利特昔替尼治疗斑秃的试验数据?

A trial of ritexitinib in the treatment of alopecia areata

A trial is evaluating the efficacy and safety of the Janus kinase inhibitors ritexitinib and brepocitinib in AA patients with ≥50% scalp alopecia.

research methods

Patients were randomized to receive once-daily brepocitinib or placebo. The primary efficacy endpoint was change from baseline in the Severity of Hair Loss Tool (SALT) score after 24 weeks. The key secondary efficacy endpoint is the proportion of patients with a 30% improvement in SALT score (SALT30).

Research results

There were 48, 47, and 47 patients in the ritixitinib, bripocitinib, and placebo groups, respectively. At Week 24, the least squares mean difference in SALT score change from baseline was 31.1 for ritexitinib and 49.2 for brepocitinib compared with placebo (P < .0001 vs. placebo).

Fifty percent of patients treated with ritixitinib achieved SALT30, 64% of patients treated with brepocitinib achieved SALT30, and 2% of patients treated with placebo achieved SALT30. Only two patients in the brepocitinib group experienced a serious adverse event (rhabdomyolysis).

Test conclusion

Ritexitinib or bripocitinib showed significant efficacy after 24 weeks of treatment and was generally well tolerated.

Another global multi-center, randomized, double-blind, placebo-controlled pivotal phase IIb/III ALLEGRO study evaluated the efficacy and safety of rituxitinib in the treatment of patients with alopecia areata aged 12 years and above (n=718, of whom 81 were enrolled in China).

The results show:

The proportion of patients treated with ritixitinib 30 mg and 50 mg daily (regardless of whether they received the initial 4-week treatment) had ≥80% scalp hair coverage at 24 weeks compared with the placebo group.

How does rituxitinib work?

Ritexitinib is a Janus kinase (JAK) inhibitor that blocks signaling molecules and immune cell activity that are thought to be responsible for alopecia areata. Compared with the first-generation pan-JAK inhibitors, ritexitinib has advantages in reducing toxicity.

Ritexitinib dosage and dosage

The recommended dose of ritixitinib is 50 mg orally once daily with or without food. Capsules should be swallowed whole. Do not crush, break or chew capsules.

If you miss a dose, take it as soon as possible, unless it is less than 8 hours before the next dose, in which case the missed dose should be skipped. Thereafter, resume dosing according to your normal dosing schedule.

Ritexitinib is not recommended in patients with severe (Child Pugh C) hepatic impairment.

Initiation of ritexitinib therapy is not recommended in patients with active TB.

Women should not breastfeed during treatment with ritixitinib and for approximately 14 hours after the last dose (approximately 6 elimination half-lives).

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References

King B, Guttman-Yassky E, Peeva E, Banerjee A, Sinclair R, Pavel AB, Zhu L, Cox LA, Craiglow B, Chen L, Banfield C, Page K, Zhang W, Vincent MS. A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results. J Am Acad Dermatol. 2021 Aug;85(2):379-387. doi: 10.1016/j.jaad.2021.03.050. Epub 2021 Mar 20. PMID: 33757798.