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Crohn’s disease severity and treatments: impact on IBDQ scores
S298
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
the growth of mesenchymal and epithelial cells in vitro. The potent growth stimulatory properties of rhFGF-20 prompted us to test for activity in a model of inflammatory bowel disease, a condition in which the integrity of the intestinal mucosa is compromised. Methods: A murine model of colitis in which Balb/c mice are administered 5% dextran sulfate sodium (DSS) for 7 days was utilized. Animals were divided into three groups: group 1 (n ⫽ 5) received vehicle only (normal control); group 2 (n ⫽ 10) received DSS and vehicle (disease control); group 3 (n ⫽ 10) received DSS and rhFGF-20 (5 mg/kg). For groups 2 and 3, DSS was administered ad libitum in drinking water throughout the duration of the experiment. rhFGF-20 or vehicle was administered ip once daily for 7 days. Results: The administration of rhFGF-20 reduced the extent and severity of mucosal damage. Specifically, rhFGF-20 resulted in the following significant protective effects (p values ⬍0.05): 93% reduction of colon content scores reflecting hemorrhagic diarrhea; 76% reduction in colon edema; 55% reduction in colon inflammation; 57% reduction in colon glandular epithelial loss; and 84% reduction in colon surface epithelial loss. rhFGF-20 administration also significantly inhibited DSS-induced decreases in colon length and body weight. Conclusions: rhFGF-20 represents a promising new candidate for the treatment of inflammatory bowel disease.
945 Crohn’s disease severity and treatments: impact on IBDQ scores Gary R Lichtenstein, MD, FACG1*, Greg Keenan, MD2, Donny M Chen, AB3, Umar M Shakur, AB3 and Jeffrey P Trotter, MM3. 1 Department of Medicine/Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, PA; 2Centocor Inc., Malvern, PA; and 3Ovation Research Group, Highland Park, IL. Purpose: To explore clinical characteristics and treatments of Crohn’s disease (CD) patients experiencing the greatest increase vs. greatest decrease in quality of life (QOL). Methods: In this prospective, observational study, physicians recorded the patient’s CD-related treatments and assessed disease severity using ACG Guidelines. At Baseline (BL), and each subsequent quarter, patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ). We assessed IBDQ scores at BL and at Week 32 (Wk 32) and identified patients with the greatest increase (top quartile) and greatest decrease (bottom quartile) in IBDQ scores. We examined these two groups in terms of CD-related treatments and clinical characteristics. Results: BL and Wk 32 IBDQ scores were available for 156 patients. IBDQ scores in the top quartile increased 33 points (145 to 178) while bottom quartile scores decreased 37 points (163 to 126). Patient demographics in these two groups were similar except that the top quartile had more females (82% vs 71%) and less CD family history (14% vs 19%). Overall, disease severity in top quartile patients improved compared to bottom quartile patients. At BL, more top quartile patients received infliximab compared to bottom quartile patients (41% vs 28%). Fewer top quartile patients received steroids at BL (35% vs 39%) and Wk 32 (24% vs 35%) than bottom quartile patients. Conclusions: Improvements in patient QOL may be related to improvements in disease severity. Physician assessment of disease severity seems related to the patient’s perception of QOL. Top Quartile
Bottom Quartile
Disease Severity
BL (n ⴝ 73)
Wk 32 (n ⴝ 34)
BL (n ⴝ 73)
Wk 32 (n ⴝ 36)
Remission (%) Mild-Moderate (%) Moderate-Severe (%) Severe-Fulminant (%) Unknown (%)
19.2 42.5 28.8 2.7 6.8
32.4 44.1 17.6 2.9 3.0
23.3 43.8 24.7 1.4 6.8
11.1 38.9 44.4 5.6 n/a
CD-Related Treatments
BL (n ⴝ 78)
Wk 32 (n ⴝ 78)
BL (n ⴝ 78)
Wk 32 (n ⴝ 75)
Infliximab (%) Immunosuppressives (%) Steroids (%) Anti-Inflammatory Agents (%) Other (%)
41.0 59.0 34.6 64.1 29.5
24.4 60.3 24.4 65.4 35.9
28.2 53.8 38.5 65.4 29.5
26.7 58.7 34.7 64.0 42.7
