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Su1149 Drug Induced Lupus (DIL) With Adalimumab and Certolizumab in Infliximab Naïve Inflammatory Bowel Disease Patients: An Analysis of the Food and Drug Administration Adverse Event Reporting System
Su1146 Awareness Amongst Patents With Inflammatory Bowel Disease for the Need for Vaccinations Whilst on Immunosuppressive Therapy Monika Widlak, Rupinder Matharu, Amera Elzubeir, Jayne Slater, Lindsey Wood, Shanika De Silva Background With the ever increasing use of immunosuppressive therapy for the management of inflammatory bowel disease (IBD), patients are being exposed to infections which can be prevented by vaccinations administered prior to or during therapy. The European Crohn's and Colitis Organisation guidelines currently recommend that IBD patients who receive immunosuppressive medications should be vaccinated yearly with the influenza vaccine and a pneumococcal vaccination 3-5 yearly. Several studies have demonstrated that despite guidelines many patients were still not being vaccinated for preventable disease. Method An audit was carried out within our department to assess our patient's knowledge and uptake of such vaccines. Patients were identified from an established database and those receiving immunosuppressive therapy were invited to complete a questionnaire. Data gathered included age, gender, current treatment, awareness and uptake of vaccinations. Results A cohort of 88 patients on immmunosuppressive therapy were analysed. 61% of patients were female and 39% male. Patients ranged between 16-21 years (11%), 22-30 years (18%), 31-50 years (40%), 51-70 years (24%) and above 70 (7%). 59 (67%) patients had Crohn's disease, 26 (29.5%) ulcerative colitis and 3 (3.5%) had indeterminate colitis. The majority of patients received immunomodulators including Azathioprine or Mycophenolate (n=48, 54%). 13 (15%) were treated with biologics alone (Infliximab or Adalimumab), 21 (24%) with combination of biologics and immunomodulators and 6 patients (7%) received immunomodulators with a reducing dose of steroids. 77% of patients were aware of recommended vaccinations but as many as 23% were not. 42% were aware of the importance of receiving dual vaccinations, 35% only aware of either the influenza or pneumococcal vaccine, with 23% unaware of the need for either. 54 (61%) patients had already had or were planning to have the influenza vaccine this year. Patients between the ages of 31-50 years had the highest awareness of the recommended vaccines (86%), with the majority of uptake of vaccines seen in the 31-50 year group (63%). Unfortunately 39% of patients were not receiving recommended vaccinations with more than half (56%) of patients being unaware of the need to avoid live vaccinations. Conclusions Our data suggest that a significant proportion of patients within our cohort are still not receiving vaccinations that were recommended to them. Although 77 % were aware of a form of recommended vaccine, 39% were not receiving them. Wider education of our IBD patients as well as their primary care doctors should be implemented to increase awareness and uptake of vaccines to provide adequate protection to this vulnerable group.
est=estimated NA= Not applicable NR= Not recorded CI = Confidence Interval SIR = Standardized Incidence Ratio * CI recalculated by statistician (AT) using Poisson distribution ** SIR recalculated from expected number and observed number reported in text Su1148 Effect of Adalimumab on Semen Quality in Inflammatory Bowel Disease Patients Zuzana Zelinkova, Cokkie van der Ent, Ernst J. Kuipers, Gert R. Dohle, Christien J. van der Woude
Su1147
Background: Inflammatory bowel diseases (IBD) patients are typically in their reproductive years. Therefore, the frequently encountered clinical problem concerns the impact of the disease and therapy on the IBD patients` fertility. Adalimumab (ADA) represents a recently introduced therapeutic effective in IBD. The wide-spread use of ADA, including IBD patients with active conception wish raises the question of its effect on the semen quality and outcomes of pregnancies conceived by males under ADA treatment. Aim: First, the aim of this study was to assess the influence of ADA on the semen quality of IBD patients using ADA. Second, we analysed the outcomes of the pregnancies conceived under the use of ADA by male IBD patients. Methods: Male IBD patients Naïve to ADA and planning to start the treatment with ADA were included. The semen sample was obtained prior to starting the treatment, at month 3 and at month 6 of the treatment. The semen quality according the WHO criteria was assessed and the influence of ADA on the semen quality was evaluated intra-individually. In addition, the patients who became fathers during the treatment with ADA were identified at the outpatient clinic during their regular consultation and outcomes of these pregnancies were assessed. Results: The effect of the treatment with ADA on the semen quality was assessed in seven IBD patients. No differences in the sperm concentration, percentage of cells with progressive motility and cells` vitality were found between the baseline samples and samples obtained at month 3 and 6 during the treatment. In addition, two patients conceived during the treatment with ADA. Both children were born à terme, without congenital malformations. Conclusion: In this small sample size inflammatory bowel disease patients` group, we did not observe any modifying effect of adalimumab on the semen quality.
