S1053 Impact of a Patient Support Program On Mesalamine Adherence in Patients with Ulcerative...

1
AGA Abstracts Standard laboratory criteria were used to define vitamin B12 deficiency as measured by RIA (low levels <250 pg/ml). Two different preparations (Benexol®, containing 1 mg of cobalamin per capsule; and Hidroxyl®, containing 0.5 mg of cobalamin per capsule) were used, in most cases one capsule OD (in a limited number of cases BID doses were used during the first week of treatment). RESULTS: We included 31 CD patients (13 men and 18 women, average age 43.1 years, range 21-63). The median age at diagnosis was 33.4 years (17-56). The classification of the patients was (in %): Age at diagnosis: A1: 0, A2 74, A3: 26; Location: L1 29, L2 10, L3 61 and Behavior: B1 42, B2 26, B3 32. 61% patients (19/31) had been operated: 4 right hemicolectomy, 8 any resection of small intestine (especially distal ileum), 4 combination of two, and 3 other procedures. The average value of vitamin B12 prior to the start of the oral treatment was 167 pg/ml (46-489) and next control (2-3 months later) 472.11 pg/ml (177-1369). The 3 patients with normal B12 values when beginning oral treatment were being treated so far by intramuscular route, and all of them maintain normal levels with oral therapy. The remaining 29 patients had low levels of B12 at the beginning of oral treatment and 27 of them normalized it. The 2 failures of oral treatment were treated by intramuscular route. CONCLUSIONS: The oral administration seems to be an effective and less annoying alternative in the treatment of vitamin B12 deficit in CD, although further studies are needed to confirm it. The deficit of vitamin B12 in these patients is common (especially when there is surgery on the distal ileum) and we should investigate it periodically. S1051 Faecal Calprotectin Home Test in Ulcerative Colitis - Is It Possible? Margarita Elkjaer, Johan Burisch, Arne Roseth, Vibeke Voxen Hansen, Birgit Deibjerg Kristensen, Dag Bremnes, Jens-Kristian S. Jensen, Pia S. Munkholm Background: Enzyme-linked immunosorbent assay (ELISA) is a quantitative method and the “Gold standard” for faecal Calprotectin (FC) analysis. A new quantitative method, the”Rapid Test” (RT), has been developed to be carried out by the lab technician. This test has further been developed into a “Home Test” (HT) to be carried out by the patients themselves. Aim: To compare the ELISA with the quantitative RT tests for FC measurement, read by a PC-scanner system or using an ordinary cell phone system. Methods: One drop of faecal extract was applied onto the RT- device and the colour intensity of the test line was read after 10 min incubation time using a lap-top linked with an ordinary table top scanner. In the HT a picture of the same RT-device was taken using a cell phone with special software built in. The user takes a picture and a software package on the cell phone sends the picture to a server in Oslo by using Mobile Internet. In this study the RT and the HT was carried out by our lab technician. Results: One hundred seventy five faecal samples have been collected from ulcerative colitis (UC) patients involved in a randomised control trail “Constant-care”. The cut off level for normal FC is 50 mg/kg. Comparison between the three tests was assessed with mean difference of 5.05 mg/kg (95% CI; ÷16.52- 26.61) in ELISA vs. RT. ELISA vs. HT mean difference of 26.73 mg/kg (95% CI; 1.31- 52.16) and RT vs. HT mean difference 21.71 mg/kg (95% CI; 11.46-31.95) of FC was found. The coefficient of variation (CV %) of ELISA vs. HT was in median 2.81% (range, 0- 21.60%) and 6.15% (range, 0-41.59%), p-value <0.01 respectively. Conclusion: A significant difference between ELISA vs. HT was revealed, p-value <0.01. However the CV is acceptable being less than 10%. In future aspects the Home Test can be implemented in UC patients as part of disease self-management. S1052 Efficacy of Enemas Containing Combination of Mesalazine and Methyl- Prednisolone in Active Distal Refractory Ulcerative Colitis Paolo Gionchetti, Fernando Rizzello, Rosy Tambasco, Giulia Straforini, Ramona Brugnera, Carlo Calabrese, Massimo Campieri Introduction and aims: Distal ulcerative colitis (UC) can be effectively treated with topical mesalazine , oral mesalazine or with combination of both. We evaluated the efficacy of mesalazine 100 ml 4g enemas with the adjunct of methylprednisolone 40 mg in patients with mild to moderate active distal UC, refractory to combined oral and topical mesalazine. Methods: A total of 120 consecutive episodes of mild to moderate active distal UC refractory to 6 weeks combined oral and enema treatment with mesalazine in 78 patients [42 male, 36 female, median age 34,5 yrs (range 20-67), 37 with left-sided colitis and 41 with proctosigmoiditis] were treated for 6 week with mesalazine 100 ml 4g enemas with the adjunct of methylprednisolone 40 mg. Patients were evaluated at inclusion and after 6 weeks, using UCDAI score, which is based on clinical signs and endoscopic evaluation. UCDAI score had to be 3 and 8. Remission was defined as a UCDAI score of <2, improvement was defined as a decrease in the UCDAI score by 2 points from baseline. Results: At week 6, the remission rate was of 71.7%. Improvement was obtained in 15%. No serious adverse events were registered during the study. Conclusions: In patients with mild to moderate distal refractory colitis the combined treatment with mesalazine+methylprednisolone enemas is highly effective and safe. S1053 Impact of a Patient Support Program On Mesalamine Adherence in Patients with Ulcerative Colitis Nabeel Chaudhary, Jahvari Junior, Melissa Tukey, Kenneth R. Falchuk, Adam Cheifetz, Alan C. Moss Background: Medication adherence rates with mesalamine treatment are reported to be variable in patients with inflammatory bowel disease (IBD). We sought to measure the impact of a patient-support program (PSP) on medication adherence and quality-of-life in patients with ulcerative colitis that were prescribed mesalamine (Asacol). Methods: Random- ized controlled trial of either standard follow-up (control) or a 23-week nurse-delivered PSP (5 support phone calls). Medication adherence was assessed using Steiner's formula based on refill intervals. Quality-of-life was measured using the short IBD questionnaire (IBDQ). Results: A total of 81 patients were enrolled; 24 received PSP, and 57 received standard A-178 AGA Abstracts care. Baseline patient characteristics were similar in both arms of the study. The mean baseline Simple Colitis Clinical Activity Index scores were 3.2 in the control arm and 2.9 in the PSP arm (remission < 2.5). The mean baseline short IBDQ score (0-7) was 5.6 in the control arm and 5.4 in the PSP arm. Medication adherence at 3 and 6 months were similar in both arms, and increased over the 6 months of the study (Table 1). Median changes in short IBDQ score (ΔsIBDQ) were 0.1 and -0.2 at 3 months, and 1.0 and -0.1 at 6 months, in the control and PSP arms respectively. There were no statistically significant differences in the change in sIBDQ from 0 to 3 months or 0 to 6 months between both arms of the study. Conclusion: This patient support program did not improve medication adherence beyond standard care. Simply being enrolled in the study improved adherence over time. S1054 How Often Is Crohn's Disease the Culprit of Perianal Fistulas? Michael Bellutti, Klaus Mönkemüller, Lucia C. Fry, Ulrike von Arnim, Kerstin Schütte, Peter Malfertheiner Introduction: Perianal fistulas (PAF) are often a hint for underlying Crohn's disease (CD) even in the absence of other symptoms. However, currently it is believed that most PAF are associated to a specific disease entity of cryptoglandular origin. Aims and Methods: The aim of the study was to examine the role of endoscopy and ultrasound to detect or exclude CD in patients (pts) with PAF. Twenty-eight pts (14w, 14m, age 25-65, mean 45.4 yrs) with PAF were evaluated for the presence of CD. All patients underwent esophagogastroduod- enoscopy (EGD) with duodenal biopsies, ileo-colonoscopy with ileal and colonic biopsies and abdominal ultrasound with additional intestinal sonography. Because of normal upper and lower endoscopy in 7 pts a capsule endoscopic (CE) exam and in 9 pts double balloon enteroscopy (DBE) with biopsies of the jejunum and ileum were performed. Results: In 10 pts. (36%, 7 w, 3m) the diagnosis of CD