Nonadherence to systemic immune-modifying therapy in people with psoriasis during the COVID-19 pandemic: findings from a global cross-sectional survey.

BACKGROUND: Nonadherence to immune-modifying therapy is a complex behaviour which, before the COVID-19 pandemic, was shown to be associated with mental health disorders in people with immune-mediated diseases. The COVID-19 pandemic has led to a rise in the global prevalence of anxiety and depression, and limited data exist on the association between mental health and nonadherence to immune-modifying therapy during the pandemic. OBJECTIVES: To assess the extent of and reasons underlying nonadherence to systemic immune-modifying therapy during the COVID-19 pandemic in individuals with psoriasis, and the association between mental health and nonadherence. METHODS: Online self-report surveys (PsoProtectMe), including validated screens for anxiety and depression, were completed globally during the first year of the pandemic. We assessed the association between anxiety or depression and nonadherence to systemic immune-modifying therapy using binomial logistic regression, adjusting for potential cofounders (age, sex, ethnicity, comorbidity) and country of residence. RESULTS: Of 3980 participants from 77 countries, 1611 (40.5%) were prescribed a systemic immune-modifying therapy. Of these, 408 (25.3%) reported nonadherence during the pandemic, most commonly due to concerns about their immunity. In the unadjusted model, a positive anxiety screen was associated with nonadherence to systemic immune-modifying therapy [odds ratio (OR) 1.37, 95% confidence interval (CI) 1.07-1.76]. Specifically, anxiety was associated with nonadherence to targeted therapy (OR 1.41, 95% CI 1.01-1.96) but not standard systemic therapy (OR 1.16, 95% CI 0.81-1.67). In the adjusted model, although the directions of the effects remained, anxiety was not significantly associated with nonadherence to overall systemic (OR 1.20, 95% CI 0.92-1.56) or targeted (OR 1.33, 95% CI 0.94-1.89) immune-modifying therapy. A positive depression screen was not strongly associated with nonadherence to systemic immune-modifying therapy in the unadjusted (OR 1.22, 95% CI 0.94-1.57) or adjusted models (OR 1.14, 95% CI 0.87-1.49). CONCLUSIONS: These data indicate substantial nonadherence to immune-modifying therapy in people with psoriasis during the pandemic, with attenuation of the association with mental health after adjusting for confounders. Future research in larger populations should further explore pandemic-specific drivers of treatment nonadherence. Clear communication of the reassuring findings from population-based research regarding immune-modifying therapy-associated adverse COVID-19 risks to people with psoriasis is essential, to optimize adherence and disease outcomes.

Immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in patients receiving secukinumab: a literature review.

Purpose: There is a paucity of evidence on the impact of immune-mediated inflammatory disease (IMID) treatments on the immunogenicity of SARS-CoV-2 vaccination. The purpose of this literature review is to address the question of whether patients with IMIDs receiving secukinumab, a fully human anti-interleukin-17A monoclonal antibody, have an adequate immune response after SARS-CoV-2 vaccination. Materials and Methods: Clinical studies that evaluated the effect of secukinumab on immune responses in patients with IMIDs after SARS-CoV-2 vaccination were searched in publication databases, including Medline and Embase, until May 2022. Results: From the 53 articles identified, a total of 11 articles were included. Overall, the majority of the patients treated with secukinumab elicited an adequate immune response to SARS-CoV-2 vaccines. Patients receiving secukinumab for IMIDs developed cellular immune responses following vaccination with the BNT162b2 vaccine, and there were no significant differences in the overall humoral and cellular immune responses between patients and healthy individuals. The third dose of the BNT162b2 mRNA vaccine resulted in a positive antibody response in secukinumab-treated patients. Conclusion: The available data provide no evidence of impairment in immunological response to SARS-CoV-2 vaccines by secukinumab in patients with IMIDs.

