- Email: [email protected]
Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute ulcerative colitis
A120 AGA ABSTRACTS
GASTROENTEROLOGYVoI.1l8, No.4
752 A POPULATION-BASED ANALYSIS OF PRESCRIPTION DRUG USE AND COSTS IN IBD. Colleen Metge, James F. Blanchard. Sandra Peterson, Charles N. Bernstein, Univ of Manitoba, Winnipeg, MB, Canada. Background and Methods: In 1996 we created the population-based University of Manitoba IBD Database. In 1997 there were 5102 subjects in this database who were current residents of Manitoba. In 1994, Manitoba Health established the Drug Program Information Network (DPIN) which identified all ambulatory prescription drugs (Rx) dispensed to each individual resident of the province. All residents have a personal health identification number and use of this number in a scrambled format allowed for linkage of the IBD database with the DPIN database. We analyzed all Rx and costs for fiscal year 1997, & stratified our analysis by age, gender, urban vs. non-urban residence & by income. Results: 87.5% of subjects received Rx in 1997 (IBD users). There was a direct significant relationship between increasing age and # different Rx IIBD user and total Rx costslIBD user (in adults only). Females used a greater # of different Rxluser but there was no difference in costs/user by gender. There was no difference in # different Rx/user or costs/user for urban vs non-urban residence or by income level. Increased age was associated with increased # different Rx for the following classes of drugs: alimentary, cardiovascular, respiratory, neural, but no difference by age for the use of immunomodulatory, antibiotics, musculoskeletal, dermatologic, hematologic, g-u or hormonal drugs. Only 7.8% used immunomodulatory Rx but these accounted for the greatest cost/user ($1404). The next most costly class was alimentary Rx at $534/user; used by 64.5%. There was increased # alimentary Rxluser with increasing age. Conclusions: Gender and urban residence do not impact on prescription drug use of IBD patients. There is increased use of Rx, including alimentary Rx with age but no differences in immunomodulatory, or antibiotic Rx. (Supported by the Crohn's Colitis Foundation Canada)
Age group
0-17 18·40 41-64 65+ Total
# IBD users
# Different Drug I user
$JIBD user
87 1738 1857 782
3.7 43 50 6.6 5.0
$826 $635 $801 $1014 $774
4464
753 INFLUENCE OF DEPRESSIVE MOOD ON INFLAMMATORY BOWEL DISEASE - 18 MONTHS FOLLOW-UP. Christian Mittermaier, Markus Beier, Wolfgang Tillinger, Alfred Gangl, Gabriele Moser, Univ of Vienna, Depts of Physical Medicine & Rehabilitation, and Gastroenterology, Vienna, Austria. A depressive coping style may interact with disease activity in inflammatory bowel disease (IBD). The aim of this prospective study was to examine the influence of depressive mood and anxiety on the course of IBD over the time period of 18 months. Methods: 51 consecutive patients (31 women and 20 men; median age 31 years) with IBD (43 Crohn s disease, 8 ulcerative colitis) in remission (5 - 12 weeks after relapse) were included. Disease activity and psychosocial status were evaluated at baseline and then every three months for 18 months by means of clinical criteria (Crohn's disease activity index, CDAI, and clinical activity index, CAl), a disease related quality of life questionnaire (IBDQ), the Beck Depression Inventory (BOI), and the Spielberger State-Trait Anxiety Inventory (STAI). Results:The study population experienced 1.65 (mean) relapses per person within 18 months. The sum of relapses during 18 months follow-up correlated with depressive mood (p = 0.02), state (p = 0.02) and trait anxiety (p = 0.04), IBDQ (p = 0.02), and with the sum of relapses within one year before inclusion. There was no correlation with baseline CDAI, CAl,C-reactive protein, and BSR. The sum of relapses within 12 months before the trial correlated with IBDQ but not with depressive mood or anxiety at baseline. Conclusion: Depressive mood, especially a depressive coping style could be a risk factor for relapse in IBD and should be included in clinical management of IBD patients. 754 EVALUATION OF PORTAL BLOOD FLOW CORRELATING ACTIVITIES OF ULCERATIVE AND ISCHEMIC COLITIS WITH DOPPLER ULTRASOUND. Yorihiro Nishiyama, Yutaka Shintani, Izumi Ishizuka, Hiroshi Ueda, Tomonobu Yokono, Shigeki Koyama, Tadao Bamba, Shiga Univ ofMed Sci, Otsu, Shiga, Japan. BACKGROUND AND AIMS: Recently, several investigators have attempted to evaluate the activity of inflammatory bowel disease from the viewpoint of blood flow of mesenteric artery. In the present study, we
