The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 75, Issue 4, 2016, Pages 687-695

  Winthrop, Kevin L ^a   Silverfield, Joel ^b   Racewicz, Arthur ^c   Neal, Jeffrey ^d   Lee, Eun Bong ^e   Hrycaj, Pawel ^f   Gomez Reino, Juan ^g   Soma, Koshika ^h   Mebus, Charles ^h   Wilkinson, Bethanie ^h   Hodge, Jennifer ^h   Fan, Haiyun ^h   Wang, Tao ^h   Bingham, Clifton O ⁱ  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b Health Point Medical Group   (United States)

^c Osteo Medic sc ^*  (Poland)

^d Bluegrass Community Research   (United States)

^e Seoul National University   (South Korea)

^f POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^g Instituto de Salud Carlos III   (Spain)

^h PFIZER INC   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G ANTIBODY; INFLUENZA VACCINE; METHOTREXATE; PLACEBO; PNEUMOCOCCUS VACCINE; PREDNISONE; TOFACITINIB; IMMUNOSUPPRESSIVE AGENT; PIPERIDINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ADULT; AGED; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; IMMUNOGENICITY; INFLUENZA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT SATISFACTION; PHASE 2 CLINICAL TRIAL; PNEUMOCOCCAL INFECTION; PRIORITY JOURNAL; PROTECTION; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; TREATMENT DURATION; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMBINATION DRUG THERAPY; IMMUNOCOMPROMISED PATIENT; IMMUNOLOGY; INFLUENZA, HUMAN; MIDDLE AGED; PNEUMOCOCCAL INFECTIONS; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOCOMPROMISED HOST; IMMUNOSUPPRESSIVE AGENTS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; METHOTREXATE; MIDDLE AGED; PIPERIDINES; PNEUMOCOCCAL INFECTIONS; PNEUMOCOCCAL VACCINES; PROTEIN KINASE INHIBITORS; PYRIMIDINES; PYRROLES; YOUNG ADULT;

EID: 84929600615     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2014-207191     Document Type: Article

References (46)

