clinical profile of patients with eosinophilic infiltration of gastrointestinal tract

1
pears to affect gastrointestinal secretion/absorption, inflammation, intesti- nal motility and visceral pain. These preliminary results suggest that Coherin may be effective for induction of remission in pts with active CD and should be investigated in a larger scale randomized, double– blind placebo– controlled trial. 764 COHERIN™ PEPTIDES EFFECTIVELY MAINTAIN REMISSION IN PATIENTS WITH CROHN’S DISEASE FOR 2 YEARS Gary R. Lichtenstein, M.D.* and Henry I. Jacoby, Ph.D. Division of Gastroenterology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA and DRC, Brigantine, NJ. Purpose: To determine efficacy of Coherin™, a peptide complex isolated from bovine or porcine posterior pituitary gland, for maintenance of re- mission x 24 M in Crohn’s disease (CD) pts. Methods: A prospective, non–placebo controlled trial with 22 pts self– administering doses of Coherin BID (0.25– 0.35 mLs) sc for 24 M was performed between 1980 –1990. All pts failed standard therapy available at that time. Data was collected monthly for 6 M and every 3 M thereafter. CD activity has been analyzed by applying Harvey Bradshaw Index (HBI) to pt data. Of 117 pts started on Coherin for treatment of long standing CD, 68 pts had followup data for 6 M and 22 of these pts for 24 M. Of 68 pts, 31 were in remission at some point in the first 6 M. Results: There were 22 pts (10 F, 12 M), mean age of 38.6 (22–73), on treatment for 24 M. Duration of disease prior to treatment was 121.5 y. All pts had refractory CD; 12 had previous surgery, 5 had history of fistulas or abscesses, and most had prior treatment with steroids (N9), sulfasal (N11), or other ther (N9). Maintenance of clinical remission (HBI 3) was observed in 73% of pts at 6 M, 86% at 21 M and 73% at 24 M (all p0.01). Statistically significant (p0.05) improvements in individual HBI scores for well– being (WB), abdominal pain (AP) and daily diarrheal stools (DS), as well as total score (TS), were observed in all periodic assessments (WB 3.0 0.2 init. ther. 0.70.1 at 6 M, 0.70.2 at 12 M to 0.4 0.1 at 24 M; AP 2.5 0.2 IT 0.80.2 at 6 M , 0.6 0.2 at 12 M to 0.5 0.1 at 24 M; DS 5.0 0.4 IT, 1.4 2.7 at 12 M to 0.8 0.3 and 1.0 0.3 at 24 M; TS 10.6 0.5 to 2.4 0.4 at 6 M, 2.7 0.6 at 12M and 1.9 0.4 at 24 M). No significant adverse effects were observed. Conclusions: This trial confirms the efficacy of Coherin in an initial 19 –pt study (Hiatt,RB and Goodman,I. Am. J. Gastroenterol 1977;67:24 –277) for rx of pts with CD . Although Coherin’s mechanism of action is not fully known, it appears to affect gastrointestinal secretion/absorption, inflam- mation, intestinal motility and visceral pain. These preliminary results suggest that Coherin may be effective for the maintenance of remission in pts with refractory CD and should be investigated in a larger scale ran- domized double– blind placebo controlled trial. 765 COHERIN™ PEPTIDES INDUCE CLINICAL RESPONSE AND REMISSION IN PATIENTS WITH ULCERATIVE COLITIS Gary R. Lichtenstein, M.D.* and Henry I. Jacoby, Ph.D. Division of Gastroenterology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA and DRC, Brigantine, NJ. Purpose: To determine efficacy of Coherin™, a peptide complex isolated from bovine or porcine posterior pituitary gland, in inducing clinical response and remission in a large cohort of ulcerative colitis (UC) pts. Coherin was co– discovered by Robert B. Hiatt, M.D. and Irving Goodman, Ph.D. at Columbia University College of Physicians and Surgeons and was found to be useful in the treatment of IBD in patients who were resistant to currently available therapy. Methods: Data from 50 UC pts rxed with Coherin between 1980 –1990 was analyzed for ability