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• W2058409077 abstract "Background & Aims: An increased risk of herpes zoster in patients with inflammatory bowel disease (IBD) is hypothesized based on altered immune function, especially among patients receiving immunosuppressive medications. Methods: We performed a retrospective cohort study and a retrospective nested case-control study using 1988–1997 data from the General Practice Research Database. In the cohort study, 7823 Crohn’s disease (CD) and 11,930 ulcerative colitis (UC) patients were matched on age, sex, and primary care practice to 79,563 randomly selected controls without CD or UC. In the nested case-control study, 185 CD patients with zoster and 266 UC patients with zoster were matched on sex and year of birth to 1787 IBD patients without zoster. Results: In the cohort study, the incidence of zoster was higher in patients with CD and UC compared with their matched controls (UC incidence rate ratio, 1.21; 95% confidence interval [CI], 1.05–1.40; CD incidence rate ratio, 1.61; 95% CI, 1.35–1.92). In the nested case-control study, receipt of a prescription for corticosteroids (adjusted odds ratio, 1.5; 95% CI, 1.1–2.2) or azathioprine/6-mercaptopurine (adjusted odds ratio, 3.1; 95% CI, 1.7–5.6) were both associated with zoster. Conclusions: Patients with IBD, especially those on immunosuppressive medications, are at higher risk for herpes zoster compared with the general population. Future studies should clarify the relative risk associated with anti–tumor necrosis factor α therapies and determine the use of the new zoster vaccine for patients with IBD. Background & Aims: An increased risk of herpes zoster in patients with inflammatory bowel disease (IBD) is hypothesized based on altered immune function, especially among patients receiving immunosuppressive medications. Methods: We performed a retrospective cohort study and a retrospective nested case-control study using 1988–1997 data from the General Practice Research Database. In the cohort study, 7823 Crohn’s disease (CD) and 11,930 ulcerative colitis (UC) patients were matched on age, sex, and primary care practice to 79,563 randomly selected controls without CD or UC. In the nested case-control study, 185 CD patients with zoster and 266 UC patients with zoster were matched on sex and year of birth to 1787 IBD patients without zoster. Results: In the cohort study, the incidence of zoster was higher in patients with CD and UC compared with their matched controls (UC incidence rate ratio, 1.21; 95% confidence interval [CI], 1.05–1.40; CD incidence rate ratio, 1.61; 95% CI, 1.35–1.92). In the nested case-control study, receipt of a prescription for corticosteroids (adjusted odds ratio, 1.5; 95% CI, 1.1–2.2) or azathioprine/6-mercaptopurine (adjusted odds ratio, 3.1; 95% CI, 1.7–5.6) were both associated with zoster. Conclusions: Patients with IBD, especially those on immunosuppressive medications, are at higher risk for herpes zoster compared with the general population. Future studies should clarify the relative risk associated with anti–tumor necrosis factor α therapies and determine the use of the new zoster vaccine for patients with IBD. The inflammatory bowel diseases (IBDs), Crohn’s disease (CD) and ulcerative colitis (UC), are chronic conditions characterized by altered regulation of the immune system. Although immune dysregulation contributes to the progressive intestinal inflammation found in IBD, it may intrinsically predispose patients to other complications, such as an increased risk of infection. Medications commonly used to treat IBD also can increase susceptibility to infection by suppressing normal immune functions.1Aberra F.N. Lichtenstein G.R. Methods to avoid infections in patients with inflammatory bowel disease.Inflamm Bowel Dis. 2005; 11: 685-695Crossref PubMed Scopus (58) Google Scholar, 2Hambleton S. Gershon A.A. Preventing varicella-zoster disease.Clin Microbiol Rev. 2005; 18: 70-80Crossref PubMed Scopus (126) Google Scholar First-line therapy for IBD includes mesalamine medications that have little effect on the systemic immune system. In contrast, second- and third-line therapies, such as corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate, cyclosporine, and anti–tumor necrosis factor (TNF)α, therapies can cause systemic immunosuppression. Although the efficacy of these drugs has been established clearly, data on the absolute and relative risk of infection and other adverse events are more limited. As a result, understanding how to best balance the benefits of therapy with the risks of infection and other side effects is not yet evident. Much of the available data on infectious complications of IBD therapy has focused on the risk of postoperative complications. The use of corticosteroids increases the risk of postoperative infections, most of which are bacterial.1Aberra F.N. Lichtenstein G.R. Methods to avoid infections in patients with inflammatory bowel disease.Inflamm Bowel Dis. 2005; 11: 685-695Crossref PubMed Scopus (58) Google Scholar, 3Aberra F.N. Lewis J.D. Hass D. et al.Corticosteroids and immunomodulators: postoperative infectious complication risk in inflammatory bowel disease patients.Gastroenterology. 2003; 125: 320-327Abstract Full Text Full Text PDF PubMed Scopus (258) Google Scholar, 4Sohail M.R. Khan A.H. Holmes Jr, D.R. et al.Infectious complications of percutaneous vascular closure devices.Mayo Clin Proc. 2005; 80: 1011-1015Abstract Full Text Full Text PDF PubMed Scopus (69) Google Scholar, 5Marchal L. D’Haens G. Van Assche G. et al.The risk of post-operative complications associated with infliximab therapy for Crohn’s disease: a controlled cohort study.Aliment Pharmacol Ther. 2004; 19: 749-754Crossref PubMed Scopus (195) Google Scholar The use of AZA or 6-MP in the same setting appears to have less risk of infection. Infliximab use is associated with disseminated tuberculosis, but data suggest little if any increased risk of bacterial infection after surgery.6Bresnihan B. Cunnane G. Infection complications associated with the use of biologic agents.Rheum Dis Clin North Am. 2003; 29: 185-202Abstract Full Text Full Text PDF PubMed Scopus (106) Google Scholar Fewer data are available on the risk of viral infections with IBD therapies. However, several patients treated for Crohn’s disease and multiple sclerosis with natalizumab developed progressive multifocal leukoencephalopathy (a lethal complication of reactivation of human papovavirus JC virus).7Kleinschmidt-DeMasters B.K. Tyler K.L. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis.N Engl J Med. 2005; 353: 369-374Crossref PubMed Scopus (954) Google Scholar, 8Langer-Gould A. Atlas S.W. Green A.J. et al.Progressive multifocal leukoencephalopathy in a patient treated with natalizumab.N Engl J Med. 2005; 353: 375-381Crossref PubMed Scopus (936) Google Scholar, 9Van Assche G. Van Ranst M. Sciot R. et al.Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn’s disease.N Engl J Med. 2005; 353: 362-368Crossref PubMed Scopus (934) Google Scholar Because treatment of IBD often involves combination therapy with multiple medications, each with the potential for immunosuppression, it is important to understand the risk of infection and the potential contribution that different medications have on that risk. Herpes zoster, also called shingles, is a common nonfatal infection characterized by a unilateral, painful vesicular rash in a dermatomal distribution.2Hambleton S. Gershon A.A. Preventing varicella-zoster disease.Clin Microbiol Rev. 2005; 18: 70-80Crossref PubMed Scopus (126) Google Scholar It results from reactivation of latent varicella–zoster virus within dorsal root ganglia.10Gnann Jr, J.W. Whitley R.J. Clinical practice Herpes zoster.N Engl J Med. 2002; 347: 340-346Crossref PubMed Scopus (646) Google Scholar The incidence and severity of zoster increase over one’s lifetime, in association with an age-related decrease in cellular immunity. A new vaccine appears to reduce the incidence of zoster among immunocompetent patients, although its efficacy in patients receiving immunosuppressive medications is unknown.11Oxman M.N. Levin M.J. Johnson G.R. et al.A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults.N Engl J Med. 2005; 352: 2271-2284Crossref PubMed Scopus (1965) Google Scholar, 12Gilden D.H. Varicella-zoster virus vaccine—grown-ups need it, too.N Engl J Med. 2005; 352: 2344-2346Crossref PubMed Scopus (21) Google Scholar An increased risk of zoster in patients with IBD is hypothesized based on altered immune function, particularly among patients receiving immunosuppressant medications.1Aberra F.N. Lichtenstein G.R. Methods to avoid infections in patients with inflammatory bowel disease.Inflamm Bowel Dis. 2005; 11: 685-695Crossref PubMed Scopus (58) Google Scholar, 13Sands B.E. Cuffari C. Katz J. et al.Guidelines for immunizations in patients with inflammatory bowel disease.Inflamm Bowel Dis. 2004; 10: 677-692Crossref PubMed Scopus (213) Google Scholar, 14Korelitz B.I. Fuller S.R. Warman J.I. et al.Shingles during the course of treatment with 6-mercaptopurine for inflammatory bowel disease.Am J Gastroenterol. 