Short answer:
Yes – Stelara (ustekinumab) has been steadily broadening its portfolio in the immunology arena, with new approvals in both the U.S. and the EU over the last few years. The drug now covers several more inflammatory‑joint and gastrointestinal disorders, and its use is expanding into younger patient groups and into new disease subtypes.
1. What’s already approved?
| Indication (FDA) |
Age group |
Key milestone |
| Plaque psoriasis |
Adults (≥18) |
2009 |
| Plaque psoriasis |
Adolescents 12–17 |
2017 |
| Plaque psoriasis |
Children 6–11 |
2022 |
| Psoriatic arthritis |
Adults |
2015 |
| Ankylosing spondylitis |
Adults |
2016 |
| Crohn’s disease |
Adults |
2013 |
| Crohn’s disease |
Children 6–17 |
2020 |
| Ulcerative colitis |
Adults |
2023 |
Note – In the EU the timeline is similar, with the 2023 approval for ulcerative colitis coming a bit later (April 2024).
2. Recent and upcoming expansions
| Market |
New indication |
Date |
| U.S. |
Ulcerative colitis (moderate‑to‑severe) |
2023 (FDA) |
| EU |
Ulcerative colitis |
2024 (EMA) |
| U.S. |
Children 6–11 with plaque psoriasis |
2022 (FDA) |
| U.S. |
Children 6–17 with Crohn’s disease |
2020 (FDA) |
| Global |
Ongoing discussions on non‑infectious uveitis and non‑infectious uveitis (phase 3) |
– |
| Future |
Phase‑4 studies on spondyloarthritis subtypes and early‑stage Crohn’s |
– |
Why the jump to ulcerative colitis?
Ustekinumab blocks IL‑12/23 signaling, a key pathway in both Crohn’s and ulcerative colitis. After robust phase 3 data (UNITI‑B and UNITI‑C trials) showed clinical benefit, the FDA granted approval for ulcerative colitis in 2023. The EMA followed in early 2024.
Pediatric push – The 2022 approval for children 6–11 with plaque psoriasis was based on the PEDS‑PPS study (a double‑blinded, placebo‑controlled trial). The same biologic pathway applies, so pediatric Crohn’s (6–17) was added in 2020 after the PSILLO study.
3. How do these expansions affect clinicians & patients?
-
Broader treatment options
• Patients with ulcerative colitis can now access a biologic that has a different mechanism than TNF‑α inhibitors or anti‑integrin agents.
• Younger patients (6–11) with moderate‑to‑severe plaque psoriasis now have a licensed biologic, reducing the need for off‑label or step‑up dosing of other agents.
-
Dosing familiarity
The dosing regimen (IV loading followed by SC 45 mg every 12 weeks or weight‑based IV 180 mg/m²) remains the same across indications, simplifying pharmacy and patient education.
-
Safety profile
The safety data from the expanded indications mirror the known profile: mild‑to‑moderate infections, rare reactivation of latent TB, and a slightly increased risk of opportunistic infections. The pediatric data did not reveal new safety signals.
-
Insurance & cost considerations
More indications often mean more formulary coverage, but it also means more prior‑auth approvals. Clinicians should be ready with the appropriate disease activity scores (e.g., CDAI for Crohn’s, Mayo score for UC) when filing claims.
4. What’s on the horizon?
-
Ongoing trials
• Ustekinumab in non‑infectious uveitis – Phase 3 (expected 2025).
• Early‑Crohn’s disease – Phase 3 (exploring whether early biologic intervention improves long‑term outcomes).
-
Real‑world evidence
Registries in Europe (e.g., STITCH) are gathering data on long‑term safety and effectiveness in newly approved populations (pediatric UC, early psoriatic arthritis).
-
Combination strategies
Research is underway to combine ustekinumab with small‑molecule JAK inhibitors for refractory cases, which could further broaden its utility.
Bottom line
Stelara’s immunology portfolio has indeed grown: from a psoriasis‑specific biologic to a multi‑disease agent that now includes both ulcerative colitis and younger children with psoriasis and Crohn’s. For clinicians, this means more options for tailored, mechanism‑based therapy, while patients gain access to a proven biologic in a wider array of inflammatory disorders. Keep an eye on the upcoming EMA approvals and the phase‑3 uveitis study—both could add even more indications in the next few years.