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Tu1920 Predictors and Characteristics of Psoriasiform Skin Lesions While on Infliximab Among Patients With Inflammatory Bowel Disease (IBD)
AGA Abstracts
disease extent, disease activity, dose and compliance of mesalamine agent, concomitant therapy for IBD. Urine samples were measured for the presence of the monoester metabolite of dibutyl phthalate (i.e. mono-n-butyl phthalate) using a liquid chromatography tandem mass spectrometry. Metabolites of phthalates in the urine were measured to prevent external contamination. Measurement of phthalate levels were blinded to the clinical information. Results: Urine samples were retrieved from five patients prescribed Mezavant (3.6 to 4.8 g daily) and four patients prescribed Asacol (2.4 to 4.8 g). Following chart review, all patients with Mezavant were compliant with medication, whereas two patients were compliant with Asacol, 1 patient discontinued Asacol (2.4 g daily) one month prior to urine collection, and 1 patient was not compliant with Asacol (3.6 g daily). Mono-n-butyl phthalate levels ranged from 2.86 to 6.16 µg/L in patients taking Mezavant. Patients compliant with Asacol had mono-n-butyl phthalate levels of 1840 and 3230 µg/L (p<0.05). In contrast, mono-nbutyl phthalate levels in patients not compliant with Asacol were 4.9 and 17.4 µg/L (Table 1). Conclusion: Patients with ulcerative colitis compliant with Asacol had an over 300-fold increased level of the metabolite of dibutyl phthalate as compared to patients compliant with Mezavant. Low levels of mono-n-butyl phthalate among patients not compliant to Asacol suggest that exposure to phthalates from Asacol maybe transient. Future studies are necessary to evaluate whether persistently elevated levels of phthalates result in adverse outcomes for patients with ulcerative colitis.
starting biological therapy. Prevalence data from systematic screening for latent TBC infection (LTBI) and HBV in patients prescribed biological therapy in a low-endemic area have not been reported thus far. METHODS From May 2012 through July 2015, all IMID patients commencing biological treatment were included. Screening consisted of a detailed medical history on risk factors for LTBI (previous diagnosis of TBC, close contact with a TBC-infected person, previous living outside Europe, North-America and Australia) and HBV infection (occupation, history of intravenous drug abuse, sexual behaviour), a Quantiferon test (QFT), serology for HBV (HBs-Ag, anti HB-core) and a chest X-ray. RESULTS In total, 547 of 549 patients (99.6%) starting biological therapy were screened. One patient (0.2%) tested positive for HBV and did not report any risk factor. As shown in table 1, 22 patients (4.0%) tested positive on QFT and were classified as LTBI patients. Of these, 14 did not report any risk factor, 18 had always lived in The Netherlands and another 18 never travelled outside of Europe, North America or Australia. Four patients had abnormalities on chest X-ray, 3 of them also tested positive on QFT and the other one turned out to have sarcoidosis, not LTBI. All LTBI patients were treated with isoniazid therapy. After a mean follow-up period of 19.8 ±8.8 months none of the patients had a reactivation of LTBI after the start of biological therapy. CONCLUSION The overall prevalence of LTBI and HBV in patients prescribed biological therapy in a low-endemic area is 4.0% and 0.2%, respectively. Systematic screening by means of QFT and HBV serology seems more reliable than history taking and chest X-rays alone. Since implementation of systematic screening of IMID patients, no patients showed reactivation of LTBI or HBV during biological therapy.
