- Email: [email protected]
Impatient and outpatient costs of care for inflammatory bowel disease in the year 2000
patients maintained a complete remission during the two years of follow-up. Conclusion. The combined oral plus topical 5-ASA treatment, continuously administered along two years, s~gnificantly modifies the clinical course of the moderate to severe UC. It is speculated that this effect has been obtained by increasing mucosal drug concentration in the study period with respect to control period. • G Fneri, Giacomelh R, Pimpo MT et al Gut 2000, 47: 41014 ;G Frieri, MT Pimp& GC Palumbo et al : Aliment Pharmacol Thor 1999; 13:1413-17
blind controlled clinical trial was performed. Outpatients with active left-sided ulcerative colitis were either started on mesalazine 1.2 gm/day or had the dose increased by an equivalent amount. They were taught to self-administer enemas which contained either EGF (5 mcg EGF in 100 ml) or an inert carrier (control) once a day for 14 days. They were reviewed at 14 and 28 days. Results: Eleven patients received EGF and 12 placebo. Both groups had similar baseline characteristics. Eight patients in the EGF group and nine in the p~acebogroup were on mesalazinebefore recruitment to the study. Two patients from the placebo group developed worsening colitis and were withdrawn. After 2 weeks of enematreatment, there were significant improvements in the EGF treated group in symptom score (score 0 or 1 for the absence or presence of liquid stools, nocturnal diarrhoea and visible blood in stools) from median 3 to 1 (p=O.O02), diarrhoea from median 5 to 2 motions/24 hours (p
58 Molticenter, Randomized Trial Comparing Oral, Topic and Oral Plus Topic Mesalazine in PreveMion of Relapse in Distal Ulcerative Colitis (DUC). Jnaquin Hinojosa, Agueda Abad, Julian Panes, Ignacio Fernandez-Blanco,Carlos M de SOl& Miquel A. Gassull, Spanish Group for the Study of IBD (GETECCU)Spain A previous study of GETECCU(Spanish Group for Study of IBD) has proved that topical and combined treatment with mesalazine are equally effective and better than oral therapy alone in inducing remission in active Oista[ Ulcerative Colitis (OUC) (Gastroenterology 2000;118:A778-9). However,ther'snt defined guides-lines in the prevention of relapse with mecalazine in the patients with DUC. Aim:Randomized,controlled trial comparing, in a large series of patients, the long-term effectiveness of oral, topic (foam) or combined mesalazine treatment in maintaining clinical and endoscopic remission Jrl patients with mild to moderately active OUC.Method:67 patients in complete remission were randomized to receive mesalazine as rectal foam (1 g/48h, n=27), oral tablets (500 mg tid,n=17)or combined treatment (n = 23). Diseaseactivity was assessed by a score combining clinical and endoscopic parameters, ranging from 0 to 6. Complete remission was defined as a score --2 and relapse when it was>2. Treatment was administered for 12 months; relapses rates were assassed each 3 months. Results: All groups were homogeneous at baseline. The global relapse was 15%(10/ 67 patients) at 12 months (8/10 at 6 m). The table shows the relapse rates in each treatment group. All treatmentS were well tolerated and mild side effects were observed only in 7 patients. Condosions:l )Mesalazineis effective in maintaining remission in patients with DUC;2) Oral,topical and combined treatment with mesalazine are equally effective in prevention of relapse
56 Idiosyncratic Adverse Reactions to 6-Meroaptopudne (6-MP) and Azathiopdne (AZA) Can Be Averted by Switching to Thioguanine(6-TG) in Patients with IBD. Maria C. Dubinsky, Edward Feldman, Maria T. Abreu, Cedars-Sinai Medical Ctr, Los Angeles, CA; Ernest G. Seidman, Ste-Justine Hosp, Montreal Canada; Darren Baroni, Tripler AMC, Honolulu, HI; Asher Kornbluth, Mount Sinai Medical Ctr, New York, NY; Stephan R. Targan, Eric A. Vasiliauskas, Cedars-Sinai Medical Ctr, Los Angeles, CA Background: Approximately 15% of IBD patients receiving 6-MP/AZA develop idiosyncratic adverse drug reactions necessitating early discontinuation of traditional thiopurines. These reactions, which include pancreatitis, abdominal pain, fever, arthralgias, royalgias, dermatitis, nausea, fatigue, typically reoccur upon rechallenge. Our recent pilot study suggested that 6TG, a closely related thiopurine, was efficacious and well tolerated in a subgroup of IBD patients resistant to 6-MP. Aim: To determine if 6-MP/AZA induced idiosyncratic adverse reactions can be avoided by swifcbing to 6-TG therapy. Methods: This cohort of IBD patents was compiled from the experience of a group of gastroenterologists who used 6-TG as an alternate thiopurine in patients intolerant to 6-MP/AZA. Idiosyncratic reactions must have been documented within 1 month of 6-MP/AZA initiation. Results: 6-TG was initiated in 17 IBD patients at a median [range] dose of 20 [10-40] mg/day. Median age was 43 [9-63] years. An idiosyncratic reaction reoccurred in only 1/17 patients (see table) at the same 2 week time point as had been previously experienced with 6-MP. Conclusions: The results of this observational study suggest that 6-TG is well tolerated and can be used as an alternate thiopurine in patients intolerant to traditional 6-MP/AZA. Based on these results, combined with the previously suggested efficacy data, further evaluation of 6-TG is warranted in IBD.
