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Efficacy of masitinib in dogs with steroid-resistant inflammatory bowel disease

Fabio Procoli DMV MRCVS, Senior Clinical Training Scholar in Small Animal Internal Medicine

Karin Allenspach Dr.med.vet. PhD DECVIM-CA MRCVS, Senior Lecturer in Small Animal Internal Medicine

 

Idiopathic inflammatory bowel disease (IBD) is the most common cause of chronic intestinal disease in dogs. Current treatment protocols most often involve the use of immunosuppressive doses of corticosteroids to reduce intestinal mucosal inflammation and achive remission.

However a number of dogs with IBD treated with corticosteroids have either no response at all to the drug or relapse after weeks to months of treatment. In addition, treatment with prednisolone often results in unacceptable side effects.

Masitinib is a protein tyrosine kinase inhibitor licensed for the use in dogs with mast cell tumours, where it has proven efficacy. There also reports that this drug can decrease inflammation in people with several immune mediated disorders, including IBD.

The Veterinary Clinical Sciences at the Royal Veterinary College is performing a clinical trial to evaluate the clinical efficacy of masitinib as a sole treatment for canine IBD in steroid-refractory cases over a period of 8 weeks.

Inclusion criteria:

- Diagnosis of IBD after excluding other causes of chronic diarrhoea based on  routine diagnostic test:

  • faecal parasitology
  • faecal bacteriology
  • CBC, serum biochemistry, urinalysis
  • abdominal ultrasound
  • serum TLI
  • serum cobalamine and folate concentration

- the presence of inflammatory cell infiltrates in mucosal biopsies obtained by gastroduodenoscopy and/or colonoscopy.

- Previous treatment with corticosteroids for at least 4 weeks with only minimal or no response

Exclusion criteria:

- Unwillingness of owner to participate

- Cases that don't meet the inclusion criteria (incomplete diagnostic tests)

Following inclusion in the study all dogs will receive masitinib orally at 12.5mg/kg/day for 8 weeks. At the time of inclusion to the study all cases will be scored with a clinical activity index (CCECAI) and serum biochemistry (including albumin) will be performed and every two weeks thereafter for the duration of the study. The latter test will serve to evaluate clinical efficacy, assess the progress of the disease and also identify the presence of adverse effects of the drug.

Consultation, physical examination, blood work and costs of the drug will be covered by the RVC. Please note that the drug will not be dispensed beyond the duration of the study (8 weeks).

The study has been approved by the RVC Ethics Committee.

We welcome suitable cases therefore if you have a dog diagnosed with IBD that has not responded to conventional immunosuppressive therapy or if you have any queries or doubt about the suitability of a case please contact us at the following email address:

cic@rvc.ac.uk

Thank you all

Fabio Procoli