The Impact of Immune-Modulating Treatments for Dermatological Diseases on the Risk of Infection with SARS-CoV-2 and Outcomes Associated with COVID-19 Illness.

Purpose of Review: Immune-modulating treatments are used in dermatology for a variety of conditions. The authors aim to review the data regarding the safety of these treatments during the COVID-19 pandemic, namely the risk of infection with SARS-CoV-2 and the outcomes associated with COVID-19-related illness. Recent Findings: Several large-scale studies found no increased risk of COVID-19 infection for patients on TNF-α inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, IL-23 inhibitors, dupilumab, and methotrexate. They also found that these patients did not have worse outcomes when infected with COVID-19. The data regarding JAK inhibitors, rituximab, prednisone, cyclosporine, mycophenolate mofetil, and azathioprine are more mixed. Summary: Based on current research and guidelines from the American Academy of Dermatology and the National Psoriasis Foundation, dermatology patients on immune-modulating therapies can continue treatment during the COVID-19 pandemic when they are not infected with SARS-CoV-2. For patients who have COVID-19, guidelines encourage individualized assessment of the benefits and risks of continuing or temporarily withholding treatment.

Brodalumab: 4-Year US Pharmacovigilance Report.

Brodalumab is an interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe psoriasis in adults without response or with loss of response to other systemic therapies. Brodalumab carries a boxed warning in the United States regarding suicidal ideation and behavior, though no causal relationship has been established. Here, we summarize 4 years of pharmacovigilance data, from August 15, 2017, through August 14, 2021, reported to Ortho Dermatologics by US patients and healthcare providers. The most common AEs listed in the brodalumab package insert (incidence ≥1%) and AEs of special interest are described. Brodalumab exposure estimates were calculated using the time between the first prescription-dispensing authorization date and last prescription-dispensing authorization date. Data were collected from 4019 patients with an estimated brodalumab exposure of 4563 patient-years. The most common AE was arthralgia (115 events; 2.52 events per 100 patient-years). No completed suicides and no new suicidal attempts were reported. There were 102 cases with serious infections; however, no serious fungal infections (including no new cases of oral candidiasis) were reported. There were 26 COVID-19 cases, and 3 of the cases with comorbid conditions were fatal. There were no new cases of Crohn’s disease. Of 37 reported malignancies among 32 cases, none were deemed related to brodalumab. Four-year pharmacovigilance data are consistent with the established safety profile reported in long-term clinical trials and 3-year pharmacovigilance data. J Drugs Dermatol. 2023;22(4) doi:10.36849/JDD.7344 Citation: Lebwohl M, Koo J, Leonardi C, et al. Brodalumab: 4-Year US pharmacovigilance report. J Drugs Dermatol. 2023;22(4):419-422. doi:10.36849/JDD.7344.

The Impact of the COVID-19 Pandemic on Racial Disparities in Patients Undergoing Total Shoulder Arthroplasty in the United States.

Introduction: The purpose of this study was to assess racial disparities in total shoulder arthroplasty (TSA) in the US and to determine whether these disparities were affected by the COVID-19 pandemic. Methods: Centers for Medicare and Medicaid Services (CMS) 100% sample was used to examine primary TSA volume from April-December from 2019-2020. Utilization was assessed for White/Black/Hispanic/Asian populations to determine if COVID-19 affected these groups differently. A regression model adjusted for age/sex/CMS-Hierarchical Condition Categories (HCC) score, dual enrollment (proxy for socioeconomic status), time fixed effects, and Core-based Statistical Area (CBSA) fixed effects was used to study difference across groups. Results: In 2019, TSA volume/1000 beneficiaries was 1.51 for White and 0.57 for non-White, a 2.6-fold difference. In 2020, the rate of TSA in White patients (1.30/1000) was 2.9 times higher than non-White (0.45/1000) during the COVID-19 pandemic (P<0.01). There was an overall 14% decrease in TSA volume/1000 Medicare beneficiaries in 2020; non-White patients had a larger percentage decrease in TSA volume than White (21% vs. 14%, estimated difference;8.7%,p = 0.02). Black patients experienced the most pronounced disparity with estimated difference of 10.1%,p = 0.05, compared with White patients. Similar disparities were observed when categorizing procedures into anatomic and reverse TSA, but not proximal humerus fracture. Conclusions: During the COVID-19 pandemic, overall TSA utilization decreased by 14% with White patients experiencing a decrease of 14%, and non-White patients experiencing a decrease of 21%. This trend was observed for elective TSA while disparities were less apparent for proximal humerus fracture.

