








key: cord-348430-8xk4dt7t
authors: Bragazzi, Nicola Luigi; Riccò, Matteo; Pacifico, Alessia; Malagoli, Piergiorgio; Kridin, Khalaf; Pigatto, Paolo; Damiani, Giovanni
title: COVID‐19 knowledge prevents biologics discontinuation: Data from an Italian multicenter survey during RED‐ZONE declaration
date: 2020-05-28
journal: Dermatol Ther
DOI: 10.1111/dth.13508
sha: 
doc_id: 348430
cord_uid: 8xk4dt7t

SARS‐CoV‐2 become pandemics and there is still a dearth of data about its the potentially among dermatological patients under biologics. We aimed to assess health literacy, disease knowledge, treatment dissatisfaction and biologics attitudes toward COVID‐19. We performed a cross‐sectional, questionnaire‐based survey on 98/105 consecutive dermatological patients treated with biologics—51 suffering from plaque psoriasis, 22 from atopic dermatitis, and 25 from hidradenitis suppurativa. An ad hoc, validated questionnaire has 44 items investigating the following domains: knowledge of COVID‐19 related to (a) epidemiology, (b) pathogenesis, (c) clinical symptoms, (d) preventive measures, and (e) attitudes. Patients data and questionnaires were collected. Despite only 8.1% thought that biologics may increase the risk of COVID‐19, 18.4% and 21.4% of the patients were evaluating the possibility to discontinue or modify the dosage of the current biologic therapy, respectively. Globally, male patients (P = .001) with higher scholarity level (P = .005) displayed higher knowledge of COVID‐19. Patients with lower DLQI (P = .006), longer disease duration (P = .051) and lower scholarity (P = .007) have thought to discontinue/modify autonomously their biologic therapy. At the multivariate logistic regression, only the knowledge of epidemiology and preventive measures resulted independent predictors of continuation vs discontinuation and modification vs no modification, respectively. Dermatologists should promote COVID‐19 knowledge to prevent biologics disruption.

COVID-19 pandemic has forced everyone to use personal protective equipment (PPE), such as goggles, N95 masks, double-layers gloves, and face-shields, and to follow methodically sanitization protocols. 2 Hence, health care workers due to too scrupulous and continuous hand-washing and use of preventive measures and protective equipment could develop hand eczema and related skin disorders. 4 Lan and colleagues recruited a sample of 542 health care and in 97% of them they found a dermatological disorder related to the personal protective equipment (PPE) and to the preventive measures, mainly affecting the nasal bridge, the hands, the cheeks and the forehead, with dryness and desquamation being the most commonly reported symptoms/signs. 5 However, mainly occupational aspects have been investigated so far.

To the best of our knowledge, there is a dearth of data concerning the COVID-19 perceptions of dermatological patients under biologics, a therapy traditionally associated to an increased risk of infections. [6] [7] [8] [9] This aspect is of particular interest since it may affect the patients' compliance leading to treatment discontinuation or autonomous modifications. 10 Although biologics have revolutionized the management of chronic dermatological disorders, their interplay between disease, disease activity, and its pharmacological treatment is complex and multifaceted, and sometimes drug-related side effects may occur (ie, airway infections). Side effects are also capable to detriment dermatologist-patients relationship leading to a decreased compliance. 11 Furthermore, also inside the dermatological field the attitude towards biologics are discordant 12, 13 due to the dearth of available data.

In these historical and scientific context of uncertainty, in which hospitals are overwhelmed by COVID-19 emergency and at the same time are struggled also by the normal routine (acute patients and chronic ones), we decided to perform a study to assess how COVID-19 impacts patients under biologics to optimize our daily approach.

The protocol study of the present investigation was in-depth reviewed, respected the ethical principles of seventh Helsinki Declaration and received full ethical clearance by the involved Institutions. All patients signed a written consent form.

This cross-sectional, questionnaire-based survey was performed in sidemast.org/blog/coronavirus). Patients scheduled for these days were consecutively enrolled if they met the eligible criteria.