Dietary supplements for the management of COVID-19 symptoms

Summary SARS-CoV-2, the etiological agent of COVID-19, caused a pandemic in 2020, which is only recently slowing down. The symptoms of COVID-19 range from cough to fever and pneumonia and may persist beyond the active state of the infection, in a condition called post-COVID syndrome. The aim of this paper is to review the relationship between COVID-19 and nutrition and to discuss to most up-to-date dietary supplements proposed for COVID-19 treatment and prevention. Nutrition and nutritional dysregulations, such as obesity and malnutrition, are prominent risk factors for severe COVID-19. These factors exert anti-inflammatory and proinflammatory effects on the immune system, thus exacerbating or reducing the immunological response against the virus. As for the nutritional habits, the Western diet induces a chronic inflammatory state, whereas the Mediterranean diet exerts anti-inflammatory effects and has been proposed for ameliorating COVID-19 evolution and symptoms. Several vaccines have been researched and commercialized for COVID-19 prevention, whereas several drugs, although clinically tested, have not shown promising effects. To compensate for the lack of treatment, several supplements have been recommended for preventing or ameliorating COVID-19 symptoms. Thus, it is critical to review the dietary supplements proposed for COVID-19 treatment. Supplements containing α-cyclodextrin and hydroxytyrosol exhibited promising effects in several clinical trials and reduced the severity of the outcomes and the duration of the infection. Moreover, a supplement containing hydroxytyrosol, acetyl L-carnitine, and vitamins B, C, and D improved the symptoms of patients with post-COVID syndrome.

Cutaneous Adverse Reactions to SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis.

Background: An increasing number of cutaneous adverse reactions (CARs) to SARS-CoV-2 vaccines have been reported, but their incidence is debated. Objective: To estimate the pooled incidence of CARs to SARS-CoV-2 vaccines in the general adult population. Methods: A systematic review and meta-analysis of original articles published on MEDLINE via PubMed and Web Of Science from 1 January 2020 to 18 July 2022 was undertaken. Studies reporting the incidence proportion of CARs (defined as number of new cases of CARs on the total of vaccinated people) were included. All types of SARS-CoV-2 vaccine were included. People receiving at least one dose were considered eligible. Local cutaneous reactions were excluded. Results: A total of 970 records were identified and screened by title and abstract; 22 observational studies were included with aggregate data on 93,165 participants. The pooled incidence of overall CARs was 5% (95%CI 4-6%; I2 = 99%; p < 0.001), ranging from <0.01 to 19.00%. Most CARs were new onset dermatitis including rash, urticaria and vascular lesions; one case of Steven-Johnson syndrome and six cases of erythema multiforme were reported. In the sensitivity analysis we found that the incidence of CARs after the first and second dose was similar, i.e., 3% (95%CI 2-3%; I2 = 96%; p < 0.001) and 3% (95%CI 2-4%; I2 = 97%; p < 0.001), respectively. The magnitude of incidence of CARs remained unchanged independently of vaccine platform and in the general population versus healthcare workers. Conclusions: CARs associated with SARS-CoV-2 vaccines are frequent but mild and self-remitting, whereas severe CARs are rare.

Use of biologics during the COVID-19 pandemic: lessons learned from psoriasis.

INTRODUCTION: Given the increased infectious risk associated with biologics, particularly with TNFα inhibitors, concerns were raised over the safety of these agents in relation to SARS-CoV-2 infection. Furthermore, the impact of biologics on SARS-CoV-2 vaccination was questioned. AREAS COVERED: In this review, studies conducted on patients with moderate to severe plaque psoriasis treated with biologics during the COVID-19 pandemic have been analyzed, including 1) the safety of biologics in psoriatic patients in terms of increased risk and/or worse outcome of SARS-CoV-2 infection; and 2) whether biologic agents could affect the safety and response to SARS-CoV-2 vaccines in psoriatic patients. EXPERT OPINION: Current evidence indicates that the use of biologics in psoriatic patients does not seem to be associated with an increased COVID-19 infection risk or worse outcome, with TNFα inhibitors being even protective of severe COVID-19 relative to other treatments or no treatment at all. Furthermore, biologic treatment does not seem to have a significant impact on the response and safety of vaccines in patients with psoriasis treated with biologics. However, uncertainty remains given the limitations of current studies which are often of short duration, limited sample sizes and do not stratify on specific biologic classes.

Update on the Management of Pediatric Psoriasis: An Italian Consensus.

