Year in Review: Crohn’s Disease

Cyltezo, the first interchangeable biosimilar for adalimumab (Humira), was approved for Crohn’s disease, while research continued on additional therapeutic options, including a study that compared two different biologics head-to-head. Studies also dug deeper into the connection between Crohn’s disease and diet.

First Interchangeable Biosimilar for Adalimumab Approved

October saw the FDA approve the first interchangeable biosimilar to adalimumab (Humira), though the therapy (Cyltezo) will not be commercially available in the U.S. until July 2023. Cyltezo is a tumor necrosis factor (TNF) inhibitor that was approved for adults with Crohn’s disease, ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. It is also indicated for use in children ages 6 and up with Crohn’s disease. The drug will contain a boxed warning due to increased risks for serious infections, as well as lymphoma and other cancers.

Biologics Go Head-to-Head as Monotherapy

The SEAVUE trial compared interleukin (IL)-12/23 antagonist ustekinumab (Stelara) to adalimumab among biologic-naive patients with moderate-to-severe Crohn’s disease, and found no difference in clinical remission or endoscopic responses.

A panel of experts discussed the trial at Digestive Disease Week, commenting that both drugs used as monotherapy were well tolerated.

“I think this is really encouraging in that it sort of supports our understanding that your first drug is the one that you have the best chance of getting your patient into clinical and endoscopic remission,” said Jill Gaidos, MD, of Yale School of Medicine in New Haven, Connecticut.

Roundtable moderator, Jason Hou, MD, of Baylor College of Medicine in Houston added, “it’s going to come down to shared decision-making.”

“What is it with the patients?” he said. “What are the factors that are important to them? Access, cost, and things like that. That’s where I think the impact will be.”

In Other Biologics News

Data from the phase III FORTIFY trial presented at the American College of Gastroenterology meeting found that risankizumab (Skyrizi) as a maintenance therapy led to sustainable clinical remission and endoscopic response for those with moderate-to-severe Crohn’s disease. The higher subcutaneous dose of 360 mg of the IL-23 blocker established a significant benefit in clinical remission at 52 weeks compared to placebo (51.8% vs 39.6%, P=0.004).

Fistulizing Crohn’s disease has been a clinical challenge for many physicians to treat, given frequent recurrences. The phase IV ENTERPRISE trial found that two different treatment regimens of a 300 mg dose of intravenous vedolizumab (Entyvio) in patients with moderate-to-severe perianal fistulizing Crohn’s disease led to fistula draining and sustained fistula closure after 30 weeks. Clinically relevant improvement was observed as early as 2 weeks and maintained through week 30, without any safety concerns.

“Overall, this study suggests that intravenous vedolizumab is effective in patients with fistulizing CD [Crohn’s disease], and I believe this treatment strategy could be implemented in the clinic,” said Melinda Engevik, PhD, of Medical University of South Carolina in Charleston.

The Role of Diet

In August, a study found that higher uptake of ultra-processed foods (UPFs), such as breakfast foods, breads, packaged sweets, in addition to frozen or readily prepared meals (commonly known as “TV dinners”), was linked to increased risk of incident Crohn’s disease. Interestingly, the researchers did not find any added risk of such UPFs with ulcerative colitis.

“Whether the risk of incident CD differs by the duration of UPF exposure and if avoiding UPFs is beneficial to those with an established disease requires further research,” study author Ashwin Ananthakrishnan, MD, of Harvard Medical School in Boston, said in an interview.

Physicians are encouraged to offer dietary recommendations to patients vulnerable to developing Crohn’s disease, as a preventative care measure, explained Engevik, who also provided comment on this research.

Healthier diets also showed positive effects for Crohn’s disease patients, as research from the Crohn’s and Colitis Conference found that the Mediterranean diet and the Specific Carbohydrate diet (first founded in the 1920s) were both associated with symptom reduction and clinical remission.

At week 6, symptomatic remission was achieved by 44% of patients on the Mediterranean diet and by 47% of those following the Specific Carbohydrate diet, and clinical remission defined by the Crohn’s Disease Activity Index also was observed in similar numbers, at 48% for the Mediterranean diet and 49% for the Specific Carbohydrate diet.

Quality-of-life measures at week 6, including fatigue, pain, sleep, and social isolation improved significantly in both groups, with no differences seen between diets.

The Specific Carbohydrate diet is characterized by a high intake of unprocessed meat, poultry, fish, shellfish, and eggs, while the Mediterranean diet has a high intake of olive oil, fruits, vegetables, nuts, and cereals. Both diets encourage a high consumption of fresh fruit and vegetables.

Additional Crohn’s disease stories reported this year include:

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