Effects on Lipid Profile after One Year of Apremilast Therapy in Patients with Psoriasis: A Monocentric Experience.

Apremilast, a phosphodiesterase-4 inhibitor, has shown promise to have a potential beneficial metabolic effect. We conducted a single-centre retrospective study on adult patients with moderate-to-severe psoriasis who underwent apremilast treatment over at least 12 and 52 weeks, respectively. Baseline characteristics, weight, lipid profile, and fasting glucose levels were collected at baseline and at 12, 24, and 52 weeks. Furthermore, we conducted a narrative review of the current scientific knowledge on the metabolic effects of apremilast in patients with psoriasis and psoriatic arthritis. We observed a significant reduction in average weight and body mass index (BMI) in patients treated with apremilast in both the initial and the subgroup analysis, a significant reduction in triglycerides levels at 24 and 52 weeks, and a significant increase in high-density lipoprotein (HDL) levels at 52 weeks, whereas there were no significant changes in total cholesterol or low-density lipoprotein (LDL) concentrations over the 52-week treatment period. These findings suggest a potential positive impact of apremilast on both weight management and lipid profile in individuals with moderate-to-severe psoriasis in the medium-long term.

Estimation of patients with psoriasis potentially eligible and currently untreated with biological drugs in Italy.

BACKGROUND: Psoriasis (PSO) patients can benefit from the growing availability of novel biological agents, that are often underused or discontinued. This real-world analysis estimated PSO patients potentially eligible and currently untreated with biologics in Italy. METHODS: An observational analysis was performed on administrative databases of a pool of healthcare entities, covering 11.3% of Italian population. During the inclusion period (2010- 2020), patients were identified by: 1) at least one prescription of topical drugs for PSO; or 2) active exemption for PSO; or 3) at least one PSO hospital discharge diagnosis. The index-date was the first PSO identification across inclusion period. Eligibility for biologics was evaluated prior to index-date (characterization period) through two not-mutually exclusive criteria: Criterion A, failure of at least one systemic treatment, and/or Criterion B, onset of psoriatic arthritis (PsA). Data were re-proportioned to the Italian population. RESULTS: The study sample showed a PSO prevalence of 2%. Projection to 2020 national population (N=59,236.213) estimated 1.43 million Italian patients affected by PSO: 95% treated with conventional therapies, 4% with biologics, and 1% untreated. Among those non-treated with biologics, 3.8% of overall PSO patients met one or both eligibility criteria for biologics, specifically 25% met criterion A (failure to conventional treatments), 68% criterion B (PsA co-diagnosis), and 7% met both. About half of them had 1 or 2 comorbidities and 30% above 3. CONCLUSIONS: These findings from real clinical practice estimated about 4% PSO patients potentially eligible for biologics, but still untreated, with nearly one-third exhibiting a complex comorbidity profile.

Anti-Interleukin-17s for successful management of pustular psoriasis.

Generalised pustular psoriasis (GPP) and acrodermatitis continua of Hallopeau (ACH) are two rare entities included in the spectrum of pustular psoriasis (PP). Due to the lack of randomised controlled clinical trials and standardized guidelines, their treatment remains a challenge for clinicians. Thus, herein we report our centre experience with the successful use of interleukin (IL)-17 inhibitors in three patients affected by PP. We also provide a brief overview of the current knowledge concerning the role of IL-17 in PP pathogenesis and of the use of IL-17 inhibitors in the treatment of PP. Based on our experience, anti-IL-17 molecules may represent a valuable therapeutical option for patients affected by different PP subtypes.

Clinical and Ultrasonographic Characterization of Hidradenitis Suppurativa in Female Patients: Impact of Early Recognition of the Disease.

Hidradenitis suppurativa (HS) is considered a post-pubertal disease; however, earlier onset is not infrequent. The burden of HS on the female population is very relevant, and early identification might reduce the quality of life impairment and improve the therapeutic approach. In this study, we investigated clinical biomarkers of HS that could impact the management of patients affected by HS. Female patients affected by stable HS were prospectively included in this study. Anamnestic data, clinical and ultrasonographic features were collected and analyzed. Overall, 53 patients were included in this study. The median age of onset was 19 (IQR: 14-25). Early onset was reported by 22/53 patients (median age of onset: 14; IQR: 11-16). Four patients had pre-menstruation occurrence. Early-onset patients had an earlier first-menstrual-cycle age and more frequent genital localization of HS, and were more often treated with biologics. Patients with early-onset-HS and genital localization had more severe disease with a higher number of areas affected, Hurley, and IHS4 scores. Genital involvement might be prevalent in patients with early-onset HS, leading to a worse impact on the global severity of the disease and tailored treatment protocols, including multidisciplinary approaches, in order to improve the early recognition of hidden lesions.

