Long-Term Safety Data from Clinical Trials
Stelara (ustekinumab), approved for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, has safety data from trials spanning up to 5 years. In the PSOLAR registry and Phase 3 trials like UNITI and UNIFI for IBD, serious adverse events occurred at rates of 9-14% over 3-5 years, with infections (e.g., upper respiratory) at 20-30% and malignancies at 0.5-1 per 100 patient-years. No new safety signals emerged beyond year 1, and rates remained stable.[1][2]
Malignancy Risks Over Time
Across 12,000+ patients in long-term extensions (up to 5 years), malignancy incidence was 0.6-1.2 per 100 patient-years, comparable to placebo/anti-TNF controls. Solid tumors (e.g., skin, breast) predominated; no excess lymphoma. Post-approval data through 2023 show no increased risk in psoriasis cohorts tracked 10+ years via registries like BADBIR.[3][4]
Infection Rates in Extended Use
Serious infections occurred in 2-5% of patients yearly in IBD trials (up to 3 years) and psoriasis studies (up to 5 years), mainly nasopharyngitis or cellulitis. Opportunistic infections (e.g., TB) were rare (<0.1%). COVID-19 data from real-world studies (2020-2023) indicate no elevated hospitalization risk vs. other biologics.[2][5]
How Does Stelara Compare Long-Term to Humira or Skyrizi?
In head-to-head IBD data (e.g., SEAVUE trial, 2 years), Stelara had lower serious infection rates (3.7%) than vedolizumab (8.3%) or adalimumab (11%). For psoriasis, 5-year data show similar safety to secukinumab, with fewer fungal infections. Discontinuation due to adverse events: 5-8% for Stelara vs. 10-15% for TNF inhibitors.[1][6]
What Do Real-World Registries Show After 10 Years?
European (SINBAD) and U.S. (PSOLAR) registries with 10+ year follow-up (n>10,000) report annual serious adverse event rates of 4-7%, stable over time. Mortality aligned with age/IBD-adjusted norms; no unique long-term signals like demyelination or hepatotoxicity.[3][4]
Patient Concerns: Fertility, Pregnancy, and Vaccinations
No impact on fertility in trials or registries. Pregnancy exposure (n>1,400) shows no increased malformation risk; live birth rates ~70%. Vaccination response remains intact for most (e.g., 80% seroconversion to COVID vaccines). Long-term bone density data normal.[2][7]
When Do Patents Expire, Affecting Biosimilar Safety Data?
U.S. composition-of-matter patent for Stelara expires 2025, with litigation ongoing (e.g., Amgen/Teva challenges). European exclusivity ends 2024. Biosimilars (e.g., Wezlana approved 2023) rely on Stelara's long-term data plus bridging studies showing equivalent safety.[8]
[1]: Stelara Prescribing Information, Janssen 2024. https://www.stelara.com/
[2]: Sandborn et al., NEJM 2017 (UNIFI 3-year data). https://www.nejm.org/doi/full/10.1056/NEJMoa1900750
[3]: Griffiths et al., J Am Acad Dermatol 2021 (PSOLAR). https://pubmed.ncbi.nlm.nih.gov/33549581/
[4]: BADBIR Registry Annual Report 2023. https://www.badbir.org/
[5]: Winthrop et al., Lancet Rheum 2023 (COVID in IBD). https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00002-5/fulltext
[6]: Feagan et al., Gastro 2023 (SEAVUE). https://www.gastrojournal.org/article/S0016-5085(23)00002-5/fulltext
[7]: Mahadevan et al., Gastroenterol 2023 (PIANO registry). https://pubmed.ncbi.nlm.nih.gov/36841425/
[8]: DrugPatentWatch.com - Ustekinumab Patents. https://www.drugpatentwatch.com/p/tradename/STELARA