Perspectives on nonmedical switching and the COVID-19 pandemic: a narrative review.

OBJECTIVES: Nonmedical switching (NMS) is a change in a patient's treatment regimen for reasons other than lack of efficacy, intolerance, adverse effects, or poor adherence. We describe the impact of NMS on patients, health care workers, and health systems, focusing on NMS to in-class biologic alternatives in US patients with chronic, immune-mediated rheumatic and dermatologic conditions. Additionally, we evaluate the ways in which the COVID-19 pandemic may exacerbate the physical, psychological, and economic impacts of NMS. STUDY DESIGN: Narrative review. METHODS: We performed a search of MEDLINE's PubMed database from October 2015 to October 2020, with a repeat search in October 2021. Search terms included relevant keywords pertaining to NMS, biologics, and disease areas. Results were supplemented by a search of key congress abstracts from 2015 to 2021 and a targeted internet search. RESULTS: NMS increases medication abandonment, errors, and adverse effects, and it can lead to longer patient visits, increased follow-up visits, additional laboratory tests and procedures, and greater overall health care resource utilization (HCRU). The increased HCRU associated with NMS increases patients' financial burden due to additional co-pays and out-of-pocket costs. CONCLUSIONS: The decision to switch treatments should result from shared decision-making between health care providers (HCPs) and patients to achieve the best clinical outcomes and optimal HCRU. The issues related to NMS may be compounded by the financial and psychosocial stress on HCPs and patients created by the COVID-19 pandemic. HCPs should advocate for continuous patient treatment and be familiar with continuity of care legislation, appeals processes, and manufacturer assistance programs.

Impact of the COVID-19 pandemic on shoulder arthroplasty: surgical trends and postoperative care pathway analysis.

BACKGROUND: COVID-19 triggered disruption in the conventional care pathways for many orthopedic procedures. The current study aims to quantify the impact of the COVID-19 pandemic on shoulder arthroplasty hospital surgical volume, trends in surgical case distribution, length of hospitalization, posthospital disposition, and 30-day readmission rates. METHODS: This study queried all Medicare (100% sample) fee-for-service beneficiaries who underwent a shoulder arthroplasty procedure (Diagnosis-Related Group code 483, Current Procedural Terminology code 23472) from January 1, 2019, to December 18, 2020. Fracture cases were separated from nonfracture cases, which were further subdivided into anatomic or reverse arthroplasty. Volume per 1000 Medicare beneficiaries was calculated from April to December 2020 and compared to the same months in 2019. Length of stay (LOS), discharged-home rate, and 30-day readmission for the same period were obtained. The yearly difference adjusted for age, sex, race (white vs. nonwhite), Centers for Medicare & Medicaid Services Hierarchical Condition Category risk score, month fixed effects, and Core-Based Statistical Area fixed effects, with standard errors clustered at the provider level, was calculated using a multivariate analysis (P < .05). RESULTS: A total of 49,412 and 41,554 total shoulder arthroplasty (TSA) cases were observed April through December for 2019 and 2020, respectively. There was an overall decrease in shoulder arthroplasty volume per 1000 Medicare beneficiaries by 14% (19% reduction in anatomic TSA, 13% reduction in reverse shoulder arthroplasty, and 3% reduction in fracture cases). LOS for all shoulder arthroplasty cases decreased by 16% (-0.27 days, P < .001) when adjusted for confounders. There was a 5% increase in the discharged-home rate (88.0% to 92.7%, P < .001), which was most prominent in fracture cases, with a 20% increase in discharged-home cases (65.0% to 73.4%, P < .001). There was no significant change in 30-day hospital readmission rates overall (P = .20) or when broken down by individual procedures. CONCLUSIONS: There was an overall decrease in shoulder arthroplasty volume per 1000 Medicare beneficiaries by 14% during the COVID-19 pandemic. A decrease in LOS and increase in the discharged-home rates was also observed with no significant change in 30-day hospital readmission, indicating that a shift toward an outpatient surgical model can be performed safely and efficiently and has the potential to provide value.