Meta-Analysis of Overall Risk of Lymphoma in Patients With Inflammatory Bowel Disease on Thiopurine Therapy With Inclusion of European and North American Studies: Differences Between Referral Center Studies and Population Based Studies David Kotlyar, James D. Lewis, Laurent Beaugerie, Ann Tierney, Colleen M. Brensinger, Edward V. Loftus, Javier P. Gisbert, Wojciech Blonski, Manuel Van Domselaar, Maria Chaparro, Sandipani Sandilya, Gary R. Lichtenstein Background: A recent meta-analysis has shown an elevated risk of lymphoma with thiopurine therapy for IBD (Kandiel 2005 Gut). It combined referral data and population (pop) data, but the risk of lymphoma in referral centers may be elevated due to referral bias (Ang 2006 PMID 16531538). Another shortcoming of a meta-analysis in 2011(Kotlyar 2011) was no North American data in the pop-based cohort. Also, only 3 studies were analyzed. In the intervening time, one additional referral center study from the US, (Ashworth 2012) and three other population studies are available (Peyrin-Biroulet 2012, Herrinton 2012, Lakatos 2012). Aims: Calculate the standard incidence rate of lymphoma in pts exposed to AZA/6MP in population cohort studies and contrast these results to referral center studies. Methods: We searched MEDLINE for: "lymphoproliferative and thiopurines"; and "azathioprine and lymphoma". Included citations were IBD cohort studies, evaluated cancer as an outcome, and pts. received AZA and/or 6-MP. Additionally a comprehensive search of the literature and abstracts from international meetings (2005-2012) was done. In our study additional data were extracted from the Spanish collaborative registry ENEIDA. Pooled standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were estimated. CIs assumed a Poisson distribution; for Herrinton this was recalculated. To examine for heterogeneity, the deviance statistic from Poisson regression models was examined. There were 13 citations found (see Table). Results: There were 484 citations, and thirteen citations were included. Two studies (Korelitz and Kinlen) were obtained from Kandiel 2005, and Lewis 2001 was replaced by Armstrong 2010 as data were of the GPRD database. In referral centers (n=7), the SIR = 6.47 (95% CI: 3.76-10.39). In pop studies (n=6), the SIR = 2.24 (95% CI: 1.563.12) Overall the SIR was = 2.85 (95% CI: 2.13-3.74). Data from referral centers did not show heterogeneity (p=0.462), but pop studies did show significant heterogeneity (p=0.038). Results between referral and pop centers showed a significant difference (Incidence Rate Ratio = 2.89, 95% CI 1.52-5.29, p=0.0004). Conclusion: Our results confirm a previous
Su1149 Drug Induced Lupus (DIL) With Adalimumab and Certolizumab in Infliximab Naïve Inflammatory Bowel Disease Patients: An Analysis of the Food and Drug Administration Adverse Event Reporting System Parakkal Deepak, Derrick J. Stobaugh, Brett D. Riederman, Eli D. Ehrenpreis Background: Cases of drug induced lupus (DIL) with tumor necrosis factor alpha (TNF- α) inhibitor therapy in inflammatory bowel disease (IBD) have been reported with current or previous exposure to infliximab. We sought to examine reports of DIL with adalimumab and certolizumab among infliximab Naïve IBD patients using the Food and Drug Administration
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AGA Abstracts
AGA Abstracts
analysis, with a significantly larger number of pts, from a more diverse geographic composition. The prior analysis was limited to 3 pop studies; here 3 additional pop studies are included with an additional 25,061 pt-yrs of followup. The advantage of inclusion of North American data is that practice patterns may differ as does the incidence of lymphoma. Pts with IBD who are treated with thiopurines have approximately a 3-fold increased risk of lymphoma as compared to the general pop. As total pt-years was 125,736, this study shows 2,418 pt-yrs per lymphoma in the exposed group. Approx one in 440 pts exposed to AZA/ 6-MP will develop lymphoma. Meta-analysis of Standardized Incidence Ratios (SIR)
