Psoriasis (PsO) is a chronic inflammatory dermatosis that often presents with erythematous, sharply demarcated lesions. Although psoriasis is primarily a dermatological disease, its immune-mediated pathogenesis produces systemic effects and is closely associated with various comorbid conditions such as cardiovascular disease (CVD), metabolic syndrome (MetS), and diabetes mellitus type II (DMII). Apremilast, an oral phosphodiesterase 4 (PDE-4) inhibitor, has shown promise in treating moderate-to-severe psoriasis and is associated with potential cardiometabolic benefits. In a 12-month prospective observational study involving 137 patients with moderate-to-severe psoriasis, we assessed changes in psoriasis clinimetric scores and metabolic profiles from baseline (T0) to 52 weeks (T1) to evaluate the efficacy of apremilast. After 52 weeks of apremilast treatment, we documented a statistically significant decrease in low-density lipoprotein (LDL) and total cholesterol, triglycerides, and glucose levels. Our findings even suggest a potential synergistic effect among patients treated with apremilast, alongside concomitant statin and/or insulin therapy. Although the results of our study must be validated on a larger scale, the use of apremilast in the treatment of psoriatic patients with cardio-metabolic comorbidities yields promising results. 

Apremilast as a Potential Targeted Therapy for Metabolic Syndrome in Patients with Psoriasis: An Observational Analysis

While several European studies have reported real-world apremilast use, patient-perceived benefits, and treatment satisfaction, local reimbursement criteria for apremilast vary and data from Italy are limited. The cross-sectional DARWIN study enrolled consecutive patients who had initiated apremilast for plaque psoriasis 6 (± 1) months prior to enrolment at a single visit across 24 Italian dermatological sites. Disease severity was assessed using body surface area (BSA) and Physician Global Assessment (PGA). Patient-reported outcomes assessed 6 (± 1) months after apremilast initiation were Dermatology Life Quality Index (DLQI), Patient Benefit Index (PBI), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Of 184 patients enrolled between July 2019 and January 2021, 180 were included in the analysis. At apremilast initiation, median (25th–75th percentile) time since psoriasis diagnosis was 8.6 (3.2–22.2) years; median BSA, 10.0% (5.0–16.0); mean (standard seviation, SD) DLQI total score, 13.5 (8.0). Over half (54.9%) of patients with available data reported psoriasis had a very or extremely large effect on their quality of life (QoL); half reported itching (50.6%) and/or special areas involvement (50.0%). Most (73.9%) had comorbidities and were biologic-naïve (81.5%). The most common reasons for initiating apremilast were lack of efficacy of previous treatment (56.7%) and contraindications to other treatments (44.4%). At 6 (± 1) months, most patients were continuing apremilast and/or reported a Global PBI score ≥ 1 (minimum clinical benefit) (86.1% and 90.0%, respectively); approximately half achieved BSA ≤ 3% and/or DLQI total score ≤ 5 (47.1% and 48.5%); 18.8% achieved PGA = 0; mean (SD) TSQM-9 global treatment satisfaction score was 59.0 (24.8). Apremilast was well tolerated; no new safety signals were identified. Patients treated with apremilast for 6 months in Italian clinical practice reported improved QoL, clinically relevant improvements in symptoms, high treatment satisfaction, and high treatment persistence. Our data indicate apremilast is a valuable treatment option for moderate plaque psoriasis. ClinicalTrials.gov identifier, NCT04031027. 

https://link.springer.com/content/pdf/10.1007/s12325-023-02516-y.pdf

Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands.


 With our better understanding of the pathogenesis of various diseases, more and more drugs and biological products are being tried and tested every day. Roughly, around 40–50 novel drugs get approved by the Food and Drug Administration (FDA) for use in the general population, making it difficult for a physician to keep track of the constant changes in therapy. This article aimed to provide a compilation of all the FDA-approved new drugs for dermatological conditions and new dermatological indications of known drugs in the recent past, especially for dermatology residents and practising dermatologists. A comprehensive analysis, based on the list of new molecular entities approved by the FDA from 2020 to 2023, as well as a thorough English language literature search from 2020 to July 2023 across multiple databases (PubMed, MEDLINE, Springer Nature, Google Scholar and Cochrane) for various keywords (alone and in combination) such as “FDA approved” OR “recent advances in therapy” OR “recent drugs” OR “novel treatment” OR “dermatology,” was performed. All data extracted were incorporated into the present compilation. A total of 33 drugs, including newly approved and newly approved indications of previously known drugs, were found. Relevant information about them has been discussed in a tabulated manner. This article provides an at a glance summarised profile of the newly FDA-approved drugs, as available in the existing literature. However, with the astonishing rate of new drugs hitting the market, more and more clinical trials are required to ensure the rational use of these agents.