could be established. Six of these pts (60%) had sonographic signs of inflammation of either the colon or the terminal ileum. Ileo-colonoscopy could confirm terminal ileitis or segmental colitis with histological signs of inflammation in 2 and 3 pts (50%) respectively. EGD and histology revealed signs of CD by means of duodenitis with granulomatous inflammation in 2 pts (20%). In 3 pts with CD a per-oral DBE was performed and detected sporadic jejunal erosions with unremarkable histology in one pt. In 18 pts with perianal fistulas no signs of CD could be detected neither sonograph- ically nor by EGD or ileo-colonoscopy. Of 7 performed capsule endoscopic exams in this group of pts sporadic jejunal erosions were detected in 2 pts, a subsequently performed DBE with biopsies was unremarkable. From a total of 9 per-oral DBE with tissue retrieval 3 could detect isolated erosions without histological evidence of inflammation. Conclusion: In the diagnostic work-up of perianal fistulas CD could be confirmed in 36% of pts. Thus, PAF even in the absence of other symptoms demand careful evaluation for the presence of CD. Following our findings ileo-colonoscopy and intestinal ultrasound are the initial diagnostic methods of choice. Small bowel endoscopy adds little to CD diagnosis in pts with PAF. S1055 Transition of Adolescent Inflammatory Bowel Disease Patients from Pediatric to Adult Health Care: An Assessment of Dutch Adult Gastroenterologists' Perspectives Renée M. Barendse, Daan J. aan de Kerk, Angelika Kindermann, Laurie N. Fishman, Joep F. Bartelsman, Hugo S. Heymans Background. Successful transition of pediatric Inflammatory Bowel Disease (IBD) patients to adult settings warrants continuous and age-appropriate health care. Pediatric providers should understand adult providers' expectations to better prepare their patients. A recent study assessed North-American adult gastroenterologists' perspectives on the transitioning process. This study addresses the insights of adult gastroenterologists in the Netherlands. Methods. A survey, identical to the survey used prior in Northern America, was sent to 288 adult gastroenterologists, identified by membership to the Dutch Association of Gastroenter- ology and Hepatology. Respondents were asked to indicate the importance of various issues involved in transition, and to report which problems occurred often in their own practice. The survey also elicited respondents' attributed importance to knowledge of medical and developmental issues unique to adolescence, and their personal competency about these issues. Broad demographic features were then identified. Results. A response rate of 46% was achieved. The majority of respondents often experience problems in patients' ability to discuss the impact of their IBD on overall daily life (60%), knowledge of their medications (53%) and the impact of substance use on their health (53%). Respondents rarely experience problems in patients' ability to attend the visit alone (12%), to undergo procedures under conscious sedation (10%) and to identify health care providers (9%). Remarkably, whereas transfer of accurate medical history by the pediatrician was ranked of highest importance, it was subject to criticism in only 14% of respondents. Physicians in academic practice and those in practice less than 5 years tended to indicate a higher frequency of problems. Importance is frequently attributed to medical (94%) and developmental (89%) issues in adolescence. However, competency regarding those issues was reported in a much smaller proportion of respondents (61% and 34%, respectively). Conclusion. The goal of successful transition is continuous and age-appropriate health care. To this end, it is important that pediatric providers timely educate patients about their medications and the impact of their IBD on social life. Adult providers would benefit from familiarity with medical and develop- mental issues in adolescence. These adjustments will improve transition and may lead to better adherence and better medical outcomes. In the Netherlands, transition may benefit from the health care system, in which pediatric and adult medicine are commonly situated within the same hospital.