Tu1922 Incidence of Steroid-Induced Mood Changes in Patients With Inflammatory Bowel Disease George Ou, Brian Bressler, Cherry Galorport, Eric Lam, Hin Hin Ko, Robert A. Enns, Jennifer J. Telford, Nathan Schaffer, Gregory Rosenfeld
Tu1920 Predictors and Characteristics of Psoriasiform Skin Lesions While on Infliximab Among Patients With Inflammatory Bowel Disease (IBD) Robyn Sharma, Michelle I. Smith, Wei Xu, Geoffrey C. Nguyen, Kenneth Croitoru, A. Hillary Steinhart, Mark S. Silverberg, Adam Weizman
Background: Corticosteroids (steroids) are effective in the treatment of immunological conditions but are associated with significant adverse effects, including diabetes, osteonecrosis, osteoporosis, and mood changes. Previous studies have assessed the incidence of mood changes among patients taking short-course oral steroids for asthma or ophthalmic conditions, but data specific to the use of steroids for the treatment of inflammatory bowel disease (IBD) is lacking. Aim: To determine the incidence of steroid-induced mood changes in IBD patients undergoing treatment for their IBD with oral prednisone. Methods: This was a prospective, observational cohort study at a university-affiliated tertiary care center from 10/2013-11/2015. Inclusion criteria: patients ‡ 19 being started on oral prednisone for IBD. Exclusion criteria: hospitalization for IBD treatment within 2 weeks of study entry; change in psychiatric medication within 1 month of study entry; and active recreational drug use or alcohol abuse. Mood changes were assessed using 2 previously validated questionnaires: Beck Depression Inventory (BDI-) II for depression (adjusted by excluding overlapping symptoms between IBD and depression) and Activation subscale of Internal State Scale Ver. 2 (AS-ISSv2) for (hypo)mania. Subjects were asked to complete the questionnaires before the start of treatment, 2 weeks into treatment, and at the end of steroid taper. Significant mood changes were defined a priori, as BDI-II (adjusted) increase by 10 (out of 54), and/ or AS-ISSv2 increase by 50 (out of 500). IBD activity was assessed at each visit using HarveyBradshaw Index (HBI) for Crohn's disease (CD) or Simple Clinical Colitis Activity Index (SCCAI) for Ulcerative Colitis (UC). The primary endpoint was the incidence of mood changes from baseline. Results: Fifty-three subjects were enrolled as of 11/2015. Twentyseven (51%) were female; mean age was 40.2 +/- 15.2 years. Thirty-eight (72%) subjects had UC and 15 (28%) had CD. Five (9.4%) subjects had underlying mental illness on stable therapy: 4 depression, 1 anxiety. There was a significant increase in the AS-ISSv2 scores at 2 weeks, but not at the end of the treatment. (Table) Twenty-four (45%) and 7 (13%) subjects experienced significant mood changes (i.e. AS-ISSv2 increase by ‡ 50) at 2 weeks and at the end of treatment, respectively. There was no change in adjusted BDI-II scores. Subjects experienced improvement in their IBD activities as measured by HBI and SCCAI at 2 weeks, but only SCCAI's change persisted until the end. Conclusion: Short-term corticosteroid treatment for IBD is associated with significant mood changes, specifically in (hypo)mania symptoms. This associated mood change needs to be taken into account when deciding whether the benefits outweigh the risk of this induction agent for IBD. Results (mean +/- SD)
BACKGROUND: Anti-tumor necrosis factor alpha (TNFa) agents are an effective treatment for inflammatory conditions, including inflammatory bowel disease (IBD) and psoriasis. Paradoxically, psoriasis development has been increasingly recognized among IBD patients treated with these agents. Literature on the prevalence, clinical characteristics, and implications on treatment are limited. METHODS: A retrospective chart review of patients treated with infliximab from 2004-2014 at Mount Sinai Hospital in Toronto, Ontario was performed. Patient charts were reviewed for clinical parameters including Montreal Classification of disease location and behavior, extra-intestinal manifestations, family history, infliximab dosing, infliximab trough level, and smoking status. Patients identified as having developed psoriasis while on infliximab underwent a detailed review of dermatologic features, dermatologic treatments, and changes in IBD treatment prompted by the development of psoriasis. Patient demographics and clinical characteristics were summarized using descriptive statistics and data analysis was undertaken using univariate logistic regression for clinical data (statistical significance at p<0.05). RESULTS: A total of 430 charts were identified and reviewed. The development of psoriasis while on infliximab occurred in 37 patients yielding a prevalence of 8.6%. The majority of patients had Crohn's disease (28/37, 76%) were female (24/37, 65%), and did not have a family history of psoriasis (97%). The psoriatic rash often involved multiple sites, most commonly flexures of extremities (46%), palmoplantar (24%), scalp (38%), face (27%) and torso (24%). The mean time to rash onset was 1144 days from initiation of infliximab. Most cases were successfully managed with the addition of topical steroids alone; however in 7/37 (19%), cessation of infliximab was required, with subsequent complete resolution of the rash. Four of these patients were switched to adalimumab, with recurrence occurring only in one patient. Referral to a dermatologist was made in 26/37 cases (70.4%). There was no significant difference in age, gender, disease location, behavior, or trough level of drug that was associated with psoriasis development among all patients treated with infliximab. CONCLUSION: We report a prevalence of infliximab-induced psoriasis in patients with IBD greater than previously described. Most patients responded well to topical therapy, highlighting the importance of early dermatology referral, which could potentially prevent unnecessary discontinuation of anti-TNF therapy. There were no clinical or IBD features that predicted psoriasis development, including infliximab trough level. Future studies evaluating psoriasis development in patients treated with infliximab and other anti-TNFs in order to determine if this is a class effect are required.