AGA Abstracts
Adverse Event Reporting System. Methods: More than 2.5 million files between January 2003 and June 2011 were downloaded and analyzed using SPSS 20 (IBM Co. Armonk, NY). They were queried for Primary Suspect (PS) cases of DIL with study (adalimumab and certolizumab, including trade names) and control drugs (5-aminosalicylic acid and sulphasalazine, including trade names) as well as control reactions with both groups (syncope, hernia, deafness and vertigo, predefined to have no association with study or control drugs) using reaction terms from the Medical Dictionary for Regulatory Activities. Reports with previous or concomitant use of infliximab were excluded. Full length reports were obtained using the Freedom of Information Act and reviewed. Cases determined to be non-DIL or drug hypersensitivity and cases with prior use of infliximab were excluded from analysis. Each study drug report was then scored using the Naranjo scale to estimate the probability of a DIL due to adalimumab or certolizumab with analysis of concomitant medications for definite, probable or possible causes of DIL. Differences in the time of onset of DIL after exposure to adalimumab and certolizumab were calculated using an unpaired two-tailed Student's t-test. Odds ratios for the risk of DIL with study drugs compared to control drugs were calculated with the Fischer's exact test. Results: Initially, 107 DIL reports were identified. Following review of full length reports, 55 reports (none in literature) with study drugs (41 with adalimumab and 14 with certolizumab) and 14 with control drugs were included in the analysis. The majority of the study drug cases (table1) were in females with Crohn's disease. No differences were seen in the time to development of DIL from onset of therapy for adalimumab and certolizumab (275±244.1 days versus 214±148.9 days respectively, p = 0.39). Most DIL cases with adalimumab and certolizumab were in the ‘possible' Naranjo category (78.1% and 78.6% respectively). The most common manifestation of DIL was rash (51.2%) with adalimumab and presence of anti-histone/anti-double stranded DNA antibodies (42.9%) with certolizumab. Lower odds (table 2) for DIL were seen with both adalimumab and certolizumab compared to 5-aminosalicylic acid and sulphasalazine. Conclusion: Although new DIL cases with adalimumab and certolizumab are reported, the odds of developing DIL among infliximab Naïve IBD patients with these TNF- α inhibitors are lower than that with 5-aminosalicylic acid formulations and sulphasalazine. Table 1: Drug induced lupus with adalimumab and certolizumab among infliximab Naïve inflammatory bowel disease patients
Su1150 Do IBD Treatment Guidelines for Immunomodulators and Anti-TNF Therapies Improve Performance for Screening and Vaccinations ? Deborah Smith, Patrick B. Allen, Abraham Varghese, Kokleong Diong, Mary Kane Background: Patients with IBD frequently receive immunosuppressive and anti-TNF therapies, potentially increasing their risk of contracting infections. The European Crohn's and Colitis Organisation issued guidance on vaccination against preventable infections in patients with IBD receiving immunosuppressive therapy. These guidelines were implemented from 2011 within our institution. Aims - To establish if guidelines improved the adherence to vaccinations and screening in IBD patients. Methods: A retrospective audit was carried out between April 2009 and June 2012. Hospital notes were checked, patients' general practitioners contacted and laboratory & X-ray systems were searched to gather information. Immunization was determined positive for each vaccine if received: annually for influenza , three to five yearly for pneumococcus and for both Human Papillomavirus (HPV) and Hepatitis B (HBV) vaccination after commencing the vaccine course; Positive Varicella Zoster Virus (VZV) immunization status was determined after; a clear history, positive serology result or VZV vaccination. Patients prescribed anti-TNFs were checked to see if a chest x-ray, and a QGT was performed. Patients who received live vaccines were identified. Statistical significance was assessed by comparing practice pre and post 2011 using a chi squared test with yates correction for small sample size. Results: 42 patients who were commenced on immunomodulator (IM) therapy (azathioprine, 6- mercaptopurine, or methotrexate) and / or anti- TNF therapy (adalimumab or infliximab) were randomly identified from the IBD clinic. 