(1) Drug introduction

Ustekinumab, a humanized monoclonal IgG1 antibody that is the common subunit p40 of IL-12 and IL-23, blocks the binding of these two inflammatory mediators to the IL-12R 1 receptors on T lymphocytes, NKC, and APCs, thereby blocking the differentiation of virgin T lymphocytes into Th1 and Th17. In the treatment of psoriasis, urinumab was slowly absorbed into the systemic circulation after a single dose of subcutaneous injection, with the median peak time between 7 and 14 days after administration, and the dose range was about 24mg to 240mg. The median half-life of Urinumab was about 3 weeks, independent of route of administration and single or multiple doses. There is no evidence that the concentration of urinumab in serum accumulates over time.

(2) To treat the target population

Plaque psoriasis

Urinumab solution is administered by subcutaneous injection. The recommended dosage is 45mg (body weight ≤ 100kg) or 90mg (body weight >100kg) at 0 and 4 weeks, and thereafter repeated every 12 weeks. If the efficacy is poor, the dosage can be increased or once every 8 weeks.

Arthropathic psoriasis

The treatment regimen is similar to that for plaque psoriasis. Ⅱ period clinical study showed that 12 weeks after treatment the treatment group patients achieve ACR 20 improve 42.1%, significantly higher than 14.3% of the placebo group.

Other types of psoriasis (pustules and erythroderma)

At present, there is no relevant research report.

(3) Therapeutic conversion

To date, the safety and efficacy of urinumab combined with other immunosuppressive agents or phototherapy have not been evaluated.

(4) Combined with other systemic treatments

At present, there is no relevant research report.

(5) Treatment for special groups

At present, there are no relevant research reports on children. No age-related differences in the clearance rate or volume of distribution of Urinumab were observed in clinical studies. Overall, there was no difference in efficacy or safety in subjects aged ≥65 years who received urinumab compared with younger subjects receiving urinumab; No studies have been conducted on the application of Urinumab in subjects with liver and kidney dysfunction. The effects on pregnant and lactating women are unclear.

(6) Pre-treatment screening program

Vaccine application, potential or active tuberculosis (chest radiograph, PPD, t-SPOT if available), history of chronic recurrent infectious diseases, laboratory tests (blood routine, liver and kidney function, HBsAg, HCV antibody, syphilis and AIDS screening)

(7) Adverse drug reactions

Usinumab is generally well tolerated by Chinese psoriasis subjects. A small number of patients may experience erythema, itching, and irritation at the injection site. Infections (bacterial, tuberculosis, viral), malignancies, cardiovascular events, and changes in the blood system have also been reported.

(8) Monitoring items in treatment

Injection site reaction, drug allergic reaction, pregnancy, malignant tumor (mainly monitoring epithelial and non-epithelial malignant tumor), opportunistic infection, the occurrence of active tuberculosis, blood routine, liver and kidney function.

(9) Contraindication

Patients with severe renal, liver, blood, gastrointestinal, endocrine, lung, heart, nervous system, brain or mental diseases, as well as malignant tumors, active tuberculosis and allergies to the drug ingredients.