"Post-surgical recurrence of Crohn's disease occurs very frequently. Unfortunately, none of the traditional drugs used to treat the naturally occurring disease has really shown a clear-cut benefit in this situation," said Dario R. Sorrentino, MD, of the University of Udine School of Medicine, Italy, and lead author of one of the studies. "Our study results indicate great potential for infliximab, a monoclonal antibody, which has shown remarkable efficacy in preventing this type of recurrence." Watch Dr. Sorrentino discuss his study at http://www.youtube.com/watch?v=g7-JSts-z40. Infliximab is known by the brand name Remicade®.
Doctors performed a prospective cohort study in 12 consecutive patients treated immediately after surgery with standard maintenance infliximab (5 mg/kg body weight every eight weeks) who did not have evidence of disease recurrence after 36 months. Treatment with infliximab was then discontinued. Patients with disease recurrence (i.e., with intestinal inflammation) were then given lower doses of infliximab in an attempt to re-establish the integrity of the intestinal mucosa, which helps ensure an adequate supply of nutrients.
The study authors showed that infliximab administration immediately after surgery effectively prevents recurrence of the disease (no intestinal inflammation and no symptoms) at three years. However, upon suspension of the medication, intestinal inflammation appears after four months in the large majority of patients (83 percent), thus indicating the need for long-term uninterrupted maintenance therapy. Nevertheless, a 40 percent reduction from the standard dose of 5 mg/kg (i.e., a dose of 3 mg/kg) was sufficient to re-establish the integrity of the intestinal mucosa and avoid disease recurrence in all patients at one year.
"Additional studies may be needed to confirm our findings. However, lowering the dose of infliximab may be potentially safer and is more cost effective than standard dose strategies for prevention of post-operative recurrence of Crohn's disease. This should be considered in the long-term management of patients undergoing surgery for this indication," added Dr. Sorrentino.
In a second study published in Clinical Gastroenterology and Hepatology, doctors found that certolizumab pegol — another type of biologic therapy — effectively maintains remission of Crohn's disease for up to 18 months. In addition, continuous therapy is more effective than interrupted therapy. Certolizumab pegol is known by the brand name Cimzia®.
Subcutaneous certolizumab pegol administered every four weeks is an effective and well-tolerated, long-term maintenance therapy for patients with moderate to severe Crohn's disease. Continuous maintenance therapy with certolizumab pegol is more likely to produce response and remission than interrupted therapy, without negatively impacting patient safety.
Doctors assessed the long-term effectiveness, safety and immunogenicity (ability to create an immune response) of five continuous versus interrupted maintenance therapy with subcutaneous certolizumab pegol in patients with Crohn's disease. Patients who responded to induction therapy at week six of the PRECiSE 2 trial (one of two large, pivotal, randomized, placebo-controlled, phase III studies) were randomly assigned to groups given certolizumab pegol (continuous) or placebo (drug-interruption). Patients who completed PRECiSE 2 were eligible to enter PRECiSE 3, an ongoing, open-label extension trial in which patients have received certolizumab pegol every four weeks for a total of 80 weeks. PRECiSE 3 is the first prospective trial in which patients received continuous or interrupted therapy for greater than 12 months and were not offered the option to increase their dose.
Responses at week 26 for the continuous and drug-interruption groups were 56.3 percent and 37.6 percent, respectively. Corresponding remission rates were 47.9 percent and 32.4 percent, respectively. Of patients responding at week 26, response rates at week 80 in the continuous and drug-interruption groups were 66.1 percent and 63.3 percent, respectively. Among patients in remission at week 26, week 80 remission rates were 62.1 percent and 63.2 percent, respectively. More patients in the drug-interruption group developed antibodies against certolizumab pegol and had lower plasma concentrations of certolizumab pegol than the continuously treated group.
About Crohn's Disease
Crohn's disease is an inflammation and ulceration process that occurs in the deep layers of the intestinal wall. The most common symptoms of Crohn's disease are pain in the abdomen (often in the lower right side), diarrhea, weight loss, rectal bleeding or fever.
To learn more about Crohn's disease, visit the patient center on the AGA Web site at www.gastro.org/patient-center.
About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org.
About Clinical Gastroenterology and Hepatology
The mission of Clinical Gastroenterology and Hepatology is to provide readers with a broad spectrum of themes in clinical gastroenterology and hepatology. This monthly peer-reviewed journal includes original articles as well as scholarly reviews, with the goal that all articles published will be immediately relevant to the practice of gastroenterology and hepatology. For more information, visit www.cghjournal.org.
Alissa J. Cruz | EurekAlert!
A sudden drop in outdoor temperature increases the risk of respiratory infections
11.01.2017 | University of Gothenburg
Urbanization to convert 300,000 km2 of prime croplands
27.12.2016 | Mercator Research Institute on Global Commons and Climate Change (MCC) gGmbH
Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...
Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.
While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...
Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales
Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...
Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.
As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...
At TU Wien, an alternative for resource intensive formwork for the construction of concrete domes was developed. It is now used in a test dome for the Austrian Federal Railways Infrastructure (ÖBB Infrastruktur).
Concrete shells are efficient structures, but not very resource efficient. The formwork for the construction of concrete domes alone requires a high amount of...
10.01.2017 | Event News
09.01.2017 | Event News
05.01.2017 | Event News
18.01.2017 | Power and Electrical Engineering
18.01.2017 | Materials Sciences
18.01.2017 | Life Sciences