Surgical outcomes for UC worse since introduction of biologics

Since the approval of infliximab in 2005 as the first biologic agent to treat ulcerative colitis, more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.

“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”

The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).

As for surgical outcomes, after 2005 rates of in-hospital death (8.1% vs. 5.5%), major events (7.4% vs. 5.3%), procedure-related complications (12.3% vs. 9.9%), and nonroutine discharge (73% vs. 46%; all P less than .01) were higher. However, patients did have shorter hospital stays, averaging 9 vs. 10 days before 2005. The adjusted odds ratio analysis found that surgery after 2005 was 40% more likely to result in complications. “Similar trends for worse adjusted outcomes in patients initially undergoing surgery after 2005 were seen at 90-day and 1-year follow-up,” Dr. Abelson and coauthors said.

A potential explanation for trends in postsurgery death may be higher rates of Clostridium difficile after 2005 (10.6% vs. 5.8%; P less than .01), but that was accounted for in the adjusted analysis and is probably not a major factor, the researchers said. After 2006 patients were slightly older and more likely to be on Medicare and nonwhite; they also were sicker, with 28% having two or more comorbidities vs. 10% before 2006.

The investigators offered another explanation: “It is also possible that the immunosuppressive effect of biologic agents ... predisposes patients to worse postoperative outcomes. In addition, it is possible that patients are referred for surgery too late in their disease course because of prolonged medical therapy.”

Dr. Abelson and coauthors reported having no financial relationships.

SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.

Since the approval of infliximab in 2005 as the first biologic agent to treat ulcerative colitis, more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.

“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”

The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).

As for surgical outcomes, after 2005 rates of in-hospital death (8.1% vs. 5.5%), major events (7.4% vs. 5.3%), procedure-related complications (12.3% vs. 9.9%), and nonroutine discharge (73% vs. 46%; all P less than .01) were higher. However, patients did have shorter hospital stays, averaging 9 vs. 10 days before 2005. The adjusted odds ratio analysis found that surgery after 2005 was 40% more likely to result in complications. “Similar trends for worse adjusted outcomes in patients initially undergoing surgery after 2005 were seen at 90-day and 1-year follow-up,” Dr. Abelson and coauthors said.

A potential explanation for trends in postsurgery death may be higher rates of Clostridium difficile after 2005 (10.6% vs. 5.8%; P less than .01), but that was accounted for in the adjusted analysis and is probably not a major factor, the researchers said. After 2006 patients were slightly older and more likely to be on Medicare and nonwhite; they also were sicker, with 28% having two or more comorbidities vs. 10% before 2006.

The investigators offered another explanation: “It is also possible that the immunosuppressive effect of biologic agents ... predisposes patients to worse postoperative outcomes. In addition, it is possible that patients are referred for surgery too late in their disease course because of prolonged medical therapy.”

Dr. Abelson and coauthors reported having no financial relationships.

SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.

Since the approval of infliximab in 2005 as the first biologic agent to treat ulcerative colitis, more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.

“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”

The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).

As for surgical outcomes, after 2005 rates of in-hospital death (8.1% vs. 5.5%), major events (7.4% vs. 5.3%), procedure-related complications (12.3% vs. 9.9%), and nonroutine discharge (73% vs. 46%; all P less than .01) were higher. However, patients did have shorter hospital stays, averaging 9 vs. 10 days before 2005. The adjusted odds ratio analysis found that surgery after 2005 was 40% more likely to result in complications. “Similar trends for worse adjusted outcomes in patients initially undergoing surgery after 2005 were seen at 90-day and 1-year follow-up,” Dr. Abelson and coauthors said.

A potential explanation for trends in postsurgery death may be higher rates of Clostridium difficile after 2005 (10.6% vs. 5.8%; P less than .01), but that was accounted for in the adjusted analysis and is probably not a major factor, the researchers said. After 2006 patients were slightly older and more likely to be on Medicare and nonwhite; they also were sicker, with 28% having two or more comorbidities vs. 10% before 2006.

The investigators offered another explanation: “It is also possible that the immunosuppressive effect of biologic agents ... predisposes patients to worse postoperative outcomes. In addition, it is possible that patients are referred for surgery too late in their disease course because of prolonged medical therapy.”

Dr. Abelson and coauthors reported having no financial relationships.

SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.