Transcript of S1053 Impact of a Patient Support Program On Mesalamine Adherence in Patients with Ulcerative...

AG

AA

bst

ract

sStandard laboratory criteria were used to define vitamin B12 deficiency as measured by RIA(low levels <250 pg/ml). Two different preparations (Benexol®, containing 1 mg of cobalaminper capsule; and Hidroxyl®, containing 0.5 mg of cobalamin per capsule) were used, inmost cases one capsule OD (in a limited number of cases BID doses were used during thefirst week of treatment). RESULTS: We included 31 CD patients (13 men and 18 women,average age 43.1 years, range 21-63). The median age at diagnosis was 33.4 years (17-56).The classification of the patients was (in %): Age at diagnosis: A1: 0, A2 74, A3: 26; Location:L1 29, L2 10, L3 61 and Behavior: B1 42, B2 26, B3 32. 61% patients (19/31) had beenoperated: 4 right hemicolectomy, 8 any resection of small intestine (especially distal ileum),4 combination of two, and 3 other procedures. The average value of vitamin B12 prior tothe start of the oral treatment was 167 pg/ml (46-489) and next control (2-3 months later)472.11 pg/ml (177-1369). The 3 patients with normal B12 values when beginning oraltreatment were being treated so far by intramuscular route, and all of them maintain normallevels with oral therapy. The remaining 29 patients had low levels of B12 at the beginningof oral treatment and 27 of them normalized it. The 2 failures of oral treatment were treatedby intramuscular route. CONCLUSIONS: The oral administration seems to be an effectiveand less annoying alternative in the treatment of vitamin B12 deficit in CD, although furtherstudies are needed to confirm it. The deficit of vitamin B12 in these patients is common(especially when there is surgery on the distal ileum) and we should investigate it periodically.

S1051

Faecal Calprotectin Home Test in Ulcerative Colitis - Is It Possible?Margarita Elkjaer, Johan Burisch, Arne Roseth, Vibeke Voxen Hansen, Birgit DeibjergKristensen, Dag Bremnes, Jens-Kristian S. Jensen, Pia S. Munkholm

Background: Enzyme-linked immunosorbent assay (ELISA) is a quantitative method andthe “Gold standard” for faecal Calprotectin (FC) analysis. A new quantitative method,the”Rapid Test” (RT), has been developed to be carried out by the lab technician. This testhas further been developed into a “Home Test” (HT) to be carried out by the patientsthemselves. Aim: To compare the ELISA with the quantitative RT tests for FC measurement,read by a PC-scanner system or using an ordinary cell phone system. Methods: One dropof faecal extract was applied onto the RT- device and the colour intensity of the test linewas read after 10 min incubation time using a lap-top linked with an ordinary table topscanner. In the HT a picture of the same RT-device was taken using a cell phone withspecial software built in. The user takes a picture and a software package on the cell phonesends the picture to a server in Oslo by using Mobile Internet. In this study the RT andthe HT was carried out by our lab technician. Results: One hundred seventy five faecalsamples have been collected from ulcerative colitis (UC) patients involved in a randomisedcontrol trail “Constant-care”. The cut off level for normal FC is 50 mg/kg. Comparisonbetween the three tests was assessed with mean difference of 5.05 mg/kg (95% CI; ÷16.52-26.61) in ELISA vs. RT. ELISA vs. HT mean difference of 26.73 mg/kg (95% CI; 1.31-52.16) and RT vs. HT mean difference 21.71 mg/kg (95% CI; 11.46-31.95) of FC wasfound. The coefficient of variation (CV %) of ELISA vs. HT was in median 2.81% (range, 0-21.60%) and 6.15% (range, 0-41.59%), p-value <0.01 respectively. Conclusion: A significantdifference between ELISA vs. HT was revealed, p-value <0.01. However the CV is acceptablebeing less than 10%. In future aspects the Home Test can be implemented in UC patientsas part of disease self-management.

