Ustekinumab-stba Receives FDA Approval for Autoimmune Disorder and Inflammatory Bowel Disease

Ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to ustekinuma (Stelara; Janssen Biotech, Inc) received FDA approval for subcutaneous injection or intravenous infusion for the treatment of adult and pediatric patients with plaque psoriasis, arthritis, and psoriatic arthritis, in addition to adult patients with Crohn disease and ulcerative colitis.¹

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"Plaque psoriasis and psoriatic arthritis are both autoimmune disorders that affect the skin and present differently in all patients," said Mark G. Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, in a news release. "The approval of new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the US adult population."¹

Plaque psoriasis and psoriatic arthritis are related chronic conditions that impact the skin and joints. Plaque psoriasis is the most common form of psoriasis that presents as red, dry, scaly patches on the skin. Psoriatic arthritis is not as common, only affecting some individuals with psoriasis, and is known to cause joint pain, stiffness, and swelling in any part of the body.²

Crohn disease and ulcerative colitis are chronic inflammatory bowel diseases that affect the digestive tract. Although Crohn disease can impact any part of the gastrointestinal tract, ulcerative colitis only affects the colon and rectum. However, both diseases share similar symptoms, including abdominal pain, diarrhea, fatigue, constipation, urgent need to have a bowel movement, and feeling like the bowel movement was not complete.³

As a fully human monoclonal antibody, ustekinumab selectively inhibits IL-12 and IL-23, 2 cytokines that aid inflammatory and immune responses. The approval of the subcutaneous injection was based on positive results from a phase 3 study that assessed ustekinumab in adults with moderate to severe plaque psoriasis.¹

The study authors noted that the subcutaneous injection is available in 2 strengths — 45 mg/0.5 mL or 90 mg/1 mL solution in a single-dose, prefilled syringe. Additionally, the intravenous infusion is delivered as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial. The approval of ustekinumab includes all implications that were previously indicated for ustekinuma, including psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis in adults and pediatric patients 6 years and older.¹

Infliximab-dyyb (Zymfentra; Celltrion) was approved by the FDA in October of 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn disease after intravenous administration of an infliximab product.⁴

According to the release, ustekinumab is expected to launch in February 2025.¹

REFERENCES

1. U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab). Celltrion. News release. December 17, 2024. Accessed December 18, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-steqeyma-ustekinumab-stba-a-biosimilar-to-stelara-ustekinumab-302334458.html.

2. What is the Difference Between Plaque Psoriasis and Psoriatic Arthritis? Dermatology Associates. News release. Accessed December 18, 2024. https://plymouthmeetingdermatology.com/plaque-psoriasis-or-psoriatic-arthritis/.

3. Crohn's disease and ulcerative colitis. Better Health. News release. Accessed December 18, 2024. https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/crohns-disease-and-ulcerative-colitis.

4. PT Staff. FDA Approves Infliximab-dyyb for Inflammatory Bowel Disease. Pharmacy Times. News release. October 23, 2023. Accessed December 18, 2024. https://www.pharmacytimes.com/view/fda-approves-biosimilar-infliximab-dyyb-for-inflammatory-bowel-disease.