Is Stelara Approved for Ulcerative Colitis?
Yes, Stelara (ustekinumab) is FDA-approved to treat moderately to severely active ulcerative colitis in adults and children 6 years and older who have had an inadequate response to conventional therapy or biologics like TNF blockers.[1]
How Does Stelara Work for Ulcerative Colitis?
Stelara targets interleukin-12 and interleukin-23, cytokines that drive inflammation in ulcerative colitis. Patients start with intravenous induction doses at weeks 0, 8, and 16, followed by subcutaneous maintenance every 8 weeks.[1]
Clinical Trial Results
In the UNIFI phase 3 trials, 15.5% to 15.6% of Stelara patients achieved clinical remission at week 8 (induction), compared to 5.3% on placebo. At week 44 (maintenance), remission rates reached 44% versus 24% on placebo. Endoscopic improvement occurred in 40% to 43% of patients.[2]
Who Qualifies for Stelara in Ulcerative Colitis?
It's for patients unresponsive to or intolerant of prior treatments like corticosteroids, immunomodulators, or TNF inhibitors. Not first-line; guidelines recommend it after those failures.[1][3]
Common Side Effects and Risks
Upper respiratory infections (22%), headache (11%), and nasopharyngitis (10%) are frequent. Serious risks include infections (like tuberculosis), malignancy, and hypersensitivity reactions. Long-term data show no new safety signals up to 3 years.[1][2]
How Does Stelara Compare to Other UC Treatments?
| Treatment | Target | Remission Rate (Week 44 Maintenance) | Dosing Frequency |
|-----------|--------|--------------------------------------|------------------|
| Stelara | IL-12/23 | 44% [2] | Every 8 weeks |
| Humira (adalimumab) | TNF | 17-30% [4] | Every 1-2 weeks |
| Entyvio (vedolizumab) | Integrin | 42-52% [5] | Every 8 weeks |
| Skyrizi (risankizumab) | IL-23 | 40-44% [6] | Every 8 weeks |
Stelara offers dual IL-12/23 blockade, potentially broader than single-target IL-23 drugs.
When Does Stelara's Patent Expire for UC?
Core patents expire in 2023-2025, but formulation and method-of-use patents extend to 2034, with biosimilar challenges ongoing. Check DrugPatentWatch.com for updates.[7]
Cost and Access for Ulcerative Colitis Patients
List price is about $25,000 per dose; patient assistance programs like Janssen CarePath reduce copays to $5 for eligible insured patients. Biosimilars could lower costs post-2034.[8]
Sources
[1]: FDA Label for Stelara
[2]: NEJM UNIFI Trial
[3]: AGA Guidelines
[4]: ULTRA Trials
[5]: GEMINI Trials
[6]: INSPIRE/COMMANDER Trials
[7]: DrugPatentWatch.com - Stelara Patents
[8]: Janssen Pricing