ReJape=reZe= TOPICAL N Lose 3m 6m 9m t2m ToMI
pancreatitis acute abdominal pain feverlmyalgiaslarthralgias rash nausea fatigue TOTAL
5 1 5 1 12
1 2 1 0 4(15%)
ORAL N Lose 17 11 10 8 1
5 0 2 t 8
R t 1 0 0 2(t1%)
COMBINED N Lose 23 19 12 8 23
3 5 3 0 11
R 1 2 1 0 4(17%)
i)>0.05 R=r~p~
59
F~equencyof IdiosyncraticreaclJonson 6-MP/AZAvs 6-TG IDIOSYNCRATIC REACTION
27 21 18 12 2
R
6-MPI/~ (n)
6-TG (n)
6 3 4 1 1 2 17
0 0 1 0 o 0 1
InpatieM And OutpMieM Costs Of Care For IMlammMoP/Bowel Disease In The Year 2000 Michael 0. Rice, Kristen O. Arsefleau, Stephen J. Bickston, Fabio Cominelli, Univ of Virginia Health System, Charlottesville, VA BACKGROUND: Inpatient and outpatient direct costs for inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are substantial and have not been estimated in a single US population since 1990. Changesin health care delivery and introduction of costly new drugs may have impacted total direct costs, as well as the distribution of costs among inpatient and outpatient care. The aim of this study was to assess the distribution of inpatient and outpatient costs for IBD patients admitted to a University Hospital (UVA) during fiscal year 2000 (FY2000). METHODS:The Clinical Data Repository (COR) is an administrative database containing clinical, financial, and demographic data on all inpatient and outpatient admissions to UVA since 1993. Adult IBD patients treated at UVA during FY2OO0were identified by ICD-9 codes. Costs for inpatient and outpatient visit were calculated using cost-charge ratios and aggregated by revenue code. Previously published cost data from 1990 were inflation-adjusted to FY2000 US dollars (Hays etal. J Clin Gastroenterol 1992;14:318-27). Two physicians reviewed the medical records of a random 30% subsample to validate ICD9 diagnosis coding. RESULTS: We identified 310 CD and 182 UC patients (90 inpatient cases, 1198 outpatient cases). Our cohort was 85% white and 53% female. ICD-9 coding accuracy was 97%. During FY2000, total annual direct costs were $1,037,360 for CO and $412,147 for UC. The average cost per CD patient was lower in 2000 than in 1990 ($3,346 vs. $8,521 [inflation-adjusted)), but similar for UC ($2,265 vs. $1,934 [inflation-adjusted)). CD total costs were evenly distributed between inpatient and outpatient care (54.8% vs. 45.2%), but UC costs were heavily weighted towards inpatient care (89.6%). CD total direct costs were distributed as follows: drug/pharmacy=44.9%, surgery=10.9%, laboratory=4.8%, radiology = 3.6%, endoscopy = 3.8%, pathology = 1.1%, clinic = 2.3%, and other (room/board, emergency room, etc)=28.6%. The distribution for UC was: drug/pharmacy=7.3%, surgery = 34.1%, laboratory = 4.4%, radiology = 1.5%, endoscopy = 5.0%, pathology = 3.9%, clinic = 1.0%, and other = 42.8%. CONCLUSIONS:The averagecost per CD patient in FY2000 was lower than in 1990, but remained constant for UC. Our results suggest that despite the high cost of new biological therapies for CD, the overall direct medical costs per patient have decreased due to a shift in practice away from hospitalizations and surgery.
