Improving of psychological status and inflammatory biomarkers during omalizumab for chronic spontaneous urticaria

Background: Depression and anxiety are the most common psychiatric comorbidities in chronic spontaneous urticaria (CSU). Omalizumab is a monoclonal antibody approved for CSU treatment. We evaluated the prevalence of anxiety and depression in CSU patients before and after treatment with omalizumab. Materials & methods: A total of 30 patients were enrolled in the study: 15 patients affected by CSU and treated with omalizumab and the other 15 healthy subjects did not receive any systemic therapy. All patients were evaluated using Hospital Anxiety and Depression Scale, CRP and erythrocyte sedimentation rate, at baseline and after 6 months. Results: The omalizumab group after 6 months of therapy had a decrease of all the scores and biomarkers. Conclusion: Omalizumab allowed an improvement of urticaria and mental comorbidities

Predictive role of vitamin A serum concentration in psoriatic patients treated with IL-17 inhibitors to prevent skin and systemic fungal infections

The use of biological drugs in psoriasis is replacing traditional therapies due to their specific mechanism and limited side effects. However, the use of Interleukin 17 inhibitors and the modification of its cytokine pathway could favor the risk of fungal infections.All-trans retinoic acid is an active metabolite of vitamin A with anti-inflammatory and immunoregulatory properties through its capacity to stimulate both innate and adaptive immunity and to its effects on proliferation, differentiation and apoptosis in a variety of immune cells. Furthermore, it has been recently discovered that All-trans retinoic acid has a direct fungistatic effect against Candida and Aspergillus Fumigatus.On the basis of these new insights, in the current review, we suggest that the evaluation of serum level of All-trans retinoic acid or vitamin A should be considered as a predictive marker for the development of fungal infections among psoriatic patients treated with Interleukin 17 inhibitors.In clinical practice, vitamin A test could be added in the routine hospital diagnostic management for a better selection of psoriatic patients eligible to Interleukin 17 inhibitors

Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry

Background and purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013

Efficacy and safety of Adalimumab in difficult-to-treat psoriasis

Psoriasis is a chronic immune-mediated inflammatory skin disorder, with a prevalence of 2-3% worldwide. Psoriatic lesions affecting scalp, nails, palms, and soles are considered difficult-to-treat and require specific management. When psoriasis involves these areas, it may be considered more severe even if the lesions are not extensive. Adalimumab (Humira®) is a fully human monoclonal antibody against tumor necrosis factor (TNF), administered via subcutaneous injection. It has already been used in the treatment of adults and children with moderate-to-severe chronic plaque psoriasis. In literature, few studies investigated its efficacy in difficult-to-treat areas, hence we conducted an observational prospective study of 24 weeks to assess its role in patients with difficult to treat psoriasis. We found out a significant improvement in nail and scalp psoriasis, whilst palmoplantar and genital psoriasis showed an improvement though not statistically significant. Therefore, adalimumab can be used in difficult-to-treat areas with great results, also allowing an improvement in the quality of life of affected patients, both adults and children. This article is protected by copyright. All rights reserved

Clinical efficacy and reflectance confocal microscopy monitoring in moderate-severe skin aging treated with a polyvinyl gel containing retinoic and glycolic acid: An assessor-blinded 1-month study proof-of-concept trial

Background Retinoids and alpha-hydroxy acids are commonly used topically as anti-aging substances. Current medical devices contain retinoic acid (0.02%) and glycolic acid (4%) in a polyvinyl gel vehicle (R-G gel). There are still no clinical data nor objective evaluation of the anti-aging effect this product has in the short term. Aims To assess in a prospective 1-month, noncomparative, primary outcome assessor-blinded proof-of-concept trial the clinical efficacy, tolerability, and the skin cells modification (evaluated through reflectance confocal microscopy; RCM), of R-G gel in skin aging treatment. Methods Twelve women with moderate-severe skin aging (Glogau score >= 3) were enrolled. The product was applied on the face three times a week for 4 weeks. Study visits were performed at baseline and after 2 and 4 weeks. RCM evaluation was performed openly at each visit using Viva Scope 1500 to evaluate the left cheek (5 mm below the zygomatic process). Results Eleven subjects concluded the trial. At baseline, the Glogau score was 3.4 +/- 0.5 and decreased significantly at week 4 (P = .0001; ANOVA test) to 2.7 +/- 0.6. Significant reductions of dark spots (-40%) and severity of wrinkles (-12%) were observed at week 4 compared to baseline. The RCM score improved significantly at week 4 with the recovery of the polygonal keratinocytes pattern as the central aspect observed. Conclusion The gel containing retinoic acid and glycolic acid showed significant improvements of the clinical signs of severe skin aging with a concomitant improvement of epidermal and dermal structures evaluated via RCM

