Long term effects of the drug Infliximab

Ulcerative colitis is a chronic disease which causes severe inflammation in the colon. The drug called Infliximab has been shown to be effective in reducing symptoms of ulcerative colitis in both the long and short term. However, ulcerative colitis varies in its course and over time, and despite being on infliximab, flare-ups of the disease can occur. This article explores the long-term efficiency and safety of the drug infliximab in a group of 250 patients with chronic active ulcerative colitis. It goes on to determine the number of individuals of the group that went into remission after 12 months and the number of individuals that needed a colectomy, a surgical procedure to remove part of the colon.

              Data was collected at the Swedish Organization for the Study of Inflammatory Bowel Disease (SOIBD) though 15 IBD centers across Sweden with a focus on patients with ulcerative colitis being treated with infliximab. Information from when the disease first started was considered baseline. There were multiple data points collected from each patient such as age, gender, disease duration, weight, and values obtained from blood tests (these included, but weren’t limited to, hemoglobin levels and white blood cells counts). The outcome of the study was measured by data collected at 3 months after baseline and at 12 months after baseline. It also considered if the patient’s disease was said to have gone into remission or if the patient needed a colectomy. Being in remission was defined as the patient not having diarrhea, blood in their stool, or abdominal pain.

              To analyze the data collected, tests were used when comparing different variables. Researchers were looking for statistically significant data, meaning that there was a very high likelihood that the relationship or lack of relationship is caused by something other than random chance.

              In total, within the study, 250 patients were included. 191 patients (76% of the total) finished their first course of infliximab treatment (which was roughly around four doses). From there fewer and fewer individuals continued with more treatment of the drug. The reason for the loss of individuals was because 75 out of the 191 patients went into remission after the first course; 47 out of 191 patients stopped responding to the drug; 35 out of the 191 patients never responded to the drug to begin with.

              Overall 123 out of the 250 patients went into remission after the 12 month period. A response to infliximab at 3 months was associated significantly with an increased chance of responding to infliximab at 12 months. After a follow up of 2.9 years 126 out of the 250 patients were in remission.

A response rate at 12 months was associated significantly with a decreased risk of needing a colectomy. The follow up of 2.9 years showed that 68 out of 250 patients needed to get the procedure. Certain markers in blood at both 3 months and 12 months showed significantly increased chances of needing a colectomy. F-calprotectin is a protein that indicates the amount of intestinal inflammation. If it has levels that are greater than 935μg/g, that increases chances of needing a colectomy. An age over 26 years was also correlated significantly with needed a colectomy.