57 Continuous Oral Plus Topical 5-ASA Administration SignificaMly Modifies The Clinical Course Of Ulcerative Colitis Mariateresa Mt Pimpo, Brigida B. Galleth, Giovanni G. Latella, Maria M. Chlaramonte, Gastroenterology Unit, L'Aquila Italy; Renzo R. Caprilli, Gastroenterology Unit, Rome Italy; Giuseppe G. Fried, Gastroenterology Unit, L'Aquila Italy Backgrouod/Aim A cross-sectional study has shown that concentration of Meealazine(5-ASA) in the large bowel mucoca is inversely correlated to severity of ulcerative colitis ~. This study was carried out with the aim to evaluate whether maintaining a long term high mucosal colonic concentrationof 5-ASA could modify the clinical course of moderate to severe disease. To date, the only established way to obtain the highest 5-ASA mucocal concentration in distal cotonic segments is the association of oral plus topical treatment 2. Methods. Eighteen consecutive UC patients in clinical remission which had had at least four moderate to severe relapses in the preceding two years (controlperiod), were assigned to a two years continuous oral plus topical 5-ASA treatment (study period). The previous treatment for all patients consisted of continuous oral 5-ASA and, during recurrences, steroids and/or topical 5-ASA. The treatment of the study period consisted in oral 5-ASA 2.4/4.8 g/day plus topical 5-ASA 12/28 g/week. Humber of recurrences, number of non-programmed visits and endoscopy, courses of steroids and days of hospitalisation were evaluated in the study period and compared with the same data recorded in the control period. The comparison was possible since in our IBD study group all patients are submitted to an identical follow-up procedure that assure a periodical or critical assessment of standardised parameters. A non parametric test for paired data (signed rank test) was used for statistical analysis. Results. Significantly lower number of recurrence (p =0.002) number of non-programmed visits (p=O,O02) and endoscopy (p = 0,016), courses of steroids (p = 0.004) and days of hospitalication (p = 0.03) were observed during the two years of oral plus topical treatment in comparison with the control period. In particular, only two patients had one mild recurrence while the remaining
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blind controlled clinical trial was performed. Outpatients with active left-sided ulcerative colitis were either started on mesalazine 1.2 gm/day or had the dose increased by an equivalent amount. They were taught to self-administer enemas which contained either EGF (5 mcg EGF in 100 ml) or an inert carrier (control) once a day for 14 days. They were reviewed at 14 and 28 days. Results: Eleven patients received EGF and 12 placebo. Both groups had similar baseline characteristics. Eight patients in the EGF group and nine in the p~acebogroup were on mesalazinebefore recruitment to the study. Two patients from the placebo group developed worsening colitis and were withdrawn. After 2 weeks of enematreatment, there were significant improvements in the EGF treated group in symptom score (score 0 or 1 for the absence or presence of liquid stools, nocturnal diarrhoea and visible blood in stools) from median 3 to 1 (p=O.O02), diarrhoea from median 5 to 2 motions/24 hours (p
58 Molticenter, Randomized Trial Comparing Oral, Topic and Oral Plus Topic Mesalazine in PreveMion of Relapse in Distal Ulcerative Colitis (DUC). Jnaquin Hinojosa, Agueda Abad, Julian Panes, Ignacio Fernandez-Blanco,Carlos M de SOl& Miquel A. Gassull, Spanish Group for the Study of IBD (GETECCU)Spain A previous study of GETECCU(Spanish Group for Study of IBD) has proved that topical and combined treatment with mesalazine are equally effective and better than oral therapy alone in inducing remission in active Oista[ Ulcerative Colitis (OUC) (Gastroenterology 2000;118:A778-9). However,ther'snt defined guides-lines in the prevention of relapse with mecalazine in the patients with DUC. Aim:Randomized,controlled trial comparing, in a large series of patients, the long-term effectiveness of oral, topic (foam) or combined mesalazine treatment in