18 patients were prescribed IM therapy and 24 on anti-TNF therapy. Overall the trend in vaccination uptake improved year on year, achieving statistical significance for Influenza (P=0.0246) and HBV (P=0.035). Uptake of VZV and pneumococcal vaccine improvement was not significant, p=0.1528 and 0.2814 respectively. There was a similar trend towards improvement in screening for latent TB. All HPV vaccines were appropriately administered in these times periods. One patient received a live vaccine from their primary care physician (typhoid). Discussion: Our study demonstrates that a strict IBD vaccination and screening policy improved the adherence to influenza and HBV vaccinations and screening for TB was similar between the two time periods. Greater effort is required by patients and practitioners to ensure they receive appropriate vaccinations; and formal education is needed with regard live vaccinations. Su1151 Incidence of Tbc Infection in Patients With Inflammatory Bowels Disease (IBD) Treated With Infliximab in Russia Elena Belousova, Nataliya Morozova, Olga Tsodikova, Elnara Tagieva Background: The use of anti-TNF therapy, in particular infliximab may lead to the development of TBC-infection due to immunosuppressive action of biologics. Purpose of the study: To determine the frequency of TBC infection in IBD patient receiving infliximab in population of Moscow region (Moscow excluded) in Russia. Materials and Methods: We observed 71 IBD patients: 45 with ulcerative colitis (UC) and 26 with Crohn's disease (CD) at the age of 18 - 54 years (mean age 37,5±4,1) M:F rate= 31:40. Duration of disease ranged from 6 months to 11 years (mean duration 6,8 years). Duration of infliximab treatment ranged from 6 months to 5 years (total 9248 pts/years). Before infliximab administration all patients were completely screened to exclude active TBC (chest x-rays, PPD test, phthisiatrician examination, history of TBC and contacts with TBC patients were taken into account). Incidence of active TBC in Russia (66 per 100000 population and 46 per 100000 in Moscow region in 2011) is higher than in Europe and USA. It was the reason to repeat screening every 6 months due to possible higher TBC risk in this group of patients. Results: In 5 patients treated with infliximab active TBC was diagnosed (about 0,05 / 100 pts/years that is not higher than in the majority of countries). In all patients it was pulmonary tuberculosis. In 4 cases there was relapses of latent TBC that was not identified at the screening, 1 patient had primary TBC infection. Infliximab was discontinued after TBC diagnosis. Specific anti tuberculosis therapy was performed. Conclusions: In countries and regions with a high TBC incidence the increase risk of TBC infection should be expected with use of biological agents in IBD patients. However in our IBD patients the frequency of TBC did not significantly exceed TBC rate in other countries. We believe that complete TBC screening before treatment with biologics and repeat it every 6 months could reduce the risk of TBC in IBD patients treated with anti TNF agents. Su1152 The Effect of Infliximab on Memory in Children With Inflammatory Bowel Disease Patients: A Pilot Study Samuel Bitton, Toba A. Weinstein, Jeremiah J. Levine, James Markowitz INTRODUCTION: Infliximab is a monoclonal antibody against tumor necrosis factor alpha, used increasingly to treat