1. Doran MF, Crowson CS, Pond GR, et al. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum 2002;46:2287-93.
2. Listing J, Gerhold K, Zink A. The risk of infections associated with rheumatoid arthritis, with its comorbidity and treatment. Rheumatology (Oxford) 2013;52:53-61.
3. Michaud K, Wolfe F. Comorbidities in rheumatoid arthritis. Best Pract Res Clin Rheumatol 2007;21:885-906.
4. Widdifield J, Bernatsky S, Paterson JM, et al. Serious infections in a populationbased cohort of 86, 039 seniors with rheumatoid arthritis. Arthritis Care Res (Hoboken) 2013;65:353-61.
5. 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.
6. 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.
7. Curtis JR, Patkar N, Xie A, et al. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007;56:1125-33.
8. 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.
9. 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.
10. Winthrop KL. Serious infections with antirheumatic therapy: are biologicals worse? Ann Rheum Dis 2006;65(Suppl 3):iii54-7.
11. Singh JA, Furst DE, Bharat A, et al. 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) 2012;64:625-39.
12. van Assen S, Elkayam O, Agmon-Levin N, et al. Vaccination in adult patients with auto-immune inflammatory rheumatic diseases: a systematic literature review for the European League Against Rheumatism evidence-based recommendations for vaccination in adult patients with auto-immune inflammatory rheumatic diseases. Autoimmun Rev 2011;10:341-52.
13. van Assen S, Agmon-Levin N, Elkayam O, et al. EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2011;70:414-22.
14. Burmester GR, Blanco R, Charles-Schoeman C, et al. Tofacitinib (CP-690, 550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet 2013;381:451-60.
15. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012;367:495-507.
16. Kremer J, Li ZG, Hall S, et al. Tofacitinib in Combination with Nonbiologic DMARDs in Patients with Active Rheumatoid Arthritis: A Randomized Trial. Ann Intern Med 2013;159:253-61.
17. Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus Methotrexate in Rheumatoid Arthritis. N Engl J Med 2014;370:2377-86.
18. van der Heijde D, Tanaka Y, Fleischmann R, et al. Tofacitinib (CP-690, 550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum 2013;65:559-70.
19. van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012;367:508-19.
20. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
21. de Jong JC, Palache AM, Beyer WE, et al. Haemagglutination-inhibiting antibody to influenza virus. Dev Biol (Basel) 2003;115:63-73.
22. Coudeville L, Bailleux F, Riche B, et al. Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a Bayesian random-effects model. BMC Med Res Methodol 2010;10:18.
23. Hobson D, Curry RL, Beare AS, et al. The role of serum haemagglutinationinhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg (Lond) 1972;70:767-77.
24. Santner TJ, Snell MK. Small-Sample Confidence Intervals for p1-p2 and p1/p2 in Contingency Tables. J Am Stat Assoc 1980;75:386-94.
25. Kapetanovic MC, Saxne T, Sjoholm A, et al. Influence of methotrexate, TNF blockers and prednisolone on antibody responses to pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis. Rheumatology (Oxford) 2006;45:106-11.
26. Bingham CO III, 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.
27. Tay L, Leon F, Vratsanos G, et al. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther 2007;9:R38.
28. Mori S, Ueki Y, Akeda Y, et al. Pneumococcal polysaccharide vaccination in rheumatoid arthritis patients receiving tocilizumab therapy. Ann Rheum Dis 2013;72:1362-6.
29. Hua C, Barnetche T, Combe B, et al. Effect of methotrexate, anti-TNFalpha and rituximab on the immune response to influenza and pneumococcal vaccines in patients with rheumatoid arthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken) 2014;66:1016-26.
30. Kogure T, Harada N, Tatsumi T, et al. Investigation of clinical characteristics as predictive factors for the humoral immune response to the influenza vaccine in patients with rheumatoid arthritis. Clin Rheumatol 2014;33:323-8.
31. Mori S, Ueki Y, Hirakata N, et al. Impact of tocilizumab therapy on antibody response to influenza vaccine in patients with rheumatoid arthritis. Ann Rheum Dis 2012;71:2006-10.
32. Elkayam O, Bashkin A, Mandelboim M, et al. The effect of infliximab and timing of vaccination on the humoral response to influenza vaccination in patients with rheumatoid arthritis and ankylosing spondylitis. Semin Arthritis Rheum 2010;39:442-7.
33. van Assen S, Holvast A, Benne CA, et al. Humoral responses after influenza vaccination are severely reduced in patients with rheumatoid arthritis treated with rituximab. Arthritis Rheum 2010;62:75-81.
34. Eisenberg RA, Jawad AF, Boyer J, et al. Rituximab-treated patients have a poor response to influenza vaccination. J Clin Immunol 2013;33:388-96.
35. Oren S, Mandelboim M, Braun-Moscovici Y, et al. Vaccination against influenza in patients with rheumatoid arthritis: the effect of rituximab on the humoral response. Ann Rheum Dis 2008;67:937-41.
36. Ribeiro AC, Laurindo IM, Guedes LK, et al. Abatacept and reduced immune response to pandemic 2009 influenza A/H1N1 vaccination in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken) 2013;65:476-80.
37. Bingham CO III, Rizzo W, Kivitz A, et al. Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA). Ann Rheum Dis 2015;74:818-22.
38. O'Shea JJ. Targeting the Jak/STAT pathway for immunosuppression. Ann Rheum Dis 2004;63(Suppl 2):ii67-71.
39. Diehl SA, Schmidlin H, Nagasawa M, et al. IL-6 triggers IL-21 production by human CD4+ T cells to drive STAT3-dependent plasma cell differentiation in B cells. Immunol Cell Biol 2012;90:802-11.
40. Wang SP, Iwata S, Nakayamada S, et al. Tofacitinib, a JAK inhibitor, inhibits human B cell activation in vitro. Ann Rheum Dis 2014;73:2213-15.
41. Dougados M, Soubrier M, Antunez A, et al. Prevalence of comorbidities in rheumatoid arthritis and evaluation of their monitoring: results of an international, cross-sectional study (COMORA). Ann Rheum Dis 2014;73:62-8.
42. Curtis JR, Arora T, Narongroeknawin P, et al. The delivery of evidence-based preventive care for older Americans with arthritis. Arthritis Res Ther 2010;12:R144.
43. Sowden E, Mitchell WS. An audit of influenza and pneumococcal vaccination in rheumatology outpatients. BMC Musculoskelet Disord 2007;8:58.
44. American Academy of Family Physicians. ACIP Expands PCV13 Immunization Recommendations, But Makes No Flu Vaccine Changes: Prevnar 13 Now Recommended for Some Immunocompromised Adults. http://www.aafp.org/news-now/health-of-the-public/20120626juneacipmtg.html (accessed 19 Nov. 2013).
45. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2012;61:816-19.
46. Paradiso PR. Pneumococcal conjugate vaccine for adults: a new paradigm. Clin Infect Dis 2012;55:259-64.