to induce a clinical response and remission. Of the 50 participating in the prospective, non–placebo controlled trial, sufficient data was obtained from 36 pts self–administering Coherin BID (0.25– 0.35 mLs) sc for 6 months, of whom 15 continued on treatment and furnished data for 24 months. Data was collected monthly for 6 months and every 3 months thereafter. The UC activity was calculated by a modified St. Mark’s Index from patient data for periods up to 24 months. Most pts were steroid– dependent or refractory to sulfasalazine or other meds. Results: Usable data was obtained from 36 pts (17F, 19M), mean age 39.2 (9 – 64), of whom 15 furnished usable monthly reports for 24 mo. Disease duration prior to rx was 8.81.1 year with active UC at initiation of rx. One had prior surgery, none had history of fistulas or abscesses and many had prior rx with steroids (N19), sulfasalazine (N27), or other rxs (N6). Clinical remission (score 1) was observed in 28% of pts (p0.01) 1 month after start of rx and 44% (p0.01) after 6 months, 52% after 12 months (p0.01), 69% after 18 months (p0.01) and 47% at 24 (p0.01). Activity, when calculated as decrease in mean score compared to initial score, was greater than 50% at all periodic measurements after 3 months. No significant adverse effects were observed Conclusions: Although Coherin’s mechanism of action is not fully known, it appears to affect gastrointestinal secretion/absorption, inflammation, intestinal motility and visceral pain. These preliminary results suggest that Coherin may be effective for induction of clinical response and remission in pts with active UC and should be investigated in a larger scale random- ized, double– blind placebo– controlled trial. 766 CLINICAL PROFILE OF PATIENTS WITH EOSINOPHILIC INFILTRATION OF GASTROINTESTINAL TRACT Manuel Martinez, M.D.*, Sivasubranania S. Narayanan, M.D., Edward Green, M.D. and Maria Geronimo, M.D. Gastroenterology and Hepatology, Metropolitan Hospital New York Medical College, New York, NY. Purpose: To study the clinical profile of patients with eosinophilic infil- tration of the gastrointestinal tract (EGIT). Methods: In a major teaching hospital serving an ethnically diverse pop- ulation, we retrospectively evaluated 33 patient charts from February 2000 to June 2001 with EGIT. Results: The results of our study were the following: Mean (range) age was 57 years (24 – 84). Out of 33 patients 16 (49%) were males. Demographics revealed even distribution among various races (Hispanics 19, Asian 4, Afro–American 9 and white 1). Clinical Data Results MAJOR SYMPTOMS ASSOCIATED CONDITIONS LAB RESULTS Abdominal Pain 67% Food Allergy 3% Anemia 40% Diarrhea 36% Drug Allergy 9% Fe Def. Anemia 18% GI Bleed 36% Asthma 12% Blood Eosinophilia 12% Weight Loss 24% Pelvic Radiation 6% Malabsorption 3% Nausea 24% Positive Stool O&P 9% Vomiting 9% Radiological studies showed thickening of the intestinal wall in 2 patients (6%). Gastrointestinal endoscopies revealed erythema (12%), ulceration (23%), polyps (39%) and normal mucosa (28%). Of these findings 36% were present in the upper gastrointestinal tract mucosa, 1% in the terminal ileum and 63% involved the colon. Causes of EGIT in this study were parasitic infestations (9%), radiation (6%), inflammatory bowel disease (9%) and idiopathic (75%). Conclusions: Our study demonstrates that various disorders should be considered in the differential diagnosis of EGIT. This disorder most com- monly presents with abdominal pain and GI bleeding. We conclude that the affects of this disorder should be expanded to include any region of the gastrointestinal tract. Furthermore it should be considered even in the absence of endoscopic abnormalities. S251 AJG – September, Suppl., 2002 Abstracts

