Future treatments

A NEW APPROACH IN THE MANAGEMENT OF CROHN’S DISEASE: OBSERVATIONS IN 20 CONSECUTIVE CASES.
del Gaudio A; Bragaglia RB; Boschi L; del Gaudio GA; Accorsi D Address Department of Surgery, University of Bologna, School of Medicine, Italy. Hepatogastroenterology, 1997 Jul, 44:16, 1095-103

Although the “modern history” of Crohn’s disease dates back to 1932, the etiology is still nebulous, the medical treatment inefficient and resective surgery results in a high recurrence rate. Twenty consecutive patients with terminal ileitis underwent ileo-cecal resection and mesenteric-epiploonplasty to enhance collaterals and lymphatic drainage. This approach was advised by experimental observations (the ligation of colonic lymphatic ducts in rabbits), by the intraoperative use of optics to better appreciate the details of the diseased bowel before and after injecting dye and by the angiographic results in one patient. In rabbit experiments, the obliteration of lymphatic drainage led to Crohn’s disease-like macroscopic and microscopic patterns, while diffusion of the dye injected in the diseased segment showed altered lymph flow. The angiographic study in one patient confirmed the presence of vascular anomalies. Direct observation through optics revealed large vessels in the serosa with milky contents and the oozing of sticky exudate. In the 8 patients who underwent this procedure over 5 years ago, there were no recurrences. We strongly believe in the vasculo-lymphatic etiology of Crohn’s disease and in mesentery-epiploonplasty as the only actual indirect approach to resolve hemolymphatic obstructions.
 

SURGERY IN CROHN'S DISEASE: WHEN, WHERE AND WHY THE RECURRENCES?
Del Gaudio A, Bragaglia RB, Boschi L, Del Gaudio GA, Fuzzi N, Department of Surgery, University of Bologna, School of Medicine, S.Orsola-Malpighi Hospital, Italy. Hepatogastroenterology 1998 Jul-Aug;45(22):978-84

One frustrating feature in the surgical management of Crohn’s disease is the high recurrence rate
which may lead to reoperation. It is common opinion that relapses occur haphazardly both in time
and in site, and the causes remain unknown. When does a recurrence really arise after surgery? Is
the site of recurrence determined by definite causes? Is there a relapsing factor? Between 1965 and
1995, 177 patients underwent surgery for Crohn’s disease. The procedures performed in 145 cases were those popular at the time, while a recent series of 20 selected patients was managed following a new approach based on epiploonplasty. This strategy stems from the strong conviction that Crohn’s disease is not a primary bowel disease but the result of stasis and superimposed infection due to a primary hemolymphatic disorder of the mesentery. The five-year recurrence rate was 62% in patients operated on according to standard procedures, while no recurrences were reported in the  epiploonplasty group. Among 12 remaining patients with recurrent disease, two cases are reported  in detail because they provide evidence in favor of the hemolymphatic theory. This study also maintains that recurrences, viewed with the hemolymphatic disorder in mind, occur immediately after surgery, while the superimposed intestinal inflammatory process and stricturing events may appear clinically at different time intervals during follow-up. The site of recurrences usually corresponds to the mesenteric region subjected to compression. Altered mesenteric microcirculation appears to be the true essence of the disease.
 

COMBINATION CIPROFLOXACIN AND METRONIDAZOLE FOR ACTIVE CROHN’S
DISEASE.
Greenbloom SL; Steinhart AH; Greenberg GR; Division of Gastroenterology, Mount Sinai Hospital,
Toronto, Ontario. Can J Gastroenterol, 1998 Jan, 12:1, 53-6

