利特昔替尼的不良反应？

Author: Medicalhalo

Release time: 2025-10-19 11:44:20

(Litfulo) include headache, fever, atopic dermatitis, rash, urticaria, folliculitis, dizziness, increased blood creatine phosphokinase, herpes zoster, diarrhea, acne, reduced red blood cell count and stomatitis. The above adverse reactions vary according to the patient's physical constitution and disease conditions. Patients should also actively exercise in their daily lives to avoid most side effects. If you feel uncomfortable, please seek medical treatment offline as soon as possible.

About ritixitinib

Ritexitinib is a dual-channel inhibitor of the JAK3/TEC kinase family developed by Pfizer of the United States. It irreversibly inhibits the activity of JAK3 and TEC kinase families by blocking the ATP binding site. The drug is taken orally once a day. For more information on the usage and dosage of ritexitinib, please refer to: and other articles.

Ritexitinib received breakthrough therapy designation for the treatment of alopecia areata from the State Food and Drug Administration in December 2020. In November 2022, it received priority review and approval qualification from the State Food and Drug Administration. Since June 2023, ritexitinib has received marketing approval for the treatment of alopecia areata in many countries and regions, including the United States, the European Union, Japan, and China.

The role of ritexitinib

Laboratory studies have shown that ritexitinib can block signaling molecules and immune cell activity that cause alopecia areata. Compared with the first-generation broad-spectrum JAK inhibitors, ritexitinib has greater advantages in reducing toxicity.

The ALLEGRO study is a pivotal Phase IIb/III multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of ritexitinib in patients with alopecia areata aged 12 years and older. The study results showed that among patients treated with ritixitinib at 30 mg and 50 mg daily (regardless of whether they received the initial 4-week treatment), the proportion of patients with scalp hair coverage ≥80% at 24 weeks was significantly higher than the placebo group.

Adverse Reactions of Ritexitinib

Because clinical trials are conducted under a variety of different conditions, the incidence of adverse reactions observed in clinical trials of one drug cannot be directly compared with the incidence in clinical trials of another drug, nor does it reflect the incidence observed in practice.

The safety of LITFULO was evaluated in 3 randomized, placebo-controlled clinical trials and 1 long-term trial in subjects 12 years of age and older with alopecia areata (including alopecia totalis and alopecia universalis). A total of 1,628 subjects were treated with LITFULO, resulting in 2,085 subject-years of exposure. There were 1,011 subjects exposed to LITFULO for at least 1 year. During the placebo-controlled period of clinical trials in alopecia areata, a total of 668 subjects were exposed to LITFULO, with 130 receiving 50 mg once daily for up to 24 weeks. The median age of subjects was 33 years, with 105 (11.9%) subjects aged 12 to < 18 years and 22 (2.5%) subjects ≥ 65 years old. The majority of subjects were white (70.7%) and female (63.6%).

The adverse reactions with an incidence rate ≥1% in the treatment group and higher than those in the placebo group are shown in Table 1. A total of 2 (1.5%) subjects receiving LITFULO 50 mg withdrew from the trial due to adverse reactions.

Table 1: Adverse reactions in clinical trials of LITFULO for the treatment of alopecia areata

	Lifure 50 mg N = 130 N(%)	PlaceboN = 213 N(%)
Headache ^b	14 (10.8)	18 (8.5)
Diarrhea ^c	13 (10.0)	8 (3.8)
Acne ^d	8 (6.2)	10 (4.7)
Rrash ^e	7 (5.4)	2 (0.9)
Urticaria	6 (4.6)	3 (1.4)
Folliculitis	4 (3.1)	4 (1.9)
Fever	4 (3.1)	0
Atopic dermatitis	3 (2.3)	1 (0.5)
Dizziness	3 (2.3)	3 (1.4)
Elevated blood creatine phosphokinase	2 (1.5)	0
Shingles	2 (1.5)	0
Decreased red blood cell count	2 (1.5)	0
Stomatitis	2 (1.5)	0

Specific adverse reactions of rituxitinib

1. Overall infections

In the 24-week placebo-controlled trial, 66 subjects who received placebo (80.35/100 subject-years) and 43 who received LITFULO 50 mg Overall infections were reported among treated subjects (74.53/100 subject-years).

2. Serious infection

In the 24-week long placebo-controlled trial, 3 subjects reported serious infections at all doses of lixitinib studied.

Treatment measures:

(1) If fever, signs of infection or other symptoms of infection occur, please inform your doctor immediately.

(2) The doctor may recommend relevant laboratory tests and determine appropriate anti-infective treatment based on the test results.

3. Herpes zoster

In the 24-week long placebo-controlled trial, 4 subjects reported herpes zoster in all lixitinib dose groups studied, and 0 subjects reported it in the placebo group.

Treatment measures:

(1) If you have symptoms of herpes zoster (such as pain, blisters, etc.), please inform your doctor immediately.

(2) Doctors may consider using antiviral drugs to reduce symptoms and promote recovery.

4. Malignant tumors

In the 24-week long placebo-controlled trial, 1 malignant tumor (breast cancer) was reported in one subject (1.33/100 subject-years) who received higher doses of ritexitinib, while no malignant tumors were reported in subjects who received placebo.

Treatment measures:

(1) If any new tumor symptoms or abnormalities occur, inform the doctor promptly.

(2) The doctor may recommend relevant examinations to further evaluate the condition.

5. Thromboembolic events

In clinical trials including long-term trials, 1 subject reported pulmonary embolism (PE) (0.06/100 subject-years). There was one report of retinal artery occlusion and one report of acute myocardial infarction.

Treatment measures:

(1) If chest pain, difficulty breathing, limb swelling or other thromboembolic symptoms occur, please seek medical treatment immediately.

(2) The doctor may conduct relevant examinations to confirm the diagnosis and determine appropriate treatment based on the situation.

6. Urticaria

In the 24-week placebo-controlled trial, urticaria was reported in 28 subjects treated with all doses of lixitinib studied and in 3 subjects treated with placebo.

Treatment measures:

(1) If you experience skin itching, erythema, urticaria and other allergic symptoms, please inform your doctor.

(2) The doctor may recommend taking anti-allergy drugs to relieve symptoms.

7. Decreased lymphocyte count

In all clinical trials, including long-term trials, 1 case (< 0.1%) Confirmed ALC < 500/mm3 occurred in subjects treated with LITFULO 50 mg. Age appears to be a risk factor for lower ALC in subjects ≥65 years of age.

8. Decreased platelet count

In a placebo-controlled trial of up to 24 weeks, LITFULO treatment was associated with a decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which time platelet counts remained stable at lower levels with continued treatment.