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Page 1: Clinical profile of patients with eosinophilic infiltration of gastrointestinal tract

pears to affect gastrointestinal secretion/absorption, inflammation, intesti-nal motility and visceral pain. These preliminary results suggest thatCoherin may be effective for induction of remission in pts with active CDand should be investigated in a larger scale randomized, double–blindplacebo–controlled trial.

764

COHERIN™ PEPTIDES EFFECTIVELY MAINTAINREMISSION IN PATIENTS WITH CROHN’S DISEASE FOR 2YEARSGary R. Lichtenstein, M.D.* and Henry I. Jacoby, Ph.D. Division ofGastroenterology, Department of Medicine, Hospital of the University ofPennsylvania, Philadelphia, PA and DRC, Brigantine, NJ.

Purpose: To determine efficacy of Coherin™, a peptide complex isolatedfrom bovine or porcine posterior pituitary gland, for maintenance of re-mission x 24 M in Crohn’s disease (CD) pts.Methods: A prospective, non–placebo controlled trial with 22 pts self–administering doses of Coherin BID (0.25–0.35 mLs) sc for 24 M wasperformed between 1980–1990. All pts failed standard therapy available atthat time. Data was collected monthly for 6 M and every 3 M thereafter. CDactivity has been analyzed by applying Harvey Bradshaw Index (HBI) to ptdata. Of 117 pts started on Coherin for treatment of long standing CD, 68pts had followup data for 6 M and 22 of these pts for 24 M. Of 68 pts, 31were in remission at some point in the first 6 M.Results: There were 22 pts (10 F, 12 M), mean age of 38.6 (22–73), ontreatment for 24 M. Duration of disease prior to treatment was 12�1.5 y.All pts had refractory CD; 12 had previous surgery, 5 had history of fistulasor abscesses, and most had prior treatment with steroids (N�9), sulfasal(N�11), or other ther (N�9). Maintenance of clinical remission (HBI� 3)was observed in 73% of pts at 6 M, 86% at 21 M and 73% at 24 M (allp�0.01). Statistically significant (p�0.05) improvements in individualHBI scores for well–being (WB), abdominal pain (AP) and daily diarrhealstools (DS), as well as total score (TS), were observed in all periodicassessments (WB 3.0 �0.2 init. ther. 0.7�0.1 at 6 M, 0.7�0.2 at 12 M to0.4 � 0.1 at 24 M; AP 2.5� 0.2 IT 0.8�0.2 at 6 M , 0.6� 0.2 at 12 M to0.5� 0.1 at 24 M; DS 5.0� 0.4 IT, 1.4� 2.7 at 12 M to 0.8� 0.3 and 1.0�0.3 at 24 M; TS 10.6� 0.5 to 2.4� 0.4 at 6 M, 2.7� 0.6 at 12M and 1.9�0.4 at 24 M). No significant adverse effects were observed.Conclusions: This trial confirms the efficacy of Coherin in an initial 19–ptstudy (Hiatt,RB and Goodman,I. Am. J. Gastroenterol 1977;67:24–277) forrx of pts with CD . Although Coherin’s mechanism of action is not fullyknown, it appears to affect gastrointestinal secretion/absorption, inflam-mation, intestinal motility and visceral pain. These preliminary resultssuggest that Coherin may be effective for the maintenance of remission inpts with refractory CD and should be investigated in a larger scale ran-domized double–blind placebo controlled trial.

765

COHERIN™ PEPTIDES INDUCE CLINICAL RESPONSE ANDREMISSION IN PATIENTS WITH ULCERATIVE COLITISGary R. Lichtenstein, M.D.* and Henry I. Jacoby, Ph.D. Division ofGastroenterology, Department of Medicine, Hospital of the University ofPennsylvania, Philadelphia, PA and DRC, Brigantine, NJ.

