Crohn disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract characterized by a relapsing course and variable presentation that often includes abdominal pain, diarrhea, and fatigue. CD frequently presents during childhood, resulting in pediatric-specific complications, such as growth failure and delayed puberty. Conventional drug therapy for moderate to severe pediatric CD includes induction of remission with corticosteroids, and maintenance of remission with immunomodulators. Patients who have an inadequate response to standard therapy are being increasingly treated with anti-tumor necrosis factor-alpha (TNFalpha) agents. Infliximab has been the most widely studied anti-TNFalpha agent in pediatric CD, and has been shown to be efficacious in this condition. Adalimumab has been proven to be efficacious in adults with CD, but there has been only a single case report in children. CDP571 has been tested in 20 children with CD, showing some efficacy. Finally, thalidomide therapy has been associated with improvement in two small case series. Toxicities of these agents include infusion reactions, infections, malignancies, neurologic disorders, and hematologic derangements.

01 Jul 2007·Current treatment options in gastroenterology

Current and future anti-TNF therapy for inflammatory bowel disease

Article

Author: Mark T. Osterman ; Gary R. Lichtenstein

Anti-tumor necrosis factor-alpha (anti-TNF) therapy has become a very important modality in the treatment of patients with inflammatory bowel disease. A number of anti-TNF medications have been investigated for this purpose, many via randomized controlled trials. Infliximab, the most studied of these agents, has shown impressive efficacy in the treatment of luminal and fistulizing Crohn's disease, as well as ulcerative colitis. Adalimumab and certolizumab have shown similar efficacy in Crohn's disease but have not yet been studied in ulcerative colitis. Less impressive results were seen in randomized controlled trials involving CDP-571, etanercept, or onercept for patients with Crohn's disease. Thalidomide and CNI-1493 have been evaluated only preliminarily in small, open-label pilot studies in patients with Crohn's disease. The future of anti-TNF therapy in inflammatory bowel disease is very bright, as exciting new developments continue to be made at a rapid pace.

01 Oct 2006·ANNALS OF PHARMACOTHERAPY

Novel Therapies for Crohn's Disease: Focus on Immunomodulators and Antibiotics

Review

Author: Osiecki, Lisa L ; Wilhelm, Sheila M ; Kale-Pradhan, Pramodini B ; Taylor, Jason D

Objective::

To review the literature on novel immunomodulators such as tumor necrosis factor alpha (TNF-α)- and interleukin (IL)-related agents, 6-thioguanine (6-TG), tacrolimus, and leflunomide, and antibiotics such as ornidazole, rifaximin, and ciprofloxacin for the treatment of Crohn's disease.

Data Sources::

Literature was accessed through MEDLINE (1966–January 2006) using the terms Crohn's disease, novel therapies, immunomodulators, and antibiotics. Article references were hand-searched for additional relevant articles and abstracts.

Study Selection and Data Extraction::

All articles in English identified from the data sources were evaluated. Studies including greater than 5 patients with primarly adult populations were included in the review.

Data Synthesis::

There are a number of new TNF-α and IL-related agents that may be useful for management of Crohn's disease. They include CDP 571, CDP 870, etanercept, onercept, thalidomide, IL-10, and IL-11. Several studies have shown that CDP 571 decreases the Crohn's Disease Activity Index score and is promising, especially in patients with refractory disease. 6-TG, tacrolimus, and leflunomide are among other immunomodulators that appear to have a role in refractory/severe disease. Finally, ornidazole, rifaximin, and ciprofloxacin are antimicrobials that may be used in patients who have failed other therapies or as adjunctive therapies.

Conclusions::

A number of new treatment modalities are being investigated for Crohn's disease. Many of them are promising, and some of these agents may be considered in treatment-refractory patients in the future. However, some of the agents reviewed here are not available in the US. Future studies need to be double-blinded and placebo- or other treatment-controlled in a more homogeneous patient population.

100 Deals associated with CDP-571

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 3	United States	PDL BioPharma, Inc.	-
Crohn Disease	Phase 3	-	Celltech Oy	-
Crohn Disease	Phase 3	-	Biogen, Inc.	-
Shock, Septic	Phase 3	United States	PDL BioPharma, Inc.	-
Shock, Septic	Phase 3	Belgium	-	-
Shock, Septic	Phase 3	France	-	-
Shock, Septic	Phase 3	Germany	-	-
Shock, Septic	Phase 3	United Kingdom	Celltech Group Plc	-
Shock, Septic	Phase 3	-	Biogen, Inc.	-
Shock, Septic	Phase 3	-	Celltech Oy	-

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