INTRODUCTION: Psoriasis affects children with a considerable burden in early life. Treating pediatric psoriasis is challenging also because of the lack of updated specific guidelines. With the recent approval of several biologics for pediatric psoriasis and the ongoing COVID-19 pandemic, the management of young psoriatic patients is facing major changes. A revision of treatment recommendations is therefore needed. METHODS: In September 2021, a board of six Italian dermatologists convened to update treatment recommendations. The board issued evidence- and consensus-based statements covering relevant areas of pediatric psoriasis, namely: assessment of psoriasis severity, management of children with psoriasis, and treatment of pediatric psoriasis. To reach consensus, the statements were submitted to a panel of 24 experts in a Delphi process performed entirely via videoconference. A treatment algorithm was produced. RESULTS: There was full consensus that psoriasis severity is determined by the extension/severity of skin lesions, site of lesions, and impact on patient quality of life. Agreement was reached on the need for a multidisciplinary approach to pediatric psoriasis and the importance of patient/parents education. The relevance of vaccinations, including COVID-19 vaccination, for psoriatic children was acknowledged by all participants. Management issues that initially failed to reach consensus included the screening for psoriasis comorbidities and early treatment with biologics to prevent them and the use of telemedicine to facilitate patient follow-up. There was full consensus that topical corticosteroids are the first choice for the treatment of mild pediatric psoriasis, while phototherapy and systemic therapy are used in children with moderate-severe psoriasis. According to the proposed treatment algorithm, biologics are the first line of systemic therapy. CONCLUSIONS: Targeted systemic therapies are changing the treatment of moderate-severe pediatric psoriasis, while topical corticosteroids continue to be the first choice for mild disease. Children-centered research is needed to further improve the treatment of pediatric psoriasis.

Italian adaptation of EuroGuiDerm guideline on the systemic treatment of chronic plaque psoriasis.

SIDeMaST (Società Italiana di Dermatologia Medica, Chirurgica, Estetica e delle Malattie Sessualmente Trasmesse) contributed to the development of the present guideline on the systemic treatment of chronic plaque psoriasis. With the permission of EuroGuiDerm, SIDeMaST adapted the guideline to the Italian healthcare context to supply a reliable and affordable tool to Italian physicians who take care of patients affected by moderate to severe plaque psoriasis. The content of the guideline includes general information on the scope and purpose, health questions covered, target users and strength/limitations of the guideline, suggestions for disease severity grading and treatment goals. It presents the general treatment recommendations as well as detailed management and monitoring recommendations for the individual drugs including acitretin, cyclosporine, fumarates, methotrexate, adalimumab, apremilast, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab. Moreover, the guideline provides guidance for specific clinical situations such as patient with concomitant psoriatic arthritis, inflammatory bowel disease, a history of malignancies, a history of depression, diabetes, viral hepatitis, disease affecting the heart or the kidneys as well as concomitant neurological disease. Advice on how to screen for tuberculosis and recommendations on how to manage patients with a positive tuberculosis test result are given. It further covers treatment for pregnant women or those with childbearing potential. Information on vaccination, immunogenicity and systemic treatment during the COVID-19 pandemic is also provided.

Cutaneous Adverse Reactions Associated with SARS-CoV-2 Vaccines.

Many patients are receiving SARS-CoV-2 vaccinations, which have been associated with a variety of adverse effects. Cutaneous adverse reactions to SARS-CoV-2 vaccinations have been progressively reported, but they have not been reviewed according to their morphological clinical patterns. The objective of this review was to summarize the existing data concerning the cutaneous adverse reactions following SARS-CoV-2 vaccines and group them according to common morphological and pathogenetic patterns. We reviewed the English language literature up to 15 August 2021, using predefined keywords to identify the relevant studies evaluating cutaneous adverse reactions associated with SARS-CoV-2 vaccines. We search for recurrent morphological patterns sharing clinical signs and symptoms and physio-pathological mechanisms. Timing to onset following the first or booster dose of the vaccine, predisposing conditions, therapeutic management, and outcome were also collected. Among the dermatological manifestations associated with SARS-CoV-2 vaccinations, we distinguished: (1) new onset reactions and (2) flares of preexisting dermatoses. The most common were injection site reactions, affecting 30-70% and generally mild or moderate. Small case series or single case reports included filler reactions, exanthemas, vascular lesions, urticaria, eczematous dermatitis, autoimmune bullous reactions, and severe cutaneous adverse reactions. In addition, the exacerbation of chronic immuno-mediated dermatoses (mainly psoriasis and atopic dermatitis) and reactivations of herpes infection were reported. The cutaneous reactions were generally mild, self-limiting, and resembled common cutaneous drug eruptions and/or COVID-19 skin manifestations.

