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Infliximab fails as salvage treatment for severe ulcerative colitis

LOS ANGELES – The inpatient use of infliximab for severe ulcerative colitis does not avoid the need for colectomy in patients who fail steroid therapy, results from a single-center study demonstrated.

In an interview at the annual meeting of the American Society of Colon and Rectal Surgeons, lead study author Dr. Rachel E. Andrew, a third-year resident in the department of surgery at Penn State Hershey Medical Center in Hershey, Pa., said that despite recent interest in providing inpatient infliximab as an alternative to surgery for those with steroid-refractory disease, 82% of those who received salvage infliximab went on to undergo a total abdominal colectomy during the same admission.

Dr. Rachel Andrew

“Our findings suggest that inpatient infliximab was not effective at improving the severity of colitis in these patients,” she said. “Further, infliximab was unreliable in avoiding the need for a total colectomy in this population of ulcerative colitis patients. One difference between our study and those previously published on this subject is that our study focuses on patients with a severity of colitis that resulted in their admission to a surgery service. In terms of evaluating the benefit of infliximab and providing a reliable avoidance of colectomy, we feel that this population of ulcerative colitis patients would be most appropriate to evaluate this issue. This possible difference in patient population may explain the difference in our study findings and those previously published.”

The researchers compared colectomy rates in 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center. Their mean age was 41 years, with 155 (90%) treated with high-dose steroids alone, and with 18 (10%) having received inpatient infliximab as salvage therapy due to a lack of response to steroids alone. Of the patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

The researchers observed no statistically significant differences between the two groups regarding rates of hospital readmission, superficial, deep and organ space surgical-site infections, unplanned return to the operating room, and all complication rates (P greater than .05). Among patients who required total colectomy, hospital costs were 27% higher among those who received infliximab compared with those who received high-dose steroids alone (a mean of $19,880 vs. $14,492, respectively), but because of the small sample size of the infliximab cohort this difference did not reach statistical significance.

“In our institution, salvage infliximab has not been shown to be effective,” Dr. Andrew said. “One key difference between our findings and other studies is that our study population had a high colectomy rate; 82% is much higher than the approximately 30% colectomy rate described in many reports from colleagues in gastroenterology. While there are several potential explanations for our higher rate of colectomy, including the potential concerns that surgeons might be inclined to opt for surgery more readily than non-surgical providers, it is likely that the patients in our study had more severe forms of colitis. It might be the case that there are certain severities of colitis that are beyond the ability of infliximab to salvage, which would be an important issue in selecting which patients to provide inpatient infliximab, so as to not unnecessarily delay surgery, increase hospital costs and to avoid escalating the degree of immunosuppression without a reasonable likelihood of clinical improvement.”

Dr. Andrew reported having no financial disclosures.

[email protected]

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LOS ANGELES – The inpatient use of infliximab for severe ulcerative colitis does not avoid the need for colectomy in patients who fail steroid therapy, results from a single-center study demonstrated.

In an interview at the annual meeting of the American Society of Colon and Rectal Surgeons, lead study author Dr. Rachel E. Andrew, a third-year resident in the department of surgery at Penn State Hershey Medical Center in Hershey, Pa., said that despite recent interest in providing inpatient infliximab as an alternative to surgery for those with steroid-refractory disease, 82% of those who received salvage infliximab went on to undergo a total abdominal colectomy during the same admission.

Dr. Rachel Andrew

“Our findings suggest that inpatient infliximab was not effective at improving the severity of colitis in these patients,” she said. “Further, infliximab was unreliable in avoiding the need for a total colectomy in this population of ulcerative colitis patients. One difference between our study and those previously published on this subject is that our study focuses on patients with a severity of colitis that resulted in their admission to a surgery service. In terms of evaluating the benefit of infliximab and providing a reliable avoidance of colectomy, we feel that this population of ulcerative colitis patients would be most appropriate to evaluate this issue. This possible difference in patient population may explain the difference in our study findings and those previously published.”