1999; 94: 424-426Crossref PubMed Scopus (48) Google Scholar, 15Fraser A.G. Orchard T.R. Jewell D.P. The efficacy of azathioprine for the treatment of inflammatory bowel disease: a 30 year review.Gut. 2002; 50: 485-489Crossref PubMed Scopus (536) Google Scholar, 16Present D.H. Meltzer S.J. Krumholz M.P. et al.6-Mercaptopurine in the management of inflammatory bowel disease: short- and long-term toxicity.Ann Intern Med. 1989; 111: 641-649Crossref PubMed Scopus (702) Google Scholar There are limited data on risk factors for zoster, particularly the use of steroids and immunomodulators, among patients with IBD. The specific aim of this study was to determine whether patients with IBD have a higher incidence of zoster than the general population. Our secondary aims were to determine among patients with IBD whether (1) use of corticosteroids is associated with zoster infection, (2) use of AZA/6-MP is associated with zoster infection, and (3) whether patients with CD have a higher risk of zoster than patients with UC. This study was conducted using data from the General Practice Research Database (GPRD) from 1988 to 1997. This database of primary care medical records from the United Kingdom has been described in detail elsewhere.17Gupta G. Gelfand J.M. Lewis J.D. Increased risk for demyelinating diseases in patients with inflammatory bowel disease.Gastroenterology. 2005; 129: 819-826Abstract Full Text Full Text PDF PubMed Scopus (202) Google Scholar, 18Lewis J.D. Aberra F.N. Lichtenstein G.R. et al.Seasonal variation in flares of inflammatory bowel disease.Gastroenterology. 2004; 126: 665-673Abstract Full Text Full Text PDF PubMed Scopus (80) Google Scholar, 19Lewis J.D. Bilker W.B. Weinstein R.B. et al.The relationship between time since registration and measured incidence rates in the General Practice Research Database.Pharmacoepidemiol Drug Saf. 2005; 14: 443-451Crossref PubMed Scopus (240) Google Scholar, 20Lewis J.D. Brensinger C. Bilker W.B. et al.Validity and completeness of the General Practice Research Database for studies of inflammatory bowel disease.Pharmacoepidemiol Drug Saf. 2002; 11: 211-218Crossref PubMed Scopus (150) Google Scholar Briefly, the GPRD contains medical records of approximately 8,000,000 patients in total, representing 6% of the UK population.21Anonymous. Office for National Statistics, London1994Google Scholar Each medical practice must show competency at entering data into the electronic database before their data are considered up to standard. Subsequently, monthly audits ensure that the data quality remained up to standard. Data recorded in the GPRD include demographic information, prescription information, clinical events and diagnoses, preventive care, hospital admissions, cause of death, and free text. In addition, significant diagnoses occurring before the initiation of the electronic medical record are recorded retrospectively. Diagnoses are recorded using Oxford Medical Indexing System codes.22Lis Y. Mann R.D. The VAMP Research multi-purpose database in the U.K..J Clin Epidemiol. 1995; 48: 431-443Abstract Full Text PDF PubMed Scopus (109) Google Scholar, 23Garcia Rodriguez L.A. Perez Gutthann S. Use of the UK General Practice Research Database for pharmacoepidemiology.Br J Clin Pharmacol. 1998; 45: 419-425Crossref PubMed Scopus (496) Google Scholar Prescribed medications are recorded using codes issued by the Prescription Pricing Authority of the National Health Service.22Lis Y. Mann R.D. The VAMP Research multi-purpose database in the U.K..J Clin Epidemiol. 1995; 48: 431-443Abstract Full Text PDF PubMed Scopus (109) Google Scholar, 23Garcia Rodriguez L.A. Perez Gutthann S. Use of the UK General Practice Research Database for pharmacoepidemiology.Br J Clin Pharmacol. 