Evolution of Patient Perceptions of Psoriatic Disease: Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) Survey.

INTRODUCTION: Since the 2012 Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey, several systemic treatments for psoriasis (PsO) and/or psoriatic arthritis (PsA) have been approved. The population-based UPLIFT survey was conducted to understand how perceptions of treatment-related outcomes have evolved, particularly for patients with mild to moderate PsO and/or PsA and their dermatologists. METHODS: This population- and web-based survey was conducted from 2 March to 3 June 2020, in North America, Europe, and Japan. Adults with self-reported healthcare practitioner (HCP)-diagnosed PsO and/or PsA and dermatologists who spent > 50% of time treating patients and treated ≥ 20 patients with PsO, including plaque PsO, per month were included. Patient participants were recruited at random from online panels; dermatologists were recruited randomly from representative physician panels. RESULTS: Of 264,054 patient responses, 3806 who self-reported an HCP diagnosis of PsO and/or PsA were included in the final sample; 67% had PsO alone, 28% had PsO and PsA, and 5% had PsA alone. The estimated population prevalence of psoriatic disease was 7% (PsO only: 4%; PsO and PsA: 2%; PsA only: 1%). Most patients (78%) reported PsO-involved body surface area (BSA) ≤ 3 palms, and ~ 90% or more reported itching, redness, flaking, and scales. Many PsO patients without diagnosed PsA reported musculoskeletal symptoms suggestive of PsA (63%). Across BSA categories, approximately one in four patients was not currently receiving treatment and > 50% had Dermatology Life Quality Index score > 5. Patients and dermatologists had different perceptions of PsO severity, office visit discussions, treatment goals, and treatment satisfaction. The survey was conducted during the coronavirus disease 2019 (COVID-19) pandemic, which could have affected assessments of patient-reported outcomes and ability to have in-person HCP visits. CONCLUSIONS: Patients with PsO and PsA in UPLIFT reported high disease burden, including patients with limited skin involvement. An opportunity exists to align patient and dermatologist perceptions to optimize management of PsO and PsA. INFOGRAPHIC: DIGITAL FEATURE: This article is published with digital features, including an infographic, to facilitate understanding of the article. To view digital features for this article go to https://doi.org/10.6084/m9.figshare.17104586 .

In recent years, several new treatments for psoriasis and psoriatic arthritis have become available. The UPLIFT survey was conducted to understand how viewpoints on psoriatic disease outcomes have changed, especially for patients whose disease is mild or moderate. UPLIFT was a large, online, population-based survey conducted in North America, Europe, and Japan. Adults with psoriasis and/or psoriatic arthritis and dermatologists who treated at least 20 patients with psoriasis per month were included. There were 3806 patients who participated; of these, most had psoriasis and few had psoriatic arthritis. Most patients (78%) with mild to moderate psoriasis had a limited area of skin affected by psoriasis. Psoriasis symptoms were common and included itching, redness, flaking, and scales. Many patients without a diagnosis of psoriatic arthritis reported symptoms that could be related to this disease (such as joint discomfort). Although many patients had psoriasis symptoms, approximately one in four was not currently receiving treatment and more than half reported psoriasis impacted their quality of life. Patients and dermatologists had different perceptions of psoriasis severity, office visit discussions, treatment goals, and treatment satisfaction. There is an opportunity to improve treatment of psoriasis and psoriatic arthritis and to better align patient and physician perceptions of psoriasis. This survey was conducted during the COVID-19 pandemic, which could have partially affected some assessments and the ability to have in-person doctor visits.

Assessing the Risk and Outcome of COVID-19 in Patients with Psoriasis or Psoriatic Arthritis on Biologic Treatment: A Critical Appraisal of the Quality of the Published Evidence.

The need to rapidly spread information about the risk of COVID-19 in patients with psoriasis and psoriatic arthritis on biologics may have hampered the methodological rigor in published literature. We analyzed the quality of papers dealing with the risk and outcomes of COVID-19 in patients with psoriasis and psoriatic arthritis receiving biologic therapies. The Newcastle-Ottawa Scale was used to estimate the quality of the published studies. Moreover, to better contextualize results, specific internal and external validity items were further considered, that is, case definition, modality of COVID-19 assessment, evidence for self-selection of participants, percentage of dropout/nonparticipants, and sample size calculation. A total of 25 of 141 papers were selected. The median Newcastle-Ottawa Scale score was 47% for psoriasis and 44% for psoriatic arthritis, indicating an overall high risk of bias. A total of 37% of psoriasis and 44% of psoriatic arthritis studies included patients with suspected COVID-19 without a positive swab. No studies provided a formal sample size calculation. A significant risk of bias in all the published papers was found. Major issues to be considered in future studies are reduction of ascertainment bias, better consideration of nonresponse or participation bias, and provision of formal statistical power calculation.