Patients were enrolled in the present study if meeting the following inclusion criteria: (a) aged ≥18 years, (b) diagnosis of plaque psoriasis, atopic dermatitis or hidradenitis suppurativa performed by two independent board-certified dermatologists lasting more than 5 years ago, (c) with a severity.

• in psoriatic patients: Psoriasis Area Severity Index (PASI) 14 ≥10 and or Disease Activity index for PSoriatic Arthritis" (DAPSA) 15 Remarkably, in these departments patients undergoing a biological therapy were affecting only by psoriasis (PsO), or atopic dermatitis (AD) or hidradenitis suppurativa (HS).

After verifying medical history and demographics already recorded in the database, two board-certified, independent dermatologists clinically assessed the enrolled patients collecting the appropriate severity scores in compliance with the Italian guidelines. [19] [20] [21] [22] [23] AD patients were evaluated using Dermatologic Quality of Life Score (DLQI) 23, 24 and Eczema Area and Severity Index (EASI). PsO patients were evaluated using DLQI, PASI and DAPSA (if psoriatic arthritis was co-diagnosed), whilst HS patients underwent DLQI, Hurley score, IHS4 and Autoinflammatory Disease Damage Index (ADDI). 25 

Before commencing any statistical analyses, data were visually inspected for capturing potential outliers. Descriptive statistics was performed, by expressing values as means ± SDs. Scores were also assessed in terms of kurtosis and skewness. Regression analyses were carried out to shed light on the determinants of the knowledge score. 

Scores for each domain and for the overall questionnaire are reported in Table 2 . Noteworthy, no differences among the disease groups Remarkably, 28 (28.6%) patients perceived that their chronic dermatological disease expose them to a moderate-to-severe risk to contract SARS-CoV2, whereas 17.3% and 54.1% regard it as low or null.

Despite only 8.1% thought that biologics expose them to a moderate to severe risk to contract SARS-CoV2, 18.4% and 21.4% of the whole patients declared that they have assessed the possibility to discontinue or modify the dosage of the current biologic therapy, respectively. 

At the multivariate regression analysis, knowledge regarding the virus epidemiology was found to correlate with male gender (coefficient Globally male patients (coefficient regression 6.97, P = .0003) with higher scholarity level (coefficient regression 2.57, P = .0049) displayed higher knowledge of COVID-19. Further details are reported in Table 3 . Table 4 . (Table 5 ).

During COVID-19 pandemics 40% of dermatological patients under biologics have thought to autonomously modify or even discontinue their therapy.

SARS-CoV2 displayed a special tropism for respiratory epithelium, thus it may cause respiratory symptoms of different severity spacing from mild cough to death in 7.2% of the cases in Italy. 27, 28 Since COVID-19 pathogenesis involved mainly respiratory airways, patients with respiratory comorbidities might have higher risk, but at the moment no data are present to confirm it. 29 In literature, both psoriasis, atopic dermatitis and hidradenitis suppurativa displayed an higher risk of respiratory comorbidities; in accord with this evidence 30% of the interviewed patients thought that their dermatological disease could increase the SARS-CoV2 infection risk.

Psoriatic patients displayed a baseline airway inflammation, 30, 31 that may lead to the epidemiologically proven increased risk of asthma, and chronic obstructive pulmonary disease (COPD). 32 AD theory of "atopic march" gives the pathogenetic rationale to the increased asthma risk found in atopic patients. 33 However, the present study is not without any limitation. The major shortcoming is represented by the relatively small sample size employed. Furthermore, the knowledge was limited to pre-pandemic period. It would be interesting to evaluate knowledge of dermatological patients undergoing biologics also in postpandemic period.

The knowledge of COVID-19 has a paramount importance in dermatological patients undergoing biologics and dermatologists should promote it. Therapy continuation during COVID-19 emergency seems to strictly depend on the quality of information that patients acquire. Discontinuing or modifying biologic therapy expose patients to the risk of losing response to a drug previously useful.

