Gastroenterology

Although the benefits of originator infliximab have been deemed to outweigh the potential harm during pregnancy, in a recent observational study, researchers looked to evaluate whether biosimilar infliximab therapy was associated with any new safety risks.

While systemic inflammation is a potential biological mechanism underlying both Parkinson disease (PD) and inflammatory bowel disease (IBD), clinical data on comorbid PD and IBD are few. In a new study published in JAMA Neurology, researchers report on a retrospective cohort study that assessed the incidence of PD among patients with IBD and sought to identify whether anti–tumor necrosis factor (anti-TNF) therapy for IBD alters the risk of PD.

The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), an umbrella organization that represents 34 patient associations around the world, recently released a report on healthcare inequities among nations and regions. In the report, the EFCCA identified disparities in access to biologics and biosimilars.

“A [3]-year time lag for the next biosimilar medicine, from market authorization to the patient switching process, should not occur," say the authors of a recent review.

In patients with IBD, it was found that gut microbial levels lack in diversity. After receiving infliximab treatment, CD patients restored their microbial diversity and increased their Clostridiales levels. Clostridiales reduced proinflammatory bacteria, produced short-chain fatty acids, and induced an immune response.

This week, the Spanish Society of Digestive Pathology (SEPD) became the most recent organization to announce an updated position statement on the use of biosimilars.

This week, Israel-based Protalix BioTherapeutics, Inc, announced positive results from a phase 2 clinical trial for its orally administered anti–tumor necrosis factor (anti-TNF) drug, OPRX-106, a plant cell–expressed recombinant human TNF receptor II fused to an IgG1 Fc domain.

Randomized controlled trials have established the clinical efficacy and safety of infliximab in treating fistulizing Crohn disease (CD), and while evidence for adalimumab and vedolizumab in this indication is weaker, these drugs are also used in clinical practice, sometimes in treatment sequences of biologics, to treat fistulizing CD. In Europe, where access to biologic drugs is largely driven by budgetary considerations, biosimilars have the potential to improve access to treatment.

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcomes—such as enhanced immunogenicity, compromised safety, or reduced efficacy—a research team, led by Hillel Cohen, PhD, conducted a systematic literature review of all available switching studies.

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.

A study published in Alimentary Pharmacology Therapeutics in December 2017 compared the outcomes, pharmacokinetics, and immunogenicity of treatment intensification strategies in patients with Crohn disease (CD) who have lost clinical response to the anti–tumor necrosis factor (anti-TNF) therapy infliximab.

Last week, at the European Crohn's and Colitis Organisation's 13th annual congress in Vienna, Austria, researchers presented data from the NOR-SWITCH EXTENSION trial—a 26-week open label extension of the NOR-SWITCH trial—concerning the inflammatory bowel disease (IBD) subgroup.

At the recent European Crohn's and Colitis Organisation’s 13th Congress in Vienna, Austria, several studies investigated the efficacy of infliximab biosimilars in treating Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA).

At the European Crohn’s and Colitis Organisation’s 13th annual congress, held in Vienna, Austria, a number of studies explored switching from reference infliximab to its biosimilar.

Today, at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), researchers released 12-month data from the Personalized Anti–Tumor Necrosis Factor (anti-TNF) Therapy in Crohn Disease (CD) Study (PANTS).

Although some studies have demonstrated an increased risk of death in patients with inflammatory bowel disease taking corticosteroids, the relationship between death and anti–tumor necrosis factor (anti-TNF) drugs has not been as clear.

Some data that physicians would like to see demonstrated in bioequivalence studies may not be feasible in clinical trials due to the number of patients who would have to be enrolled in the studies.

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.

Switching patients from originator biologics to biosimilars is associated with the potential for a “nocebo” effect, a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would—essentially, the opposite of the placebo effect.

Anti–tumor necrosis factor drugs are expensive, and there are a limited number of choices for IBD treatment, highlighting the need to use every existing agent optimally.

In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.