Preference for Telemedicine Versus In-Person Visit Among Patients with Psoriasis Receiving Biological Drugs.

INTRODUCTION: The use of telemedicine has significantly increased since the outbreak of the SARS-CoV-2 pandemic. In the dermatological setting, patients with stable plaque psoriasis on maintenance therapy with biological drugs may be suitable candidates for telemedicine, although their preference for telemedicine has not yet been investigated. The aim of this study was to investigate the preference for telemedicine versus in-person visit among patients with psoriasis receiving biological drugs and the reported reasons behind their preferences. METHODS: Consecutive adult patients with chronic plaque psoriasis in stable clinical remission (Psoriasis Area Severity Index [PASI] ≤ 3 for at least 12 months) receiving maintenance biological therapy answered a survey investigating whether they would choose telemedicine or in-person visit for the next scheduled visit and the reasons behind their preference. The survey was undertaken through a questionnaire that was developed according to a structured process. RESULTS: Of the 246 participants in the survey, 118 (48%) preferred telemedicine over an in-person visit for their next scheduled visit with a dermatologist. Multivariate logistic regression analysis revealed that previous experience with digital video-communication tools was a significant predictor for the preference for telemedicine (odds ratio [OR] 10.75; 95% confidence interval [CI] 3.61-32.03), while older age (< 60 years) was negatively associated with the preference for telemedicine (OR 0.30; 95% CI 0.10-0.90). The most common reasons (75%) for preferring telemedicine were saving time and safety in relation to the risk presented by the Sars-CoV-2 pandemic (38%). In contrast, 56% of the patients who preferred the in-person visit option declared that they were unable to use video-communication tools. CONCLUSION: About half of the patients with stable psoriasis receiving biological drugs may be good candidates for telemedicine.

The safety profile of hydroxychloroquine: major cutaneous and extracutaneous adverse events

Hydroxychloroquine is an established therapy for several rheumatological disorders, and very recently it has been proposed as a possible treatment for the new coronavirus disease 2019 even if recent randomised trials did not prove any benefit. Notably, hydroxychloroquine has been associated with a heterogeneous range of cutaneous and extra-cutaneous adverse events. We carried out a narrative review of the literature up to November 1st, 2020, related to the safety of hydroxychloroquine. In particular, cutaneous and extra-cutaneous adverse events associated with hydroxychloroquine were reviewed. The following databases were consulted: PubMed, Embase, Google Scholar and ResearchGate. The research of articles was conducted by using the following search terms: ''hydroxychloroquine," ''adverse event/effect,'' "cutaneous", "skin", "cardiotoxicity", "retinopathy", gastrointestinal and neurological toxicity". The main indication for which hydroxychloroquine was used in the reports was an immune mediated disorder. Adverse events were described mostly in females over 50 years of age. The most common cutaneous adverse effect was maculopapular and erythematous rash occurring within 4 weeks of initiating hydroxychloroquine and disappearing within few weeks of discontinuation. Gastrointestinal symptoms and headache were the most frequent extracutaneous manifestations. Rarer cutaneous manifestations include hyperpigmentation, psoriasiform dermatitis, photodermatitis, stomatitis, melanonychia and hair loss. More severe conditions were acute generalised exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome/toxic epidermal necrolysis, and among extra-cutaneous adverse events cardiotoxicity and retinopathy. Since hydroxychloroquine is widely prescribed in rheumatology, it is important for rheumatologists to be familiar with its safety profile.

Time of Onset of Selected Skin Lesions Associated with COVID-19: A Systematic Review.