Tu1921 The Prevalence of Latent Tuberculosis and Hepatitis B Found After Systematic Screening of Patients Starting With Biological Therapy in a Low-Endemic Area Marin de Jong, Danielle Roosen, Andy Peters, Ad Masclee, Valerie Verstraeten, Astrid V. Tubergen, Marie Pierik
*Final data pending; SD = standard deviation; AS-ISSv2 = Activation subscale of Internal State Scale Ver. 2; BDI-II = Beck Depression Inventory II; HBI = Harvey-Bradshaw Index; SCCAI = Simple Clinical Colitis Activity Index; NS = Non-significant
BACKGROUND Biologicals are a powerful treatment option for moderate to severe immunemediated inflammatory diseases (IMID). Since biologicals modulate the immune system, the risk for reactivation of latent infections with a fulminant disease course, such as tuberculosis (TBC) or Hepatitis B (HBV), is increased. Guidelines therefore recommend screening for TBC and HBV before starting biological therapy. Since 2012, in Maastricht University Medical Centre+, we have a central, multi-disciplinary and systematic screening of all IMID patients
AGA Abstracts
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disease extent, disease activity, dose and compliance of mesalamine agent, concomitant therapy for IBD. Urine samples were measured for the presence of the monoester metabolite of dibutyl phthalate (i.e. mono-n-butyl phthalate) using a liquid chromatography tandem mass spectrometry. Metabolites of phthalates in the urine were measured to prevent external contamination. Measurement of phthalate levels were blinded to the clinical information. Results: Urine samples were retrieved from five patients prescribed Mezavant (3.6 to 4.8 g daily) and four patients prescribed Asacol (2.4 to 4.8 g). Following chart review, all patients with Mezavant were compliant with medication, whereas two patients were compliant with Asacol, 1 patient discontinued Asacol (2.4 g daily) one month prior to urine collection, and 1 patient was not compliant with Asacol (3.6 g daily). Mono-n-butyl phthalate levels ranged from 2.86 to 6.16 µg/L in patients taking Mezavant. Patients compliant with Asacol had mono-n-butyl phthalate levels of 1840 and 3230 µg/L (p<0.05). In contrast, mono-nbutyl phthalate levels in patients not compliant with Asacol were 4.9 and 17.4 µg/L (Table 1). Conclusion: Patients with ulcerative colitis compliant with Asacol had an over 300-fold increased level of the metabolite of dibutyl phthalate as compared to patients compliant with Mezavant. Low levels of mono-n-butyl phthalate among patients not compliant to Asacol suggest that exposure to phthalates from Asacol maybe transient. Future studies are necessary to evaluate whether persistently elevated levels of phthalates result in adverse outcomes for patients with ulcerative colitis.