aimed to assess the effectiveness of measuring portal vein (PV) blood flow in clinical course of patients suffering from ischemic colitis(IC) and ulcerative colitis(UC), regarding their disease activity. SUBJECTIVES AND METHODS: Dopplerultrasonographic measurement of PV blood flow were performed in 32 patients (IC 14,3 males;UC 18, 12 males) and 10 healthy volunteers. Patients with DC nominated in this study were either pancolitis type or subcolitis type in active stage and patients with IC diagnosed within 24h from their onsets were enrolled. Patients having complicated diseases, which may affect portal vein blood flow such as liver cirrhosis and cardiac diseases were excluded. Disease activity was determined with endoscopic findings, laboratory investigations and clinical examination. Using ultrasonography with doppler units, the PV blood flow parameters (velocity; V ern/sec and flow volume; FV ml/min) were evaluated. Data were analyzed by an unpaired student t- and Wilcoxon tests. RESULTS:Comparing the parameters between active andinactive state of the diseases, PV velocity of the patients with UC demonstrated no remarkable change (Vact: 21.8+/-4.5, Vinact: 22.4+/-5.3)., however, PV flow volume was significantly reduced with improvement of inflammation concomitantly (FVact: 972.6+/-183.6, FVinact: 825.3+/-168.6). On the other hand, PV velocity of the patients with IC revealed an increase (Vact: 14.9+/-4.5, Vinact: 18.0+/-2.4), but not PV flow volume. The variance of PV velocity and flow volume in healthy volunteers could not be shown when measurement was carried out at some intervals by an identical examiner. CONCLUSIONS: Activity of UC and IC causes substantial changes in PV velocity and flow volume. Ultrasonographical measurement of portal vein blood flow may be an important non-invasive tool that can be used to monitor disease activity of UC and Ie.
755 CLINICAL FEATURES OF ERYTHEMA NODOSUM (EN) AND UVEITIS ASSOCIATED WITH INFLAMMATORY BOWEL DISEASE (18D). Tim R. Orchard, C. Chua, H. Cheng, Derek P. Jewell, Univ of Oxford, Oxford, United Kingdom; Oxford Eye Hosp, Oxford, United Kingdom. Background - Uveitis and erythema nodosum (EN) are well recognised complications of inflammatory bowel disease, but description of their clinical features has been variable. This study identified those patients attending the Oxford IBD clinic who had suffered these, in order to establish clearly their natural history and clinical features. Patients and Methods - The case notes of the 1459 patients under active follow up were reviewed to identify those who had suffered from eye complications (iritis, episcleritis, scleritis or uveitis) or erythema nodosum. Information on the timecourse, relationship to the bowel disease and to other extraintestinal manifestations (ElM's) was collected. In addition, a proportion of patients who had suffered eye complications underwent an ophthalmological examination to establish the long term effects of ocular inflammation in IBD. Results - 53 patients with eye complications and 39 with erythema nodosum were identified (a prevalence of 2.8% in UC and 5.4% in Crohn's disease for eye complications and I % and 6% for EN). There was a strong female bias in both groups with a ratio of 6:1 in the EN group and 3:1 in the eye group. In the EN group 53% had EN at or before the time of diagnosis of the IBD, and it was related to relapse of the IBD in 93% of cases. 27% of patients had recurrent episodes. Median duration of episodes was 3weeks (range 1-16 weeks) and they responded to treatment of the bowel disease. In the eye group the commonest diagnosis was iritis, accounting for 60% of patients, with episcleritis accounting for 30% and anterior uveitis for 10%. It was present at or before the time of diagnosis in 19%, and was related to relapse of the IBD in 72%.30% of patients had recurrent episodes. Of the 15 patients who underwent examination, none had symptoms of eye disease but 5 (33%) had signs of old inflammation, all in the anterior chamber. Both Type I and Type 2 arthritis were present in increased numbers in the eye group, but there was only an increase in Type I in the EN group. There was no increase in eye complications in the EN group or vice versa. Conclusions - EN and uveitis are more common in Crohn's disease than DC, and there is a female preponderance in both EIM's. They both tend to occur with relapse of the IBD, although about 30% of uveitis runs a course independent of the IBD. Both present as acute episodes and the majority of patients do not suffer any long term sequelae. Type I Arthritis is more common in both groups and Type 2 in uveitis, but there is no apparent overlap between uveitis and EN per se.