1998; 45: 419-425Crossref PubMed Scopus (496) Google Scholar Several studies have shown that the clinical information in the computer record is sufficiently accurate for use in epidemiologic studies, including studies of IBD.20Lewis J.D. Brensinger C. Bilker W.B. et al.Validity and completeness of the General Practice Research Database for studies of inflammatory bowel disease.Pharmacoepidemiol Drug Saf. 2002; 11: 211-218Crossref PubMed Scopus (150) Google Scholar, 24Jick H. Jick S.S. Derby L.E. Validation of information recorded on general practitioner based computerised data resource in the United Kingdom.BMJ. 1991; 302: 766-768Crossref PubMed Scopus (739) Google Scholar, 25Jick S.S. Kaye J.A. Vasilakis-Scaramozza C. et al.Validity of the general practice research database.Pharmacotherapy. 2003; 23: 686-689Crossref PubMed Scopus (491) Google Scholar This study was conducted using a previously described cohort.17Gupta G. Gelfand J.M. Lewis J.D. Increased risk for demyelinating diseases in patients with inflammatory bowel disease.Gastroenterology. 2005; 129: 819-826Abstract Full Text Full Text PDF PubMed Scopus (202) Google Scholar, 26Lewis J.D. Bilker W.B. Brensinger C. et al.Inflammatory bowel disease is not associated with an increased risk of lymphoma.Gastroenterology. 2001; 121: 1080-1087Abstract Full Text Full Text PDF PubMed Scopus (280) Google Scholar, 27Lewis J.D. Schwartz J.S. Lichtenstein G.R. Azathioprine for maintenance of remission in Crohn’s disease: benefits outweigh the risk of lymphoma.Gastroenterology. 2000; 118: 1018-1024Abstract Full Text Full Text PDF PubMed Scopus (231) Google Scholar The IBD patients include all patients with a diagnosis of UC or CD and at least 1 year of follow-up time. Patients diagnosed only as “IBD not otherwise specified” or with codes for both CD and UC were excluded. Each IBD patient had previously been matched to up to 4 control subjects on year of birth ± 5 years, sex, and primary care practice from the remaining population of patients without a diagnosis of IBD or potentially related conditions (eg, proctitis) who were cared for by GPRD physicians. We excluded patients with missing registration dates and any patients with a diagnosis of zoster before or within the first 3 months of the start of follow-up evaluation.19Lewis J.D. Bilker W.B. Weinstein R.B. et al.The relationship between time since registration and measured incidence rates in the General Practice Research Database.Pharmacoepidemiol Drug Saf. 2005; 14: 443-451Crossref PubMed Scopus (240) Google Scholar In addition, we excluded IBD patients for whom no matched controls remained after applying these exclusion criteria (n = 25). The primary outcome for the cohort study was a first diagnosis of zoster, defined as herpes zoster, shingles, or a zoster-related diagnosis. Zoster-related diagnoses included ophthalmic herpes zoster, ophthalmic shingles, herpetic neuralgia, postherpetic pain, and Ramsay Hunt syndrome. Herpes zoster geniculate or herpes zoster auricularis also were included in the definition but no patients had these diagnoses. We have shown previously that diagnoses of acute conditions and infections, including zoster, can be overreported in GPRD if time periods shortly after registration are not excluded.19Lewis J.D. Bilker W.B. Weinstein R.B. et al.The relationship between time since registration and measured incidence rates in the General Practice Research Database.Pharmacoepidemiol Drug Saf. 2005; 14: 443-451Crossref PubMed Scopus (240) Google Scholar Therefore, the follow-up period began with the latest of the following: 3 months after registration with the physician’s practice, the start of up-to-standard data collection, and, for patients with IBD, the date of the first diagnosis of IBD. Follow-up evaluation ended with earliest of the date of the first diagnosis with zoster, death, transfer out of the practice, or the end of the data. Only data through 1997 (ie, before the introduction of anti-TNFα medications to the market) were included in this study because use of anti-TNFα therapies generally is not recorded in the database. To understand the relationship between IBD therapies and the risk of zoster, we conducted a case-control study nested within the cohort of IBD patients. Case and control subjects were those IBD patients with or without zoster, respectively. The date of first diagnosis of zoster was used as the case subject’s index date. Each case patient (IBD patient with zoster) was matched on sex, year of birth, and duration of follow-up evaluation in the cohort to up to 4 IBD patients who did not have zoster during the follow-up period using incidence density sampling.28Rothman K.J. Greenland S. Case-control studies.in: Rothman K.J. Greenland S. Modern epidemiology. 