Gastroenterology

Study: Biosimilar Infliximab Most Cost-Effective Biologic for Fistulizing CD

March 13th 2018

By Kelly Davio

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.

Systematic Literature Review Shows Low Risk of Safety Concerns or Loss of Efficacy After Switching to a Biosimilar

March 5th 2018

By Kelly Davio

Article

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.

Biosimilar Gastroenterology Roundup: February

February 28th 2018

By The Center for Biosimilars Staff

Article

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.

Anti-Infliximab Antibodies Can Guide Treatment Intensification in Patients With CD

February 23rd 2018

By Samantha DiGrande

Article

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.

Could NOR-SWITCH EXTENSION Data Allay Concerns About Switching in IBD?

February 20th 2018

By Kelly Davio

Article

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.

New Studies Investigate Infliximab Biosimilars in Treating CD, UC, and RA

February 20th 2018

By Samantha DiGrande

Article

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).

4 Studies Highlight Biosimilar Switching's Effect on Patients With IBD

February 19th 2018

By Kelly Davio

Article

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.

PANTS Study Supports Effectiveness, Safety, and Immunogenicity of Biosimilar Infliximab

February 17th 2018

By Kelly Davio

Article

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).

Treating Crohn Disease With Anti-TNF Drugs Reduces Mortality Rates

January 25th 2018

By Kelly Davio

Article

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.

Physician Survey Reveals "Disconnect" Between Expectations, Feasibility in Bioequivalence Studies

January 22nd 2018

By Kelly Davio

Article

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.