756 BALSALAZIDE IS SUPERIOR TO MESALAMINE IN THE TIME TO IMPROVEMENT OF SIGNS AND SYMPTOMS OF ACUTE ULCERATIVE COLITIS. Ronald Pruitt, John Hanson, Michael Safdi, Lawrence Wruble, Robert Hardi, John F. Johanson, George Koval, Dennis Riff, Barry Winston, Amanda Cross, Pamela Doty, Lorin K. Johnson, Nashville Med Research Ctr, Nashville, TN; Charlotte Gastroenterology and Hepatology, Charlotte, NC; Consultants for C1in Research, Cincinnati, OH; Mid-South C1in Research, Memphis, TN; Metropolitan Gastroenterology Group, P C, Chevy Chase, MD; Rockford Gastroenterology Assoc, Ltd, Rockford, IL; West Hills Gastroenterology Assoc, Portland, OR; Assoc Gastroenterology Med Group, Anaheim, CA; Houston Med Research Assoc. Houston, TX; Cato Research, Ltd, Durham, NC; Salix Pharmaceuticals, Inc, Palo Alto, CA. Previous studies in acute ulcerative colitis (UC) patients comparing the efficacy of balsalazide (BZ), (5-ASA diazo-bonded to an inert carrier) and mesalamine (pH dependent release) have shown differential results. In one
Aprit2000
AGAAllll
12-wk study with 60% newly diagnosed patients (Gastroenterology 1998; 114:15), BZ was statistically superior to mesalamine in complete remission and time to complete relief of symptoms. In another 8-wk study with 16% newly diagnosed patients (Gastroenterology 1997;112:A709), BZ was numerically though not statistically superior to mesalamine in symptom improvement. The present study compared BZ to mesalamine in an 8-wk study with 42% newly diagnosed patients. Methods: 175 patients with acute mild to moderate UC were randomized to BZ 6.75g (=2.4g 5-ASA) or mesalamine 2.4g daily. Patients were stratified according to time since diagnosis (new or relapse) and extent of disease (:54Ocm or > 4Ocm). Endpoints: Primary endpoint was symptomatic remission (SR: absence of rectal bleeding and patient functional assessment of normal or mild) at 8 wk. Secondary endpoints were time to SR, proportion of patients with improved sigmoidoscopic score, stool frequency, physician's global assessment (PGA), absence of rectal bleeding and incidence of adverse events (AE). Results: At 8 wks both groups were comparable in all endpoints. However, among all patients, BZ patients achieved SR 12 days earlier (median time: BZ 25 days vs mesalamine 37 days patients. p=O.I94). In newly diagnosed patients with :540cm of disease, median time to SR was shorter for BZ ( I I days) than mesalamine patients (22 days, p=O.035 ). A significantly greater proportion of all BZ patients had improved symptoms at 14 days vs all mesalamine patients: sigmoidoscopic score 48% vs 30%, p=0.OO2, bowel frequency score 55% vs 36%, p=0.OO6, absence of rectal bleeding 30% vs 15%, p =0.OO6, PGA 48% vs 33%, p=0.0I3. The incidence of AEs was BZ 54% vs mesalamine 64% (n.s.). More rapid symptom improvement was accompanied by a significantly greater mean weight gain in BZ patients ( + l.251bs) compared with mesalamine patients (-0.26Ibs, p=0.049). Conclusions: BZ 6.75g/d is well tolerated and is superior to mesalamine in the time to improvement of signs and symptoms of acute, mild to moderate Uc. Improvement in BZ patients is observed 12-14 days ahead of mesalamine patients with the greatest benefit observed in newly diagnosed patients with left-sided disease (:540 em). Funded by Salix Pharmaceuticals, Inc., Palo Alto, CA 94303 USA.
757 SMALL BOWEL CANCER IN CROHN'S DISEASE: THE UNIVER SITY OF cmCAGO EXPERIENCE. David T. Rubin, Bryan McVerry, Stephen B. Hanauer, Univ of Chicago, Chicago, IL. Background: Adenocarcinoma of the small bowel (SBCA) is a rare, but increasingly recognized, complication of Crohn' s disease(CD). Pre vious reports have proposed: long duration of unresected disease, surgically excluded small bowel, chronic fisrulae, prolonged immune modulation, occupational carcinogen exposure, jejunal CD, and male gender as risk factors for development of SBCA. Aim: To evaluate risk factors for SBCA in a tertiary CD population. Methods: The University of Chicago Inflammatory Bowel Disease (IBD) registry was searched for patients with CD and SBCA. Medical records were reviewed to identify potential risk factors of SBCA as well as smoking history and family history of IBD or intestinal cancer. Results: Eight cases of SBCA were identified amongst the 2657 CD registry patients (~ 30 l/1 00000) . None had surgically excluded bowel or recognized occupational carcinogen exposure. One patient had a family history of IBD (pt #1), and none had a family history of intestinal cancer. The mean duration of disease before the diagnosis of SBCA was 21.5 yrs (range 3-37). Additional characteristic s are listed. Conclusions: The primary risk factor of SBCA in this large, tertiary IBD population was a long duration of unresected disease . SBCA was diagnosed in both the ileum and jejunum in the absence of surgical bypass, fistulizing disease, or prolonged immune modulation. Novel surveillance techniques for SBCA in longstanding small bowel CD will become increasingly important as chronic medical therapy improves. #
1 2 3 4
5 6 7 8
Sex
M
F F M M M M
F
Age@
D1seue
SBCA
COdx
duration'
location
11 15 33 22 17 26
22 31 10 22 27
jejunum ileum jejunum ileum ileum jejunum
48
20 3
12
37
Tobacco
ileum jejunum
'Duration ofCDprior todiagnosisof SBCA, "6-lIleICaptopurine>6mos.
