阿普斯特片治疗效果怎么样

A Phase III, multicenter, double-blind, placebo-controlled study randomized adults (2:1) to apremilast or placebo. At week 16, the placebo group switched to apremilast at week 32, followed by a randomized withdrawal phase at week 52. The χ(2) test was used for the two end points; the analysis of covariance was used for the continuous end points.

Results: A total of 844 patients were randomized (n=282, placebo; n=562, Apremilast). At Week 16, patients taking apremilast achieved a 75% or greater reduction in Psoriasis Area and Severity Index Score (PASI-75) (33.1%) from baseline compared to placebo (5.3%).

The majority (61.0%) of patients re-treated at Week 32 reached PASI-75 at Week 52, compared with 11.7% of patients re-treated with placebo. Among patients who received apremilast again 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. No new significance emerged with continued exposure to apremilast compared with the placebo-controlled period.

Conclusion: Apremilast is effective in treating moderate to severe plaque psoriasis.

Apremilast is a new oral immunomodulatory drug that has been approved by the US FDA for the treatment of oral ulcers in psoriasis, psoriatic arthritis and Behcet's disease. In the Phase 30 ESTEEM trial, apremilast 3 mg twice daily reduced the severity of moderate to severe plaque psoriasis and improved difficult-to-treat nail, scalp, and palmoplantar psoriasis.

Most patient-reported outcomes, including pruritus and total dermatology quality of life index, also improved significantly more with apremilast than with placebo, with significant improvements in pruritus and skin discomfort/pain visual analog scale scores as early as week 2 in the apremilast group. In the Phase 30 PALACE trial, apremilast 3 mg twice daily improved signs and symptoms of active psoriatic arthritis in disease-modifying antirheumatic drug (DMARD)-naïve and DMARD-experienced patients.

Apremilast tablets are effective in treating oral ulcers caused by psoriasis, psoriatic arthritis and Behcet's disease. It is recommended that patients take the medication under the guidance of a doctor and treat it symptomatically.

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References

[1.]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.

[2.]Keating GM. Apremilast: A Review in Psoriasis and Psoriatic Arthritis. Drugs. 2017 Mar;77(4):459-472. doi: 10.1007/s40265-017-0709-1. PMID: 28213862.