Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial.

BACKGROUND: Alopecia areata is characterised by non-scarring loss of scalp, face, or body hair. We investigated the efficacy and safety of ritlecitinib, an oral, selective dual JAK3/TEC family kinase inhibitor, in patients with alopecia areata. METHODS: In this randomised, double-blind, multicentre, phase 2b-3 trial done at 118 sites in 18 countries, patients aged 12 years and older with alopecia areata and at least 50% scalp hair loss were randomly assigned to oral ritlecitinib or placebo once-daily for 24 weeks, with or without a 4-week loading dose (50 mg, 30 mg, 10 mg, 200 mg loading dose followed by 50 mg, or 200 mg loading dose followed by 30 mg), followed by a 24-week extension period during which ritlecitinib groups continued their assigned doses and patients initially assigned to placebo switched to ritlecitinib 50 mg or 200 mg loading dose followed by 50 mg. Randomisation was done by use of an interactive response system and was stratified by baseline disease severity and age. The sponsor, patients, and investigators were masked to treatment, and all patients received the same number of tablets to maintain masking. The primary endpoint was Severity of Alopecia Tool (SALT) score 20 or less at week 24. The primary endpoint was assessed in all assigned patients, regardless of whether they received treatment. This study was registered with ClinicalTrials.gov, NCT03732807. FINDINGS: Between Dec 3, 2018, and June 24, 2021, 1097 patients were screened and 718 were randomly assigned to receive ritlecitinib 200 mg + 50 mg (n=132), 200 mg + 30 mg (n=130), 50 mg (n=130), 30 mg (n=132), 10 mg (n=63), placebo to 50 mg (n=66), or placebo to 200 mg + 50 mg (n=65). 446 (62%) of 718 patients were female and 272 (38%) were male. 488 (68%) were White, 186 (26%) were Asian, and 27 (4%) were Black or African American. Of 718 patients randomly assigned, 104 patients discontinued treatment (34 withdrew, 19 adverse events [AEs], 12 physician decision, 12 lack of efficacy, 13 lost to follow up, five rolled over to long-term study transfer, four pregnancies, two protocol deviations, one declined to attend follow-up due to COVID-19, one attended last visit very late due to COVID-19, and one non-compliance). At week 24, 38 (31%) of 124 patients in the ritlecitinib 200 mg + 50 mg group, 27 (22%) of 121 patients in the 200 mg + 30 mg group, 29 (23%) of 124 patients in the 50 mg group, 17 (14%) of 119 patients in the 30 mg group, and two (2%) of 130 patients in the placebo group had a response based on SALT score 20 or less. The difference in response rate based on SALT score 20 or less between the placebo and the ritlecitinib 200 mg + 50 mg group was 29·1% (95% CI 21·2-37·9; p<0·0001), 20·8% (13·7-29·2; p<0·0001) for the 200 mg + 30 mg group, 21·9% (14·7-30·2; p<0·0001) for the 50 mg group, and 12·8% (6·7-20·4; p=0·0002) for the 30 mg group. Up to week 48 and including the follow-up period, AEs had been reported in 108 (82%) of 131 patients in the ritlecitinib 200 mg + 50 mg group, 105 (81%) of 129 patients in the 200 mg + 30 mg group, 110 (85%) of 130 patients in the 50 mg group, 106 (80%) of 132 patients in the 30 mg group, 47 (76%) of 62 patients in the 10 mg group, 54 (83%) of 65 patients placebo to ritlecitinib 200 mg + 50 mg in the extension period, and 57 (86%) of 66 patients in the placebo to 50 mg group. The incidence of each AE was similar between groups, and there were no deaths. INTERPRETATION: Ritlecitinib was effective and well tolerated in patients aged 12 years and older with alopecia areata. Ritlecitinib might be a suitable treatment option for alopecia areata in patients who are candidates for systemic therapy. FUNDING: Pfizer.

Coping of Chronically-Ill Patients during the COVID-19 Pandemic: Comparison between Four Groups.

