Infliximab Called 'Optimal' for Refractory Ulcerative Colitis

SAN DIEGO – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab (Remicade) also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

Alex Otto/IMNG Medical Media

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

"If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring," Dr. Patel said.

"I think infliximab would be the optimal medical rescue therapy for these patients" in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

"In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy," Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes "allow you to move on to medical or surgical rescue therapy early on," he said.

"But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy," despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

"Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons," Dr. Patel said.

Dr. Patel said he has no disclosures.

SAN DIEGO – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab (Remicade) also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

Alex Otto/IMNG Medical Media

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

"If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring," Dr. Patel said.

"I think infliximab would be the optimal medical rescue therapy for these patients" in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

"In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy," Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes "allow you to move on to medical or surgical rescue therapy early on," he said.

"But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy," despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

"Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons," Dr. Patel said.

Dr. Patel said he has no disclosures.

SAN DIEGO – Infliximab is the optimal rescue therapy for severe, acute, steroid-refractory ulcerative colitis, gastroenterologist Dr. Derek R. Patel said at the annual meeting of the Society of Hospital Medicine.

The tumor necrosis factor–alpha inhibitor, which carries ulcerative colitis (UC) indications, works as well as cyclosporine, the traditional option, without its complications, which include a 1% mortality rate and the need for extensive monitoring.

Infliximab (Remicade) also works better than azathioprine, the agent to which steroid-refractory patients often are switched once they leave the hospital, said Dr. Patel of the department of medicine at the University of California, San Diego.

Alex Otto/IMNG Medical Media

In a randomized trial by Dr. D. Laharie and colleagues that compared infliximab in 56 steroid-refractory UC patients with cyclosporine in 55 similar patients, about 85% of those in each arm responded to treatment within 1 week; 10 (18%) of the cyclosporine patients and 13 (23%) in the infliximab group had undergone a colectomy by the third month of follow-up. Serious adverse events were reported in 9 (16%) cyclosporine patients and 16 (29%) infliximab patients. There were no deaths.

"If you look at all the important end points, whether they be early response, overall treatment failure, or colectomy, there are no significant short-term differences between cyclosporine and infliximab, suggesting that infliximab is not inferior to cyclosporine. [It also] is much easier to use and requires minimal monitoring," Dr. Patel said.

"I think infliximab would be the optimal medical rescue therapy for these patients" in most cases, he said.

Another study – a 16-week, randomized, double-blind, controlled trial by Dr. R. Panccione and colleagues – compared azathioprine monotherapy, infliximab monotherapy, and combination therapy in 239 steroid-refractory UC patients.

"In the two most important end points of steroid-free clinical remission and mucosal healing, infliximab-based therapy, whether monotherapy or combination therapy, was significantly better than azathioprine monotherapy," Dr. Patel said.

Steroid failure can generally be predicted after 3 days of treatment by the Travis or Lindgren indexes, which take into account number of bowel movements per day, C-reactive protein levels, and other factors. Those and other indexes "allow you to move on to medical or surgical rescue therapy early on," he said.

"But remember medical therapy isn’t for everyone. Some patients probably should have a colectomy," despite the possible complications, Dr. Patel cautioned.

Patients who are likely to need surgery include those with massive unrelenting hemorrhage, toxic megacolon, coexisting cancer or dysplasia, and intractable UC of long duration, as well as noncompliant patients.

"Patients and physicians alike tend to assume surgery is failure, [but] that’s not true. At the end of the day, our goal is to save lives and quality of life, not necessarily colons," Dr. Patel said.

Dr. Patel said he has no disclosures.