Psoriasis in difficult to treat areas: treatment role in improving health-related quality of life and perception of the disease stigma

Background:When psoriasis affects scalp, nails, palms and soles, it is considered difficult to treat and causes severe impairment of life quality. Objective:We evaluated which difficult site most impacts on the patient's quality of life and how quality of life changes during treatment. Methods:We conducted a prospective observational study in patients receiving adalimumab over a 24 weeks period, through assessment at weeks 0, 4 and 24 using PASI, PAIN VAS, ITCH VAS, DLQI, NAPSI, PSSI. Pearson correlation was used to evaluate the relationship between the various measurements on the basis of three different deltas (between T0 and T24, between T0 and T4, between T0 and average between T4 and T24) Results:The correlation matrix between T0 and T24 shows a significant correlation between delta PASI and delta ITCH and delta ITCH and delta DLQI and a significant correlation between ITCH delta and DLQI delta and a correlation close to significance between DLQI and NAPSI. Conclusion:We identified itching as a mediator between the cutaneous extension of psoriasis and the impact on quality of life. We also documented the predominant role of nail psoriasis in defining the impact on the quality of life of the psoriatic patient

Coesisting inflammatory skin diseases: Tildrakizumab to control psoriasis and omalizumab for urticaria

In Western countries, the number of individuals suffering from an autoimmune condition is constantly growing and often patients suffering from autoimmune disease are susceptible to developing a second autoimmune disorder. We report a case of an adult female patient affected by psoriasis vulgaris and treated with tildrakizumab, a humanized monoclonal antibody targeting interleukin-23, who later developed chronic spontaneous urticaria and started omalizumab, a humanized antibody to IgE, showing a favorable outcome. We speculate that the two combined therapies have restored the cytokine balance bringing it toward tolerance and remission of the two pathologies. It is conceivable that tildrakizumab may have a synergic action with omalizumab in the treatment of urticaria in patients affected by both psoriasis and urticaria. Our case and the study of the mechanisms of action of the two drugs suggest how the two therapies can act with an interlocking mechanism in achieving the final therapeutic effect

Efficacy of a Topical Product Containing Purified Omental Lipids and Three Anti-Itching Compounds in the Treatment of Chronic Pruritus/Prurigo Nodularis in Elderly Subjects: A Prospective, Assessor-Blinded, 4-Week Trial with Transepidermal Water Loss and Optical Coherence Tomography Assessments

Purpose: To investigate the efficacy of a cream containing purified omental lipids 10% and three anti-itching substances (polidocanol/stimutex/palmitoylethanolamine) in elderly subjects with chronic pruritus/prurigo nodularis (CP/CPN). Patients and methods: Thirty-five subjects (6 men; mean age 67±4 years) with CP/CPN were enrolled in a prospective, assessor-blinded, 4-week study. The cream was applied twice daily in the most affected body area. The primary endpoints were the evolution of the 10-cm visual analogue itch severity scale (VAS) and the 4-point verbal itching rating scale (VRS) (from 0 to 3). Secondary endpoints were the evolution of optical coherence tomography (OTC) of four skin parameters (acanthosis/hyperkeratosis/scale/dermal vascular pattern), assessed in a target lesioned area, and the transepidermal water loss (TEWL). Study endpoints were evaluated at baseline and after 2 and 4 weeks by an investigator unaware of the type of treatment. Results: All the enrolled subjects concluded the trial. At baseline, the mean±SD scores for VAS and VRS were 4.9±2.2 and 1.7±0.7, respectively. The treatment was associated with a significant reduction (p=0.0001) of VAS score of 60% at week 2 and of 86% at week 4. VRS score was significantly reduced by 49% after 2 weeks and by 81% after 4 weeks, in comparison with baseline. TEWL (expressed as g/m2/h) mean values were 18±5.4 at baseline and 12.7±4.4 at week 2 and 9.8±4.7 at week 4 (P=0.0001 vs baseline). All the OCT parameters evaluated improved during active treatment; acanthosis grade was 0.22 mm at baseline, 0.19 mm at week 2 and 0.17 mm at week 4 (p=0.0005), representing a 23% reduction in comparison with baseline. The product was very well tolerated. Conclusion: This purified omental lipid with three anti-itching components cream reduces significantly itch intensity in subjects with chronic pruritus/prurigo nodularis, improving the skin barrier function and skin structure. Trial number: ISRCTN869561669