S1052

Efficacy of Enemas Containing Combination of Mesalazine and Methyl-Prednisolone in Active Distal Refractory Ulcerative ColitisPaolo Gionchetti, Fernando Rizzello, Rosy Tambasco, Giulia Straforini, Ramona Brugnera,Carlo Calabrese, Massimo Campieri

Introduction and aims: Distal ulcerative colitis (UC) can be effectively treated with topicalmesalazine , oral mesalazine or with combination of both. We evaluated the efficacy ofmesalazine 100 ml 4g enemas with the adjunct of methylprednisolone 40 mg in patientswith mild to moderate active distal UC, refractory to combined oral and topical mesalazine.Methods: A total of 120 consecutive episodes of mild to moderate active distal UC refractoryto 6 weeks combined oral and enema treatment with mesalazine in 78 patients [42 male,36 female, median age 34,5 yrs (range 20-67), 37 with left-sided colitis and 41 withproctosigmoiditis] were treated for 6 week with mesalazine 100 ml 4g enemas with theadjunct of methylprednisolone 40 mg. Patients were evaluated at inclusion and after 6weeks, using UCDAI score, which is based on clinical signs and endoscopic evaluation.UCDAI score had to be ≥ 3 and ≤ 8. Remission was defined as a UCDAI score of <2,improvement was defined as a decrease in the UCDAI score by ≥2 points from baseline.Results: At week 6, the remission rate was of 71.7%. Improvement was obtained in 15%.No serious adverse events were registered during the study. Conclusions: In patients withm i l d t o mode r a t e d i s t a l r e f r a c t o r y co l i t i s t h e comb ined t r e a tmen t w i thmesalazine+methylprednisolone enemas is highly effective and safe.

S1053

Impact of a Patient Support Program On Mesalamine Adherence in Patientswith Ulcerative ColitisNabeel Chaudhary, Jahvari Junior, Melissa Tukey, Kenneth R. Falchuk, Adam Cheifetz,Alan C. Moss

Background: Medication adherence rates with mesalamine treatment are reported to bevariable in patients with inflammatory bowel disease (IBD). We sought to measure theimpact of a patient-support program (PSP) on medication adherence and quality-of-life inpatients with ulcerative colitis that were prescribed mesalamine (Asacol). Methods: Random-ized controlled trial of either standard follow-up (control) or a 23-week nurse-delivered PSP(5 support phone calls). Medication adherence was assessed using Steiner's formula basedon refill intervals. Quality-of-life was measured using the short IBD questionnaire (IBDQ).Results: A total of 81 patients were enrolled; 24 received PSP, and 57 received standard

A-178AGA Abstracts

care. Baseline patient characteristics were similar in both arms of the study. The meanbaseline Simple Colitis Clinical Activity Index scores were 3.2 in the control arm and 2.9in the PSP arm (remission < 2.5). The mean baseline short IBDQ score (0-7) was 5.6 inthe control arm and 5.4 in the PSP arm. Medication adherence at 3 and 6 months weresimilar in both arms, and increased over the 6 months of the study (Table 1). Medianchanges in short IBDQ score (ΔsIBDQ) were 0.1 and -0.2 at 3 months, and 1.0 and -0.1at 6 months, in the control and PSP arms respectively. There were no statistically significantdifferences in the change in sIBDQ from 0 to 3 months or 0 to 6 months between botharms of the study. Conclusion: This patient support program did not improve medicationadherence beyond standard care. Simply being enrolled in the study improved adherenceover time.

S1054

How Often Is Crohn's Disease the Culprit of Perianal Fistulas?Michael Bellutti, Klaus Mönkemüller, Lucia C. Fry, Ulrike von Arnim, Kerstin Schütte,Peter Malfertheiner

