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Outcome of combination therapy with sulfasalazine or 5-aminosalicylates and corticosteroids in a population-based cohort of patients with inflammatory bowel disease
AJG – September, Suppl., 2001
Abstracts
zation of healthcare services. At Baseline (BL) and every subsequent quarter, patients complete the Inflammatory Bowel Disease Questionnaire (IBDQ) and a work status questionnaire. Our analysis focused on patients who, at BL, were either working (full-time/part-time) or were not working as a result of their CD. Results: Of the 861 patients enrolled by 05/01/01, 105 (12.2%) of all patients were unable to work due to CD; 455 (52.8%) were working at BL. Non-working patients were older than those working (43.9 vs. 39.8 yrs., p ⫽ 0.001), had CD longer (13.7 vs. 10.1 yrs., p ⫽ 0.001), comprised of more females (72.1% vs. 56.4%, p ⫽ 0.003) and smokers (35.6% vs. 19.0%, p ⬍ 0.001). In general, nonworking patients had more active disease. More non-working patients received steroids at BL (45.7% vs. 32.3%, p ⫽ 0.009); this trend continued at Q4 (41.9% vs. 22.3%, p ⬍ 0.001). The mean IBDQ score was higher in working patients at BL (168.9 vs. 119.8) and at 48 weeks (165.9 vs. 117.8). Conclusions: CD impacts patients’ lives and affects their ability to work. Non-working patients in this study exhibited significantly lower quality of life compared to patients able to work. Baseline
Remission (%) Mild-Moderate (%) Moderate-Severe (%) Severe-Fulminant (%) Unknown (%)
48 Weeks
Working
Non-working
Working
Non-working
23.1 41.5 23.1 1.6 10.7
9.5 35.8 36.8 4.2 13.7
26.8 38.0 30.3 2.1 2.8
2.7 54.1 35.1 8.1 n/a
Baseline NonWorking working Infliximab (%) Immunosuppresives (%) Steroids (%) Anti-Inflammatory Agents (%) Other (%)
Q4 p
NonWorking working
p
33.2 54.1 32.3 64.2
43.8 50.5 45.7 60.0
0.399 ns 0.0093 ns
19.9 55.7 22.3 67.1
23.3 54.7 41.9 61.6
ns ns 0.0002 ns
24.2
42.9
0.0001
31.6
62.8
⬍0.0001
948 Outcome of combination therapy with sulfasalazine or 5aminosalicylates and corticosteroids in a population-based cohort of patients with inflammatory bowel disease Edward V Loftus1*, William A Faubion1 and William J Sandborn1. 1 Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota, United States. Purpose: Whether combination therapy with sulfasalazine (SAS) or 5-aminosalicylates (5-ASA) and corticosteroids (CS) results in improved outcomes or steroid sparing for treatment of inflammatory bowel disease (IBD) is controversial. A retrospective study of CS responsiveness, dependence, and resistance in population-based cohorts of ulcerative colitis (UC) and Crohn’s disease (CD) suggested that concomitant use of SAS and 5-ASA was associated with short-term response to CS, but this was not examined in detail (Faubion et al; Gastroenterology 2001:in press). We sought to determine if concomitant therapy with SAS or 5-ASA influenced the response to or dependence upon a first course of CS for UC and CD. Methods: The medical records of Olmsted County, Minnesota residents who were diagnosed with IBD between 1970 and 1993, and who received a first course of CS for IBD between 1970 and 1997, were reviewed for details of concomitant medical therapy in the year following initiation of CS therapy. Short-term (30-day) complete, partial, and non-response to CS were as previously defined. One-year prolonged response, CS dependence, and post-surgery categories were as previously defined. Chi-square test was used to compare response rates among groups. Results: Of 141 IBD patients who received CS therapy, 4 withdrew research authorization, leaving 137 pts for study (74 CD, 63 UC). Combined complete and partial short-term response was noted in 38/42 UC pts (90%) who received SAS/5ASA within 14 days of initiating CS, versus
S299
15/21 (71%) who did not (p ⫽ 0.051); and in 27/31 (87%) in CD pts who received initial SAS/5ASA versus 35/43 (81%) who did not (p ⫽ NS). Concomitant SAS/5ASA within 14 days of CS initiation did not influence 1-year response for either UC or CD. Of 18 CD pts who received ⱖ5 months of SAS/5ASA within the year following CS initiation, 10 pts had prolonged response (56%) vs. 14/56 (25%) in those who did not (p ⬍ 0.02). In UC, 20/32 who had ⱖ5 months SAS/5ASA had prolonged response (63%) vs. 10/31 (32%) in those who did not (p ⬍ 0.02). Conclusions: In this retrospective study of a population-based IBD cohort, concomitant administration of sulfasalazine or 5ASA was associated with improved short-term response to corticosteroids in UC but not CD. Although initial concomitant therapy was not associated with long-term CS response, administration of 5 months or greater of SAS/5ASA was associated with improved long-term CS response. Supported by Procter and Gamble Pharmaceuticals.
