阿普斯特片效果怎么样

The efficacy and safety of Apremilast tablets in patients with psoriatic arthritis (PsA) were evaluated in three similarly designed Phase III clinical trials (PALACE 1, 2 and 3, namely NCT01172938, NCT01212757 and NCT01212770).

Methods: After a 24-week randomized (30 mg twice daily, 20 mg twice daily, or placebo), double-blind phase and a 28-week blinded active treatment phase, patients can receive Apremilast tablets for an additional 4 years in an open-label extension study. Eligible adult patients were active for ≥6 months, had swelling in three or more joints, and tenderness in three or more joints despite prior treatment with disease-modifying antirheumatic drugs.

Results: A total of 1,493 randomized patients received one or more doses of study medication (placebo: n = 496; tablet 30 mg twice daily: n = 497; apremilast 20 mg twice daily: n = 500). In patients who continued to receive Apremilast tablets, responses were sustained and no new safety concerns emerged. At week 260, 67.2% of remaining patients achieved ACR20 responses, 44.4% and 27.4% achieved ACR50 and ACR70 responses, respectively.

Among patients with digititis at baseline, 62.4% had a Maastricht Ankylosing Spondylitis Dactylitis Score of 0 and 80.9% had a digititis count of 0. Among patients with baseline psoriasis of ≥3% body surface area, 43.6% had a ≥75% reduction in Psoriasis Area and Severity Index score from baseline.

The most common adverse events with Apremilast tablets are diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis. Most diarrhea and nausea adverse events occur within the first 2 weeks of treatment and usually resolve within 4 weeks. The reported incidence of depression during the study period was low (≤1.8%). Most patients' weight remained within 5% of baseline during the study. No new safety concerns were observed over the long term, and no increase in the incidence or severity of adverse events was observed.

Conclusion: Apremilast tablets maintain clinical benefits and a good safety profile in PsA patients for up to 5 years.

Apremilast is the first oral drug approved for psoriasis in the past 20 years and the first oral drug approved for psoriatic arthritis (PsA) in the past 15 years. Globally, Apremilast has been approved in more than 50 countries and markets. It is recommended that patients take medication as directed by their doctor and receive symptomatic treatment.

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