阿普斯特治疗银屑病的试验结果数据?

Apremilast Trial in Psoriasis

ESTEEM 1 evaluated the efficacy/safety of Apremilast in the treatment of moderate to severe plaque psoriasis at a dose of 30 mg twice daily.

Research Methods

This Phase III, multicenter, double-blind, placebo-controlled study randomly assigned adults (2:1) to receive or placebo. At week 16, the placebo group switched to apremilast until week 32, and then was randomly discontinued until week 52. Bi$ endpoints were analyzed using the χ(2) test; continuous endpoints were analyzed using covariance analysis.

Trial results

A total of 844 patients received randomized treatment (282 patients with placebo and 562 patients with apremilast). At Week 16, a significantly higher proportion of patients taking apremilast achieved a 75% or greater reduction in baseline Psoriasis Area and Severity Index (PASI-75) score (33.1%) than those taking placebo (5.3%, P < .0001; primary endpoint).

The majority (61.0%) of patients who were rerandomized to receive apremilast at Week 32 achieved PASI-75 at Week 52, compared with only 11.7% of patients who were rerandomized to receive placebo. Among patients who were rerandomized to receive apremilast at Week 32, the mean percentage change from baseline PASI score was -88% to -81% (Weeks 32-52).

During the placebo-controlled period, 55.7% and 69.3% of patients randomized to receive placebo and apremilast experienced one or more adverse events, respectively. Most adverse events were mild/moderate in severity. There were no new exacerbations with continued apremilast compared with the placebo-controlled period.

Trial Conclusion

Apremilast is effective in moderate to severe plaque psoriasis.

Efficacy of Apremilast

Apremilast tablets can usually reduce pain transmission by regulating the balance of neurotransmitters and regulating cell signaling pathways, and can usually have analgesic effects and effects. Apremilast reduces inflammatory reactions, relieves skin disease symptoms and arthritis pain by regulating cell signaling pathways, and inhibits the activity of immune cells by reducing the release of inflammatory mediators, thereby balancing the immune system and reducing abnormal immune responses.

Indications, usage and dosage of Apremilast

Apremilast is suitable for adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

The recommended initial titration of Apremilast tablets is from Day 1 to Day 5, and after 5 days of titration, the recommended maintenance dose is 30 mg twice daily orally starting on Day 6. This titration is intended to reduce gastrointestinal symptoms associated with initial treatment.

Day 1: 10 mg in the morning

Day 2: 10 mg in the morning, 10 mg in the evening

Day 3: 10 mg in the morning, 20 mg in the evening

Day 4: 20 mg in the morning g, 20 mg in the evening

Day 5: 20 mg in the morning, 30 mg in the evening

Day 6 and beyond: 30 mg twice daily

Apremilast tablets may be administered without regard to meals. Do not crush, split, or chew tablets.

The price of the Indian version of Apremilast

On August 16, 2021, Apremilast was officially launched in China. Patients can purchase it at domestic hospital pharmacies with a doctor's prescription. Prices vary depending on the pharmaceutical factory. Patients can consult local pharmacy personnel.

Through the help of domestic professional overseas medical service organizations (such as Medical Companion Travel), we learned that the price of the Indian Glenmark version of Apremilast, 30mg*30 tablets, is about 160$; the price of 30mg*60 tablets is about 230$$, but the price is not fixed due to various factors. For specific costs and acquisition procedures, it is recommended to consult customer service staff to ensure that you can obtain the medicine.

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References

Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, Hu C, Stevens RM, Day RM, Gordon KB, Korman NJ, Griffiths CE. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015 Jul;73(1):37-49. doi: 10.1016/j.jaad.2015.03.049. PMID: 26089047.