starting biological therapy. Prevalence data from systematic screening for latent TBC infection (LTBI) and HBV in patients prescribed biological therapy in a low-endemic area have not been reported thus far. METHODS From May 2012 through July 2015, all IMID patients commencing biological treatment were included. Screening consisted of a detailed medical history on risk factors for LTBI (previous diagnosis of TBC, close contact with a TBC-infected person, previous living outside Europe, North-America and Australia) and HBV infection (occupation, history of intravenous drug abuse, sexual behaviour), a Quantiferon test (QFT), serology for HBV (HBs-Ag, anti HB-core) and a chest X-ray. RESULTS In total, 547 of 549 patients (99.6%) starting biological therapy were screened. One patient (0.2%) tested positive for HBV and did not report any risk factor. As shown in table 1, 22 patients (4.0%) tested positive on QFT and were classified as LTBI patients. Of these, 14 did not report any risk factor, 18 had always lived in The Netherlands and another 18 never travelled outside of Europe, North America or Australia. Four patients had abnormalities on chest X-ray, 3 of them also tested positive on QFT and the other one turned out to have sarcoidosis, not LTBI. All LTBI patients were treated with isoniazid therapy. After a mean follow-up period of 19.8 ±8.8 months none of the patients had a reactivation of LTBI after the start of biological therapy. CONCLUSION The overall prevalence of LTBI and HBV in patients prescribed biological therapy in a low-endemic area is 4.0% and 0.2%, respectively. Systematic screening by means of QFT and HBV serology seems more reliable than history taking and chest X-rays alone. Since implementation of systematic screening of IMID patients, no patients showed reactivation of LTBI or HBV during biological therapy.
Tu1922 Incidence of Steroid-Induced Mood Changes in Patients With Inflammatory Bowel Disease George Ou, Brian Bressler, Cherry Galorport, Eric Lam, Hin Hin Ko, Robert A. Enns, Jennifer J. Telford, Nathan Schaffer, Gregory Rosenfeld
Tu1920 Predictors and Characteristics of Psoriasiform Skin Lesions While on Infliximab Among Patients With Inflammatory Bowel Disease (IBD) Robyn Sharma, Michelle I. Smith, Wei Xu, Geoffrey C. Nguyen, Kenneth Croitoru, A. Hillary Steinhart, Mark S. Silverberg, Adam Weizman
Background: Corticosteroids (steroids) are effective in the treatment of immunological conditions but are associated with significant adverse effects, including diabetes, osteonecrosis, osteoporosis, and mood changes. Previous studies have assessed the incidence of mood changes among patients taking short-course oral steroids for asthma or ophthalmic conditions, but data specific to the use of steroids for the treatment of inflammatory bowel disease (IBD) is lacking. Aim: To determine the incidence of steroid-induced mood changes in IBD patients undergoing treatment for their IBD with oral prednisone. Methods: This was a prospective, observational cohort study at a university-affiliated tertiary care center from 10/2013-11/2015. Inclusion criteria: patients ‡ 19 being started on oral prednisone for IBD. Exclusion criteria: hospitalization for IBD treatment within 2 weeks of study entry; change in psychiatric medication within 1 month of study entry; and active recreational drug use or alcohol abuse. Mood changes were assessed using 2 previously validated questionnaires: Beck Depression Inventory (BDI-) II for depression (adjusted by excluding overlapping symptoms between IBD and depression) and Activation subscale of Internal State Scale Ver. 2 (AS-ISSv2) for (hypo)mania. Subjects were asked to complete the questionnaires before the start of treatment, 2 weeks into treatment, and at the end of steroid taper. Significant mood changes were defined a priori, as BDI-II (adjusted) increase by 10 (out of 54), and/ or AS-ISSv2 increase by 50 (out of 500). IBD activity was assessed at each visit using HarveyBradshaw Index (HBI) for Crohn's disease (CD) or Simple Clinical Colitis Activity Index (SCCAI) for Ulcerative Colitis (UC). The primary endpoint was the incidence of mood changes from baseline. Results: Fifty-three subjects were enrolled as of 11/2015. Twentyseven (51%) were female; mean age was 40.2 +/- 15.2 years. Thirty-eight (72%) subjects had UC and 15 (28%) had CD. Five (9.4%) subjects had underlying mental illness on stable therapy: 4 depression, 1 anxiety. There was a significant increase in the AS-ISSv2 scores at 2 weeks, but not at the end of the treatment. (Table) Twenty-four (45%) and 7 (13%) subjects experienced significant mood changes (i.e. AS-ISSv2 increase by ‡ 50) at 2 weeks and at the end of treatment, respectively. There was no change in adjusted BDI-II scores. Subjects experienced improvement in their IBD activities as measured by HBI and SCCAI at 2 weeks, but only SCCAI's change persisted until the end. Conclusion: Short-term corticosteroid treatment for IBD is associated with significant mood changes, specifically in (hypo)mania symptoms. This associated mood change needs to be taken into account when deciding whether the benefits outweigh the risk of this induction agent for IBD. Results (mean +/- SD)