INTRODUCTION: Distinct skin lesions associated with coronavirus disease 2019 (COVID-19) have been described, but data regarding their time of onset during the COVID-19 course are scant. Our objective was to systematically review the studies reporting the time of onset of selected skin lesions with respect to the reported onset of the COVID-19 core symptoms. METHODS: A comprehensive search of studies published before 21 January 2021 was performed on MEDLINE via PubMed database using a predefined strategy to identify relevant articles. RESULTS: Out of 354 references, 87 were selected, reporting a total of 895 patients with skin lesions associated with COVID-19. The most frequent pattern was exanthema (n = 430, 48%), followed by vascular (n = 299, 33%), urticarial (n = 105, 12%) and others (n = 66, 7%). Skin lesions occurred more frequently in the first 4 weeks from the COVID-19 onset (n = 831, 92%), whereas prodromal or late lesions were rarer (n = 69, 8%). The urticarial and exanthema patterns were more frequent in the first 2 weeks. About the vascular pattern some differences were noted among its subtypes. Livedoid lesions occurred mainly in the first 2 weeks, while chilblain-like lesions between weeks 2 and 4. Purpuric/petechial lesions were equally distributed during the first 4 weeks. Several skin manifestations did not fall into the pattern classification, including erythema multiforme, generalized pruritus, Kawasaki disease and others. CONCLUSION: The diversity in the time of onset of skin lesions as well as their polymorphic nature likely reflects the diversity of the pathogenetic underlying mechanisms. PROSPERO DATABASE REGISTRATION NUMBER: CRD42021236331.

The clinical spectrum of COVID-19-associated cutaneous manifestations: An Italian multicenter study of 200 adult patients.

BACKGROUND: COVID-19 is associated with a wide range of skin manifestations. OBJECTIVE: To describe the clinical characteristics of COVID-19-associated skin manifestations and explore the relationships among the 6 main cutaneous phenotypes and systemic findings. METHODS: Twenty-one Italian Dermatology Units were asked to collect the demographic, clinical, and histopathologic data of 200 patients with COVID-19-associated skin manifestations. The severity of COVID-19 was classified as asymptomatic, mild, moderate, or severe. RESULTS: A chilblain-like acral pattern was significantly associated with a younger age (P < .0001) and, after adjusting for age, significantly associated with less severe COVID-19 (P = .0009). However, the median duration of chilblain-like lesions was significantly longer than that of the other cutaneous manifestations taken together (P < .0001). Patients with moderate/severe COVID-19 were more represented than those with asymptomatic/mild COVID-19 among the patients with cutaneous manifestations other than chilblain-like lesions, but only the confluent erythematous/maculo-papular/morbilliform phenotype was significantly associated with more severe COVID-19 (P = .015), and this significance disappeared after adjustment for age. LIMITATIONS: Laboratory confirmation of COVID-19 was not possible in all cases. CONCLUSIONS: After adjustment for age, there was no clear-cut spectrum of COVID-19 severity in patients with COVID-19-related skin manifestations, although chilblain-like acral lesions were more frequent in younger patients with asymptomatic/pauci-symptomatic COVID-19.

The safety profile of hydroxychloroquine: major cutaneous and extracutaneous adverse events.

Hydroxychloroquine is an established therapy for several rheumatological disorders, and very recently it has been proposed as a possible treatment for the new coronavirus disease 2019 even if recent randomised trials did not prove any benefit. Notably, hydroxychloroquine has been associated with a heterogeneous range of cutaneous and extra-cutaneous adverse events. We carried out a narrative review of the literature up to November 1st, 2020, related to the safety of hydroxychloroquine. In particular, cutaneous and extra-cutaneous adverse events associated with hydroxychloroquine were reviewed. The following databases were consulted: PubMed, Embase, Google Scholar and ResearchGate. The research of articles was conducted by using the following search terms: ''hydroxychloroquine," ''adverse event/effect,'' "cutaneous", "skin", "cardiotoxicity", "retinopathy", gastrointestinal and neurological toxicity". The main indication for which hydroxychloroquine was used in the reports was an immune mediated disorder. Adverse events were described mostly in females over 50 years of age. The most common cutaneous adverse effect was maculopapular and erythematous rash occurring within 4 weeks of initiating hydroxychloroquine and disappearing within few weeks of discontinuation. Gastrointestinal symptoms and headache were the most frequent extracutaneous manifestations. Rarer cutaneous manifestations include hyperpigmentation, psoriasiform dermatitis, photodermatitis, stomatitis, melanonychia and hair loss. More severe conditions were acute generalised exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, Stevens-Johnson syndrome/toxic epidermal necrolysis, and among extra-cutaneous adverse events cardiotoxicity and retinopathy. Since hydroxychloroquine is widely prescribed in rheumatology, it is important for rheumatologists to be familiar with its safety profile.