Fistula
6·MP"
758 PERSONALITY FACTORS ARE IMPORTANT PREDICTORS OF PSYCHOLOGICAL MORBIDITY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. Katherine M. Sheehan, Christopher Steele, Adrian O'Gara, Anna M. Kelly, Eva Doherty. Steven E. Patchett. Frank E. Murray, Gastroenterology Dept, Beaumont Hosp, Dublin, Ireland; Dept of Psychology, Royal Coli of Surgeons in Ireland, Dublin, Ireland. Background: Although several studies have suggested increased anxiety and depression in patients with inflammatory bowel disease (IBD), the relationship of these features to disease activity is unclear . The aim of this study was to assess I) the level of psychological distress in IBD patients and 2) whether it was related to disease activity, or personality variables, such as a patients self efficacy (belief in one s ability to control outcome) and acceptance of illness. Patients and Methods: 57 patients were evaluated (36 Crohns, 2 1 Ulcerative Colitis). Median age was 34 yrs (range 16-7 \) . The mean duration of illness was 5.8 years. Anxiety and depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS). Self Efficacy was scored using the Generalized Self Efficacy Scale (GSES). Adjustment to illness was evaluated using the Acceptance of IIIness Scale (AIS) and disease activity was measured using the Crohns Disease Activity IIIness (COAl) and the Clinical Activity I1lness for Ulcerative Colitis (CAl) . Levels of pain were also scored using a \Ocm visual analogue scale (VAS). Results: A high level of psychological morbidity was observed in this cohort, 61% of patients demonstrated anxiety levels above the cut-off point while 24% of patients reported depression levels above the cut-off. Anxiety levels correlated with depressive symptoms (p=0.OO8). Females showed higher depression scores than males (p=0.03). Age correlated significantly with anxiety (p=O .OI) but not depression. 40% of patients reported pain on the VAS. Multiple regression analyses did not demonstrate a relationship between anxiety or depressive symptoms, and duration of illness, pain or disease activity. On the other hand, poor self efficacy correlated with both anxiety (p=0.OO03) and depression (p =O.OO4). Low acceptance of illness scores also significantly correlated with both anxiety (p =O.OOO4) and depression (p
759 PSYCHOLOGIGAL WELL-BEING AND GASTROINTESTINAL SYMPTOMS IN INFLAMMATORY BOWEL DISEASE IN REMISSION. Magnus Sirnren, Jenny Axelsson, Hasse Abrahamsson, Jan Svedlund, Einar S. Bjsrnsson, Sahlgrenska Univ Hosp, Gothenburg, Sweden. Patients with inflammatory bowel disease (IBD) demonstrate reduced health-related quality of life. We wanted to explore if this is true also when the lBO-patients are in remission, by assessing the psychological general well-being and subjective gastrointestinal (GI) symptoms. Methods: 83 patients with IBD (43 ulcerative colitis (UC), 40 Crohn's disease (CD); 36 males, 47 females; age 21-80 years) completed the following self-administered questionnaires: the Psychological General Well-being Index (PGWB) and the Gastrointestinal Symptom Rating Scale (GSRS). Patients were in clinical, biochemical and endoscopical remission for at least 10 months when participating in the study. The results were compared between UC and CD and with reference values from the general population (Dimenas et al; Scand J Gastroenterol 1996; 31 Suppl 221 :8-13). Results: The PGWB index in the IBD patients (103.1. 95% CI 99.4-106.8) were similar to that in the general population (102.9 (102.1-103.8)). However, the psychological general well-being was better in UC (107.4 (l03.2106.8)) than in CD (98.5 (92.5- 104.6») (p = O.0 4). Vitality was lower in CD (15.5 (14.1- 16.9)) compared both to the reference values (17.2 (17.0-17.4)) (p = O.02) and 10 UC (17.8 (16.8- 18.9)) (p= 0.02) . CD also had less positive well-being (p= O.OO4) and self-control (p= O.OI) than Uc. Subjective gastrointestinal symptoms were higher in IBD patients (GSRS total score 2.92 (2.74-3.10)) than in the general population (1.53 (1.50-1.55). CD rated their subjective GI symptoms higher than UC (p = O.004), especially abdominal pain (p = O.OO4), diarrhea (p
GASTROENTEROLOGYVoI.1l8, No.4