Consistency of Bacterial Triggers in the Pathogenesis of Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is an inflammatory skin disease whose pathogenesis remains poorly defined. Over the past decades, the bacterial role in HS patients has been a focus of research. According to the literature, the HS skin (and probably gut) bacterial composition is different to that of healthy controls. To date, a key question is whether compositional changes in the microbial populations are responsible for the development of HS (primum movens), or only secondarily reflect the ongoing inflammatory process. The great diversity of methodologies that have been used to study microbial role in HS have led to an accumulation of conflicting results. Thus, in view of these considerations, the aim of this article is to provide the reader with an overview about different hypotheses proposed to explain the bacterial role in HS pathogenesis.

Hidradenitis Suppurativa: The Influence of Gender, the Importance of Trigger Factors and the Implications for Patient Habits.

Hidradenitis suppurativa (HS) is a debilitating, chronic, inflammatory skin disease primarily affecting apocrine gland-rich areas of the body. On the one hand, the presence of triggering factors-some identified, others only hypothesized-may initiate or perpetuate the pathogenic process of HS. In addition to cigarette smoking and diet, other trigger factors, including choice of clothing, are frequently observed in clinical practice. On the other hand, the presence of disease may influence habits of HS patients. Indeed, high incidences of sexual and sleep impairment have been reported in these patients. Consequently, alcohol and substance abuse may be a coping strategy for the emotional and psychological disease burden. Furthermore, a greater awareness of gender differences in HS may be important for dermatologists in their own clinical practice (i.e., pregnancy and breastfeeding). Consequently, in this loop interaction, comprehensive knowledge of all factors involved is crucial for the management of HS patients. Thus, the objective of this review is to (i) discuss the influence of gender on HS, (ii) summarize the most frequent triggering factors of HS and (iii) analyze the impact of HS on patient habits.

Therapy of PsO in Special Subsets of Patients.

Psoriasis is a chronic, inflammatory skin disease that may occur at any age, with a bimodal peak of incidence around the age of 16-20 years of age (early onset) and 57-60 years (late-onset). It is estimated that roughly 70% of patients develop the disease before the age of 40, which coincides with the reproductive years. Moreover, psoriasis is a chronic disease, meaning that, with increased life-duration expectancy, the number of patients affected with psoriasis aged over 65 years is going to increase and represent a big therapeutic challenge. Actually, no specific drug recommendation is available, based only on the age of the patients, while therapeutic prescription should take into account that elderly patients have more comorbidities than younger patients, with polypharmacy and an increased risk of drug interactions. Women with psoriasis are more likely to report a worse influence of the disease on their quality of life, and they are more susceptible to the development of depression. Furthermore, pregnancy and lactation represent a major contraindication to several systemic agents, and only a few studies exist providing the safety of certain drugs during these periods of life of a woman, such as certolizumab pegol. In this paper, we discuss systemic therapeutic strategies, including conventional and biological therapies, in a special subset of patients affected with moderate-to-severe psoriasis focusing on elderly patients and on female patients in fertile age, pregnancy, and lactation.

Targeting IL-17A for the treatment of pustular psoriasis: a comprehensive review.

INTRODUCTION: Pustular psoriasis (PP) is a rare subtype of psoriasis. Overall, the growing evidence - in particular for acute generalized PP (GPP) - supports that it is a separate entity with a specific pathogenetic pathway. Interleukin (IL)-17/T-helper 17 (Th17) axis involvement may play an important role in the pathophysiology of PP. Biologicals, often required to achieve clinical remission, have changed the treatment of PP. AREAS COVERED: We provide the reader with an overview of all the available evidence on the use of the antibody-based therapy targeting IL-17A in patients with PP. EXPERT OPINION: Although papers reported in this review do not provide definitive evidence (due to methodological limitations) to support the use of IL-17 inhibitors as potential first-line for the treatment of PP, based on our own experience and according to most of the reported literature, targeting IL-17A, may represent the best therapeutical approach in this peculiar clinical spectrum of psoriasis.

Tuscany consensus for the treatment of moderate-severe psoriasis: update and focus on practical guidelines for place in therapy of anti-IL-17 and anti-IL-23 biologics.

Psoriasis is a common chronic skin disease characterized by a worldwide distribution and a natural tendency towards progression. According to the many clinical forms, the extension of the disease and the many comorbidities, almost the 20% of the patients require a systemic treatment. Biologics have greatly changed the ongoing of psoriasis and the quality of life of psoriasis patients. After the anti-TNF-alpha, which were the first biologics in use for psoriasis, the improvement in knowledge of the pathogenetic mechanisms underlying the disease has led to the development of a series of more specific therapies for psoriasis. This "second generation" of biologics includes the interleukin (IL)-12/23 inhibitor ustekinumab, IL-17 inhibitors (secukinumab and ixekizumab), the IL-17 receptor A (IL-17RA) antagonist brodalumab, and the IL-23 inhibitors guselkumab, risankizumab and tildrakizumab. This study represents an update of the Tuscany consensus focused on the use of new drugs, such as anti-IL-17 and anti-IL-23 in moderate-to-severe psoriasis and their correct place in therapy according to specific clinical requests and in full respect of the current financial restrictions.