Immune Response to Vaccination in Patients with Psoriasis Treated with Systemic Therapies.

Psoriasis is a chronic inflammatory skin disease usually treated with immunomodulatory/immunosuppressive agents. The use of these agents has been associated with an increased susceptibility to infections. Vaccination might represent a critical aspect in the management of patients with psoriasis treated with immunomodulatory/immunosuppressive therapies. This narrative review aimed to provide an overview on the immune response to vaccines in subjects treated with systemic agents used to treat patients with moderate to severe psoriasis. Publications appearing in PubMed, Scopus, and ISI-Web of Knowledge database were selected using Medical Subject Headings key terms. Overall, published data confirmed that vaccination with attenuated live vaccines during therapy with immunomodulatory/immunosuppressive therapies should be avoided. For nonlive vaccines, a more favorable safety profile of biologic agents compared to conventional systemic agents is described as the humoral response to vaccines is in general well-preserved. Treatment with cyclosporine and methotrexate is associated with lower antibody titers to vaccines, and thus these agents are better discontinued during vaccination. In contrast, treatment with biological agents is not associated with lower antibody response and can thus be continued safely.

The Risk of COVID-19 Pandemic in Patients with Moderate to Severe Plaque Psoriasis Receiving Systemic Treatments.

Chronic plaque psoriasis is an inflammatory skin disease affecting 2-3% of the general population. Approximately one-third of patients are candidates for systemic immunosuppressive treatments, such as synthetic or biological disease-modifying antirheumatic drugs, because of disease extensions, localization in sensitive or visible areas and/or resistance to topical treatments. These therapies have been associated with increased risk of infection, including upper respiratory tract viral infection. Psoriasis is frequently associated with cardio-metabolic comorbidities, such as obesity and diabetes, that are risk factors for poor prognosis in the case of coronavirus disease (COVID-19) pneumonia. A narrative review of the literature based on an electronic search of the PubMed® database was undertaken with the objective of investigating whether there is an increased risk of COVID-19 infection in psoriasis patients on systemic treatment. Original articles, such as case reports, published up to 1 November 2020 were included. There is no evidence that patients with moderate-to-severe psoriasis receiving systemic treatments, including biologics, have higher risk of SARS-CoV-2 infection and/or increased hospitalization and death related to COVID-19 compared to the general population. Several case reports described full recovery from COVID-19 with favorable outcomes in psoriasis patients who were being treated with synthetics or biologicals. Nonetheless, caution should be maintained in this setting, and more data are needed to draw definitive conclusions.

Characteristic of chronic plaque psoriasis patients treated with biologics in Italy during the COVID-19 Pandemic: Risk analysis from the PSO-BIO-COVID observational study.

Background: The susceptibility of patients with chronic plaque psoriasis and the risks or benefits related to the use of biological therapies for COVID-19 are unknown. Few data about prevalence, clinical course and outcomes of COVID-19 among psoriatic patients were reported. The aims of this study were 1) to assess the prevalence and severity of COVID-19 in psoriatic patients treated with biologic agents during the first phase of the emergency (22 February to 22 April 2020) in Italy, and 2) to report the clinical outcomes of patients who have been exposed to individuals with confirmed SARS-CoV-2 infection. Methods: Patients with moderate-to-severe chronic plaque psoriasis, aged ≥18 years and undergoing treatment with biologic agents as of 22 February 2020, were eligible to be included in PSO-BIO-COVID study. Demographic and clinical characteristics of patients using any biologic for psoriasis treatment between 22 February and 22 April 2020 were registered. Results: A total of 12,807 psoriatic patients were included in the PSO-BIO-COVID study. In this cohort 26 patients (0.2%) had a swab confirmation of SARS-CoV-2 infection. Eleven patients required hospitalization and two died. Conclusion: The incidence of COVID-19 observed in our cohort of psoriatic patients (0.2%) is similar to that seen in the general population (0.31%) in Italy. However, the course of the disease was mild in most patients. Biological therapies may likely lessen 'cytokine storm' of COVID-19, which sometimes lead to multiple organ failure, ARDS, and death.