autoimmune disease such as inflammatory bowel disease (IBD). There have been documented neurological sequalae after infliximab use. Complaints from patients regarding memory and cognitive deficit after infliximab use have been anecdotally reported but have not yet been substantiated in the literature. The aim of this pilot study was to objectively characterize the memory and cognitive effects, if any, of infliximab on pediatric IBD patients. METHODS: Patients were prospectively recruited from our pediatric GI clinic. Inclusion criteria included patients with IBD who were to start infliximab or immunomodulator (IM) treatment, and children being treated for functional gastrointestinal disease (FGID) as control. All subjects completed a previously validated, self-administered computerized neuropsychological test, the pediatric Automated Neuropsychological Assessment Metrics (pedANAM). Subjects had a baseline test (pre-medication for IBD patients, or when identified as an eligible FGID control), and a re-test after a period of 10-14 weeks. The five tests that best evaluated working memory and computation within the pedANAM battery were chosen for analysis. Baseline results were compared to an age and sex matched reference database of healthy children and considered abnormal if the result fell at least 1 standard deviation below the mean. In those subjects who completed both the baseline and
* anti-histone /anti-double stranded DNA antibodies Table 2: Reported odds of developing drug induced lupus with adalimumab or certolizumab in infliximab Naïve inflammatory bowel disease patients
AGA Abstracts
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est=estimated NA= Not applicable NR= Not recorded CI = Confidence Interval SIR = Standardized Incidence Ratio * CI recalculated by statistician (AT) using Poisson distribution ** SIR recalculated from expected number and observed number reported in text Su1148 Effect of Adalimumab on Semen Quality in Inflammatory Bowel Disease Patients Zuzana Zelinkova, Cokkie van der Ent, Ernst J. Kuipers, Gert R. Dohle, Christien J. van der Woude
Su1147
Background: Inflammatory bowel diseases (IBD) patients are typically in their reproductive years. Therefore, the frequently encountered clinical problem concerns the impact of the disease and therapy on the IBD patients` fertility. Adalimumab (ADA) represents a recently introduced therapeutic effective in IBD. The wide-spread use of ADA, including IBD patients with active conception wish raises the question of its effect on the semen quality and outcomes of pregnancies conceived by males under ADA treatment. Aim: First, the aim of this study was to assess the influence of ADA on the semen quality of IBD patients using ADA. Second, we analysed the outcomes of the pregnancies conceived under the use of ADA by male IBD patients. Methods: Male IBD patients Naïve to ADA and planning to start the treatment with ADA were included. The semen sample was obtained prior to starting the treatment, at month 3 and at month 6 of the treatment. The semen quality according the WHO criteria was assessed and the influence of ADA on the semen quality was evaluated intra-individually. In addition, the patients who became fathers during the treatment with ADA were identified at the outpatient clinic during their regular consultation and outcomes of these pregnancies were assessed. Results: The effect of the treatment with ADA on the semen quality was assessed in seven IBD patients. No differences in the sperm concentration, percentage of cells with progressive motility and cells` vitality were found between the baseline samples and samples obtained at month 3 and 6 during the treatment. In addition, two patients conceived during the treatment with ADA. Both children were born à terme, without congenital malformations. Conclusion: In this small sample size inflammatory bowel disease patients` group, we did not observe any modifying effect of adalimumab on the semen quality.
