Stelara Gains FDA Approval To Treat Crohn's Disease

The FDA has granted approval for ustekinumab (Stelara/Janssen Biotech) to treat adults with moderately-to severely active Crohn’s disease (CD).

The FDA has granted approval for ustekinumab (Stelara/Janssen Biotech) to treat adults with moderately-to severely active Crohn’s disease (CD). The patients targeted were those intolerant to immunomodulators or corticosteroids, but handled treatment with tumor necrosis factor (TNF) blockers.

Stelara is the first biologic therapy that targets interleukin (IL)-12 and interleukin (IL)-23 cytokines for CD.

Based on study results from the clinical developmental program including more than 1,300 patients, 34% (UNITI-1 study) and 56% (UNITI-2 study) of the patients who were either new to or failed biologic therapy experienced relief from their CD symptoms in six weeks after taking the one-time intravenous (IV) dosage of Stelara.

Researchers had even witnessed noticeable improvement as early as three weeks.

Also, the majority of patients who responded favorable and continued Stelara treatment every eight weeks were in remission at the end of 44 weeks.

Stelara is the only approved CD treatment that’s a one-time IV infusion induction dose followed by “subcutaneous maintenance” injections every eight weeks to keep the symptoms under control.

Representatives of Janssen reported in the news release they will work closely with payers, providers, and pharmacy benefit managers to ensure Stelara is widely accessible and affordable for patients. Janssen offers a few patient support programs including a co-pay card for patients who have commercial and reduced their out-of-pocket cost for Stelara to no more than $5/dose — something that is also offered to psoriasis and psoriatic arthritis patients, as well.

Though, as a prescription medicine affecting the immune system, the most commonly reported adverse events for Stelara are serious infections.

According to study investigator William J. Sandborn, MD, chief of the Division of Gastroenterology, and professor of medicine, at UC San Diego School of Medicine, “The FDA approval of Stelara represents 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.”