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FDA Approves Stelara for the Treatment of Crohn’s

Janssen Biotech, Inc. has just received FDA approval for their new biologic, Stelara, for the treatment of Crohn’s disease. Stelara (ustekinumab) acts as an interleukin-12 and interleukin-23 inhibitor, specifically targeting cytokines in the immune response pathway. The new drug is currently approved and utilized for the treatment of plaque psoriasis and psoriatic arthritis.

Stelara’s efficiency was confirmed across three Phase 3 trials that included over 1,300 individuals with Crohn’s disease. The individuals in the studies either failed or were intolerant to conventional therapies, such as corticosteroids or immunomodulators. Additionally, these individuals had either never utilized TNF treatments (tumor necrosis factor), or had experience with TNF treatments, but they were ineffective or intolerable. Stelara is specifically for individuals who are at least 18-years-old, and who fit into these categories.

William J. Sandborn, MD, Chief, Division of Gastroenterology, and professor of medicine at the University of California, San Diego, School of Medicine, said the treatment is, “an important advancement in treating patients with Crohn’s disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn’s disease.” Sentiments like these have led to much enthusiasm surrounding the treatment’s potential.

The results of the Phase 3 studies that led to Stelara’s approval indicated that within six weeks after receiving the initial, one-time, intravenous dose of the treatment, 34-56% of individuals who had either failed, were new to, or who were experienced with TNF blockers experienced relief from symptoms. For some individuals, improvement was noticed within three weeks. Those who continued with the treatment after the original dosage received subcutaneous administration of Stelara every eight weeks. After 52 weeks from the original dosage, most of these individuals reported being in remission.

The most common side effects of Stelara have been reported as headache, tiredness, nausea, vomiting, joint pain, yeast infections, urinary tract infections, and upper respiratory infections. Additionally, the treatment could lead to an increased risk of other infections or decreased ability to fight off infection.