"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!
Amputees can learn to control a robotic arm with their minds
28.11.2017 | University of Chicago Medical Center
The importance of biodiversity in forests could increase due to climate change
17.11.2017 | Deutsches Zentrum für integrative Biodiversitätsforschung (iDiv) Halle-Jena-Leipzig
Tiny pores at a cell's entryway act as miniature bouncers, letting in some electrically charged atoms--ions--but blocking others. Operating as exquisitely sensitive filters, these "ion channels" play a critical role in biological functions such as muscle contraction and the firing of brain cells.
To rapidly transport the right ions through the cell membrane, the tiny channels rely on a complex interplay between the ions and surrounding molecules,...
The miniaturization of the current technology of storage media is hindered by fundamental limits of quantum mechanics. A new approach consists in using so-called spin-crossover molecules as the smallest possible storage unit. Similar to normal hard drives, these special molecules can save information via their magnetic state. A research team from Kiel University has now managed to successfully place a new class of spin-crossover molecules onto a surface and to improve the molecule’s storage capacity. The storage density of conventional hard drives could therefore theoretically be increased by more than one hundred fold. The study has been published in the scientific journal Nano Letters.
Over the past few years, the building blocks of storage media have gotten ever smaller. But further miniaturization of the current technology is hindered by...
With innovative experiments, researchers at the Helmholtz-Zentrums Geesthacht and the Technical University Hamburg unravel why tiny metallic structures are extremely strong
Light-weight and simultaneously strong – porous metallic nanomaterials promise interesting applications as, for instance, for future aeroplanes with enhanced...
An interdisciplinary group of researchers interfaced individual bacteria with a computer to build a hybrid bio-digital circuit - Study published in Nature Communications
Scientists at the Institute of Science and Technology Austria (IST Austria) have managed to control the behavior of individual bacteria by connecting them to a...
Physicists in the Laboratory for Attosecond Physics (run jointly by LMU Munich and the Max Planck Institute for Quantum Optics) have developed an attosecond electron microscope that allows them to visualize the dispersion of light in time and space, and observe the motions of electrons in atoms.
The most basic of all physical interactions in nature is that between light and matter. This interaction takes place in attosecond times (i.e. billionths of a...
11.12.2017 | Event News
08.12.2017 | Event News
07.12.2017 | Event News
11.12.2017 | Information Technology
11.12.2017 | Power and Electrical Engineering
11.12.2017 | Event News