Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study.

INTRODUCTION: Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings. METHODS: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated. RESULTS: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events. CONCLUSION: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04053881 https://www. CLINICALTRIALS: gov/study/NCT04053881 .

Secukinumab in Hidradenitis Suppurativa Patients Who Failed Adalimumab: A 52-Week Real-Life Study.

Background: The treatment of hidradenitis suppurativa (HS) has always been a real challenge for dermatologists; to date, adalimumab the only biologic drug approved for HS is adalimumab, an anti-tumor necrosis factor (TNF)-α drug, the approval of this drug dates to 2015, data provided by real life show an effectiveness rate of about 60% percent. Recently (31 October 2023) FDA approves secukinumab for moderate-severe HS. The treatment and management of HS is very challenging as available treatments are very limited and show very variable outcomes. Methods: We conducted a prospective monocentric study designed to evaluate the efficacy and safety of secukinumab treatment in HS patients in a real-life setting. Results: The initial cohort of patients recruited included 21 HS patients including 12 females and 9 males. About 57.1% of patients achieved the primary endpoint and recorded significant decrease in all the severity assessment scales (IHS4, DLQI and VAS pain scale) at week 16 and 52, when HiSCR reached 71.4%. Conclusion: The results of our study highlight that treatment with secukinumab in patients with severe HS who failed adalimumab may be a safe and effective therapeutic weapon.

Irisin, a novel metabolic biomarker in hidradenitis suppurativa: correlation with clinical responsivity to anti-TNF-α therapy.

BACKGROUND: Suppurative hidradenitis (HS) is a chronic, inflammatory skin disease of the hair follicle unit. Adalimumab (ADA), an anti-tumor necrosis factor (TNF) alpha, is the only FDA-approved biologic available for the management of HS. TNF-α can also affect glucose and lipid metabolism, promoting insulin resistance and obesity by negatively regulating irisin, a new adipomyokine. METHODS: A total of 17 HS patients were enrolled in the study. Blood samples were collected from all patients at baseline and week-16. Plasma irisin levels were detected by ELISA assay. RESULTS: Plasma irisin levels were significantly increased after 16 weeks of ADA therapy in HS patients compared to baseline. Interestingly, plasma irisin levels correlated with clinical response. CONCLUSIONS: The link between skin inflammatory diseases and metabolic disorders has aroused great interest in order to research new biomarkers able to early identify metabolic comorbidities. Among these emerging biomarkers, irisin is one of the most recently discovered. We examined a group of patients affected by moderate-severe HS treated with anti-TNF-α, demonstrating for the first time how a therapy able to block an inflammatory cytokine can also affect the metabolic profile by modifying levels of irisin.

Advanced Squamous Cell Carcinoma Developed on Chronic Hidradenitis Suppurativa, Successfully Treated with Cemiplimab: A Case Report.

Hidradenitis suppurativa (HS) is an inflammatory skin disease showing a chronic-remitting course. It has been rarely reported that long-term inflammation in HS could lead to serious complications like cutaneous squamous cell carcinoma. Cemiplimab is a fully human antibody immunotherapy that inhibits programmed cell death protein-1, approved for the treatment of locally advanced squamous cell carcinoma, or metastatic squamous cell carcinoma, in patients not eligible for curative surgery or radiotherapy. Herein, we report the case of a 56-year-old patient developing an invasive SCC on longstanding and unresponsive HS lesions successfully treated with cemiplimab.

A Case of Recalcitrant Circinate Generalized (Lapière) Psoriasis Successfully Treated with Risankizumab.

Circinate (Lapière) psoriasis represents a rare variety of generalized subacute pustular psoriasis clinically characterized by rapid onset of annular circinate lesions with micro-pustules at the borders without classic plaque psoriasis manifestations. Most reported cases have been described in childhood with a relative benign course, fast and long-term remission after treatment. However, the recalcitrant course may result in an important negative impact on patients' quality of life. Many systemic treatments have been reported for the management of moderate to severe forms, with variable clinical outcomes. However, data about the use of biologics in this rare psoriasis subtype are still lacking. Herein, we report the first case of circinate psoriasis unresponsive to methotrexate and almost all classes of biologics approved for psoriasis (anti-tumour necrosis factor (TNF), anti-interleukin (IL)-12/23, and anti-IL-17) which was successfully treated with risankizumab (anti-IL-23).

Paradoxical Hidradenitis Suppurativa during Biologic Therapy, an Emerging Challenge: A Systematic Review.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease usually occurring after puberty with painful, deep-seated, inflammatory lesions in the apocrine gland-bearing areas of the body. Although HS pathogenesis is still unproven, recent major research advantages have increased our knowledge of the mechanisms behind HS lesions. Particularly, follicular occlusion followed by follicular rupture has been shown to be crucial to HS development, leading to immune response activation, and resulting in typical clinical HS lesions. Moreover, an increased and imbalanced cytokine production, such as interleukin (IL) 17 and tumor necrosis factor (TNF) α, may play a role in HS. In recent years, paradoxical adverse events have been described during treatment. Since the recent increased use of biologic treatments in HS, an increased number of paradoxical HS occurrences have been reported. In this review, we analyzed all current data on paradoxical HS triggered by biological drugs.