752 A POPULATION-BASED ANALYSIS OF PRESCRIPTION DRUG USE AND COSTS IN IBD. Colleen Metge, James F. Blanchard. Sandra Peterson, Charles N. Bernstein, Univ of Manitoba, Winnipeg, MB, Canada. Background and Methods: In 1996 we created the population-based University of Manitoba IBD Database. In 1997 there were 5102 subjects in this database who were current residents of Manitoba. In 1994, Manitoba Health established the Drug Program Information Network (DPIN) which identified all ambulatory prescription drugs (Rx) dispensed to each individual resident of the province. All residents have a personal health identification number and use of this number in a scrambled format allowed for linkage of the IBD database with the DPIN database. We analyzed all Rx and costs for fiscal year 1997, & stratified our analysis by age, gender, urban vs. non-urban residence & by income. Results: 87.5% of subjects received Rx in 1997 (IBD users). There was a direct significant relationship between increasing age and # different Rx IIBD user and total Rx costslIBD user (in adults only). Females used a greater # of different Rxluser but there was no difference in costs/user by gender. There was no difference in # different Rx/user or costs/user for urban vs non-urban residence or by income level. Increased age was associated with increased # different Rx for the following classes of drugs: alimentary, cardiovascular, respiratory, neural, but no difference by age for the use of immunomodulatory, antibiotics, musculoskeletal, dermatologic, hematologic, g-u or hormonal drugs. Only 7.8% used immunomodulatory Rx but these accounted for the greatest cost/user ($1404). The next most costly class was alimentary Rx at $534/user; used by 64.5%. There was increased # alimentary Rxluser with increasing age. Conclusions: Gender and urban residence do not impact on prescription drug use of IBD patients. There is increased use of Rx, including alimentary Rx with age but no differences in immunomodulatory, or antibiotic Rx. (Supported by the Crohn's Colitis Foundation Canada)
Age group
0-17 18·40 41-64 65+ Total
# IBD users
# Different Drug I user
$JIBD user
87 1738 1857 782
3.7 43 50 6.6 5.0
$826 $635 $801 $1014 $774
4464
753 INFLUENCE OF DEPRESSIVE MOOD ON INFLAMMATORY BOWEL DISEASE - 18 MONTHS FOLLOW-UP. Christian Mittermaier, Markus Beier, Wolfgang Tillinger, Alfred Gangl, Gabriele Moser, Univ of Vienna, Depts of Physical Medicine & Rehabilitation, and Gastroenterology, Vienna, Austria. A depressive coping style may interact with disease activity in inflammatory bowel disease (IBD). The aim of this prospective study was to examine the influence of depressive mood and anxiety on the course of IBD over the time period of 18 months. Methods: 51 consecutive patients (31 women and 20 men; median age 31 years) with IBD (43 Crohn s disease, 8 ulcerative colitis) in remission (5 - 12 weeks after relapse) were included. Disease activity and psychosocial status were evaluated at baseline and then every three months for 18 months by means of clinical criteria (Crohn's disease activity index, CDAI, and clinical activity index, CAl), a disease related quality of life questionnaire (IBDQ), the Beck Depression Inventory (BOI), and the Spielberger State-Trait Anxiety Inventory (STAI). Results:The study population experienced 1.65 (mean) relapses per person within 18 months. The sum of relapses during 18 months follow-up correlated with depressive mood (p = 0.02), state (p = 0.02) and trait anxiety (p = 0.04), IBDQ (p = 0.02), and with the sum of relapses within one year before inclusion. There was no correlation with baseline CDAI, CAl,C-reactive protein, and BSR. The sum of relapses within 12 months before the trial correlated with IBDQ but not with depressive mood or anxiety at baseline. Conclusion: Depressive mood, especially a depressive coping style could be a risk factor for relapse in IBD and should be included in clinical management of IBD patients. 754 EVALUATION OF PORTAL BLOOD FLOW CORRELATING ACTIVITIES OF ULCERATIVE AND ISCHEMIC COLITIS WITH DOPPLER ULTRASOUND. Yorihiro Nishiyama, Yutaka Shintani, Izumi Ishizuka, Hiroshi Ueda, Tomonobu Yokono, Shigeki Koyama, Tadao Bamba, Shiga Univ ofMed Sci, Otsu, Shiga, Japan. BACKGROUND AND AIMS: Recently, several investigators have attempted to evaluate the activity of inflammatory bowel disease from the viewpoint of blood flow of mesenteric artery. In the present study, we