946 Infliximab tolerability in Crohn’s disease patients Gary R Lichtenstein, MD, FACG1*, Greg Keenan, MD2, Mary Glenn Vreeland, MHA3 and Donny M Chen, AB3. 1Department of Medicine/ Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, PA; 2Centocor Inc., Malvern, PA; and 3Ovation Research Group, Highland Park, IL. Purpose: To assess infliximab tolerability in patients receiving infusions during a prospective, observational study examining clinical outcomes associated with Crohn’s disease (CD). Methods: A prospective evaluation of patients treated by physicians in academic centers (n ⫽ 13) and community-based centers (n ⫽ 112) was undertaken. In this observational study, each physician treated patients according to local standards, in a non-protocol driven manner. Infliximab frequency, reactions, and completion status were analyzed for patients receiving at least one infusion during the first six months of the study. Results: As of 05/01/01, 861 patients were actively participating; 279 (32.4%) patients received infliximab during the analysis timeframe. At Baseline (BL), mean age was 38.9⫾12.6 years, 57.6% were female and mean CD duration was 11.0 years. In the year prior to enrollment, 74.8% received infliximab. At BL, physicians assessed CD severity (n ⫽ 241): 12.9% were in remission, 39.8% had mild-moderate disease, 43.2% had moderate-severe disease, and 4.1% had severe-fulminant disease. During the first six months of the study, 493 infliximab infusions were administered: 44.8% of patients received only one infusion, 37.6% received two infusions, and 17.6% received ⬎2 infusions. The mean time to second infusion was 68.3⫾42.9 days. The majority of infusions (57.9%) were administered in a hospital outpatient setting. Infusion reactions typically occurred within 4 hours of administration (65.3%); remaining reactions (34.7%) occurred between 4 hours and 2 weeks post infusion. Minor reactions were observed in 11.0% of all infusions; the most frequent reaction was headache (3.6%), followed by nausea (2.2%). The majority of infliximab infusions (95%) were completed without interruption; 4% were interrupted and then completed; 1% were not completed. Of the infusions not completed (n ⫽ 6), 4 patients received a subsequent infusion that was completed without interruption; 2 patients did not receive any additional infusions. Conclusions: CD patients in this observational study tolerated infliximab well. The vast majority of infusions were well tolerated and completed without interruption.
947 Impact of Crohn’s disease on work status Gary R Lichtenstein, MD, FACG1*, Mohan Bala, PhD2, Matthew J Gordon, BA3 and Donny M Chen, AB3. 1Department of Medicine/Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, PA; 2Centocor Inc., Malvern, PA; and 3Ovation Research Group, Highland Park, IL. Purpose: To explore clinical characteristics and healthcare utilization of Crohn’s disease (CD) patients that are unable to work due to CD compared to those able to work. Methods: In this prospective, observational study, physicians record data related to the patient’s disease severity, CD-related treatments, and utili-
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
the growth of mesenchymal and epithelial cells in vitro. The potent growth stimulatory properties of rhFGF-20 prompted us to test for activity in a model of inflammatory bowel disease, a condition in which the integrity of the intestinal mucosa is compromised. Methods: A murine model of colitis in which Balb/c mice are administered 5% dextran sulfate sodium (DSS) for 7 days was utilized. Animals were divided into three groups: group 1 (n ⫽ 5) received vehicle only (normal control); group 2 (n ⫽ 10) received DSS and vehicle (disease control); group 3 (n ⫽ 10) received DSS and rhFGF-20 (5 mg/kg). For groups 2 and 3, DSS was administered ad libitum in drinking water throughout the duration of the experiment. rhFGF-20 or vehicle was administered ip once daily for 7 days. Results: The administration of rhFGF-20 reduced the extent and severity of mucosal damage. Specifically, rhFGF-20 resulted in the following significant protective effects (p values ⬍0.05): 93% reduction of colon content scores reflecting hemorrhagic diarrhea; 76% reduction in colon edema; 55% reduction in colon inflammation; 57% reduction in colon glandular epithelial loss; and 84% reduction in colon surface epithelial loss. rhFGF-20 administration also significantly inhibited DSS-induced decreases in colon length and body weight. Conclusions: rhFGF-20 represents a promising new candidate for the treatment of inflammatory bowel disease.