Fresh Baked: An Overview of Newly FDA-Approved Drugs for Dermatological Usage

Psoriasis is a chronic immune-mediated skin disorder characterized by intense local inflammation, epidermal hyperplasia, and leukocyte infiltration. Current treatment approaches for psoriasis aim to alleviate symptoms and prevent disease progression, including systemically administered drugs with whole body side effects. Despite some advances in psoriasis treatment, success has been quite limited. To begin to address this challenge, we undertook an initial investigation of whether transcutaneous delivery of an endogenous anti-inflammatory cytokine could provide an effective, local treatment of psoriatic-like skin conditions. To do this, we utilized a previously documented rodent model of psoriasis, induced via a single topical application of Imiquimod (IMQ) to the shaved back of rats. The therapeutic approach used for this initial investigation was delivery of plasmid DNA encoding rat interleukin-10 (pDNA-rIL10), a non-viral gene therapy approach previously shown to be effective in suppressing neuroinflammatory disorders after localized delivery either intracerebrally or intrathecally. Translation of this CNS therapeutic for use in psoriatic-like skin disorders required reformulation to enable transcutaneous delivery. Toward that end, pDNA-rIL10 was topically applied in Lipoderm HMW, a base explicitly designed to deliver higher molecular weight compounds into skin. Here we show that a single topical application of pDNA-rIL10 in Lipoderm HMW was effective in decreasing mRNA levels of pro-inflammatory cytokines as well as reducing the recruitment of T-cells to IMQ-treated skin. Furthermore, this transcutaneous IL-10 gene therapy decreased signs of skin inflammation, reflected by reduced erythema. Moreover, the results provide an initial indication that IL10 may stimulate hair regrowth in psoriatic-like skin.

An initial investigation of transcutaneous delivery of plasmid DNA encoding interleukin-10 for the treatment of psoriatic skin conditions

The broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria. This is the first study to report data on the real-world use of apremilast in the region. APPRECIATE (NCT02740218) was an observational, retrospective, cross-sectional study assessing psoriasis patients 6 (± 1) months after apremilast treatment initiation. The study aimed to describe the characteristics of patients with psoriasis receiving apremilast, estimate treatment outcomes, including Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI), and assess dermatologists' and patients' perspectives on treatment using questionnaires including the Patient Benefit Index (PBI). Adverse event reports were taken from the medical records. Fifty patients (Croatia: 25; Czech Republic: 20; Slovenia: 5) were enrolled. In patients continuing apremilast at 6 (± 1) months, mean (± SD) PASI score was reduced from 16.2 ± 8.7 points at treatment initiation to 3.1 ± 5.2 at 6 (± 1) months; BSA from 11.9% ± 10.3% to 0.8% ± 0.9%; DLQI from 13.7 ± 7.4 points to 1.6 ± 3.2. PASI 75 was reached by 81% of patients. Physicians reported that the overall treatment success fulfilled their expectations in more than two thirds of patients (68%). At least three-quarters of patients reported apremilast had a quite or very high benefit on the needs they identified as being most important. Apremilast was well tolerated; no serious or fatal adverse events were identified. Apremilast was effective in reducing skin involvement and improving quality of life in CEE patients having severe disease. Treatment satisfaction among physicians and patients was very high. These data add to the growing body of evidence showing consistent effectiveness of apremilast across the continuum of psoriasis disease severity and manifestations. ClinicalTrials.gov identifier, NCT02740218. 

/pdf/apremilast-use-in-severe-psoriasis-real-world-data-from-1hwrebph.pdf

Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe

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Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe