الفهرس 
Acknowledgement
Pathology of ulcerative colitisOnly 14 pages are availabe for public view
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Abstract
We aimed to evaluate infliximab efficacy and safety in treating moderate to severe UC not responding to conventional therapy, and to determine the accuracy of fecal calprotectin in predicting mucosal injury and healing during therapy.
- In this prospective study, forty eight patients were enrolled from the outpatient clinics and the in-patient department of Gastroenterology Unit of Farwaniya (FAR) Hospital, Kuwait, during the period from February 2013 to September 2015.
- Those patients have an established diagnosis of moderate to severe ulcerative colitis based on standard clinical , endoscopic , radiological and histopathological criteria, not responding to full dose or could not tolerate conventional therapy and eligible for infliximab therapy.
- Their mean age was (32.6 ± 1.6 years) and the majority were males (n=26, 59.1%). left sided colitis was found in 61.4% (27 patients) and pancolitis in 38.6% (17 patients).
- Also a group of 20 apparently healthy volunteers ( age range 18- 57 years ), collected from visitors to Gastroenterology Unit and all their investigations were normal including colonoscopy, were enrolled in the study to define the normal reference range of fecal calprotectin level in healthy persons.
- Apart from 4 patients dropped out of the study (1 developed solar anaphylactic reaction, 1 developed vitiligo and 1 developed abnormal lymphocytosis and 1 developed toxic megacolon), most side effects of infliximab were mild to moderate and did not mandate therapy discontinuation, where, 5 cases had allergic reactions ( including skin urticarial rash, itching, and mild pain at the infusion site) and 2 patients had mild asymptomatic ALT elevations (90 and 75 IU/L) respectively after the 1st dose of IFX and returned to normal level on week 6. No mortalities had been reported during this study.
- Mucosal healing (MH) has been achieved in 65.9 % of study patients who received the 3 doses of IFX induction regimen and completed the study without serious side effects.
- Patients with mucosal healing had at week 12 lower Mayo score, endoscopic subscore and fecal calprotectin level than those without mucosal healing, with statistical significance (P < 0.001 for all).
- FC had the largest AUC for (0.99) and (0.949) in predicting mucosal injury and mucosal healing respectively.
- Other inflammatory markers, such as ESR and CRP, cannot be reliable ways to assess mucosal injury and healing, and clinical and endoscopic response to therapy.
- FC with cutoff of > 464.5μ g/g, had 93.8% sensitivity and 95.8% specificity in predicting moderate to severe mucosal injury.
- FC with cutoff of <58 μg/g, had 89.7% sensitivity and 93.3% specificity in predicting mucosal healing.
Conclusion
Infliximab is a good therapeutic choice for patients with moderate to severe ulcerative colitis who did not respond to conventional therapy, with a good safety profile and response rate. Fecal Calprotectin is a good predictor of mucosal injury and healing and can be used alone in the course of ulcerative colitis as a non-invasive alternative way to assess the mucosal state and to evaluate response to therapy.