Crohn’s disease scores with the interchangeable biosimilar Humira


October 18, 2021, MedPage today reported on the approval of Cyltezo, the first interchangeable biosimilar approval for adalimumab (Humira), covering a range of indications, including Crohn’s disease (CD). We offer here a follow-up of this history and further developments of the CD since this initial report.

The FDA has made Cyltezo (adalimumab-adbm) the second biosimilar to achieve coveted interchangeable status, and the first biosimilar to Humira (adalimumab) with this designation.

“What’s new is that this is the first biosimilar that has been designated as both ‘biosimilar’ and ‘interchangeable’, meaning that non-medical switches are of less concern for loss of response, effects. unwanted or other problems, “Dana Lukin, MD, PhD, of Weill Cornell Medicine in New York City, said MedPage today. “Humira [developer AbbVie] at blocked one of the biosimilars of launch for a while despite FDA approvals. “

Cyltezo was initially approved as a standard biosimilar in 2017 but will not be commercially available in the United States until 2023.

In adults, approval for tumor necrosis factor (TNF) -alpha inhibitor covers indications in moderate to severe CD as well as in several other chronic inflammatory diseases – ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, multiple psoriasis and ankylosing spondylitis. In pediatrics, the biosimilar is indicated for moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years of age and older, and for CD in children 6 years of age and older.

“I believe the biosimilars are equal to the originals and can be used for patients,” noted Paul Lebovitz, MD, of Allegheny Health Network in Pittsburgh. “In many ways, each original batch is a little different from the last as it comes from living organisms, so it is already in some ways a biosimilar.”

“However, I would prefer not to change mid-induction of a drug if possible,” Lebovitz added.

The approval of interchangeable status for Cyltezo was based on a demonstration of equivalence in the randomized phase III VOLTAIRE-X test, which involved multiple passages from Cyltezo to Humira compared to Humira given continuously in patients with plaque psoriasis.

Other developments in CD

“For patients with moderate or severe Crohn’s disease, it is more appropriate to use induction therapy with an alpha tumor necrosis factor antagonist – ustekinumab. [Stelara], or vedolizumab [Entyvio]”Lukin explained. During induction, a limited course of corticosteroids may be beneficial for inflammation and symptoms, but” should be reduced as quickly as possible, “he said.

For patients with severe CD in a postoperative condition, or with perianal fistula, the class of TNF antagonists has “provided the greatest efficacy and may be preferred for those with joint pain associated with their Crohn’s disease. Lukin added.

At the 2021 meeting of the American College of Gastroenterology (ACG), the results of the phase III FORTIFY study were presented. In this trial, two different subcutaneous maintenance doses of risankizumab (Skyrizi) maintained clinical remission and endoscopic responses for moderate to severe CD previously treated with anti-interleukin (IL) -23 antibody.

Investigator Marla Dubinsky, MD, of Icahn School of Medicine in Mount Sinai, New York, reported that 55.4% and 52.2% of patients receiving subcutaneous doses of risankizumab of 360 mg or 180 mg, respectively, were in clinical remission at week 52 compared to 40.9% of those who received placebo (PP

The recently published long-term results of the TAILORIX trial showed that achieving sustained clinical remission without steroids with complete endoscopic remission at onset of CD was not related to less disease progression, with similar progression-free survival at 1, 3 and 5 years for CD patients achieving the criteria for remission and those who did not.

Investigator David Laharie, MD, of Hôpital Haut-Lévêque in Bordeaux, France, said his group supported the early use of aggressive treatment to alter the historical course of CD, and an “approach. flexible of the target concept to be treated ”in routine practice. “The threshold to define endoscopic remission in CD remains unknown,” said Laharie. “We need prospective trials to better define treatment goals that actually alter the natural course of the disease and prevent complications.”

Lukin added that “there is a great need for new, safe and effective therapies for mild to moderate Crohn’s disease, those with fibrostenotic complications (stenosis), Crohn’s disease with perianal and internal fistulization, and therapies based. on the microbiota “.

  • Zaina Hamza is a writer for MedPage Today, covering gastroenterology and infectious diseases. She is based in Chicago.

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