阿普斯特效果怎么样?
Apremilast can be used to treat adults with active psoriatic arthritis. How effective is it?
The safety and efficacy of apremilast were evaluated in 3 multicenter, randomized, double-blind, placebo-controlled clinical studies (Studies PSA-1, PSA-2, and PSA-3). A total of 1493 adult patients with PSA who had been diagnosed with PSA for at least 6 months participated in the study. In 3 trials, patients were randomized to receive placebo (n = 496), apremilast 20 mg (n = 500), or 30 mg (n = 497) bid. Patients can continue to take DMARDs (methotrexate, sulfasalazine, leflunomide, low-dose oral corticosteroids, and/or non-steroidal anti-inflammatory drugs (NSAIDs)). The primary endpoint is the percentage of patients who achieve an American College of Rheumatology (ACR) 20 response at week 16. In 3 studies, the proportion of patients taking Apremilast who responded to ACR20 at week 16 was significantly higher than that of the placebo group, and Apremilast 30 in study PSA-1 mg, bid + DMARDs group was 38%, placebo + DMARDs group was 19%; in the PSA-2 study, the Apremilast group was 32%, the placebo group was 19%; in the PSA-3 study, the Apremilast group was 41%, the placebo group was 18%.
In study PSA-1, patients taking 30 mg, bid, had significantly greater improvements in signs and symptoms, physical function, and other characteristic manifestations of psoriatic arthritis at week 16 than the placebo group, including joint swelling and tenderness, skin, and quality of life; Health Assessment Questionnaire Disability Index (HAQ-DI) scores also improved significantly compared with the placebo group. The proportion of HAQ-DI responders was 38% in the apremilast group and 27% in the placebo group. This is consistent with the results observed in PSA-2 and PSA-3. The results of these three studies all show that Apremilast is effective in treating PSA, and the adverse reactions are within acceptable limits.
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