Perspectives on Nonmedical Switching and the COVID-19 Pandemic: A Narrative Review

Objectives: Nonmedical switching (NMS) is a change in a patient's treatment regimen for reasons other than lack of efficacy, intolerance, adverse effects, or poor adherence. We describe the impact of NMS on patients, health care workers, and health systems, focusing on NMS to in-class biologic alternatives in US patients with chronic, immune-mediated rheumatic and dermatologic conditions. Additionally, we evaluate the ways in which the COVID-19 pandemic may exacerbate the physical, psychological, and economic impacts of NMS. Study Design: Narrative review. Methods: We performed a search of MEDLINE's PubMed database from October 2015 to October 2020, with a repeat search in October 2021. Search terms included relevant keywords pertaining to NMS, biologics, and disease areas. Results were supplemented by a search of key congress s from 2015 to 2021 and a targeted internet search. Results: NMS increases medication abandonment, errors, and adverse effects, and it can lead to longer patient visits, increased follow-up visits, additional laboratory tests and procedures, and greater overall health care resource utilization (HCRU). The increased HCRU associated with NMS increases patients' financial burden due to additional co-pays and out-of-pocket costs. Conclusions: The decision to switch treatments should result from shared decision-making between health care providers (HCPs) and patients to achieve the best clinical outcomes and optimal HCRU. The issues related to NMS may be compounded by the financial and psychosocial stress on HCPs and patients created by the COVID-19 pandemic. HCPs should advocate for continuous patient treatment and be familiar with continuity of care legislation, appeals processes, and manufacturer assistance programs.

"I'm Off My Meds": Public Perception of Interactions Between SARS-CoV-2 Vaccines and Anti-Psoriatic Treatments Online.

IMPORTANCE: Psoriasis patients may seek information about the SARS-CoV-2 vaccine and their diagnosis from social media platforms. Analyses of social media interactions may help guide dermatologists’ educational efforts during this pandemic. OBJECTIVES: This study analyzed the content and sentiment of online social media posts about the medication interaction between SARS-CoV-2 vaccines and anti-psoriatic therapies among psoriasis patients. DESIGN: Publicly accessible Facebook and Reddit groups regarding psoriasis and psoriatic arthritis were identified. Posts uploaded between March 1, 2021, and July 31, 2021, with information about the SARS-CoV-2 vaccine and psoriasis and psoriatic arthritis, were extracted. Themes, sentiment scores, and engagement scores were assigned to each post. RESULTS: 477 posts contained content pertaining to the vaccine and psoriatic medications. 19 (4%) of the posts contain negative sentiment, 232 (48.6%) contain neutral sentiment, and 226 (47.4%) contain positive sentiment. Several themes emerged from this study. A majority of posts (32.5%) contained concerns about holding or stopping medications prior to obtaining the vaccine. Other common concerns included fear of negative reaction (21.8%) and uncertainty about the ability to generate an efficient immune response to the vaccine while on anti-psoriatic medications (19.9%). CONCLUSIONS AND RELEVANCE: Concerns identified by our content analysis should be incorporated into education efforts to address the reasons for vaccine hesitancy among patients with psoriatic diseases. These patient concerns can also help guide our strategy for implementing evidence-based recommendations on COVID-19 vaccination. J Drugs Dermatol. 2022;21(8):901-905. doi:10.36849/JDD.6853.