945 Crohn’s disease severity and treatments: impact on IBDQ scores Gary R Lichtenstein, MD, FACG1*, Greg Keenan, MD2, Donny M Chen, AB3, Umar M Shakur, AB3 and Jeffrey P Trotter, MM3. 1 Department of Medicine/Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, PA; 2Centocor Inc., Malvern, PA; and 3Ovation Research Group, Highland Park, IL. Purpose: To explore clinical characteristics and treatments of Crohn’s disease (CD) patients experiencing the greatest increase vs. greatest decrease in quality of life (QOL). Methods: In this prospective, observational study, physicians recorded the patient’s CD-related treatments and assessed disease severity using ACG Guidelines. At Baseline (BL), and each subsequent quarter, patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ). We assessed IBDQ scores at BL and at Week 32 (Wk 32) and identified patients with the greatest increase (top quartile) and greatest decrease (bottom quartile) in IBDQ scores. We examined these two groups in terms of CD-related treatments and clinical characteristics. Results: BL and Wk 32 IBDQ scores were available for 156 patients. IBDQ scores in the top quartile increased 33 points (145 to 178) while bottom quartile scores decreased 37 points (163 to 126). Patient demographics in these two groups were similar except that the top quartile had more females (82% vs 71%) and less CD family history (14% vs 19%). Overall, disease severity in top quartile patients improved compared to bottom quartile patients. At BL, more top quartile patients received infliximab compared to bottom quartile patients (41% vs 28%). Fewer top quartile patients received steroids at BL (35% vs 39%) and Wk 32 (24% vs 35%) than bottom quartile patients. Conclusions: Improvements in patient QOL may be related to improvements in disease severity. Physician assessment of disease severity seems related to the patient’s perception of QOL. Top Quartile
Bottom Quartile
Disease Severity
BL (n ⴝ 73)
Wk 32 (n ⴝ 34)
BL (n ⴝ 73)
Wk 32 (n ⴝ 36)
Remission (%) Mild-Moderate (%) Moderate-Severe (%) Severe-Fulminant (%) Unknown (%)
19.2 42.5 28.8 2.7 6.8
32.4 44.1 17.6 2.9 3.0
23.3 43.8 24.7 1.4 6.8
11.1 38.9 44.4 5.6 n/a
CD-Related Treatments
BL (n ⴝ 78)
Wk 32 (n ⴝ 78)
BL (n ⴝ 78)
Wk 32 (n ⴝ 75)
Infliximab (%) Immunosuppressives (%) Steroids (%) Anti-Inflammatory Agents (%) Other (%)
41.0 59.0 34.6 64.1 29.5
24.4 60.3 24.4 65.4 35.9
28.2 53.8 38.5 65.4 29.5
26.7 58.7 34.7 64.0 42.7
946 Infliximab tolerability in Crohn’s disease patients Gary R Lichtenstein, MD, FACG1*, Greg Keenan, MD2, Mary Glenn Vreeland, MHA3 and Donny M Chen, AB3. 1Department of Medicine/ Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, PA; 2Centocor Inc., Malvern, PA; and 3Ovation Research Group, Highland Park, IL. Purpose: To assess infliximab tolerability in patients receiving infusions during a prospective, observational study examining clinical outcomes associated with Crohn’s disease (CD). Methods: A prospective evaluation of patients treated by physicians in academic centers (n ⫽ 13) and community-based centers (n ⫽ 112) was undertaken. In this observational study, each physician treated patients according to local standards, in a non-protocol driven manner. Infliximab frequency, reactions, and completion status were analyzed for patients receiving at least one infusion during the first six months of the study. Results: As of 05/01/01, 861 patients were actively participating; 279 (32.4%) patients received infliximab during the analysis timeframe. At Baseline (BL), mean age was 38.9⫾12.6 years, 57.6% were female and mean CD duration was 11.0 years. In the year prior to enrollment, 74.8% received infliximab. At BL, physicians assessed CD severity (n ⫽ 241): 12.9% were in remission, 39.8% had mild-moderate disease, 43.2% had moderate-severe disease, and 4.1% had severe-fulminant disease. During the first six months of the study, 493 infliximab infusions were administered: 44.8% of patients received only one infusion, 37.6% received two infusions, and 17.6% received ⬎2 infusions. The mean time to second infusion was 68.3⫾42.9 days. The majority of infusions (57.9%) were administered in a hospital outpatient setting. Infusion reactions typically occurred within 4 hours of administration (65.3%); remaining reactions (34.7%) occurred between 4 hours and 2 weeks post infusion. Minor reactions were observed in 11.0% of all infusions; the most frequent reaction was headache (3.6%), followed by nausea (2.2%). The majority of infliximab infusions (95%) were completed without interruption; 4% were interrupted and then completed; 1% were not completed. Of the infusions not completed (n ⫽ 6), 4 patients received a subsequent infusion that was completed without interruption; 2 patients did not receive any additional infusions. Conclusions: CD patients in this observational study tolerated infliximab well. The vast majority of infusions were well tolerated and completed without interruption.
947 Impact of Crohn’s disease on work status Gary R Lichtenstein, MD, FACG1*, Mohan Bala, PhD2, Matthew J Gordon, BA3 and Donny M Chen, AB3. 1Department of Medicine/Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, PA; 2Centocor Inc., Malvern, PA; and 3Ovation Research Group, Highland Park, IL. Purpose: To explore clinical characteristics and healthcare utilization of Crohn’s disease (CD) patients that are unable to work due to CD compared to those able to work. Methods: In this prospective, observational study, physicians record data related to the patient’s disease severity, CD-related treatments, and utili-