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.
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.
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.
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.
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.
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.
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.
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 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.
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.

Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

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