The researchers compared colectomy rates in 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center. Their mean age was 41 years, with 155 (90%) treated with high-dose steroids alone, and with 18 (10%) having received inpatient infliximab as salvage therapy due to a lack of response to steroids alone. Of the patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

The researchers observed no statistically significant differences between the two groups regarding rates of hospital readmission, superficial, deep and organ space surgical-site infections, unplanned return to the operating room, and all complication rates (P greater than .05). Among patients who required total colectomy, hospital costs were 27% higher among those who received infliximab compared with those who received high-dose steroids alone (a mean of $19,880 vs. $14,492, respectively), but because of the small sample size of the infliximab cohort this difference did not reach statistical significance.

“In our institution, salvage infliximab has not been shown to be effective,” Dr. Andrew said. “One key difference between our findings and other studies is that our study population had a high colectomy rate; 82% is much higher than the approximately 30% colectomy rate described in many reports from colleagues in gastroenterology. While there are several potential explanations for our higher rate of colectomy, including the potential concerns that surgeons might be inclined to opt for surgery more readily than non-surgical providers, it is likely that the patients in our study had more severe forms of colitis. It might be the case that there are certain severities of colitis that are beyond the ability of infliximab to salvage, which would be an important issue in selecting which patients to provide inpatient infliximab, so as to not unnecessarily delay surgery, increase hospital costs and to avoid escalating the degree of immunosuppression without a reasonable likelihood of clinical improvement.”

Dr. Andrew reported having no financial disclosures.

[email protected]

LOS ANGELES – The inpatient use of infliximab for severe ulcerative colitis does not avoid the need for colectomy in patients who fail steroid therapy, results from a single-center study demonstrated.

In an interview at the annual meeting of the American Society of Colon and Rectal Surgeons, lead study author Dr. Rachel E. Andrew, a third-year resident in the department of surgery at Penn State Hershey Medical Center in Hershey, Pa., said that despite recent interest in providing inpatient infliximab as an alternative to surgery for those with steroid-refractory disease, 82% of those who received salvage infliximab went on to undergo a total abdominal colectomy during the same admission.

Dr. Rachel Andrew

“Our findings suggest that inpatient infliximab was not effective at improving the severity of colitis in these patients,” she said. “Further, infliximab was unreliable in avoiding the need for a total colectomy in this population of ulcerative colitis patients. One difference between our study and those previously published on this subject is that our study focuses on patients with a severity of colitis that resulted in their admission to a surgery service. In terms of evaluating the benefit of infliximab and providing a reliable avoidance of colectomy, we feel that this population of ulcerative colitis patients would be most appropriate to evaluate this issue. This possible difference in patient population may explain the difference in our study findings and those previously published.”

The researchers compared colectomy rates in 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center. Their mean age was 41 years, with 155 (90%) treated with high-dose steroids alone, and with 18 (10%) having received inpatient infliximab as salvage therapy due to a lack of response to steroids alone. Of the patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

The researchers observed no statistically significant differences between the two groups regarding rates of hospital readmission, superficial, deep and organ space surgical-site infections, unplanned return to the operating room, and all complication rates (P greater than .05). Among patients who required total colectomy, hospital costs were 27% higher among those who received infliximab compared with those who received high-dose steroids alone (a mean of $19,880 vs. $14,492, respectively), but because of the small sample size of the infliximab cohort this difference did not reach statistical significance.

“In our institution, salvage infliximab has not been shown to be effective,” Dr. Andrew said. “One key difference between our findings and other studies is that our study population had a high colectomy rate; 82% is much higher than the approximately 30% colectomy rate described in many reports from colleagues in gastroenterology. While there are several potential explanations for our higher rate of colectomy, including the potential concerns that surgeons might be inclined to opt for surgery more readily than non-surgical providers, it is likely that the patients in our study had more severe forms of colitis. It might be the case that there are certain severities of colitis that are beyond the ability of infliximab to salvage, which would be an important issue in selecting which patients to provide inpatient infliximab, so as to not unnecessarily delay surgery, increase hospital costs and to avoid escalating the degree of immunosuppression without a reasonable likelihood of clinical improvement.”

Dr. Andrew reported having no financial disclosures.

[email protected]

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Infliximab fails as salvage treatment for severe ulcerative colitis
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Key clinical point: Infliximab was not effective as inpatient salvage therapy for severe ulcerative colitis.

Major finding: Of patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

Data source: A study of 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center.

Disclosures: Dr. Andrew reported having no financial disclosures.