In many countries, the COVID-19 pandemic led to healthcare reorganization limiting access to diagnostic or therapeutic procedures for chronically-ill patients. In this article, we describe the psychological consequences and coping strategies of several groups of chronically-ill patients. During the cross-sectional survey conducted in 2020, we enrolled 398 patients with four different chronic conditions (psoriasis, multiple sclerosis, and patients who have undergone a kidney transplant or received dialysis). The study sample was examined regarding the experienced stress levels (Perceived Stress Scale) and coping strategies (Brief-COPE). All four groups of patients most commonly declared using problem-focused coping strategies and least commonly reported the use of avoidant coping. Higher levels of perceived stress strongly correlated with self-blaming. The participants who declared previous psychiatric treatment or psychotherapy were more likely to use self-blaming, behavioral disengagement, substance use, and avoidant coping, while previous psychotherapy additionally correlated with emotion-focused coping. Group comparison identifies patients with a chronic neurological disease, such as multiple sclerosis, at higher risk of a less beneficial coping profile than kidney transplant recipients. Further focus on education and early interventions in at-risk individuals is needed, and widely targeted mental health programs are indicated in order to improve the mental health of patients suffering from chronic diseases.

Psychopathological Symptoms Among Chronically Ill Patients During SARS-CoV-2 Pandemic in Poland.

Introduction: The global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic had a drastic psychological and economic impact on the global population. Having a chronic disease during the pandemic is associated with numerous limitations and challenges like regular hospital visits, access to health-care units and getting specialized treatment. In addition, chronically ill patients are at great risk of acquiring the SARS-CoV-2 virus and at experiencing a more severe course of illness, due to comorbid conditions as well as more frequent encounters with health-care workers and other patients in medical facilities. The aim of this study was to examine the psychological disturbances, during the pandemic in chronically ill patients. Methods: During the cross-sectional survey conducted between May and October 2020, 398 patients with four different chronic conditions (psoriasis, multiple sclerosis and patients who have undergone a kidney transplant or received dialysis). Study sample was examined regarding the occurrence of psychopathological symptoms (General Health Questionnaire 28) and their perceived stress levels (Perceived Stress Scale). Results: The highest scores were found in the MS group and the lowest scores were found in the kidney transplantation group in every subscale of the GHQ-28. Close to half of the studied population (48.74%, n = 193) patients scored above the cut-off for psychopathology. Conclusion: As the study was conducted during the SARS-CoV-2 pandemic in Poland, it stands to reason that the pandemic affected the psychological wellbeing of chronically ill patients. A COVID-19 infection, being quarantined and having had contact with a person who was infected, did not significantly affect the outcome measures; however, further research is needed to explore this topic.

Itch in Adult Population with Type 2 Diabetes Mellitus: Clinical Profile, Pathogenesis and Disease-Related Burden in a Cross-Sectional Study.

BACKGROUND: Despite growing interest in itch, data regarding itch in type 2 diabetes mellitus (DM2) are still limited, and mostly based on outdated studies. This study aimed to evaluate the clinical characteristics of itch in the adult population with DM2 and explore potential underlying causes. METHODS: The study group consisted of 109 adult patients with DM2. Standardized questionnaires were completed in order to assess the itch intensity [Numerical Rating Scale (three days, 24hours) (NRS)] and the Four-item Itch Questionnaire (4IIQ) and to assess the psychological impact of itch [ItchyQoL, Six-Item Stigmatization Scale (6-ISS), Hospital Anxiety and Depression Scale (HADS)]. Skin dryness was evaluated clinically and by non-invasive assessment of epidermis moisturizing. Neuropathy was assessed using the clinical Katzenwadel neuropathy scale. RESULTS: Itch occurred in 35.8% of adult patients with DM2, with NRSmax three days 6.31 ± 2.16 and 8.1 ± 3.5 points in 4IIQ. Itchy patients have had significantly higher FPG levels compared with the non-itchy population (p = 0.01). Patients with itch had a significantly higher possibility of neuropathy compared with non-itchy subjects (p < 0.01). Skin xerosis was significantly more advanced in patients with itch compared to those without (p < 0.01). The mean ItchyQol score was assessed as 41.2 ± 13.4 points, indicating mild life quality impairment and correlated positively with itch intensity. Itchy subjects had significantly higher scores in both anxiety and depression dimensions of HADS (in each p < 0.01). CONCLUSIONS: We suggest that the primary cause of itch is prolonged poor diabetes control with altered glucose and insulin levels, subsequently causing skin dryness and neuropathy in long-lasting DM2.