T A B L E 5 Multivariate logistic regression analyses shedding light on the determinants of continuation vs discontinuation and modification vs no modification of biologic therapies in the considered sample of dermatological patients 

The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak

The SARS-CoV-2 outbreak: what we know

Phototherapeutic approach to dermatological patients during the 2019 coronavirus pandemic: real-life data from the Italian red zone

Occupational skin disease among healthcare workers during the coronavirus (COVID-19) epidemic

Skin damage and the risk of infection among healthcare workers managing coronavirus disease-2019

Biologics increase the risk of SARS-CoV-2 infection and hospitalization, but not ICU admission and death: real-life data from a large cohort during RED-ZONE declaration

Comparative risk of serious infections among real-world users of biologics for psoriasis or psoriatic arthritis

Conversion to positive latent tuberculosis infection status is low in Hidradenitis Suppurativa patients taking biologic medications

Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2)

Medication adherence: WHO cares?

Female patients are less satisfied with biological treatment for psoriasis and experience more side-effects than male patients: results from the prospective BioCAPTURE registry

COVID-19 and psoriasis: is it time to limit treatment with immunosuppressants? A call for action

Should biologics for psoriasis be interrupted in the era of COVID-19?

Severe psoriasis-oral therapy with a new retinoid

Evaluation of the appropriateness of composite disease activity measures for assessment of psoriatic arthritis

The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis

Axillary hyperhidrosis, apocrine bromhidrosis, hidradenitis suppurativa and familial benign pemphigus. Surgical approach

Development and validation of the international Hidradenitis Suppurativa severity score system (IHS4), a novel dynamic scoring system to assess HS severity

Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis

Italian guidelines for therapy of atopic dermatitis-adapted from consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis)

Hidradenitis suppurativa: guidelines of the Italian Society of Dermatology and Venereology (SIDeMaST) for the use of anti-TNF-α agents

Italian guidelines in patch testingadapted from the European Society of Contact Dermatitis (ESCD)

Validation of a visual-aided questionnaire for the self-assessment of hidradenitits suppurativa

Dermatology life quality index (DLQI): a simple practical measure for routine clinical use

Autoinflammatory disease damage index (ADDI): a possible newborn also in hidradenitis suppurativa daily practice

Point-of-Care diagnostic of SARS-CoV-2: knowledge, attitudes, and beliefs (KAP) of medical workforce in Italy

COVID-19, cytokines and immunosuppression: what can we learn from severe acute respiratory syndrome?

Case-fatality rate and characteristics of patients dying in relation to COVID-19 in Italy

Clinical Features of 69 Cases With Coronavirus Disease

Increased airway inflammation in patients with psoriasis

Narrowband ultraviolet B phototherapy in psoriasis reduces proinflammatory cytokine levels and improves vitiligo and neutrophilic asthma

Psoriasis and respiratory comorbidities: the added value of fraction of exhaled nitric oxide as a new method to detect, evaluate, and monitor psoriatic systemic involvement and therapeutic efficacy

Collegium Internationale Allergologicum Update 2020

Psoriasis and smoking: links and risks

Hidradenitis suppurativa and smoking: a systematic review and meta-analysis

Active smoking is not associated with severity of coronavirus disease 2019 (COVID-19)

Two phase 3 trials of Adalimumab for Hidradenitis Suppurativa

Dupilumab safety and efficacy in uncontrolled asthma: a systematic review and meta-analysis of randomized clinical trials

Coronavirus disease 2019 and transplantation: a view from the inside

Coronaviruses and immunosuppressed patients. The facts during the third epidemic

Poor medication adherence in patients with psoriasis and a successful intervention

Web app based patient education in psoriasis -a randomized controlled trial

Biologic therapy adherence, discontinuation, switching, and restarting among patients with psoriasis in the US Medicare population

Facing Covid-19 in Italy -ethics, logistics, and therapeutics on the Epidemic's front line

Global coronavirus pandemic (2019-nCOV): implication for an Italian medium size dermatological clinic of a ii level hospital

COVID-19 in Italy: momentous decisions and many uncertainties

COVID-19 knowledge prevents biologics discontinuation: Data from an Italian multicenter survey during RED-ZONE declaration

The authors declare no potential conflict of interest. 