Meta-Analysis of Overall Risk of Lymphoma in Patients With Inflammatory Bowel Disease on Thiopurine Therapy With Inclusion of European and North American Studies: Differences Between Referral Center Studies and Population Based Studies David Kotlyar, James D. Lewis, Laurent Beaugerie, Ann Tierney, Colleen M. Brensinger, Edward V. Loftus, Javier P. Gisbert, Wojciech Blonski, Manuel Van Domselaar, Maria Chaparro, Sandipani Sandilya, Gary R. Lichtenstein Background: A recent meta-analysis has shown an elevated risk of lymphoma with thiopurine therapy for IBD (Kandiel 2005 Gut). It combined referral data and population (pop) data, but the risk of lymphoma in referral centers may be elevated due to referral bias (Ang 2006 PMID 16531538). Another shortcoming of a meta-analysis in 2011(Kotlyar 2011) was no North American data in the pop-based cohort. Also, only 3 studies were analyzed. In the intervening time, one additional referral center study from the US, (Ashworth 2012) and three other population studies are available (Peyrin-Biroulet 2012, Herrinton 2012, Lakatos 2012). Aims: Calculate the standard incidence rate of lymphoma in pts exposed to AZA/6MP in population cohort studies and contrast these results to referral center studies. Methods: We searched MEDLINE for: "lymphoproliferative and thiopurines"; and "azathioprine and lymphoma". Included citations were IBD cohort studies, evaluated cancer as an outcome, and pts. received AZA and/or 6-MP. Additionally a comprehensive search of the literature and abstracts from international meetings (2005-2012) was done. In our study additional data were extracted from the Spanish collaborative registry ENEIDA. Pooled standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were estimated. CIs assumed a Poisson distribution; for Herrinton this was recalculated. To examine for heterogeneity, the deviance statistic from Poisson regression models was examined. There were 13 citations found (see Table). Results: There were 484 citations, and thirteen citations were included. Two studies (Korelitz and Kinlen) were obtained from Kandiel 2005, and Lewis 2001 was replaced by Armstrong 2010 as data were of the GPRD database. In referral centers (n=7), the SIR = 6.47 (95% CI: 3.76-10.39). In pop studies (n=6), the SIR = 2.24 (95% CI: 1.563.12) Overall the SIR was = 2.85 (95% CI: 2.13-3.74). Data from referral centers did not show heterogeneity (p=0.462), but pop studies did show significant heterogeneity (p=0.038). Results between referral and pop centers showed a significant difference (Incidence Rate Ratio = 2.89, 95% CI 1.52-5.29, p=0.0004). Conclusion: Our results confirm a previous
Su1149 Drug Induced Lupus (DIL) With Adalimumab and Certolizumab in Infliximab Naïve Inflammatory Bowel Disease Patients: An Analysis of the Food and Drug Administration Adverse Event Reporting System Parakkal Deepak, Derrick J. Stobaugh, Brett D. Riederman, Eli D. Ehrenpreis Background: Cases of drug induced lupus (DIL) with tumor necrosis factor alpha (TNF- α) inhibitor therapy in inflammatory bowel disease (IBD) have been reported with current or previous exposure to infliximab. We sought to examine reports of DIL with adalimumab and certolizumab among infliximab Naïve IBD patients using the Food and Drug Administration
S-411
AGA Abstracts
AGA Abstracts
analysis, with a significantly larger number of pts, from a more diverse geographic composition. The prior analysis was limited to 3 pop studies; here 3 additional pop studies are included with an additional 25,061 pt-yrs of followup. The advantage of inclusion of North American data is that practice patterns may differ as does the incidence of lymphoma. Pts with IBD who are treated with thiopurines have approximately a 3-fold increased risk of lymphoma as compared to the general pop. As total pt-years was 125,736, this study shows 2,418 pt-yrs per lymphoma in the exposed group. Approx one in 440 pts exposed to AZA/ 6-MP will develop lymphoma. Meta-analysis of Standardized Incidence Ratios (SIR)
AGA Abstracts