Is Face and Mask Touching a Real Struggle During the COVID-19 Pandemic? A Prospective Study Among Medical Students.

There are limited data in the literature on the frequency of face- and mask-touching behavior as a potential vector for the self-inoculation and transmission of the novel coronavirus. In this prospective study, we assessed the facial touching behavior of 204 medical students. One hundred thirty-four subjects (65.68%) during the 15-min observation at least once touched the area of the mask (38.23%), eyes (38.23%), or other parts of the facial zone (49.02%). The mean number of touches was 11.98 ± 16.33 per hour. The results of our study reveal that there is no significant association between mask wearing and gender; however, there might be a tendency for people with eyeglasses to touch the area near the eyes more often.

New Coronavirus (SARS-CoV-2) Crossing Borders Beyond Cities, Nations, and Continents: Impact of International Travel.

The third outbreak of coronavirus in the form of the COVID-19 infection started in Wuhan, China, in December 2019. The early and rapid spread of this infection across borders can be largely attributed to international air travel that has become a part of modern globalization. In this article, we analyze the spread of the novel coronavirus (SARS-CoV-2) along the routes of international travel, both by air and by sea. Pitfalls of various screening methods used at the airports and the importance of optimal aircraft ventilation are discussed. Also, we suggest measures that can be taken to reduce the risk of transmission associated with air travel.

Face Mask Usage among Young Polish People during the COVID-19 Epidemic-An Evolving Scenario.

The usage of face masks has been mandated in many countries in an attempt to diminish the spread of SARS-CoV-2. In this cross-sectional study, we aimed to determine face mask-wearing behaviors and practices in 1173 young Polish people during the second wave of the COVID-19 epidemic in October 2020. The majority of respondents (97.4%) declared that they wore face masks in areas/situations where it is mandatory. The most common types of utilized face masks were cloth masks (47.7%) and surgical masks (47%), followed by respirators (N95/FFP3) (3.2%) and half-face elastomeric respirators (0.9%). Over 38% reported frequently disinfecting their face masks, especially females. Respondents reporting personal atopic predisposition (64.5% vs. 72.1%; p = 0.02) or sensitive skin (65.5% vs. 74.3%; p = 0.005) declared multiple use of face masks less commonly than other individuals. Individuals suffering from facial skin lesions declared disinfecting face masks more commonly (40.8% vs. 34.9%; p = 0.04). Overall, the self-declared utilization of face masks among young people in Poland has improved since the beginning of the epidemic as compared with our previous study. Until the mass vaccination of the public is achieved and government policy is changed, face mask use remains a valuable tool to decrease the transmission of SARS-CoV-2.

Do University Students Adhere to WHO Guidelines on Proper Use of Face Masks during the COVID-19 Pandemic?—Analysis and Comparison of Medical and Non-Medical Students

Covering the mouth and nose has become the common standard for protection from human-to-human virus transmission during the COVID-19 pandemic. The aim of the study was to investigate whether students at universities (medical and non-medical students) do adhere to WHO recommendations on the proper use of face protection. The study was based on the survey created with Google® Forms regarding data on demographics and self-reported skin conditions. The main questions addressed the WHO guideline on the correct use of face masks. Responses were obtained from 1173 students. Compliance with all WHO criteria among the whole group of respondents was very low at less than 1% with no significant difference between medical and non-medical students. Covering of the nose and mouth with the face mask was the criterion most commonly complied with (81.2%);contact avoidance of touching the mask with hands appeared to be the most difficult criterion to comply with (2.8%). Medical students were significantly more compliant with three out of seven criteria. In general, compliance with the WHO guidelines on the proper use of face masks was dramatically low among all the students. Education campaigns should be introduced to increase the awareness of the correct use of face coverings during the viral pandemic.

Systemic Medications of Dermatological Importance in COVID-19.

Early December 2019 witnessed an international outbreak of a novel coronavirus (COVID 19) designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). Since then, a number of therapeutic molecules have been explored to have potential efficacy against the SARS-Cov-2 per se or its sequelae. There are no Food and Drug Administration specific therapies approved so far; however, numerous drugs based on varying levels of evidence, in vitro studies and compassionate drug trials are being established as therapeutic agents, especially drugs approved for previous emergence of the severe acute respiratory syndrome (SARS-CoV-1) and Middle east respiratory syndrome coronavirus (MERS-Cov). Numerous active clinical trials for COVID-19 with more than 150 drugs and products are under study. Needless to say, many dermatological drugs are being employed to mitigate this pandemic threat. We aim to review drugs with potential against SARS-Cov-2 widely used in dermatology practice. Additionally, rampant and overzealous use of these drugs as well as introduction of new molecules might lead to emergence of adverse effects associated with these agents. Dermatologists must be on lookout for any cutaneous adverse effects of these drugs. J Drugs Dermatol. 2020;19(9):889-892. doi:10.36849/JDD.2020.5323.

The Utilization of Protective Face Masks among Polish Healthcare Workers during COVID-19 Pandemic: Do We Pass the Exam?

Relevant personal protective measures during the COVID-19 pandemic include face masks, possibly decreasing the risk of infection among the general population and healthcare workers (HCW) if utilized properly. The aim of the study was to assess whether different Polish HCW utilize face masks according to the 2020 World Health Organization guidance (WHO) criteria. This cross-sectional study included 1156 respondents who participated in an internet survey evaluating mask-related behaviors. All the WHO criteria were complied with by 1.4% of participants, regardless of medical profession, specialty or place of employment. HCW mostly adhered to criterion 1 (C1; strict covering of the face and mouth with the mask; 90.8%), C4 (washing/disinfecting the hands after touching/taking off the mask; 49%) and C3 (taking off the mask properly without touching the anterior surface; 43.4%), whereas C2 (avoidance of touching the mask with hands) was complied with least commonly (6.8%). HCW with mask-induced itch (31.6%) complied to C2 less often (odds ratio 0.53; p = 0.01). The study reveals that Polish HCW rarely adhere to all the 2020 WHO guidance criteria on the use of masks, whereas the adherence to particular criteria is variable and may be associated with the presence of skin-related conditions and other factors. Better compliance with the recommendations in the future is necessary to increase personal safety of HCW and prevent the transmission of SARS-CoV-2.

Cutaneous Manifestations in COVID-19: Report on 31 Cases from Five Countries.

The increasingly frequent cutaneous manifestations of coronavirus disease (COVID-19) remain to pose a problem to clinicians. Herein, we aimed to describe the clinical and pathological findings of skin lesions in patients with COVID-19. The case series, which was based on the International Dermatological Registry circulated to dermatologists worldwide, was conducted across organizations and societies belonging to five different countries. We documented 31 patients with dermatologic manifestations associated with COVID-19, including maculopapular rashes (16.10%), urticarial lesions (26.80%), pseudochilblains (22.60%), petechiae/purpura (6.50%), distal ischaemia and necrosis (6.50%), livedo racemosa (12.90%), and others (9.70%). Twenty-six cases (83.90%) were qRT-PCR-confirmed COVID-19 cases, two (6.50%) were serologically confirmed, while two others (9.7%) were suspected cases owing to previous contact with COVID-19-positive patients. Therefore, our findings indicate that a febrile rash or even a rash in an afebrile state in the early stages of the disease may be the only clinical manifestation of COVID-19. In the future, we recommend close monitoring of all patients with skin lesions not attributable to other causal factors; in the diagnostic perspective, clinicians should aim to confirm if the skin lesions are associated with COVID-19.

Increased Prevalence of Face Mask-Induced Itch in Health Care Workers.

