crohns phase II trial - 2002

[Guest guest]

I found this in the links Norman posted about the Crohns studies.

This is a small trial, but a damn sweet success. Real nice numbers.

If the phase III trial comes out remotely as well, I would imagine

it should be a sensation. Phase III trials cannot be ignored or

buried.

The success of these particular drugs does provide some very loose

evidence that the offending bacterium may be a mycobacterium.

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Dig Liver Dis. 2002 Jan;34(1):29-38. Related Articles, Links

Comment in:

Dig Liver Dis. 2002 Jan;34(1):9-12.

Treatment of severe Crohn's disease using antimycobacterial triple

therapy--approaching a cure?

Borody TJ, Leis S, Warren EF, Surace R.

Centre for Digestive Diseases, Sydney, Australia. tborody@...

BACKGROUND: Mycobacterium avium subspecies paratuberculosis is

probably the best candidate for a microbial cause of Crohn's disease

although arguments to the contrary can be equally convincing.

Growing evidence suggests that prolonged antimycobacterial

combination therapy can improve Crohn's disease in some patients.

AIM: To report long-term observations in patients with severe

Crohn's disease treated with triple macrolide-based

antimycobacterial therapy. PATIENTS: A series of 12 patients (7

male, 5 female; aged 15-42 years) with severe, obstructive or

penetrating Crohn's disease were recruited. METHODS: Patients

failing maximal therapy were commenced prospectively on a

combination of rifabutin (450 mg/d), clarithromycin (750 mg/d) and

clofazimine (2 mg/kg/d). Progress was monitored through colonoscopy,

histology, clinical response and Harvey-Bradshaw activity index.

RESULTS: Follow-up data were available for up to 54 months of

therapy Six out of 12 patients experienced a full response to the

antiMycobacterium avium subspecies paratuberculosis combination

achieving complete clinical, colonoscopic and histologic remission

of Crohn's disease. Four of these patients were able to cease

treatment after 24-46 months, 3 of whom remained in total remission

without treatment for up to 26 months and one patient relapsed after

six months off treatment. A partial response to the anti-

Mycobacterium avium subspecies paratuberculosis combination was seen

in 2 patients showing complete clinical remission with mild

histologic inflammation. Return to normal of terminal ileal

strictures occurred in 5 patients. Harvey-Bradshaw activity index in

patients showing a full or partial response to therapy fell from an

initial 13.4 +/- 1. 91 to 0. 5 +/- 0. 47 [n = 8, p < 0. 001) after

52-54 months. CONCLUSIONS: Reversal of severe Crohn's disease has

been achieved in 6/12 patients using prolonged combination anti-

Mycobacterium avium subspecies paratuberculosis therapy alone. Three

patients remain in long-term remission with no detectable Crohn's

disease off all therapy These results support a causal role for

Mycobacterium avium subspecies paratuberculosis in Crohn's disease

while also suggesting that a cure may become possible.

PMID: 11926571 [PubMed - indexed for MEDLINE]