Stelara

(1) Adolescents (≥6 years old) and adult patients with moderate to severe plaque psoriasis;

(2) Adult patients with active psoriatic arthritis;

(3) Adult patients with moderate to severe Crohn's disease (CD);

(4) Adult patients with moderate to severe active ulcerative colitis (UC).

Dosage:

Psoriasis: For patients weighing <100 kg (220 lbs), the recommended dose is 45 mg initially and after 4 weeks, then 45 mg every 12 weeks. For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and after 4 weeks, then 90 mg every 12 weeks.

Psoriatic Arthritis: The recommended dose is 45 mg initially and 4 weeks later, then 45 mg every 12 weeks. For patients with moderate to severe plaque psoriasis weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, then 90 mg every 12 weeks.

Adverse reactions:

The most common adverse reactions (incidence ≥3% and greater than placebo):

Nasopharyngitis, upper respiratory tract infection, headache, and fatigue.

Contraindications:

Clinically significant hypersensitivity to ustekinumab or to any excipient.

Note:

Infection: Serious infection has occurred. Do not initiate STELARA® during any clinically important active infection. If serious infection occurs, discontinue STELARA® until infection resolves.

Theoretical risk for specific infections: Serious infections from Mycobacterium, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccination have been reported in patients with genetic deficiencies in IL-12/IL-23. Diagnostic testing for these infections should be considered based on clinical circumstances.

Tuberculosis (TB): Evaluate patients for TB before initiating treatment with STELARA®. Start latent TB treatment before giving STELARA®.

Malignant diseases: STELARA® may increase the risk of malignant diseases. The safety of STELARA® has not been evaluated in patients with or known medical history of malignant disease.

Anaphylaxis or other clinically significant hypersensitivity reactions may occur.

Reversible posterior leukoencephalopathy syndrome (RPLS): 1 case reported, if suspected, treat immediately and discontinue STELARA.

Storage:

Store at 2-8℃ away from light. Store in original packaging until use. Do not freeze. Shaking is prohibited.

Mechanism of action:

Ustekinumab is a humanized IgGIk monoclonal antibody that can specifically bind with high affinity to the p40 protein subunit of human interleukins IL-12 and IL-23. IL-12 and IL-23 are naturally occurring cytokines involved in inflammation and immune response processes. In vitro models show that ustekinumab can disrupt IL-12 and IL-23-mediated signaling and cytokine cascades by blocking the interaction with the cell surface receptor chain IL-12Rβ1. IL-12 and IL-23 contribute significantly to chronic inflammation, a hallmark of Crohn's disease. In animal models of colitis, genetic deletion or antibody blockade of the p40 protein subunit of IL-12 and IL-23, the targets of ustekinumab, showed protective effects.

Safety and efficacy:

Johnson & Johnson (JNJ) at the 28th European Digestive Diseases Week (UEG Week) in 2020 2020) The latest and final 5-year data of the phase 3 IM-UNITI open-label extension (LTE) study of the anti-inflammatory drug Stelara (Chinese trade name: Xidanuo, generic name: ustekinumab, ustekinumab injection) was announced at the virtual meeting. Results show that Stelara treatment can maintain long-term remission for up to 5 years in patients with moderate to severe Crohn's disease (CD).

In China, Stelara (Selara®) was launched in June 2019. The drug is a biological agent with an innovative dosing mode - subcutaneous injection every three months during the maintenance period. It is used to treat adult patients with moderate to severe plaque psoriasis who are unresponsive, contraindicated or intolerant to other systemic treatments such as cyclosporine, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).