aimed to assess the effectiveness of measuring portal vein (PV) blood flow in clinical course of patients suffering from ischemic colitis(IC) and ulcerative colitis(UC), regarding their disease activity. SUBJECTIVES AND METHODS: Dopplerultrasonographic measurement of PV blood flow were performed in 32 patients (IC 14,3 males;UC 18, 12 males) and 10 healthy volunteers. Patients with DC nominated in this study were either pancolitis type or subcolitis type in active stage and patients with IC diagnosed within 24h from their onsets were enrolled. Patients having complicated diseases, which may affect portal vein blood flow such as liver cirrhosis and cardiac diseases were excluded. Disease activity was determined with endoscopic findings, laboratory investigations and clinical examination. Using ultrasonography with doppler units, the PV blood flow parameters (velocity; V ern/sec and flow volume; FV ml/min) were evaluated. Data were analyzed by an unpaired student t- and Wilcoxon tests. RESULTS:Comparing the parameters between active andinactive state of the diseases, PV velocity of the patients with UC demonstrated no remarkable change (Vact: 21.8+/-4.5, Vinact: 22.4+/-5.3)., however, PV flow volume was significantly reduced with improvement of inflammation concomitantly (FVact: 972.6+/-183.6, FVinact: 825.3+/-168.6). On the other hand, PV velocity of the patients with IC revealed an increase (Vact: 14.9+/-4.5, Vinact: 18.0+/-2.4), but not PV flow volume. The variance of PV velocity and flow volume in healthy volunteers could not be shown when measurement was carried out at some intervals by an identical examiner. CONCLUSIONS: Activity of UC and IC causes substantial changes in PV velocity and flow volume. Ultrasonographical measurement of portal vein blood flow may be an important non-invasive tool that can be used to monitor disease activity of UC and Ie.
755 CLINICAL FEATURES OF ERYTHEMA NODOSUM (EN) AND UVEITIS ASSOCIATED WITH INFLAMMATORY BOWEL DISEASE (18D). Tim R. Orchard, C. Chua, H. Cheng, Derek P. Jewell, Univ of Oxford, Oxford, United Kingdom; Oxford Eye Hosp, Oxford, United Kingdom. Background - Uveitis and erythema nodosum (EN) are well recognised complications of inflammatory bowel disease, but description of their clinical features has been variable. This study identified those patients attending the Oxford IBD clinic who had suffered these, in order to establish clearly their natural history and clinical features. Patients and Methods - The case notes of the 1459 patients under active follow up were reviewed to identify those who had suffered from eye complications (iritis, episcleritis, scleritis or uveitis) or erythema nodosum. Information on the timecourse, relationship to the bowel disease and to other extraintestinal manifestations (ElM's) was collected. In addition, a proportion of patients who had suffered eye complications underwent an ophthalmological examination to establish the long term effects of ocular inflammation in IBD. Results - 53 patients with eye complications and 39 with erythema nodosum were identified (a prevalence of 2.8% in UC and 5.4% in Crohn's disease for eye complications and I % and 6% for EN). There was a strong female bias in both groups with a ratio of 6:1 in the EN group and 3:1 in the eye group. In the EN group 53% had EN at or before the time of diagnosis of the IBD, and it was related to relapse of the IBD in 93% of cases. 27% of patients had recurrent episodes. Median duration of episodes was 3weeks (range 1-16 weeks) and they responded to treatment of the bowel disease. In the eye group the commonest diagnosis was iritis, accounting for 60% of patients, with episcleritis accounting for 30% and anterior uveitis for 10%. It was present at or before the time of diagnosis in 19%, and was related to relapse of the IBD in 72%.30% of patients had recurrent episodes. Of the 15 patients who underwent examination, none had symptoms of eye disease but 5 (33%) had signs of old inflammation, all in the anterior chamber. Both Type I and Type 2 arthritis were present in increased numbers in the eye group, but there was only an increase in Type I in the EN group. There was no increase in eye complications in the EN group or vice versa. Conclusions - EN and uveitis are more common in Crohn's disease than DC, and there is a female preponderance in both EIM's. They both tend to occur with relapse of the IBD, although about 30% of uveitis runs a course independent of the IBD. Both present as acute episodes and the majority of patients do not suffer any long term sequelae. Type I Arthritis is more common in both groups and Type 2 in uveitis, but there is no apparent overlap between uveitis and EN per se.