949 The epidemiology and natural history of Crohn’s disease in population-based patient cohorts from North America: a systematic review Edward V Loftus1*, Philip S Schoenfeld2 and William J Sandborn1. 1 Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota, United States; and 2Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan, United States. Purpose: To quantify through systematic review the incidence and prevalence of Crohn’s disease in North America, and to examine the natural history of Crohn’s disease, including disease activity, frequency of medication use, and frequency of surgery. Methods: The online bibliographic databases MEDLINE and Current Contents/Science Edition were searched to identify English language articles published between 1966 and September 2000. The Medical Subject Heading (MeSH) terms “Crohn’s disease [epidemiology]” or “inflammatory bowel disease [epidemiology]”, and “Crohn’s disease” or “inflammatory bowel disease” and “prognosis” were used to perform keyword searches of the database. Selected articles: (1) had samples of patients followed from time of initial diagnosis; (2) had appropriate and objective diagnostic criteria for disease; and, (3) were published in full manuscript form. Studies about natural history also had sufficiently long and complete follow-up using objective definitions of disease activity. For prevalence studies, data on sample size, incidence, prevalence, gender distribution, and age at diagnosis was extracted. For natural history studies, data about disease activity, use of medications and surgery was extracted. Data were extracted independently and in duplicate by two investigators. Results: A total of 1,138 references were reviewed. Thirteen studies of 10 cohorts satisfied the inclusion criteria for incidence cohort studies to determine the prevalence, incidence, gender distribution, and age of onset of Crohn’s disease in North America. The prevalence of Crohn’s disease in North America ranges from 26.0 to 198.5 cases per 100,000 persons. The incidence rates range from 3.1 to 14.6 cases per 100,000 person-years. Female predominance ranges from 48% to 66%. Mean age at diagnosis ranges from 33 to 45 years. During the first 7 years, 20% of patients will have chronically active disease, 13% will have a relapse-free course, and 67% will fluctuate between years with relapse and years in remission. During the first 3 years following diagnosis, 58% of patients did not receive corticosteroids, 19% received corticosteroids during 1 year, and 22% received corticosteroids for 2 or more years. The cumulative probability of operation 15 years after the diagnosis of Crohn’s disease is 70%. Conclusions: Between 400,000 and 600,000 patients in North America have Crohn’s disease, and the natural history is marked by frequent exacerbations requiring treatment with corticosteroids, 5-aminosalicylate products, and surgery. Supported by AstraZeneca.
Abstracts
zation of healthcare services. At Baseline (BL) and every subsequent quarter, patients complete the Inflammatory Bowel Disease Questionnaire (IBDQ) and a work status questionnaire. Our analysis focused on patients who, at BL, were either working (full-time/part-time) or were not working as a result of their CD. Results: Of the 861 patients enrolled by 05/01/01, 105 (12.2%) of all patients were unable to work due to CD; 455 (52.8%) were working at BL. Non-working patients were older than those working (43.9 vs. 39.8 yrs., p ⫽ 0.001), had CD longer (13.7 vs. 10.1 yrs., p ⫽ 0.001), comprised of more females (72.1% vs. 56.4%, p ⫽ 0.003) and smokers (35.6% vs. 19.0%, p ⬍ 0.001). In general, nonworking patients had more active disease. More non-working patients received steroids at BL (45.7% vs. 32.3%, p ⫽ 0.009); this trend continued at Q4 (41.9% vs. 22.3%, p ⬍ 0.001). The mean IBDQ score was higher in working patients at BL (168.9 vs. 119.8) and at 48 weeks (165.9 vs. 117.8). Conclusions: CD impacts patients’ lives and affects their ability to work. Non-working patients in this study exhibited significantly lower quality of life compared to patients able to work. Baseline
Remission (%) Mild-Moderate (%) Moderate-Severe (%) Severe-Fulminant (%) Unknown (%)
48 Weeks
Working
Non-working
Working
Non-working
23.1 41.5 23.1 1.6 10.7
9.5 35.8 36.8 4.2 13.7
26.8 38.0 30.3 2.1 2.8
2.7 54.1 35.1 8.1 n/a
Baseline NonWorking working Infliximab (%) Immunosuppresives (%) Steroids (%) Anti-Inflammatory Agents (%) Other (%)
Q4 p
NonWorking working
p
33.2 54.1 32.3 64.2
43.8 50.5 45.7 60.0
0.399 ns 0.0093 ns
19.9 55.7 22.3 67.1
23.3 54.7 41.9 61.6
ns ns 0.0002 ns
24.2
42.9
0.0001
31.6
62.8
⬍0.0001