Adverse Event Reporting System. Methods: More than 2.5 million files between January 2003 and June 2011 were downloaded and analyzed using SPSS 20 (IBM Co. Armonk, NY). They were queried for Primary Suspect (PS) cases of DIL with study (adalimumab and certolizumab, including trade names) and control drugs (5-aminosalicylic acid and sulphasalazine, including trade names) as well as control reactions with both groups (syncope, hernia, deafness and vertigo, predefined to have no association with study or control drugs) using reaction terms from the Medical Dictionary for Regulatory Activities. Reports with previous or concomitant use of infliximab were excluded. Full length reports were obtained using the Freedom of Information Act and reviewed. Cases determined to be non-DIL or drug hypersensitivity and cases with prior use of infliximab were excluded from analysis. Each study drug report was then scored using the Naranjo scale to estimate the probability of a DIL due to adalimumab or certolizumab with analysis of concomitant medications for definite, probable or possible causes of DIL. Differences in the time of onset of DIL after exposure to adalimumab and certolizumab were calculated using an unpaired two-tailed Student's t-test. Odds ratios for the risk of DIL with study drugs compared to control drugs were calculated with the Fischer's exact test. Results: Initially, 107 DIL reports were identified. Following review of full length reports, 55 reports (none in literature) with study drugs (41 with adalimumab and 14 with certolizumab) and 14 with control drugs were included in the analysis. The majority of the study drug cases (table1) were in females with Crohn's disease. No differences were seen in the time to development of DIL from onset of therapy for adalimumab and certolizumab (275±244.1 days versus 214±148.9 days respectively, p = 0.39). Most DIL cases with adalimumab and certolizumab were in the ‘possible' Naranjo category (78.1% and 78.6% respectively). The most common manifestation of DIL was rash (51.2%) with adalimumab and presence of anti-histone/anti-double stranded DNA antibodies (42.9%) with certolizumab. Lower odds (table 2) for DIL were seen with both adalimumab and certolizumab compared to 5-aminosalicylic acid and sulphasalazine. Conclusion: Although new DIL cases with adalimumab and certolizumab are reported, the odds of developing DIL among infliximab Naïve IBD patients with these TNF- α inhibitors are lower than that with 5-aminosalicylic acid formulations and sulphasalazine. Table 1: Drug induced lupus with adalimumab and certolizumab among infliximab Naïve inflammatory bowel disease patients
Su1150 Do IBD Treatment Guidelines for Immunomodulators and Anti-TNF Therapies Improve Performance for Screening and Vaccinations ? Deborah Smith, Patrick B. Allen, Abraham Varghese, Kokleong Diong, Mary Kane Background: Patients with IBD frequently receive immunosuppressive and anti-TNF therapies, potentially increasing their risk of contracting infections. The European Crohn's and Colitis Organisation issued guidance on vaccination against preventable infections in patients with IBD receiving immunosuppressive therapy. These guidelines were implemented from 2011 within our institution. Aims - To establish if guidelines improved the adherence to vaccinations and screening in IBD patients. Methods: A retrospective audit was carried out between April 2009 and June 2012. Hospital notes were checked, patients' general practitioners contacted and laboratory & X-ray systems were searched to gather information. Immunization was determined positive for each vaccine if received: annually for influenza , three to five yearly for pneumococcus and for both Human Papillomavirus (HPV) and Hepatitis B (HBV) vaccination after commencing the vaccine course; Positive Varicella Zoster Virus (VZV) immunization status was determined after; a clear history, positive serology result or VZV vaccination. Patients prescribed anti-TNFs were checked to see if a chest x-ray, and a QGT was performed. Patients who received live vaccines were identified. Statistical significance was assessed by comparing practice pre and post 2011 using a chi squared test with yates correction for small sample size. Results: 42 patients who were commenced on immunomodulator (IM) therapy (azathioprine, 6- mercaptopurine, or methotrexate) and / or anti- TNF therapy (adalimumab or infliximab) were randomly identified from the IBD clinic. 