Public Perception of SARS-CoV-2 Vaccines Among Psoriasis Patients in Social Media: Content, Sentiment, and Engagement Analysis

BackgroundPsoriasis patients may seek information about the SARS-CoV-2 vaccine and their disease from social media platforms. Analyses of social media interactions may help guide dermatologists? educational efforts during this pandemic.ObjectivesThis study analyzes social media interactions among patients with psoriasis and psoriatic arthritis regarding the SARS-CoV-2 vaccine to determine the misinformation circulating and the apprehension to receiving the vaccine.MethodsPublicly accessible Facebook and Reddit groups regarding psoriasis and psoriatic arthritis were identified. Posts uploaded between March 1, 2021 and July 31, 2021 which contained information about the SARS-CoV-2 vaccine were extracted. First-order themes, sub-themes, sentiment scores and engagement scores were assigned to each post.Results345 posts within the first-order theme of vaccination decision and 1379 posts within the first-order theme of vaccine reaction were analyzed. Within vaccination decision, common sub-themes for refusing the vaccine include fear of psoriasis flare up, vaccine is experimental, vaccine is unnecessary, vaccine is dangerous, and concern for reaction/vaccine efficacy while on psoriasis medications. 41.4% of posts contained positive sentiment;whereas, 38.3% contained negative sentiment. Within vaccine reaction, common sub-themes identified were no change to psoriasis, skin/joint flare up, skin flare up attributed specifically to stopping psoriasis medications, skin/joint improvement, and skin flare up but vaccine was worth it. 77.8% of posts contained positive sentiment;whereas, 6.2% contained negative sentiment.ConclusionsOur study identified common SARS-CoV-2 vaccine concerns within the psoriasis community which should be used to guide educational efforts.

The Use of Biologics During the COVID-19 Pandemic.

During the coronavirus disease 2019 (COVID-19) pandemic, there has been considerable discussion regarding the use of biologics in patients with inflammatory skin conditions, such as psoriasis, hidradenitis suppurativa, and atopic dermatitis. This article discusses clinical trial data, real-world evidence, and guidelines and recommendations for biologics that inhibit tumor necrosis factor, interleukin (IL)-12/23, IL-17, IL-23, and IL-4/13 during the COVID-19 pandemic. Across these inflammatory skin conditions, existing data generally suggest that biologics do not seem to increase the risk of COVID-19 infection or worsen COVID-19 outcomes. The impact of biologics on COVID-19 is an area of active exploration.

Psoriasis.

Psoriasis is a common, chronic papulosquamous skin disease occurring worldwide, presenting at any age, and leading to a substantial burden for individuals and society. It is associated with several important medical conditions, including depression, psoriatic arthritis, and cardiometabolic syndrome. Its most common form, chronic plaque or psoriasis vulgaris, is a consequence of genetic susceptibility, particularly in the presence of the HLA-C*06:02 risk allele, and of environmental triggers such as streptococcal infection, stress, smoking, obesity, and alcohol consumption. There are several phenotypes and research has separated pustular from chronic plaque forms. Immunological and genetic studies have identified IL-17 and IL-23 as key drivers of psoriasis pathogenesis. Immune targeting of these cytokines and of TNFα by biological therapies has revolutionised the care of severe chronic plaque disease. Psoriasis cannot currently be cured, but management should aim to minimise physical and psychological harm by treating patients early in the disease process, identifying and preventing associated multimorbidity, instilling lifestyle modifications, and employing a personalised approach to treatment.

The time to offer treatments for COVID-19.

Background: COVID-19 has several overlapping phases. Treatments to date have focused on the late stage of disease in hospital. Yet, the pandemic is by propagated by the viral phase in out-patients. The current public health strategy relies solely on vaccines to prevent disease.Methods: We searched the major national registries, pubmed.org, and the preprint servers for all ongoing, completed and published trial results.Results: As of 2/15/2021, we found 111 publications reporting findings on 14 classes of agents, and 9 vaccines. There were 62 randomized controlled studies, the rest retrospective observational analyses. Only 21 publications dealt with outpatient care. Remdesivir and high titer convalescent plasma have emergency use authorization for hospitalized patients in the U.S.A. There is also support for glucocorticoid treatment of the COVID-19 respiratory distress syndrome. Monoclonal antibodies are authorized for outpatients, but supply is inadequate to treat all at time of diagnosis. Favipiravir, ivermectin, and interferons are approved in certain countries.Expert Opinion: Vaccines and antibodies are highly antigen specific, and new SARS-Cov-2 variants are appearing. We call on public health authorities to authorize treatments with known low-risk and possible benefit for outpatients in parallel with universal vaccination.