756 BALSALAZIDE IS SUPERIOR TO MESALAMINE IN THE TIME TO IMPROVEMENT OF SIGNS AND SYMPTOMS OF ACUTE ULCERATIVE COLITIS. Ronald Pruitt, John Hanson, Michael Safdi, Lawrence Wruble, Robert Hardi, John F. Johanson, George Koval, Dennis Riff, Barry Winston, Amanda Cross, Pamela Doty, Lorin K. Johnson, Nashville Med Research Ctr, Nashville, TN; Charlotte Gastroenterology and Hepatology, Charlotte, NC; Consultants for C1in Research, Cincinnati, OH; Mid-South C1in Research, Memphis, TN; Metropolitan Gastroenterology Group, P C, Chevy Chase, MD; Rockford Gastroenterology Assoc, Ltd, Rockford, IL; West Hills Gastroenterology Assoc, Portland, OR; Assoc Gastroenterology Med Group, Anaheim, CA; Houston Med Research Assoc. Houston, TX; Cato Research, Ltd, Durham, NC; Salix Pharmaceuticals, Inc, Palo Alto, CA. Previous studies in acute ulcerative colitis (UC) patients comparing the efficacy of balsalazide (BZ), (5-ASA diazo-bonded to an inert carrier) and mesalamine (pH dependent release) have shown differential results. In one
Aprit2000
AGAAllll
12-wk study with 60% newly diagnosed patients (Gastroenterology 1998; 114:15), BZ was statistically superior to mesalamine in complete remission and time to complete relief of symptoms. In another 8-wk study with 16% newly diagnosed patients (Gastroenterology 1997;112:A709), BZ was numerically though not statistically superior to mesalamine in symptom improvement. The present study compared BZ to mesalamine in an 8-wk study with 42% newly diagnosed patients. Methods: 175 patients with acute mild to moderate UC were randomized to BZ 6.75g (=2.4g 5-ASA) or mesalamine 2.4g daily. Patients were stratified according to time since diagnosis (new or relapse) and extent of disease (:54Ocm or > 4Ocm). Endpoints: Primary endpoint was symptomatic remission (SR: absence of rectal bleeding and patient functional assessment of normal or mild) at 8 wk. Secondary endpoints were time to SR, proportion of patients with improved sigmoidoscopic score, stool frequency, physician's global assessment (PGA), absence of rectal bleeding and incidence of adverse events (AE). Results: At 8 wks both groups were comparable in all endpoints. However, among all patients, BZ patients achieved SR 12 days earlier (median time: BZ 25 days vs mesalamine 37 days patients. p=O.I94). In newly diagnosed patients with :540cm of disease, median time to SR was shorter for BZ ( I I days) than mesalamine patients (22 days, p=O.035 ). A significantly greater proportion of all BZ patients had improved symptoms at 14 days vs all mesalamine patients: sigmoidoscopic score 48% vs 30%, p=0.OO2, bowel frequency score 55% vs 36%, p=0.OO6, absence of rectal bleeding 30% vs 15%, p =0.OO6, PGA 48% vs 33%, p=0.0I3. The incidence of AEs was BZ 54% vs mesalamine 64% (n.s.). More rapid symptom improvement was accompanied by a significantly greater mean weight gain in BZ patients ( + l.251bs) compared with mesalamine patients (-0.26Ibs, p=0.049). Conclusions: BZ 6.75g/d is well tolerated and is superior to mesalamine in the time to improvement of signs and symptoms of acute, mild to moderate Uc. Improvement in BZ patients is observed 12-14 days ahead of mesalamine patients with the greatest benefit observed in newly diagnosed patients with left-sided disease (:540 em). Funded by Salix Pharmaceuticals, Inc., Palo Alto, CA 94303 USA.
757 SMALL BOWEL CANCER IN CROHN'S DISEASE: THE UNIVER SITY OF cmCAGO EXPERIENCE. David T. Rubin, Bryan McVerry, Stephen B. Hanauer, Univ of Chicago, Chicago, IL. Background: Adenocarcinoma of the small bowel (SBCA) is a rare, but increasingly recognized, complication of Crohn' s disease(CD). Pre vious reports have proposed: long duration of unresected disease, surgically excluded small bowel, chronic fisrulae, prolonged immune modulation, occupational carcinogen exposure, jejunal CD, and male gender as risk factors for development of SBCA. Aim: To evaluate risk factors for SBCA in a tertiary CD population. Methods: The University of Chicago Inflammatory Bowel Disease (IBD) registry was searched for patients with CD and SBCA. Medical records were reviewed to identify potential risk factors of SBCA as well as smoking history and family history of IBD or intestinal cancer. Results: Eight cases of SBCA were identified amongst the 2657 CD registry patients (~ 30 l/1 00000) . None had surgically excluded bowel or recognized occupational carcinogen exposure. One patient had a family history of IBD (pt #1), and none had a family history of intestinal cancer. The mean duration of disease before the diagnosis of SBCA was 21.5 yrs (range 3-37). Additional characteristic s are listed. Conclusions: The primary risk factor of SBCA in this large, tertiary IBD population was a long duration of unresected disease . SBCA was diagnosed in both the ileum and jejunum in the absence of surgical bypass, fistulizing disease, or prolonged immune modulation. Novel surveillance techniques for SBCA in longstanding small bowel CD will become increasingly important as chronic medical therapy improves. #
1 2 3 4
5 6 7 8
Sex
M
F F M M M M
F
Age@
D1seue
SBCA
COdx
duration'
location
11 15 33 22 17 26
22 31 10 22 27
jejunum ileum jejunum ileum ileum jejunum
48
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12
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ileum jejunum
'Duration ofCDprior todiagnosisof SBCA, "6-lIleICaptopurine>6mos.
