Biologic – interleukin-12 and -23 inhibitor
ATC code: L04AC05 (Ustekinumab)
Brand names
Stelara, Pyzchiva, Wezenla
A fully human IgG1κ monoclonal antibody binding the shared p40 subunit of IL-12 and IL-23. Blocks binding to IL-12Rβ1 on T-cells, NK cells, and antigen-presenting cells. Suppresses Th1 and Th17 differentiation – key cells in psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Half-life 15–32 days – infrequent injections every 8–12 weeks.
Second line
Second-line for moderate-to-severe Crohn's disease per 2024 after anti-TNFα (infliximab, adalimumab) failure or intolerance. IV induction by body weight (260–520 mg), then 90 mg subcutaneously every 8 weeks. UNITI showed 30% reduction in relapse risk over 44 weeks.
Second line
Second-line for moderate-to-severe plaque psoriasis per AEDV 2024 and EuroGuiderm after failure or intolerance of systemic therapies (methotrexate, cyclosporine). Starting dose 45 mg (or 90 mg if over 100 kg) subcutaneously at weeks 0 and 4, then every 12 weeks. Sbidian 2022 meta-analysis: ustekinumab underperforms anti-IL-17 and anti-IL-23 agents (secukinumab, ixekizumab, guselkumab, risankizumab) on PASI 90.
Second line
Second-line for moderate-to-severe ulcerative colitis per 2024. IV induction by weight, then 90 mg subcutaneously every 8–12 weeks.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Ustekinumab is a monoclonal antibody against interleukins 12 and 23 (IL-12/23). It is prescribed for moderate-to-severe psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis ( 2020, 2024, 2023 guidelines). In anti-aging circles, ustekinumab is promoted as a biological against aging-related inflammation and autoimmune background in healthy people. In healthy adults, no clinical studies of prophylactic use exist. The drug has serious risks: severe infections (including opportunistic), reactivation of tuberculosis (requires screening before start), increased malignancy risk on long-term use, and hypersensitivity reactions. If ustekinumab was recommended to suppress aging-related inflammation in a healthy person, seek a second opinion immediately.
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FDA category B. Pregnancy use when indicated. Crosses the placenta in T2 and T3. Defer infant live vaccines for 6 months.
Low milk concentrations, minimal infant GI absorption. Compatible with breastfeeding.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Ustekinumab is evaluated for the following indications with varying evidence strength: Ulcerative colitis (evidence tier A), Crohn's disease (evidence tier A), Psoriasis (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Ustekinumab (≥ 1 in 100): Injection site reactions, Upper respiratory infections, Nasopharyngitis, Headache, Fatigue. See the Safety section for uncommon and serious reactions.
FDA category B. FDA category B. Pregnancy use when indicated. Crosses the placenta in T2 and T3. Defer infant live vaccines for 6 months.
Low milk concentrations, minimal infant GI absorption. Compatible with breastfeeding.
Ustekinumab is contraindicated in: Ustekinumab hypersensitivity; Active tuberculosis or other severe infections; Severe sepsis in the prior year; Age under 6 (most indications). Full list in the Safety section.