伊曲莫德说明书,医保,价格,疗效,副作用

Etrasimod is a new oral selective sphingosine 1-phosphate (S1P) receptor modulator, suitable for the treatment of adults with moderately to severely active ulcerative colitis. The drug exerts an anti-inflammatory effect by regulating lymphocyte migration. On October 13, 2023, the U.S. Food and Drug Administration (FDA) approved etrasimod as an oral drug for adult patients with moderately to severely active ulcerative colitis (UC).

Basic information about Itrimod

As an innovative treatment drug, it provides a new treatment option for patients with moderate to severe ulcerative colitis.

Mechanism of drug action

Itrimod inhibits the migration of lymphocytes from lymph nodes to peripheral circulation by selectively binding to S1P1, S1P4 and S1P5 receptors, thereby reducing immune cell infiltration in intestinal inflammation sites and exerting anti-inflammatory effects.

Dosage forms and specifications

Itramod is a round green film-coated tablet. Each tablet contains 2 mg of active ingredient, which is equivalent to 2.76 mg of itramod arginine salt. The tablets are engraved with "ETR" on one side and the "2" logo on the other side.

This drug has been approved for marketing in many countries and regions, bringing new treatment hope to patients with ulcerative colitis.

Domestic listing and medical insurance status of Itrimod

The domestic listing of Itrimod has provided patients with more treatment options, and understanding its accessibility is important for clinical decision-making.

Domestic marketing status

Itramod has been approved for marketing in mainland China under the trade name Velsipity®. The approved indication is adults with moderately to severely active ulcerative colitis, providing a new option for patients who have poor response to traditional treatments.

Medical insurance coverage and price

Currently, itramod has not been included in China’s national medical insurance catalog. Patients need to purchase it at their own expense and the actual price shall prevail.

Efficacy and side effects of Itrimod

Understanding the therapeutic effects and potential adverse reactions of Itrimod can help doctors and patients jointly develop individualized treatment plans.

Clinical efficacy data

The key phase III clinical trial showed that the clinical remission rate of itridimod was higher after 12 weeks of treatment, which was significantly higher than that of the placebo group. The clinical remission rate in the maintenance treatment group was higher at 52 weeks, and patients who had failed previous biologic treatment could still benefit.

Common adverse reactions

Headache, elevated liver enzymes and dizziness are the most common adverse reactions. Serious adverse reactions include increased risk of infection, bradycardia, liver damage and macular edema.

Special groups such as pregnant women, lactating women and children need to be particularly cautious when using itramod, and the risk-benefit ratio should be fully evaluated before treatment. Patients with hepatic insufficiency need to adjust the dose, and it is contraindicated in patients with severe hepatic impairment. Fundus examinations should be performed regularly at baseline and during treatment; timely assessment should be made when visual acuity changes occur, and drug discontinuation should be considered after diagnosis is confirmed.