Fistula
6·MP"
758 PERSONALITY FACTORS ARE IMPORTANT PREDICTORS OF PSYCHOLOGICAL MORBIDITY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. Katherine M. Sheehan, Christopher Steele, Adrian O'Gara, Anna M. Kelly, Eva Doherty. Steven E. Patchett. Frank E. Murray, Gastroenterology Dept, Beaumont Hosp, Dublin, Ireland; Dept of Psychology, Royal Coli of Surgeons in Ireland, Dublin, Ireland. Background: Although several studies have suggested increased anxiety and depression in patients with inflammatory bowel disease (IBD), the relationship of these features to disease activity is unclear . The aim of this study was to assess I) the level of psychological distress in IBD patients and 2) whether it was related to disease activity, or personality variables, such as a patients self efficacy (belief in one s ability to control outcome) and acceptance of illness. Patients and Methods: 57 patients were evaluated (36 Crohns, 2 1 Ulcerative Colitis). Median age was 34 yrs (range 16-7 \) . The mean duration of illness was 5.8 years. Anxiety and depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS). Self Efficacy was scored using the Generalized Self Efficacy Scale (GSES). Adjustment to illness was evaluated using the Acceptance of IIIness Scale (AIS) and disease activity was measured using the Crohns Disease Activity IIIness (COAl) and the Clinical Activity I1lness for Ulcerative Colitis (CAl) . Levels of pain were also scored using a \Ocm visual analogue scale (VAS). Results: A high level of psychological morbidity was observed in this cohort, 61% of patients demonstrated anxiety levels above the cut-off point while 24% of patients reported depression levels above the cut-off. Anxiety levels correlated with depressive symptoms (p=0.OO8). Females showed higher depression scores than males (p=0.03). Age correlated significantly with anxiety (p=O .OI) but not depression. 40% of patients reported pain on the VAS. Multiple regression analyses did not demonstrate a relationship between anxiety or depressive symptoms, and duration of illness, pain or disease activity. On the other hand, poor self efficacy correlated with both anxiety (p=0.OO03) and depression (p =O.OO4). Low acceptance of illness scores also significantly correlated with both anxiety (p =O.OOO4) and depression (p
759 PSYCHOLOGIGAL WELL-BEING AND GASTROINTESTINAL SYMPTOMS IN INFLAMMATORY BOWEL DISEASE IN REMISSION. Magnus Sirnren, Jenny Axelsson, Hasse Abrahamsson, Jan Svedlund, Einar S. Bjsrnsson, Sahlgrenska Univ Hosp, Gothenburg, Sweden. Patients with inflammatory bowel disease (IBD) demonstrate reduced health-related quality of life. We wanted to explore if this is true also when the lBO-patients are in remission, by assessing the psychological general well-being and subjective gastrointestinal (GI) symptoms. Methods: 83 patients with IBD (43 ulcerative colitis (UC), 40 Crohn's disease (CD); 36 males, 47 females; age 21-80 years) completed the following self-administered questionnaires: the Psychological General Well-being Index (PGWB) and the Gastrointestinal Symptom Rating Scale (GSRS). Patients were in clinical, biochemical and endoscopical remission for at least 10 months when participating in the study. The results were compared between UC and CD and with reference values from the general population (Dimenas et al; Scand J Gastroenterol 1996; 31 Suppl 221 :8-13). Results: The PGWB index in the IBD patients (103.1. 95% CI 99.4-106.8) were similar to that in the general population (102.9 (102.1-103.8)). However, the psychological general well-being was better in UC (107.4 (l03.2106.8)) than in CD (98.5 (92.5- 104.6») (p = O.0 4). Vitality was lower in CD (15.5 (14.1- 16.9)) compared both to the reference values (17.2 (17.0-17.4)) (p = O.02) and 10 UC (17.8 (16.8- 18.9)) (p= 0.02) . CD also had less positive well-being (p= O.OO4) and self-control (p= O.OI) than Uc. Subjective gastrointestinal symptoms were higher in IBD patients (GSRS total score 2.92 (2.74-3.10)) than in the general population (1.53 (1.50-1.55). CD rated their subjective GI symptoms higher than UC (p = O.004), especially abdominal pain (p = O.OO4), diarrhea (p