Recent experimental evidence underscores the contribution of intestinal bacteria to the inflammatory
process of Crohn’s disease. This open study examined the efficacy and safety of combination
ciprofloxacin and metronidazole for patients with active Crohn’s disease of the ileum and/or colon.
Seventy-two patients with active Crohn’s disease of the ileum (n = 27), ileocolon (n = 22) or colon
(n = 23) were treated with ciprofloxacin 500 mg bid and metronidazole 250 mg tid for a mean of 10
weeks. Clinical remission was defined as a Harvey-Bradshaw index of three points or less; an index
reduction of at least three points indicated a clinical response. Clinical remission was observed in 49
patients (68%), and 55 patients (76%) showed a clinical response. A clinical response was noted in
29 of 43 patients (67%) who were not taking concurrent prednisone treatment and in 26 of 29
patients (90%) receiving prednisone (mean dose of 15 mg/day). A clinical response also occurred in
a greater proportion of patients with colonic disease, with or without ileal involvement (84%),
compared with patients with ileal disease alone (64%), and in patients without resection (86%)
compared with those with previous resection (61%). Five patients discontinued antibiotics because
of adverse events. After a mean follow-up of nine months, clinical remission was maintained in 26
patients off treatment and in 12 patients who continued antibiotic therapy. Ciprofloxacin in
combination with metronidazole is well tolerated and appears to play a beneficial role in achieving
clinical remission for patients with active Crohn’s disease, particularly when there is involvement of
the colon.
 

ORAL BUDESONIDE IS AS EFFECTIVE AS ORAL PREDNISOLONE IN ACTIVE CROHN'S DISEASE. THE GLOBAL BUDESONIDE STUDY GROUP.
Campieri M; Ferguson A; Doe W; Persson T; Nilsson LG; Medical and Gastroenterological Clinic, University of Bologna, Italy. Gut, 1997 Aug, 41:2, 209-14

BACKGROUND: The use of corticosteroids in active Crohn’s disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism. AIMS: To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn’s disease affecting the ileum and/or the ascending colon. PATIENTS AND METHODS: One hundred and seventy eight patients were randomised to receive budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The treatment period was 12 weeks.  The primary efficacy variable was clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) of 150 or less. RESULTS: After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p = 0.062). The presence of glucocorticoid associated side effects was similar in all groups; however, moon face was more common in the prednisolone group (p = 0.0005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p = 0.0023). CONCLUSIONS: Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in active Crohn’s disease. The single dose administration is as promptly effective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects.
 

TREATMENT OF ACTIVE AND POSTACTIVE ILEAL AND COLONIC CROHN'S DISEASE WITH ORAL PH-MODIFIED-RELEASE BUDESONIDE. GERMAN BUDESONIDE STUDY GROUP.
Caesar I; Gross V; Roth M; Andus T; Schmidt C; Raedsch R; Weber A; Gierend M; Ewe K; Schölmerich J  Department of Internal Medicine University of Regensburg.  Hepatogastroenterology, 1997 Mar, 44:14, 445-51

BACKGROUND/AIMS: Budesonide is a glucocorticoid with a high topical anti-inflammatory but low systemic activity due to its rapid hepatic inactivation. The aim of this open, multicenter study was to investigate efficacy and safety of oral pH-modified-release budesonide in patients with active Crohn’s disease of the ileum and colon and in maintaining budesonide-induced remission in postactive Crohn’s disease. MATERIALS AND METHODS: 81 patients (intention-to-treat) received 3 x 3 mg budesonide/day for 6 weeks, followed by 3 x 2 mg budesonide for another 6 weeks in case of response to initial treatment. Clinical and laboratory parameters were assessed at study entry as well as after 2, 4, 6 and 12 weeks of treatment. RESULTS: On an intention-to-treat basis remission was induced in 54.3% of 81 patients with active Crohn’s disease, 71.4% of 35 patients stayed in remission after the acute-phase treatment until the end of the trial. Typical steroid-related side effects were observed during the acute-phase treatment in only 18% of the patients. Duration, severity and extent of disease at study entry played no significant role in the outcome of the trial, but there was a tendency towards better results during the acute-phase treatment in patients with moderate disease activity and affection of the terminal ileum and proximal colon. CONCLUSIONS: Budesonide could be an alternative to conventional steroid treatment in patients with active Crohn's disease.
 
 
AN INTRAVENOUS LOADING DOSE OF AZATHIOPRINE DECREASES THE TIME TO RESPONSE IN PATIENTS WITH CROHN'S DISEASE.
Sandborn WJ; Van O EC; Zins BJ; Tremaine WJ; Mays DC; Lipsky JJ; Inflammatory Bowel Disease Clinic, Mayo Clinic, Rochester, Minnesota, USA.  Gastroenterology, 1995 Dec, 109:6, 1808-17