2nd ed. Lippincott-Raven, Philadelphia, PA1998: 98Google Scholar This method requires that the control patient not have been diagnosed with zoster before the index date. However, as is customary with incidence density sampling, if a control subject was later diagnosed with zoster, he or she could serve as a case subject as well.28Rothman K.J. Greenland S. Case-control studies.in: Rothman K.J. Greenland S. Modern epidemiology. 2nd ed. Lippincott-Raven, Philadelphia, PA1998: 98Google Scholar Forty-two patients were included as both case and control subjects. Organ transplantation and infection with the human immunodeficiency virus both result in impaired cellular immunity and increased risk of viral infections. Because organ transplantation and human immunodeficiency virus infection are relatively rare, we excluded patients with these diagnoses from the nested case-control study. In total, we excluded 76 patients with documented organ/tissue transplantation and 22 patients with human immunodeficiency virus infection or acquired immune deficiency syndrome. Among these excluded patients, 3 had been diagnosed with zoster in the cohort study. All 3 had a history of transplant, 1 of whom also had a history of human immunodeficiency virus/acquired immune deficiency syndrome. Exposures were measured from the index date, which was the date of the first zoster diagnosis among the case patients and the same date for the matched control patients. The primary exposures of interest were the underlying IBD (CD vs UC) and use of immunosuppressant medications (corticosteroids, AZA/6-MP, methotrexate, or cyclosporine A/tacrolimus) in the period immediately before the index date. Mesalamine, which is not believed to cause systemic immunosuppression, was used as a negative control exposure. Of note, there was no use of cyclosporine A or tacrolimus by either case patients or matched control patients within 30 days of the index date. However, 1 control patient was noted to have received a prescription of cyclosporine A or tacrolimus within 61–90 days of the index date. Because prescriptions of corticosteroids frequently include instructions to take as directed, we did not attempt to determine the prescribed duration of each prescription. Rather, we defined exposure on the basis of the dates that the prescriptions were written. We decided a priori that our primary exposure definition would include any prescription received within 30 days before the index date. We also examined several alternative definitions of exposure in secondary analyses to better understand the time course between exposure to immunosuppressant medications and risk of zoster. Current use was defined as a prescription within 30 days of the index date, and previous use was defined as having a prescription during the period 31–90 days before the index date but not within 30 days of the index date. Persistent use was defined as receipt of a prescription both in the period 31–90 days before the index date and in the period 1–30 days before the index date. New use was defined as a prescription for the medication within 1–30 days of the index date and no prescriptions in the period 31–90 days before the index date. Based on previous reports of potential association, patients’ smoking status, alcohol abuse, cancer, and depression were evaluated as potential confounder variables in the diagnosis of zoster.29Irwin M. Costlow C. Williams H. et al.Cellular immunity to varicella-zoster virus in patients with major depression.J Infect Dis. 1998; 178: S104-S108Crossref PubMed Scopus (86) Google Scholar, 30Thomas S.L. Hall A.J. What does epidemiology tell us about risk factors for herpes zoster?.Lancet Infect Dis. 2004; 4: 26-33Abstract Full Text Full Text PDF PubMed Scopus (421) Google Scholar, 31McCormick A. Charlton