Secukinumab for the treatment of palmoplantar psoriasis: a 2-year, multicenter, real-life observational study.

BACKGROUND: Palmoplantar psoriasis is difficult to treat and often recalcitrant to conventional therapies. Clinical trials have demonstrated the efficacy and safety of secukinumab for this debilitating psoriasis form, but real-life evidence is currently limited. Therefore, here we described the outcomes of patients treated with secukinumab in clinical practice. RESEARCH DESIGN AND METHODS: This was a real-life, retrospective, observational study involving patients with palmoplantar psoriasis treated with secukinumab (300 mg, subcutaneously) at seven dermatologic clinics in Italy. Treatment effectiveness was evaluated based on the changes of the Psoriasis Area and Severity Index (PASI) and palmoplantar (pp) PASI during treatment and by recording safety and tolerability issues over 104 weeks. RESULTS: Forty-three patients initiated treatment with secukinumab. Previous treatments included topical and systemic therapies; half of patients had already tried one or more biologics. Secukinumab improved mean PASI rapidly and substantially with a 78.2% decrease at 16 weeks. Mean ppPASI also improved substantially, but more gradually, with reductions of 55.0% and 79.3% at 16 and 104 weeks, respectively. Approximately half of patients achieved complete skin clearance at 40 weeks. Secukinumab was well tolerated and no relevant treatment-related adverse events were reported. CONCLUSIONS: Secukinumab appears to be effective for the treatment of palmoplantar psoriasis also in the real-life setting.

Long-term safety and efficacy of anti-tumor necrosis factor-alpha biosimilar agents in the treatment of psoriasis: a single center study.

Biosimilar anti-tumor necrosis factor (TNF)-alpha drugs are widely used in the treatment of psoriasis, but only few studies reported the long-term experience of the various biosimilar agents in the real world practice. A monocentric retrospective observational study was performed to assess the long-term efficacy, tolerability, and safety of biosimilars adalimumab (bADA), biosimilar etanercept (bETN), and biosimilar infliximab (bIFX) in psoriasis patients. A total of 73 patients (19 patients treated with bADA, 37 with bETN and 17 with bIFX) were enrolled and observed up to 48 months of follow-up. Regarding the efficacy, across all biosimilar treatments combined, the mean PASI score was ≤2 (1.2) after 12 months of treatments. Notably, the mean PASI score remained relatively stable during all 48 months of follow-up. With regard to tolerability and safety in the present study, 34 (28%) patients experienced adverse events during all biosimilar therapy, and three (4.3%) discontinued treatment. No severe adverse events, death, or malignancy cases were recorded during the study period. Our results support that biosimilar anti-TNF-alpha drugs are effective and well tolerated drugs for the long-term treatment of psoriasis.

Skin Manifestations in Psoriatic and HS Patients in Treatment with Biologicals during the COVID-19 Pandemic.

The Coronavirus Disease 2019 (COVID-19) pandemic, a global public health emergency, has changed dermatology practice and daily routine in just under two years. Much has been written in the literature about COVID-19-associated skin manifestations. Nevertheless, much less has been written regarding skin manifestations in patients affected by severe immune-mediated skin diseases, e.g., psoriasis and hidradenitis suppurativa, undergoing biological treatment during the COVID-19 outbreak. Thus, the aim of this article is to provide the reader with an overview of the cutaneous manifestations during the COVID-19 pandemic in this subset of patients.

Insights into the Pathogenesis of HS and Therapeutical Approaches.

Hidradenitis suppurativa (HS) is a debilitating, chronic, (auto)inflammatory disease primarily affecting apocrine gland-rich areas of the body. Although pathogenic mechanisms responsible for HS have not yet been fully elucidated, it is a multifactorial process whose main target is the terminal follicle. The role of the inflammatory process (and consequently of cytokine milieu) and of several other factors (genetics, lifestyle, hormonal status, microbiome, innate and adaptive immune systems) involved in HS pathogenesis has been investigated (and often defined) over the years with a view to transferring research results from bench to bedside and describing a unique and universally accepted pathogenetic model. This review will update readers on recent advances in our understanding of HS pathogenesis and novel (potential) medical therapies for patients with moderate-to-severe HS.

Clinical experience with adalimumab biosimilar imraldi in hidradenitis suppurativa.

Adalimumab is the only biologic therapy approved for the treatment of patients with hidradenitis suppurativa, a chronic and disabling skin condition. To date, there are no studies in the literature about the effectiveness of adalimumab biosimilar SB5 in hidradenitis suppurativa. The aim of this study was to evaluate its efficacy and safety. A retrospective observational study was performed in hidradenitis suppurativa adalimumab naive patients and in patients who were switched from the adalimumab originator. Eleven patients were included in the study. Our results support adalimumab SB5 as an effective and well tolerated drug, with a good interchangeability with its originator also for the treatment of hidradenitis suppurativa.