BACKGROUND: Face mask use has increased significantly due to the COVID-19 pandemic. Health care workers (HCW) wear masks for prolonged periods and are prone to adverse effects. Very little is known about face-mask-associated itch. METHODS: This Internet survey study investigated the prevalence, intensity and clinical characteristics of itch related to the use of face masks by HCW during the COVID-19 pandemic. The results were subsequently compared to the students' group. RESULTS: A total of 1156 HCW completed the survey. Among them, 31.6% (365) reported suffering from itch associated with face mask use. Itch was more frequent among females. Moreover, subjects who reported sensitive skin, atopic predispositions and facial dermatoses tended to report itch more frequently. The worst case of itch in the seven days prior to the study, assessed with the numeric rating scale (NRS), was 4.6 ± 2.0 points. Itch prevalence increased along with the duration of face mask use, being 34.6% among those who wore masks for more than 4 h. HCW reported itch significantly more frequently than students. CONCLUSIONS: Face-mask-associated itch is a frequent problem among HCW in the COVID-19 pandemic. Itch sensation may cause scratching, which may decrease necessary protection during the pandemic.

Influence of COVID-19 pandemic on hospitalizations at the tertiary dermatology department in south-west Poland.

New virus SARS-Cov-2 infection has spread over the world affecting all daily activities, including functioning of health services. Due to pandemic, many hospitals were ordered to re-organize their work. The aim of the current report was to evaluate the influence of COVID-19 pandemic on the hospitalizations at the tertiary dermatology department in south-west Poland. Two corresponding periods of 2019 and 2020 were compared in aspect of number of hospitalizations, sex, and age profile of inpatients. We clearly showed a significant reduction of hospitalized patients during the pandemic period, with marked reduction of female patients. Moreover, the significant decrease of admissions to dermatology ward was observed within children and patients older than 70 years. Patients with chronic inflammatory dermatoses (eg, atopic dermatitis, eczemas, lichen planus, pityriasis rubra pilaris) were less often hospitalized during the pandemic period. In contrast, patients suffering from dermatitis due to substances taken internally, erysipelas, syphilis, and primary cutaneous lymphomas constituted significantly higher rate of hospitalized subjects in the year 2020.

The use of face masks during the COVID-19 pandemic in Poland: A survey study of 2315 young adults.

Face masks wearing during the coronavirus disease 2019 (COVID-19) pandemic became ubiquitous. The aim of our study was to assess the use of face masks among young adults during the current viral pandemic. The survey was based on specially created Google Forms and posted on numerous Facebook groups for young people in Poland. Seven days were considered as a recall period. A total of 2315 answers were obtained, 2307 were finally analysis, as eight questionnaires were removed because of data incompleteness. 60.4% of responders declared using the face masks. Those who reported an atopic predisposition wore face masks significantly (P = .007) more commonly (65.5% and 57.7%, respectively). Cloth masks (46.2%) appeared to be most popular ones, followed by surgical masks (39.2%), respirators (N95 and FFP) (13.3%), half-face elastomeric respirators (0.8%) and full-face respirators (0.4%). Females significantly more frequently (P = .0001) used cloth masks; respirators, half-face elastomeric respirators and full-face respirators were used more commonly by males (P < .0001, P = .001 and P = .001, respectively). 23.9% of responders who used single-use mask wore it again. Moreover, 73.6% participants declared mask decontamination; however, the procedures were not always appropriate. We suggest that our results may be of help in construction of general public education campaigns on the proper use of face masks.

Face Mask-induced Itch: A Self-questionnaire Study of 2,315 Responders During the COVID-19 Pandemic.

Little is known about itch related to the use of face masks. This internet survey study investigated the prevalence, intensity and clinical characteristics of itch related to the use of face masks by the general public during the COVID-19 pandemic. A total of 2,315 replies were received, of which 2,307 were included in the final analysis. Of the respondents, 1,393 (60.4%) reported using face masks during the previous week, and, of these, 273 (19.6%) participants reported having itch. Subjects who reported sensitive skin and atopic predisposition, and those with facial dermatoses (acne, atopic dermatitis or seborrhoeic dermatitis) were at significantly higher risk of itch development. The high-est rating of itch for the whole group on the Itch Numeral Rating Scale was 4.07 ± 2.06 (itch of moderate intensity). Responders who wore masks for longer periods more frequently reported itch. Almost 30% of itchy subjects reported scratching their face without removing the mask, or after removing the mask and then scratching. Wearing face masks is linked to development of itch, and scratching can lead to incorrect use of face masks, resulting in reduced protection.