maintaining clinical and endoscopic remission Jrl patients with mild to moderately active OUC.Method:67 patients in complete remission were randomized to receive mesalazine as rectal foam (1 g/48h, n=27), oral tablets (500 mg tid,n=17)or combined treatment (n = 23). Diseaseactivity was assessed by a score combining clinical and endoscopic parameters, ranging from 0 to 6. Complete remission was defined as a score --2 and relapse when it was>2. Treatment was administered for 12 months; relapses rates were assassed each 3 months. Results: All groups were homogeneous at baseline. The global relapse was 15%(10/ 67 patients) at 12 months (8/10 at 6 m). The table shows the relapse rates in each treatment group. All treatmentS were well tolerated and mild side effects were observed only in 7 patients. Condosions:l )Mesalazineis effective in maintaining remission in patients with DUC;2) Oral,topical and combined treatment with mesalazine are equally effective in prevention of relapse
56 Idiosyncratic Adverse Reactions to 6-Meroaptopudne (6-MP) and Azathiopdne (AZA) Can Be Averted by Switching to Thioguanine(6-TG) in Patients with IBD. Maria C. Dubinsky, Edward Feldman, Maria T. Abreu, Cedars-Sinai Medical Ctr, Los Angeles, CA; Ernest G. Seidman, Ste-Justine Hosp, Montreal Canada; Darren Baroni, Tripler AMC, Honolulu, HI; Asher Kornbluth, Mount Sinai Medical Ctr, New York, NY; Stephan R. Targan, Eric A. Vasiliauskas, Cedars-Sinai Medical Ctr, Los Angeles, CA Background: Approximately 15% of IBD patients receiving 6-MP/AZA develop idiosyncratic adverse drug reactions necessitating early discontinuation of traditional thiopurines. These reactions, which include pancreatitis, abdominal pain, fever, arthralgias, royalgias, dermatitis, nausea, fatigue, typically reoccur upon rechallenge. Our recent pilot study suggested that 6TG, a closely related thiopurine, was efficacious and well tolerated in a subgroup of IBD patients resistant to 6-MP. Aim: To determine if 6-MP/AZA induced idiosyncratic adverse reactions can be avoided by swifcbing to 6-TG therapy. Methods: This cohort of IBD patents was compiled from the experience of a group of gastroenterologists who used 6-TG as an alternate thiopurine in patients intolerant to 6-MP/AZA. Idiosyncratic reactions must have been documented within 1 month of 6-MP/AZA initiation. Results: 6-TG was initiated in 17 IBD patients at a median [range] dose of 20 [10-40] mg/day. Median age was 43 [9-63] years. An idiosyncratic reaction reoccurred in only 1/17 patients (see table) at the same 2 week time point as had been previously experienced with 6-MP. Conclusions: The results of this observational study suggest that 6-TG is well tolerated and can be used as an alternate thiopurine in patients intolerant to traditional 6-MP/AZA. Based on these results, combined with the previously suggested efficacy data, further evaluation of 6-TG is warranted in IBD.
ReJape=reZe= TOPICAL N Lose 3m 6m 9m t2m ToMI
pancreatitis acute abdominal pain feverlmyalgiaslarthralgias rash nausea fatigue TOTAL
5 1 5 1 12
1 2 1 0 4(15%)
ORAL N Lose 17 11 10 8 1
5 0 2 t 8
R t 1 0 0 2(t1%)
COMBINED N Lose 23 19 12 8 23
3 5 3 0 11
R 1 2 1 0 4(17%)
i)>0.05 R=r~p~
59
F~equencyof IdiosyncraticreaclJonson 6-MP/AZAvs 6-TG IDIOSYNCRATIC REACTION
27 21 18 12 2
R
6-MPI/~ (n)
6-TG (n)
6 3 4 1 1 2 17
0 0 1 0 o 0 1
InpatieM And OutpMieM Costs Of Care For IMlammMoP/Bowel Disease In The Year 2000 Michael 0. Rice, Kristen O. Arsefleau, Stephen J. Bickston, Fabio Cominelli, Univ of Virginia Health System, Charlottesville, VA BACKGROUND: Inpatient and outpatient direct costs for inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are substantial and have not been estimated in a single US population since 1990. Changesin health care delivery and introduction of costly new drugs may have impacted total direct costs, as well as the distribution of costs among inpatient and outpatient care. The aim of this study was to assess the distribution of inpatient and outpatient costs for IBD patients admitted to a University Hospital (UVA) during fiscal year 2000 (FY2000). METHODS:The Clinical Data Repository (COR) is an administrative database containing clinical, financial, and demographic data on all inpatient and outpatient admissions to UVA since 1993. Adult IBD patients treated at UVA during FY2OO0were identified by ICD-9 codes. Costs for inpatient and outpatient visit were calculated using cost-charge ratios and aggregated by revenue code. Previously published cost data from 1990 were inflation-adjusted to FY2000 US dollars (Hays etal. J Clin Gastroenterol 1992;14:318-27). Two physicians reviewed the medical records of a random 30% subsample to validate ICD9 diagnosis coding. RESULTS: We identified 310 CD and 182 UC patients (90 inpatient cases, 1198 outpatient cases). Our cohort was 85% white and 53% female. ICD-9 coding accuracy was 97%. During FY2000, total annual direct costs were $1,037,360 for CO and $412,147 for UC. The average cost per CD patient was lower in 2000 than in 1990 ($3,346 vs. $8,521 [inflation-adjusted)), but similar for UC ($2,265 vs. $1,934 [inflation-adjusted)). CD total costs were evenly distributed between inpatient and outpatient care (54.8% vs. 45.2%), but UC costs were heavily weighted towards inpatient care (89.6%). CD total direct costs were distributed as follows: drug/pharmacy=44.9%, surgery=10.9%, laboratory=4.8%, radiology = 3.6%, endoscopy = 3.8%, pathology = 1.1%, clinic = 2.3%, and other (room/board, emergency room, etc)=28.6%. The distribution for UC was: drug/pharmacy=7.3%, surgery = 34.1%, laboratory = 4.4%, radiology = 1.5%, endoscopy = 5.0%, pathology = 3.9%, clinic = 1.0%, and other = 42.8%. CONCLUSIONS:The averagecost per CD patient in FY2000 was lower than in 1990, but remained constant for UC. Our results suggest that despite the high cost of new biological therapies for CD, the overall direct medical costs per patient have decreased due to a shift in practice away from hospitalizations and surgery.
57 Continuous Oral Plus Topical 5-ASA Administration SignificaMly Modifies The Clinical Course Of Ulcerative Colitis Mariateresa Mt Pimpo, Brigida B. Galleth, Giovanni G. Latella, Maria M. Chlaramonte, Gastroenterology Unit, L'Aquila Italy; Renzo R. Caprilli, Gastroenterology Unit, Rome Italy; Giuseppe G. Fried, Gastroenterology Unit, L'Aquila Italy Backgrouod/Aim A cross-sectional study has shown that concentration of Meealazine(5-ASA) in the large bowel mucoca is inversely correlated to severity of ulcerative colitis ~. This study was carried out with the aim to evaluate whether maintaining a long term high mucosal colonic concentrationof 5-ASA could modify the clinical course of moderate to severe disease. To date, the only established way to obtain the highest 5-ASA mucocal concentration in distal cotonic segments is the association of oral plus topical treatment 2. Methods. Eighteen consecutive UC patients in clinical remission which had had at least four moderate to severe relapses in the preceding two years (controlperiod), were assigned to a two years continuous oral plus topical 5-ASA treatment (study period). The previous treatment for all patients consisted of continuous oral 5-ASA and, during recurrences, steroids and/or topical 5-ASA. The treatment of the study period consisted in oral 5-ASA 2.4/4.8 g/day plus topical 5-ASA 12/28 g/week. Humber of recurrences, number of non-programmed visits and endoscopy, courses of steroids and days of hospitalisation were evaluated in the study period and compared with the same data recorded in the control period. The comparison was possible since in our IBD study group all patients are submitted to an identical follow-up procedure that assure a periodical or critical assessment of standardised parameters. A non parametric test for paired data (signed rank test) was used for statistical analysis. Results. Significantly lower number of recurrence (p =0.002) number of non-programmed visits (p=O,O02) and endoscopy (p = 0,016), courses of steroids (p = 0.004) and days of hospitalication (p = 0.03) were observed during the two years of oral plus topical treatment in comparison with the control period. In particular, only two patients had one mild recurrence while the remaining
A-12