J. Morbidity statistics from general practice: 4th national study 1991–92. HM Stationery Office, London1995Google Scholar, 32Schmader K. George L.K. Burchett B.M. et al.Race and stress in the incidence of herpes zoster in older adults.J Am Geriatr Soc. 1998; 46: 973-977PubMed Google Scholar Cancer was defined as leukemia, lymphoma, and malignant tumors other than squamous or basal cell skin cancer. In the case-control study, exposure was defined as a diagnosis of cancer or depression within 1 year, or alcoholism within 5 years, of the index date. Continuous variables are reported as means with SDs. Categoric variables are reported as counts and percentages. In the cohort study, we calculated incidence rate ratios (IRRs) and corresponding 95% confidence intervals (CIs) to compare the incidence of zoster among IBD patients and controls. In the nested case-control study, we used conditional logistic regression to calculate odds ratios and 95% CIs. We examined the associations for evidence of confounding by including all potential confounder variables in a single multivariable model. We retained in the final model any variable that could not be removed without resulting in a 10% or greater change in the odds ratio (OR) for either the association of corticosteroids or AZA/6-MP with zoster. Ultimately, the only confounders of these associations were the other medication group (ie, corticosteroid use was a confounder of the association of AZA/6-MP with zoster and vice versa). All analyses were performed using STATA version 9.0 (STATA Corp, College Station, TX). All analyses used 2-sided statistical tests. The study protocol was approved by the Scientific and Ethical Advisory Group of the GPRD and the University of Pennsylvania’s institutional review board. The final study population for the cohort study included 7823 patients with CD (58.5% women; mean age at start of follow-up period, 42.5 ± 18.3 y) and 11,930 patients with UC (50.2% women; mean age at start of follow-up period, 48.8 ± 17.7 y) (Table 1). All IBD patients had at least 1 matched control and more than 95% had 4 matched controls, resulting in a total of 79,563 control patients (53.5% women; mean age at start of follow-up period, 46.3 ± 18.3 y).Table 1Characteristics of Patients in the Cohort StudyCD (n = 7823)UC (n = 11,930)Controls (n = 79,563)Sex (% women in total population)4573 (58.5)5989 (50.2)42,561 (53.5)Median number of years of follow-up evaluation, y (interquartile range)4.7 (1.9–6.5)5.0 (2.3–6.6)4.4 (1.8–6.4)Mean age at start of follow-up evaluation, y (SD)42.5 (18.3)48.8 (17.7)46.3 (18.3)Smoking status Smoker (%)2467 (31.5%)2207 (18.5%)20,010 (25.2%) Nonsmoker (%)3234 (41.3%)6658 (55.8%)33,693 (42.4%) Unknown (%)2122 (27.1%)3065 (25.7%)25,860 (32.5%)Number of patients with zoster Ages 0–4, y (%)0 (0.0%)0 (0.0%)0 (0.0%) Ages 5–14, y (%)3 (0.0%)1 (0.0%)16 (0.0%) Ages 15–44, y (%)66 (0.8%)60 (0.5%)367 (0.5%) Ages 45–64, y (%)69 (0.9%)106 (0.9%)537 (0.7%) Ages 65+, y (%)48 (0.6%)101 (0.8%)537 (0.7%)Diagnoses of herpes zoster, n (%) Herpes zoster61 (0.8%)75 (0.6%)446 (0.6%) Shingles131 (1.7%)198 (1.7%)1120 (1.4%) Herpes zoster or shingles181 (2.3%)262 (2.2%)1506 (1.9%) Ophthalmic herpes zoster3 (0.0%)5 (0.0%)21 (0.0%) Ophthalmic shingles1 (0.0%)3 (0.0%)15 (0.0%) Herpes zoster geniculate0 (0.0%)0 (0.0%)0 (0.0%) Herpes zoster auricularis0 (0.0%)0 (0.0%)0 (0.0%) Herpetic neuralgia6 (0.1%)3 (0.0%)33 (0.0%) Postherpetic pain9 (0.1%)16 (0.1%)62 (0.1%) Ramsay Hunt syndrome1 (0.0%)2 (0.0%)2 (0.0%)NOTE. Some patients had more than 1 zoster-related diagnosis on the index date. Open table in a new tab NOTE. Some patients had more than 1 zoster-related diagnosis on the index date. To examine the completeness of the recording of zoster in the GPRD, we first examined the incidence rates of zoster among the patient groups. During the follow-up period, 186 patients with CD and 268 patients with UC were diagnosed with zoster compared with 534 patients and 982 patients in the matched control groups, respectively. Among both the IBD patients and the controls, incidence rates of zoster increased with increasing age (Figure 1). A prior population-based study performed within the United Kingdom reported age-specific incidence rates of zoster as follows (rate per 100,000 person-years): ages 0–4 years (92), 5–14 years (219), 15–44 years (212), 45–64 years (712), and 65 years and older (932).33Brisson M. Edmunds W.J. Epidemiology of Varicella-Zoster virus in England and Wales.J Med Virol. 