Introduction: Perianal fistulas (PAF) are often a hint for underlying Crohn's disease (CD)even in the absence of other symptoms. However, currently it is believed that most PAFare associated to a specific disease entity of cryptoglandular origin. Aims and Methods: Theaim of the study was to examine the role of endoscopy and ultrasound to detect or excludeCD in patients (pts) with PAF. Twenty-eight pts (14w, 14m, age 25-65, mean 45.4 yrs)with PAFwere evaluated for the presence of CD. All patients underwent esophagogastroduod-enoscopy (EGD) with duodenal biopsies, ileo-colonoscopy with ileal and colonic biopsiesand abdominal ultrasound with additional intestinal sonography. Because of normal upperand lower endoscopy in 7 pts a capsule endoscopic (CE) exam and in 9 pts double balloonenteroscopy (DBE) with biopsies of the jejunum and ileum were performed. Results: In 10pts. (36%, 7 w, 3m) the diagnosis of CD could be established. Six of these pts (60%) hadsonographic signs of inflammation of either the colon or the terminal ileum. Ileo-colonoscopycould confirm terminal ileitis or segmental colitis with histological signs of inflammation in2 and 3 pts (50%) respectively. EGD and histology revealed signs of CD by means ofduodenitis with granulomatous inflammation in 2 pts (20%). In 3 pts with CD a per-oralDBE was performed and detected sporadic jejunal erosions with unremarkable histology inone pt. In 18 pts with perianal fistulas no signs of CD could be detected neither sonograph-ically nor by EGD or ileo-colonoscopy. Of 7 performed capsule endoscopic exams in thisgroup of pts sporadic jejunal erosions were detected in 2 pts, a subsequently performedDBE with biopsies was unremarkable. From a total of 9 per-oral DBE with tissue retrieval3 could detect isolated erosions without histological evidence of inflammation. Conclusion:In the diagnostic work-up of perianal fistulas CD could be confirmed in 36% of pts. Thus,PAF even in the absence of other symptoms demand careful evaluation for the presence of CD.Following our findings ileo-colonoscopy and intestinal ultrasound are the initial diagnosticmethods of choice. Small bowel endoscopy adds little to CD diagnosis in pts with PAF.

S1055

Transition of Adolescent Inflammatory Bowel Disease Patients from Pediatricto Adult Health Care: An Assessment of Dutch Adult Gastroenterologists'PerspectivesRenée M. Barendse, Daan J. aan de Kerk, Angelika Kindermann, Laurie N. Fishman, JoepF. Bartelsman, Hugo S. Heymans

Background. Successful transition of pediatric Inflammatory Bowel Disease (IBD) patientsto adult settings warrants continuous and age-appropriate health care. Pediatric providersshould understand adult providers' expectations to better prepare their patients. A recentstudy assessed North-American adult gastroenterologists' perspectives on the transitioningprocess. This study addresses the insights of adult gastroenterologists in the Netherlands.Methods. A survey, identical to the survey used prior in Northern America, was sent to 288adult gastroenterologists, identified by membership to the Dutch Association of Gastroenter-ology and Hepatology. Respondents were asked to indicate the importance of various issuesinvolved in transition, and to report which problems occurred often in their own practice.The survey also elicited respondents' attributed importance to knowledge of medical anddevelopmental issues unique to adolescence, and their personal competency about theseissues. Broad demographic features were then identified. Results. A response rate of 46%was achieved. The majority of respondents often experience problems in patients' ability todiscuss the impact of their IBD on overall daily life (60%), knowledge of their medications(53%) and the impact of substance use on their health (53%). Respondents rarely experienceproblems in patients' ability to attend the visit alone (12%), to undergo procedures underconscious sedation (10%) and to identify health care providers (9%). Remarkably, whereastransfer of accurate medical history by the pediatrician was ranked of highest importance,it was subject to criticism in only 14% of respondents. Physicians in academic practice andthose in practice less than 5 years tended to indicate a higher frequency of problems.Importance is frequently attributed to medical (94%) and developmental (89%) issues inadolescence. However, competency regarding those issues was reported in a much smallerproportion of respondents (61% and 34%, respectively). Conclusion. The goal of successfultransition is continuous and age-appropriate health care. To this end, it is important thatpediatric providers timely educate patients about their medications and the impact of theirIBD on social life. Adult providers would benefit from familiarity with medical and develop-mental issues in adolescence. These adjustments will improve transition and may lead tobetter adherence and better medical outcomes. In the Netherlands, transition may benefitfrom the health care system, in which pediatric and adult medicine are commonly situatedwithin the same hospital.