BACKGROUND & AIMS: Azathioprine, an effective therapy for Crohn’s disease, is limited by a prolonged time to response. The aim of this study was to determine the safety and utility of a loading dose of azathioprine to decrease the time to response in patients with Crohn’s disease. METHODS: Twelve patients were studied: 6 with 13 fistulae and 6 with inflammatory disease. All patients received an intravenous infusion of azathioprine (50 mg/h for 36 hours). Response was determined by physical and radiographic examination for fistulae and by the Crohn’s Disease Activity Index for inflammatory disease. Erythrocyte concentrations of azathioprine metabolites were measured by chromatography. RESULTS: Seven of 13 fistulae closed by week 4, and three had a temporary decrease in drainage. One fistula improved at week 16. Two fistulae failed to improve. Four of 6 patients with inflammatory disease achieved remission, and 1 improved temporarily. Improvement was rapid (< or = 4 weeks). Peak concentrations of azathioprine metabolites occurred within 3 days. Clinical response did not correlate with azathioprine metabolite concentrations at the azathioprine dose studied. No adverse events occurred. CONCLUSIONS: An 1800-mg intravenous loading dose of azathioprine is safe and may decrease the time to response to < or = 4 weeks in patients with Crohn’s disease. Correlation between clinical response and azathioprine metabolite concentrations at larger azathioprine doses should be determined.
 

Thalidomide
 

TREATMENT OF THERAPY-RESISTANT PERINEAL METASTATIC CROHN’S DISEASE AFTER PROCTECTOMY USING ANTI-TUMOR NECROSIS FACTOR CHIMERIC MONOCLONAL ANTIBODY, CA2: REPORT OF TWO CASES.
van Dullemen HM; de Jong E; Slors F; Tytgat GN; van Deventer SJ; Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.  Dis Colon Rectum, 1998 Jan, 41:1, 98-102

PURPOSE: Two young females with well-documented Crohn’s disease and nonhealing perineal wounds following proctectomy compatible with “metastatic Crohn’s disease” are described. We hypothesized that metastatic Crohn’s disease would be a tumor necrosis factor-dependent inflammatory reaction and have treated these two patients with the anti-tumor necrosis factor chimeric monoclonal antibody, cA2. MAIN FINDINGS: Administration of cA2 was followed by a rapid reduction of subjective and objective parameters of inflammation and caused a substantial reduction of the wound size. CONCLUSION: These preliminary data are consistent with a tumor necrosis factor-dependent inflammatory cause of Crohn’s disease and its extraintestinal manifestations and provide support for targeting tumor necrosis factor in this condition.
 
 
INTERLEUKIN 10 SUPPRESSES EXPERIMENTAL CHRONIC, GRANULOMATOUS INFLAMMATION INDUCED BY BACTERIAL CELL WALL POLYMERS.
Herfarth HH; Mohanty SP; Rath HC; Tonkonogy S; Sartor RB; Department of Medicine, University of North Carolina, Chapel Hill 27599-7080, USA. Gut, 1996 Dec, 39:96, 836-45

BACKGROUND AND AIMS: Interleukin 10 (IL10) inhibits monocyte/macrophage and T lymphocyte effector functions. This study examined the effect of systemically administered IL10 on acute and chronic granulomatous enterocolitis, hepatitis, and arthritis in a rat model. METHODS: Lewis rats were injected intramurally with streptococcal peptidoglycan-polysaccharide (PG-APS) polymers. Beginning 12 hours before PG-APS injection, rats were treated daily with subcutaneous murine recombinant IL10 or vehicle for three or 17 days. RESULTS: IL10 attenuated acute enterocolitis in a dose dependent fashion (p < 0.01). Protective effects were more profound in the chronic granulomatous phase with decreased enterocolitis and markedly inhibited leucocytosis, hepatic granulomas, and chronic erosive arthritis (p < 0.001). IL10 downregulated tissue IL1, IL6, tumour necrosis factor alpha, and interferon gamma gene expression, consistent with the in vitro effects of IL10 on PG-APS-stimulated splenocytes. Caecal IL1 protein concentrations and IL2 and interferon gamma secretion by in vitro stimulated mesenteric lymph nodes were downregulated in IL10 treated animals. CONCLUSIONS: These results indicate that exogenous IL10 can inhibit experimental granulomatous inflammatory responses and suggest that IL10 treatment could be an effective new therapeutic approach in human disorders such as Crohn's disease, rheumatoid arthritis, and sarcoidosis.

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