BACKGROUND: Anti-tumor necrosis factor alpha (TNFa) agents are an effective treatment for inflammatory conditions, including inflammatory bowel disease (IBD) and psoriasis. Paradoxically, psoriasis development has been increasingly recognized among IBD patients treated with these agents. Literature on the prevalence, clinical characteristics, and implications on treatment are limited. METHODS: A retrospective chart review of patients treated with infliximab from 2004-2014 at Mount Sinai Hospital in Toronto, Ontario was performed. Patient charts were reviewed for clinical parameters including Montreal Classification of disease location and behavior, extra-intestinal manifestations, family history, infliximab dosing, infliximab trough level, and smoking status. Patients identified as having developed psoriasis while on infliximab underwent a detailed review of dermatologic features, dermatologic treatments, and changes in IBD treatment prompted by the development of psoriasis. Patient demographics and clinical characteristics were summarized using descriptive statistics and data analysis was undertaken using univariate logistic regression for clinical data (statistical significance at p<0.05). RESULTS: A total of 430 charts were identified and reviewed. The development of psoriasis while on infliximab occurred in 37 patients yielding a prevalence of 8.6%. The majority of patients had Crohn's disease (28/37, 76%) were female (24/37, 65%), and did not have a family history of psoriasis (97%). The psoriatic rash often involved multiple sites, most commonly flexures of extremities (46%), palmoplantar (24%), scalp (38%), face (27%) and torso (24%). The mean time to rash onset was 1144 days from initiation of infliximab. Most cases were successfully managed with the addition of topical steroids alone; however in 7/37 (19%), cessation of infliximab was required, with subsequent complete resolution of the rash. Four of these patients were switched to adalimumab, with recurrence occurring only in one patient. Referral to a dermatologist was made in 26/37 cases (70.4%). There was no significant difference in age, gender, disease location, behavior, or trough level of drug that was associated with psoriasis development among all patients treated with infliximab. CONCLUSION: We report a prevalence of infliximab-induced psoriasis in patients with IBD greater than previously described. Most patients responded well to topical therapy, highlighting the importance of early dermatology referral, which could potentially prevent unnecessary discontinuation of anti-TNF therapy. There were no clinical or IBD features that predicted psoriasis development, including infliximab trough level. Future studies evaluating psoriasis development in patients treated with infliximab and other anti-TNFs in order to determine if this is a class effect are required.
Tu1921 The Prevalence of Latent Tuberculosis and Hepatitis B Found After Systematic Screening of Patients Starting With Biological Therapy in a Low-Endemic Area Marin de Jong, Danielle Roosen, Andy Peters, Ad Masclee, Valerie Verstraeten, Astrid V. Tubergen, Marie Pierik
*Final data pending; SD = standard deviation; AS-ISSv2 = Activation subscale of Internal State Scale Ver. 2; BDI-II = Beck Depression Inventory II; HBI = Harvey-Bradshaw Index; SCCAI = Simple Clinical Colitis Activity Index; NS = Non-significant
BACKGROUND Biologicals are a powerful treatment option for moderate to severe immunemediated inflammatory diseases (IMID). Since biologicals modulate the immune system, the risk for reactivation of latent infections with a fulminant disease course, such as tuberculosis (TBC) or Hepatitis B (HBV), is increased. Guidelines therefore recommend screening for TBC and HBV before starting biological therapy. Since 2012, in Maastricht University Medical Centre+, we have a central, multi-disciplinary and systematic screening of all IMID patients
AGA Abstracts
X : 10052$CH01 03-28-16 00:57:28 PDFd : 10052B : e
S-978
Page 978