Purpose: To determine efficacy of Coherin™, a peptide complex isolatedfrom bovine or porcine posterior pituitary gland, in inducing clinicalresponse and remission in a large cohort of ulcerative colitis (UC) pts.Coherin was co–discovered by Robert B. Hiatt, M.D. and Irving Goodman,Ph.D. at Columbia University College of Physicians and Surgeons and wasfound to be useful in the treatment of IBD in patients who were resistantto currently available therapy.Methods: Data from 50 UC pts rxed with Coherin between 1980–1990was analyzed for ability to induce a clinical response and remission. Of the50 participating in the prospective, non–placebo controlled trial, sufficientdata was obtained from 36 pts self–administering Coherin BID (0.25–0.35mLs) sc for 6 months, of whom 15 continued on treatment and furnished

data for 24 months. Data was collected monthly for 6 months and every 3months thereafter. The UC activity was calculated by a modified St. Mark’sIndex from patient data for periods up to 24 months. Most pts weresteroid–dependent or refractory to sulfasalazine or other meds.Results: Usable data was obtained from 36 pts (17F, 19M), mean age 39.2(9–64), of whom 15 furnished usable monthly reports for 24 mo. Diseaseduration prior to rx was 8.8�1.1 year with active UC at initiation of rx. Onehad prior surgery, none had history of fistulas or abscesses and many hadprior rx with steroids (N�19), sulfasalazine (N�27), or other rxs (N�6).Clinical remission (score � 1) was observed in 28% of pts (p�0.01) 1month after start of rx and 44% (p�0.01) after 6 months, 52% after 12months (p�0.01), 69% after 18 months (p�0.01) and 47% at 24 (p�0.01).Activity, when calculated as decrease in mean score compared to initialscore, was greater than 50% at all periodic measurements after 3 months.No significant adverse effects were observedConclusions: Although Coherin’s mechanism of action is not fully known,it appears to affect gastrointestinal secretion/absorption, inflammation,intestinal motility and visceral pain. These preliminary results suggest thatCoherin may be effective for induction of clinical response and remissionin pts with active UC and should be investigated in a larger scale random-ized, double– blind placebo–controlled trial.

766

CLINICAL PROFILE OF PATIENTS WITH EOSINOPHILICINFILTRATION OF GASTROINTESTINAL TRACTManuel Martinez, M.D.*, Sivasubranania S. Narayanan, M.D., EdwardGreen, M.D. and Maria Geronimo, M.D. Gastroenterology andHepatology, Metropolitan Hospital New York Medical College, NewYork, NY.

Purpose: To study the clinical profile of patients with eosinophilic infil-tration of the gastrointestinal tract (EGIT).Methods: In a major teaching hospital serving an ethnically diverse pop-ulation, we retrospectively evaluated 33 patient charts from February 2000to June 2001 with EGIT.Results: The results of our study were the following: Mean (range) age was57 years (24–84). Out of 33 patients 16 (49%) were males. Demographicsrevealed even distribution among various races (Hispanics 19, Asian 4,Afro–American 9 and white 1).

Clinical Data Results

MAJORSYMPTOMS

ASSOCIATEDCONDITIONS LAB RESULTS

Abdominal Pain 67% Food Allergy 3% Anemia 40%Diarrhea 36% Drug Allergy 9% Fe Def. Anemia 18%GI Bleed 36% Asthma 12% Blood Eosinophilia 12%Weight Loss 24% Pelvic Radiation 6% Malabsorption 3%Nausea 24% Positive Stool O&P 9%Vomiting 9%

Radiological studies showed thickening of the intestinal wall in 2 patients (6%).Gastrointestinal endoscopies revealed erythema (12%), ulceration (23%), polyps(39%) and normal mucosa (28%). Of these findings 36% were present in the uppergastrointestinal tract mucosa, 1% in the terminal ileum and 63% involved the colon.Causes of EGIT in this study were parasitic infestations (9%), radiation (6%),inflammatory bowel disease (9%) and idiopathic (75%).

Conclusions: Our study demonstrates that various disorders should beconsidered in the differential diagnosis of EGIT. This disorder most com-monly presents with abdominal pain and GI bleeding. We conclude that theaffects of this disorder should be expanded to include any region of thegastrointestinal tract. Furthermore it should be considered even in theabsence of endoscopic abnormalities.

S251AJG – September, Suppl., 2002 Abstracts