18 patients were prescribed IM therapy and 24 on anti-TNF therapy. Overall the trend in vaccination uptake improved year on year, achieving statistical significance for Influenza (P=0.0246) and HBV (P=0.035). Uptake of VZV and pneumococcal vaccine improvement was not significant, p=0.1528 and 0.2814 respectively. There was a similar trend towards improvement in screening for latent TB. All HPV vaccines were appropriately administered in these times periods. One patient received a live vaccine from their primary care physician (typhoid). Discussion: Our study demonstrates that a strict IBD vaccination and screening policy improved the adherence to influenza and HBV vaccinations and screening for TB was similar between the two time periods. Greater effort is required by patients and practitioners to ensure they receive appropriate vaccinations; and formal education is needed with regard live vaccinations. Su1151 Incidence of Tbc Infection in Patients With Inflammatory Bowels Disease (IBD) Treated With Infliximab in Russia Elena Belousova, Nataliya Morozova, Olga Tsodikova, Elnara Tagieva Background: The use of anti-TNF therapy, in particular infliximab may lead to the development of TBC-infection due to immunosuppressive action of biologics. Purpose of the study: To determine the frequency of TBC infection in IBD patient receiving infliximab in population of Moscow region (Moscow excluded) in Russia. Materials and Methods: We observed 71 IBD patients: 45 with ulcerative colitis (UC) and 26 with Crohn's disease (CD) at the age of 18 - 54 years (mean age 37,5±4,1) M:F rate= 31:40. Duration of disease ranged from 6 months to 11 years (mean duration 6,8 years). Duration of infliximab treatment ranged from 6 months to 5 years (total 9248 pts/years). Before infliximab administration all patients were completely screened to exclude active TBC (chest x-rays, PPD test, phthisiatrician examination, history of TBC and contacts with TBC patients were taken into account). Incidence of active TBC in Russia (66 per 100000 population and 46 per 100000 in Moscow region in 2011) is higher than in Europe and USA. It was the reason to repeat screening every 6 months due to possible higher TBC risk in this group of patients. Results: In 5 patients treated with infliximab active TBC was diagnosed (about 0,05 / 100 pts/years that is not higher than in the majority of countries). In all patients it was pulmonary tuberculosis. In 4 cases there was relapses of latent TBC that was not identified at the screening, 1 patient had primary TBC infection. Infliximab was discontinued after TBC diagnosis. Specific anti tuberculosis therapy was performed. Conclusions: In countries and regions with a high TBC incidence the increase risk of TBC infection should be expected with use of biological agents in IBD patients. However in our IBD patients the frequency of TBC did not significantly exceed TBC rate in other countries. We believe that complete TBC screening before treatment with biologics and repeat it every 6 months could reduce the risk of TBC in IBD patients treated with anti TNF agents. Su1152 The Effect of Infliximab on Memory in Children With Inflammatory Bowel Disease Patients: A Pilot Study Samuel Bitton, Toba A. Weinstein, Jeremiah J. Levine, James Markowitz INTRODUCTION: Infliximab is a monoclonal antibody against tumor necrosis factor alpha, used increasingly to treat autoimmune disease such as inflammatory bowel disease (IBD). There have been documented neurological sequalae after infliximab use. Complaints from patients regarding memory and cognitive deficit after infliximab use have been anecdotally reported but have not yet been substantiated in the literature. The aim of this pilot study was to objectively characterize the memory and cognitive effects, if any, of infliximab on pediatric IBD patients. METHODS: Patients were prospectively recruited from our pediatric GI clinic. Inclusion criteria included patients with IBD who were to start infliximab or immunomodulator (IM) treatment, and children being treated for functional gastrointestinal disease (FGID) as control. All subjects completed a previously validated, self-administered computerized neuropsychological test, the pediatric Automated Neuropsychological Assessment Metrics (pedANAM). Subjects had a baseline test (pre-medication for IBD patients, or when identified as an eligible FGID control), and a re-test after a period of 10-14 weeks. The five tests that best evaluated working memory and computation within the pedANAM battery were chosen for analysis. Baseline results were compared to an age and sex matched reference database of healthy children and considered abnormal if the result fell at least 1 standard deviation below the mean. In those subjects who completed both the baseline and
* anti-histone /anti-double stranded DNA antibodies Table 2: Reported odds of developing drug induced lupus with adalimumab or certolizumab in infliximab Naïve inflammatory bowel disease patients
AGA Abstracts
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