Gastroenterology

Study: Using Biologics Early in Patients With Pediatric Crohn Disease Improves Linear Growth

January 17th 2018

By Kelly Davio

A newly published retrospective study found that patients who received a combination therapy with infliximab and azathioprine early on had significantly increased linear growth compared to patients whose therapy was stepped up.

Protalix Announces Positive Phase 2 Clinical Data for Oral Anti-TNF Agent

January 3rd 2018

By Kelly Davio

Article

Israel-based Protalix BioTherapeutics has announced positive interim data from its phase 2 clinical trial of a proposed oral anti–tumor necrosis factor (anti-TNF) therapy, OPRX-106.

Disability as a More Objective Measure in Inflammatory Bowel Disease

December 30th 2017

By Jackie Syrop

Article

As the treatment paradigm in inflammatory bowel disease (IBD) has shifted from controlling symptoms to fully controlling disease in order to prevent organ damage and disability, some have argued that disability is a better, more objective measure than quality of life in clinical trials and population studies of IBD.

First Brazilian Study of Adalimumab to Treat Ulcerative Colitis Demonstrates Efficacy and Safety

December 29th 2017

By Jackie Syrop

Article

Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.

Extrapolation Framework Can Guide Off-Label Determinations for Biosimilars, Study Argues

December 27th 2017

By Kelly Davio

Article

In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.

Adalimumab Effective in Treating Stricturing Crohn Disease

December 18th 2017

By Kelly Davio

Article

While anti–tumor necrosis factor (anti-TNF) therapies are effective in helping patients with Crohn disease (CD) gain remission, data on using anti-TNFs in patients with stricturing CD are conflicting; some reports suggest that anti-TNF agents increase the risk of intestinal obstruction.

Measuring Antibodies to Infliximab To Guide Treatment Intensification in Crohn Disease

December 14th 2017

By Jackie Syrop

Article

A significant proportion of patients with Crohn disease (CD) who initially respond to infliximab therapy experience secondary loss of response with symptom flares. Treatment intensification (using increases in dose, dose frequency, or a combination of both to implement intensification) is a suggested strategy for regaining response.

Study Finds Switching Patients to Biosimilar Infliximab Safe and Effective in IBD

December 7th 2017

By Jackie Syrop

Article

No differences in drug levels or disease activity were found when adult patients with inflammatory bowel disease (IBD) were switched from originator infliximab (Remicade) to a biosimilar infliximab (Inflectra) as part of routine care, according to the results of a Dutch study.

Biologics, and Costs, Are on the Rise in IBD Treatment, Study Finds

November 28th 2017

By The Center for Biosimilars Staff

Article

Biologics are increasingly used in the treatment of inflammatory bowel disease (IBD), but real-world data quantifying the costs of these therapies have been lacking. A new study, published in Alimentary Pharmacology and Therapeutics, sought to determine trends in costs and relative market share of IBD therapies in the United States over the past 9 years.

Review Identifies Factors Predicting Response to Anti-TNF Therapy

November 15th 2017

By Jackie Syrop

Article

The ability to identify factors that predict efficacy of anti–tumor necrosis factor (TNF) agents is crucial if clinicians are to optimize treatment and minimize side effects and costs.