M, Watson KD, Symmons DP, Silman AJ; British Society for Rheumatology Biologics Register. Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum 2007;56:1320.
28. Smolen JS, Landewe R, Breedveld FC et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheu-matic drugs: 2013 update. Ann Rheum Dis 2014;73:492509.
29. 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;50:12431.
30. 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;70:191420.
31. Zink A, Manger B, Kaufmann J et al. Evaluation of the RABBIT Risk Score for serious infections. Ann Rheum Dis 2014;73:16736.