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Rebamipide for prevention and treatment of Crohn's disease

A Crohn's disease, rebamipide technology, applied in the field of rebamipide, can solve the problems of infection sensitivity, unmet medical needs, high risk of malignant tumors, etc.

Pending Publication Date: 2022-04-12
方电力有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Monoclonal antibodies have a relatively rapid onset of action and induce mucosal healing, but up to 30% of patients do not respond to treatment (primary non-responders), and up to 50% of patients who benefit initially from these drugs may be at twelve Loss of response to treatment within 1 month (secondary nonresponder), requiring dose escalation or change in therapy
Although monotherapy is considered relatively safe, patients are more susceptible to infection and have a higher risk of malignancy
Furthermore, treatment withdrawal in patients who have achieved sustained remission remains an ongoing problem
[0007] Although some of the above treatments may lead to long-term remission of disease symptoms, most CD patients eventually require surgery
Therefore, there remains a high unmet medical need for treatments that suppress intestinal inflammation and lead to sustained complete remission of disease symptoms

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] A 39-year-old female patient was diagnosed with Crohn's ileocolitis 16 years ago. During the course of her disease, she was given various medications, including oral, parenteral, and topical corticosteroids, azathioprine, and the TNFα inhibitors infliximab and adalimumab. After developing an immune response against these antibodies affecting the skin and joints, the patient was switched to vedolizumab (Entyvio), which was able to stabilize her for the next 22 months. During disease relapse, the patient suffered from abdominal pain, increased stool frequency, joint and muscle pain, mild fever, fatigue, and dry dermatitis, with a fecal calprotectin level as high as 1939 μg / g and a CDAI score of 358. She continued treatment with methylprednisolone 24 mg / day without success. Concurrently with corticosteroid therapy, she was initiated on rebamipide 100 mg three times daily, which resulted in rapid disease remission, as evidenced by a reduction in disease symptoms (CDAI of 1...

Embodiment 2

[0066] A 27-year-old man was diagnosed with Crohn's ileocolitis 5 years ago and was treated with mesalazine (Pentasia), budesonide, and metronidazole. Three months after taking mesalamine, he developed pancreatitis. Subsequently, the drug was switched to azathioprine combined with prednisone, followed by methotrexate. However, the drug was not well tolerated and patients were prescribed biologic therapy. He was treated with infliximab (Remicade) followed by adalimumab (Humira). After the last relapse (calprotectin 2215 μg / g; CDAI score 479), he was given prednisone 40 mg / day, but remission could not be achieved. He started taking rebamipide 200mg three times a day as a supplement to prednisone. After 6 weeks (calprotectin 356 μg / g; CDAI 225 points), the rebamipide dose was adjusted to 100 mg three times a day, and the prednisone dose was adjusted to 30 mg / day. The prednisone dose was then reduced by 10 mg every 2 weeks and stopped completely after another 6 weeks (calprote...

Embodiment 3

[0068] A 32-year-old female patient was diagnosed with Crohn's ileitis 12 years ago. Treatment with budesonide and mesalazine maintains remission for approximately 10 years. Subsequently, she was hospitalized for abdominal pain and loose stools 3-4 times a day, her calprotectin level was as high as 1051 μg / g, and her CDAI was 377 points. She was prescribed azathioprine, which had to be discontinued after two weeks due to acute pancreatitis. She continued treatment with 50 mg / day prednisone concurrently with 100 mg rebamipide three times daily. After 14 days, the dose of prednisone was adjusted to 25 mg due to the relief of clinical symptoms. After another 6 weeks, the calprotectin level dropped to 122 μg / g, and the CDAI score was 98. She continued to take only rebamipide. To date, no worsening of disease activity has been observed.

[0069] Results obtained with patient samples showed that rebamipide was able to control disease symptoms, normalize calprotectin levels and in...

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PUM

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Abstract

The present invention provides rebamipide for use in a method of preventing and / or treating Crohn's disease. In particular, rebamipide is used to prevent and / or treat Crohn's disease in a person suffering from or at risk of increased intestinal permeability.

Description

[0001] field of invention [0002] The present invention relates to a method for the prevention and / or treatment of Crohn's disease, in particular rebamipide for use in humans with or at risk of increased intestinal permeability. Background technique [0003] Crohn's disease (CD) is a disease that belongs to inflammatory bowel disease (IBD). It is a chronic multifactorial disorder in which genetic, environmental and microbial factors are involved. Although the exact cause is unknown, it appears that disease onset is triggered by environmental factors that interfere with the mucosal barrier, alter the healthy balance of the gut microbiota, and aberrantly stimulate the gut immune response. This results in chronic inflammation of the bowel with typical symptoms such as diarrhea, weight loss, fatigue, rectal bleeding and abdominal pain. [0004] The condition can occur at any age, but it usually begins in the teens and twenties. It is estimated to affect about 3 in 1,000 people...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4704A61K45/06A61P1/00A61K9/20A61K31/573
CPCA61K31/4704A61P1/00A61K31/573A61K2300/00A61K45/06A61P1/12A61K31/4164A61K31/436A61K31/496A61K31/519A61K31/606A61K31/655A61K38/13A61K39/3955
Inventor 不公告发明人
Owner 方电力有限公司
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