A Subungual Exostosis Mimicking a Periungual Granuloma in a 9-Year-Old Boy: An Unexpected Dermoscopic Pattern.

Subungual exostosis (SE) is an uncommon osteocartilaginous tumor. Classic dermoscopic features of SE include vascular ectasia, hyperkeratosis, onycholysis, and ulceration. In this case, a 9-year-old boy presented SE showing a dermoscopic mesh dilated blood vessel pattern surrounded by a scar-like peripheral ring, which represents a novel finding in the medical literature.

Topical oil formulation of plant extracts and vitamins as effective treatment for stretch marks and xerosis-An observational longitudinal study.

BACKGROUND: Stretch marks are linear scars that result from elastic fiber destruction. They usually occur as the consequence of rapid change in the body mass (weight gain and loss, pregnancy, weightlifting), long-term steroid use, or endocrinopathies. Treatment is challenging and mainly based on topical and procedural therapies, although the standard of care is still under debate. PURPOSE: To evaluate the efficacy and tolerance of a topical oil formulation of plant extracts and vitamins on the aesthetic improvement of stretch marks and xerosis. MATERIALS AND METHODS: Fifty male and female patients, aged between 14 and 45 years, with stretch marks referring at the University Hospital Federico II, Naples, were enrolled between March and November 2019. Topical application of plant extracts and vitamin-rich oil was performed twice daily on affected skin for 4 months. Patients were monitored at baseline (T0), and at two-month (T1) and 4-month (T2) follow-ups, through clinical and dermoscopic assessment, confocal microscopy, cutaneous ultrasound, MoistureMeterEpiD, and X-Rite spectrocolorimeter. Primary endpoints were as follows: 70% clinical improvement of stretch marks and 3-point decrease in clinical score from baseline to T2. Secondary endpoints were as follows: change in the T0 parallel pattern of collagen fibers at confocal microscopy, cutaneous thickness increase at ultrasounds, cutaneous hydration increase at MoistureMeterEpiD, erythema reduction at X-Rite spectrocolorimeter, and safety and adverse events (AEs). RESULTS: At 4-month follow-up, stretch marks improved objectively and subjectively in all patients (p < 0.001). In detail, there was a 29% and 71% improvement in clinical appearance of stretch marks at T1 and T2, respectively, as documented dermoscopically and by the 3-point reduction in the assessor's mean clinical score at each follow-up visits [from 8.1±0.7 at baseline to 5.7±1.0 at T1 and 2.3 ±0.5 at T2 (p < 0.001)]. Erythema decreased by 15% and 30% and in parallel hydration increased by 25% and 71%, at T1 and T2, respectively (p < 0.001). At T2 confocal microscopy of stretch marks, dermal collagenous fibers assumed casual disposition with reticular pattern and refractivity, as signs of collagen remodeling and neocollagenesis, and also the T2 cutaneous ultrasound revealed increased epidermal thickness and decreased dermal hypoechogenicity as for a higher skin hydration. CONCLUSION: Our study showed that a topical oil formulation rich in plant extracts and vitamins appears to be effective and safe in treating stretch marks and xerosis.

Ultraviolet radiation, vitamin D, and COVID-19.

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), has become pandemic on March 11th, 2020. COVID-19 has a range of symptoms that includes fever, fatigue, dry cough, aches, and labored breathing to acute respiratory distress and possibly death. Health systems and hospitals have been completely rearranged since March 2020 in order to limit the high rate of virus spreading. Hence, a great debate on deferrable visits and treatments including phototherapy for skin diseases is developing. In particular, as regards phototherapy very few data are currently available regarding the chance to continue it, even if it may be a useful resource for treating numerous dermatological patients. However, phototherapy has an immunosuppressive action possibly facilitating virus infection. In the context of COVID-19 infection risk it is important to pointed out whether sunlight, phototherapy and in particular ultraviolet radiation (UV-R) constitute or not a risk for patients. In this review we aimed to focus on the relationship between UV-R, sunlight, phototherapy, and viral infections particularly focusing on COVID-19.

A Case of Steatocystoma Multiplex in a Psoriatic Patient during Treatment with Anti-IL-12/23.

Steatocystoma multiplex (SM) is an autosomal dominant disorder developing in adolescence or early adult age. The occurrence of multiple asymptomatic cutaneous cysts on the axillae, groin, trunk, and limbs characterizes the disease. SM is associated with a missense mutation in the keratin 17 gene (KRT17), a gene encoding for a type I intermediate filament (keratin 17 [K17]), mainly expressed in the epithelial appendages (hair follicles and sebaceous glands). Here, we report a case of appearance of multiple steatocystomas in a psoriatic patient during ustekinumab treatment, an interleukin (IL)-12/IL-23 inhibitor. Our hypothesis is that ustekinumab could have unmasked a potential genetic predisposition to SM by reducing the expression of interferon-γ and IL-17/IL-22 and consequently acting on the K17 pathway.