title: Patients with Crohn's disease on anti-tumor necrosis factor therapy are at significant risk of inadequate response to the 23-valent pneumococcal polysaccharide vaccine.
abstract: OBJECTIVE
  The effect of immunosuppressants on the efficacy of a variety of vaccines is a controversial issue in patients with inflammatory bowel disease (IBD). In this study we determined whether specific immunosuppressants impair the serological response to the standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) in a large cohort of patients with Crohn's disease (CD).
  
  
  METHODS
  This was a multi-center, prospective observational study of adult patients with CD at 15 academic teaching hospitals in Korea. The study population received one intramuscular injection of PPSV23. Anti-pneumococcal IgG antibody titers were measured by immunoassay prior to and 4weeks after vaccination. All vaccination-related adverse events and the effect of the vaccine on disease activity were also evaluated.
  
  
  RESULTS
  The overall serological response rate was 67.5% (133/197). The serological response rate was significantly lower in patients on anti-tumor necrosis factor (anti-TNF) therapy (50.0% on anti-TNF alone; 58.0% on anti-TNF combined with an immunomodulator, IM) than patients on 5-aminosalicylate (78.4%; all P-values vs. 5-aminosalicylate<0.05); 45.6% (41/90) of patients on anti-TNF therapy were not protected against PPSV23. IM did not affect the immunologic response to the vaccine. Female gender and anti-TNF therapy were significant predictors of non-response to the vaccine (odds ratio [OR] 2.316, P=0.015; OR 2.582, P=0.048, respectively). Vaccination was generally safe and tolerated by all patients.
  
  
  CONCLUSIONS
  Patients with CD on anti-TNF therapy are at significant risk of an inadequate response to PPSV23. The pneumococcal vaccination strategy should be optimized for patients with CD on anti-TNF therapy.
authors.affiliation: Kyung Hee University School of Medicine, Seoul, Republic of Korea.
authors.forename: Chang Kyun
authors.initials: CK
authors.lastname: Lee
authors.affiliation: Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Electronic address: hyskim@yonsei.ac.kr.
authors.forename: Hyun-Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Byong Duk
authors.initials: BD
authors.lastname: Ye
authors.affiliation: The Catholic University of Korea School of Medicine, Seoul, Republic of Korea.
authors.forename: Kang-Moon
authors.initials: KM
authors.lastname: Lee
authors.affiliation: Inje University College of Medicine, Seoul, Republic of Korea.
authors.forename: You Sun
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Kyung Hee University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sang Youl
authors.initials: SY
authors.lastname: Rhee
authors.affiliation: Kyung Hee University School of Medicine, Seoul, Republic of Korea.
authors.forename: Hyo-Jong
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Suk-Kyun
authors.initials: SK
authors.lastname: Yang
authors.affiliation: Kosin University College of Medicine, Busan, Republic of Korea.
authors.forename: Won
authors.initials: W
authors.lastname: Moon
authors.affiliation: Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Ja-Seol
authors.initials: JS
authors.lastname: Koo
authors.affiliation: Soonchunhyang University College of Medicine, Cheonan, Republic of Korea.
authors.forename: Suck-Ho
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Wonkwang University School of Medicine, Iksan, Republic of Korea.
authors.forename: Geom Seog
authors.initials: GS
authors.lastname: Seo
authors.affiliation: Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Soo Jung
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Chung-Ang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Chang Hwan
authors.initials: CH
authors.lastname: Choi
authors.affiliation: Ewha Womans University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sung-Ae
authors.initials: SA
authors.lastname: Jung
authors.affiliation: Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sung Noh
authors.initials: SN
authors.lastname: Hong
authors.affiliation: Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jong Pil
authors.initials: JP
authors.lastname: Im
authors.affiliation: Keimyung University School of Medicine, Daegu, Republic of Korea.
authors.forename: Eun Soo
authors.initials: ES
authors.lastname: Kim
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000276:immunology*; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D008297:Male; D022242:Pneumococcal Vaccines / Q000008:administration & dosage*; D011446:Prospective Studies; D056910:Republic of Korea; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D015415:Biomarkers; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D014409:Tumor Necrosis Factor-alpha
keywords: Crohn's disease; Immunosuppressive agents; Inflammatory bowel disease; Pneumococcal vaccine