948 Outcome of combination therapy with sulfasalazine or 5aminosalicylates and corticosteroids in a population-based cohort of patients with inflammatory bowel disease Edward V Loftus1*, William A Faubion1 and William J Sandborn1. 1 Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota, United States. Purpose: Whether combination therapy with sulfasalazine (SAS) or 5-aminosalicylates (5-ASA) and corticosteroids (CS) results in improved outcomes or steroid sparing for treatment of inflammatory bowel disease (IBD) is controversial. A retrospective study of CS responsiveness, dependence, and resistance in population-based cohorts of ulcerative colitis (UC) and Crohn’s disease (CD) suggested that concomitant use of SAS and 5-ASA was associated with short-term response to CS, but this was not examined in detail (Faubion et al; Gastroenterology 2001:in press). We sought to determine if concomitant therapy with SAS or 5-ASA influenced the response to or dependence upon a first course of CS for UC and CD. Methods: The medical records of Olmsted County, Minnesota residents who were diagnosed with IBD between 1970 and 1993, and who received a first course of CS for IBD between 1970 and 1997, were reviewed for details of concomitant medical therapy in the year following initiation of CS therapy. Short-term (30-day) complete, partial, and non-response to CS were as previously defined. One-year prolonged response, CS dependence, and post-surgery categories were as previously defined. Chi-square test was used to compare response rates among groups. Results: Of 141 IBD patients who received CS therapy, 4 withdrew research authorization, leaving 137 pts for study (74 CD, 63 UC). Combined complete and partial short-term response was noted in 38/42 UC pts (90%) who received SAS/5ASA within 14 days of initiating CS, versus
S299
15/21 (71%) who did not (p ⫽ 0.051); and in 27/31 (87%) in CD pts who received initial SAS/5ASA versus 35/43 (81%) who did not (p ⫽ NS). Concomitant SAS/5ASA within 14 days of CS initiation did not influence 1-year response for either UC or CD. Of 18 CD pts who received ⱖ5 months of SAS/5ASA within the year following CS initiation, 10 pts had prolonged response (56%) vs. 14/56 (25%) in those who did not (p ⬍ 0.02). In UC, 20/32 who had ⱖ5 months SAS/5ASA had prolonged response (63%) vs. 10/31 (32%) in those who did not (p ⬍ 0.02). Conclusions: In this retrospective study of a population-based IBD cohort, concomitant administration of sulfasalazine or 5ASA was associated with improved short-term response to corticosteroids in UC but not CD. Although initial concomitant therapy was not associated with long-term CS response, administration of 5 months or greater of SAS/5ASA was associated with improved long-term CS response. Supported by Procter and Gamble Pharmaceuticals.
949 The epidemiology and natural history of Crohn’s disease in population-based patient cohorts from North America: a systematic review Edward V Loftus1*, Philip S Schoenfeld2 and William J Sandborn1. 1 Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota, United States; and 2Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan, United States. Purpose: To quantify through systematic review the incidence and prevalence of Crohn’s disease in North America, and to examine the natural history of Crohn’s disease, including disease activity, frequency of medication use, and frequency of surgery. Methods: The online bibliographic databases MEDLINE and Current Contents/Science Edition were searched to identify English language articles published between 1966 and September 2000. The Medical Subject Heading (MeSH) terms “Crohn’s disease [epidemiology]” or “inflammatory bowel disease [epidemiology]”, and “Crohn’s disease” or “inflammatory bowel disease” and “prognosis” were used to perform keyword searches of the database. Selected articles: (1) had samples of patients followed from time of initial diagnosis; (2) had appropriate and objective diagnostic criteria for disease; and, (3) were published in full manuscript form. Studies about natural history also had sufficiently long and complete follow-up using objective definitions of disease activity. For prevalence studies, data on sample size, incidence, prevalence, gender distribution, and age at diagnosis was extracted. For natural history studies, data about disease activity, use of medications and surgery was extracted. Data were extracted independently and in duplicate by two investigators. Results: A total of 1,138 references were reviewed. Thirteen studies of 10 cohorts satisfied the inclusion criteria for incidence cohort studies to determine the prevalence, incidence, gender distribution, and age of onset of Crohn’s disease in North America. The prevalence of Crohn’s disease in North America ranges from 26.0 to 198.5 cases per 100,000 persons. The incidence rates range from 3.1 to 14.6 cases per 100,000 person-years. Female predominance ranges from 48% to 66%. Mean age at diagnosis ranges from 33 to 45 years. During the first 7 years, 20% of patients will have chronically active disease, 13% will have a relapse-free course, and 67% will fluctuate between years with relapse and years in remission. During the first 3 years following diagnosis, 58% of patients did not receive corticosteroids, 19% received corticosteroids during 1 year, and 22% received corticosteroids for 2 or more years. The cumulative probability of operation 15 years after the diagnosis of Crohn’s disease is 70%. Conclusions: Between 400,000 and 600,000 patients in North America have Crohn’s disease, and the natural history is marked by frequent exacerbations requiring treatment with corticosteroids, 5-aminosalicylate products, and surgery. Supported by AstraZeneca.