2003; 70: S9-S14Crossref PubMed Scopus (123) Google Scholar These rates are quite similar to those observed in our non-IBD control cohorts (Figure 1). Compared with their matched controls, the incidence rate of zoster was significantly higher for both patients with CD (IRR, 1.6; 95% CI, 1.4–1.9) and UC (IRR, 1.2; 95% CI, 1.1–1.4). Nearly identical results were obtained when we restricted the outcome to a diagnosis of herpes zoster or shingles (CD: IRR, 1.6; 95% CI, 1.4–1.9; UC: IRR, 1.2; 95% CI, 1.1–1.4). In subgroup analyses, the significant differences in incidence rates were limited to patients with CD in the age groups 15–44, 45–64, and 65 and older (Figure 1). The final study population in the nested case-control study included 451 cases (51.2% women; mean age at start of follow-up period, 55.3 ± 17.4 y) and 1787 controls (51.4% women; mean age at start of follow-up period, 55.3 ± 17.3 y) (Table 2). The first zoster diagnosis in the medical record was “herpes zoster” or “shingles” in more than 96% of the cases. Of the cases, 185 (41%) had CD and 266 (59%) had UC. Patients with CD were more likely to have been diagnosed with zoster than patients with UC, even after adjusting for use of medications and other potential confounders (adjusted OR, 1.3; 95% CI, 1.0–1.6). All the potential confounders examined were more common in the cases than the controls, only reaching statistical significance for cancer. However, the prevalence of these risk factors was generally lower than that of steroid use and AZA/6-MP use among the cases.Table 2Characteristics of Study Cohorts in Nested Case-Control StudyCases (n = 451)Controls (n = 1787)P value*Sex (% women in total population)231 (51.2)918 (51.4)N/AMean age at start of follow-up evaluation, y (SD)55.3 (17.4)55.3 (17.3)N/AMedian time at risk, y (interquartile range)2.2 (0.9–4.1)2.2 (0.9–4.1)N/AIBD diagnoses CD, n (%)185 (41.0)617 (34.5)Ref UC, n (%)266 (59.0)1170 (65.5).01Smoking status Nonsmoker, n (%)268 (59.4)1025 (57.4)Ref Smoker, n (%)101 (22.4)385 (21.5).91 Unknown, n (%)82 (18.2)377 (21.1).15Medication use (exposure within 30 days of index date) AZA/6-MP, n (%)22 (4.9%)26 (1.5%).00 Oral steroids, n (%)48 (10.6%)118 (6.6%).00 Oral mesalamine, n (%)96 (21.3%)374 (20.9%).83 Oral or injected methotrexate, n (%)1 (0.2%)1 (0.1%).33 Any immunosuppressant, n (%)aAny Immunosuppressant includes use of at least 1 or more of the following medications: AZA/6-MP, oral steroids, or oral or injected methotrexate.63 (14.0%)133 (7.4%).00Medical diagnoses (exposure period) Cancer (1 y)13 (2.9%)22 (1.2%).02 Depression (1 y)23 (5.1%)68 (3.8%).21 Alcoholism (5 y)3 (0.7%)7 (0.4%).44NOTE. P value shown represents unadjusted results.N/A, patients were matched on these variables.a Any Immunosuppressant includes use of at least 1 or more of the following medications: AZA/6-MP, oral steroids, or oral or injected methotrexate. Open table in a new tab NOTE. P value shown represents unadjusted results. N/A, patients were matched on these variables. In both unadjusted and adjusted analyses, receipt of a prescription for corticosteroids (adjusted OR, 1.5; 95% CI, 1.1–2.2) or AZA/6-MP (adjusted OR, 3.1; 95% CI, 1.7–5.6) were both associated with the risk of zoster (Table 3). Fourteen percent of case subjects were exposed to at least 1 immunosuppressant medication (AZA/6-MP, steroids, or methotrexate) within 30 days of the index date (any immunosuppressant medication use: OR, 2.0; 95% CI, 1.5–2.8).Table 3Association of IBD Medication Use and Risk of ZosterExposure periodOral steroids OR (95% CI)AZA/6-MP OR (95% CI)Oral mesalamines OR (95% CI)Unadjusted 1–14 days2.0 (1.3–3.2)3.8 (1.8–8." @default.
• W2058409077 created "2016-06-24" @default.
• W2058409077 creator A5020580204 @default.
• W2058409077 creator A5041936168 @default.
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• W2058409077 date "2006-12-01" @default.
• W2058409077 modified "2023-10-01" @default.
• W2058409077 title "Incidence and Risk Factors for Herpes Zoster Among Patients With Inflammatory Bowel Disease" @default.
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