National Psoriasis Foundation COVID-19 Task Force guidance for management of psoriatic disease during the pandemic: Version 2-Advances in psoriatic disease management, COVID-19 vaccines, and COVID-19 treatments.

OBJECTIVE: To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic. STUDY DESIGN: The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation staff. Clinical questions relevant to the psoriatic disease community were informed by inquiries received by the National Psoriasis Foundation. A Delphi process was conducted. RESULTS: The TF updated evidence for the original 22 statements and added 5 new recommendations. The average of the votes was within the category of agreement for all statements, 13 with high consensus and 14 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is variable in quality and/or quantity. CONCLUSIONS: These statements provide guidance for the treatment of patients with psoriatic disease on topics including how the disease and its treatments affect COVID-19 risk, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 (including novel vaccination), and what they should do if they develop COVID-19. The guidance is a living document that is continuously updated by the TF as data emerge.

Updates on treatment guidelines for psoriasis, atopic dermatitis (eczema), hidradenitis suppurativa, and acne/rosacea during the COVID-19 pandemic.

Owing to the evolving COVID-19 pandemic and emerging data regarding immunosuppressant therapies for inflammatory cutaneous diseases, dermatologists are being encouraged to reevaluate their patients' treatment regimens to minimize any potential risk of SARS-CoV-2 infection. This article includes an overview of the up-to-date international and U.S. treatment guidelines for psoriasis, atopic dermatitis, hidradenitis suppurativa, and acne/rosacea; it provides tables summarizing these resources to assist providers and patients in remaining updated regarding recommended treatment modifications during the pandemic (See Tables 1-4).

Strategies to maximize clinical efficiency while maintaining patient safety during the COVID-19 pandemic: an interview-based study from private practice dermatologists.

BACKGROUND: Many dermatologists have experienced significant changes to their practices due to the COVID-19 pandemic. OBJECTIVE: It is vital to recognize how the pandemic has affected dermatology practices and identify methods to maximize clinical efficiency while maintaining patient safety. METHODS: Private practice dermatologists in metropolitan areas were interviewed regarding various issues, including patient volume, types of visits or procedures being performed, screening for COVID-19, and operational modifications. RESULTS: On average, there was a 65.2% decrease in patient volume during the initial surge of the COVID-19 outbreak, which was improved to a 15.5% decrease in July 2020. Despite this reduction in patient volume, the proportion of acute dermatologic issues, biopsies performed, and skin cancer concerns were all increased compared to pre-COVID. All of the dermatologists reported notable changes in regards to scheduling, staff, operations, and workplaces. LIMITATIONS: Interview participants were limited to metropolitan dermatologists mainly within the California region. CONCLUSION: Improving patient communication, implementing protocols to facilitate social distancing, and utilizing teledermatology were reported to be essential to optimizing efficiency and safety. As the COVID-19 pandemic continues to evolve, it is important that dermatologists identify specific ways to practice efficiently and effectively, while mitigating the spread of the virus.

National Psoriasis Foundation COVID-19 Task Force Guidance for Management of Psoriatic Disease During the Pandemic: Version 1.

OBJECTIVE: To provide guidance about management of psoriatic disease during the coronavirus disease 2019 (COVID-19) pandemic. STUDY DESIGN: A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by questions received by the NPF. A Delphi process was conducted. RESULTS: The TF approved 22 guidance statements. The average of the votes was within the category of agreement for all statements. All guidance statements proposed were recommended, 9 with high consensus and 13 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is limited in quality. CONCLUSION: These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk and outcome, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 and what they should do if they develop COVID-19. The guidance is intended to be a living document that will be updated by the TF as data emerge.

The American Board of Orthopaedic Surgery Response to COVID-19.

The COVID-19 pandemic has disrupted every aspect of society in a way never previously experienced by our nation's orthopaedic surgeons. In response to the challenges the American Board of Orthopaedic Surgery has taken steps to adapt our Board Certification and Continuous Certification processes. These changes were made to provide flexibility for as many Candidates and Diplomates as possible to participate while maintaining our high standards. The American Board of Orthopaedic Surgery is first and foremost committed to the safety and well-being of our patients, physicians, and families while striving to remain responsive to the changing circumstances affecting our Candidates and Diplomates.