Apremilast improves symptom burden and quality of life in genital psoriasis

Apremilast significantly improves symptom burden and quality of life in patients with genital psoriasis, according to published study results. Psoriasis is a chronic inflammatory skin disease whose most stigmatized form, plaque psoriasis, may affect up to 63% of adults with psoriasis at some point. A lack of effective communication between patients and healthcare providers often results in under-reporting, under-diagnosis or misdiagnosis of the disease, with many patients being ashamed or unwilling to express their concerns, resulting in psoriasis diagnosis and treatment being compromised. Additionally, there is relatively limited research on the safety and effectiveness of psoriasis treatments, making the treatment process challenging.

Currently, the only drug specifically for psoriasis patients is the IL-17 inhibitor ixekizumab, while apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, is generally approved to treat psoriasis of all severities. Its research and development and clinical application have brought new hope to the majority of psoriasis patients.

1. Study Parameters and Patient Characteristics

This study involved289 patients with psoriasis and adopted a phase 3 multicenter randomized trial design. Patients were randomly assigned to receive 30 mg of apremilast (n=143) or placebo (n=146) twice daily for 16 weeks. To better assess treatment effectiveness, the researchers divided patients into two groups based on body surface area (BSA): those with less than 10% BSA involvement and those with 10% or more BSA involvement. It should be noted that the maximum allowable proportion of patients with less than 10% body surface area involvement is 60% of the total study population.

The primary endpoint is the number of patients who achieve a modified Physician's Global Assessment (PGA) response at week 16, defined as a score of 0 (clear) or 1 (almost clear) and a decrease of 2 points or more from baseline.

At baseline examination, the majority of patients in the apremilast group (86.0%) and placebo group (87.7%) showed moderate changes in PGA scores. Compared with the placebo group, patients who received apremilast were generally younger (mean age43.5 years vs 46.4 years), a slightly higher body mass index (BMI) (mean 30.2 vs 29.9 kg/m²), and a relatively shorter duration of psoriasis (mean 11.0 vs 11.9 years).

2. Improvement of the efficacy of apremilast

The study results showed that more than one-third of patients treated with apremilast achieved the primary effect, while only about one-fifth of patients who received placebo achieved this goal (39.6% vs. 19.5%), a significant treatment difference of 20.1% (P=0.0003). At Week 16, the secondary efficacy outcome of overall static PGA response was achieved in 22.2% of patients in the apremilast group compared with 6.9% in the placebo group, a treatment difference of 15.2% (95% CI, 6.9-23.6; P=0.0004).

Meanwhile, patients treated with apremilast showed a more significant response on the Psoriasis Itch Numerical Rating Scale compared with the placebo group (47.3% vs. 19.6%), a treatment difference of 27. 4% (95% CI, 15.4-39.3; P < 0.001); and for change in BSA participation, the treatment difference from baseline was -3.33 (95% CI, -5.18 to -1.47; P < 0.001).

3. Safety results and practical applications of apremilast

The safety results for apremilast were consistent with events observed in previous trials, and the researchers acknowledged that the study was limited by the lack of an active control group and that only short-term data are currently available. However, they highlight the importance of studying psoriasis, particularly given its significant impact on quality of life areas such as sexual health, functioning and relationships, although these impacts often go undiagnosed and untreated.

Taken together, the clinical efficacy and significant patient-reported improvement in quality of life of apremilast in patients with moderate to severe psoriasis suggest that it has the potential to be a convenient oral systemic treatment for psoriasis. This provides new treatment options for the majority of psoriasis patients, brings hope, and promotes the development of the field of psoriasis treatment. In the future, with in-depth research on the long-term efficacy and safety of apremilast, we look forward to providing more comprehensive treatment options for psoriasis patients.

Reference materials:https://go.drugbank.com/drugs/DB05676