Vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis: Delphi consensus from the medical board of the National Psoriasis Foundation.

BACKGROUND: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis. OBJECTIVE: To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines. METHODS: Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts. RESULTS: Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination. LIMITATIONS: Studies regarding infection rates after vaccination are lacking. CONCLUSION: Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.

Palmoplantar Pustulosis: Therapy Update

Palmoplantar pustulosis is a variant of psoriasis and a chronic skin disorder in which pruritic pustular eruptions appear on the palms and soles. It is thought to arise from a variety of genetic and environmental factors, is limited in prevalence, and has proven quite difficult to treat. The symptoms it inflicts on those affected are quite debilitating and the treatment landscape is constantly evolving, thus emphasizing the need for updates of the literature as time passes. Current treatments include topical agents, oral therapies, and phototherapy, amongst other treatments. In this systemic review, we explore newer literature from 2015 to 2022 on various treatment regimens for palmoplantar pustulosis. J Drugs Dermatol. 2024;23(8):626-631.     doi:10.36849/JDD.doi:10.36849/7612R1.

Benefit of Topical Combination Therapy for Acne: Analyzing Effect Size Using Number Needed to Treat.

BACKGROUND: Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment. METHODS: Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses.  Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8. CONCLUSION: A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49.  doi:10.36849/JDD.7927.

Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel.

BACKGROUND: Plaque psoriasis is a chronic, relapsing systemic illness that has a significant effect on quality of life. Bimekizumab is the first monoclonal antibody to target both interleukin (IL)-17A and IL-17F, and recently received Food and Drug Administration (FDA) approval for moderate to severe plaque psoriasis. Guidance is necessary regarding the safety of bimekizumab. METHODS: A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the safety of bimekizumab for moderate to severe psoriasis. A panel of 9 dermatologists and 1 rheumatologist with significant expertise in the treatment of psoriasis gathered to review the articles and create consensus statements on this new medication. A modified Delphi process was used to approve each statement, and strength of recommendation was assigned using the Strength of Recommendation Taxonomy criteria. RESULTS: The literature search produced 110 articles that met the criteria. A thorough screening of the studies for relevance to the research question resulted in 15 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 5 consensus statements and recommendations, all of which were given a strength of "A". CONCLUSION: Bimekizumab has a safety profile consistent with other biologics, except for a higher risk of oral candidiasis. Its hepatic safety profile is comparable with other currently FDA-approved biologics for plaque psoriasis. In addition, the data do not support an association of bimekizumab with suicide, and the incidence of inflammatory bowel disease is not greater than the incidence of other IL-17 blockers. J Drugs Dermatol. 2024;23(8):592-599. doi:10.36849/JDD.8246.

Sociodemographic and clinical characteristics associated with multiple biologic failure in psoriasis: A 2015-2022 prospective cohort analysis of the CorEvitas psoriasis registry.

BACKGROUND: Psoriasis patients with poor therapeutic response to multiple biologic agents are not well-characterized. OBJECTIVE: To describe the characteristics associated with development of multiple biologic failure (MBF) versus good clinical response (GR) to the first biologic. METHODS: This prospective cohort analysis evaluated patients in the multicenter CorEvitas Psoriasis Registry who initiated their first biologic between 2015 and 2020 and were followed for ≥24 months. Multivariable logistic regression identified sociodemographic, clinical, and patient-reported outcomes that differed between MBF (discontinued ≥2 biologics of different classes, each used for ≥90 days, due to inadequate efficacy) and GR (continued use of first biologic for ≥2 years) patients. RESULTS: One thousand thirty-nine patients were analyzed (490 GR [47.2%], 65 MBF [6.3%]). Female sex, shorter psoriasis duration, earlier year of biologic initiation, prior nonbiologic systemic therapy use, history of hyperlipidemia, and Medicaid insurance were significantly associated with MBF, though the latter 2 variables exhibited wider confidence intervals, indicating a lower level of support. The first-to-second biologic sequence most observed with MBF was Tumor necrosis factor-α inhibitor to IL-17 inhibitor use. LIMITATIONS: Biologic adherence between visits was not evaluated. CONCLUSION: Approximately 6% of psoriasis patients met MBF criteria. The results identify characteristics associated with MBF that may distinguish patients warranting more frequent follow-up.

Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial.

BACKGROUND: Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin. OBJECTIVE: To evaluate the efficacy and safety of ritlecitinib, an oral JAK3 (Janus kinase)/TEC (tyrosine kinase expressed in hepatocelluar carcinoma) inhibitor, in patients with active nonsegmental vitiligo in a phase 2b trial (NCT03715829). METHODS: Patients were randomized to once-daily oral ritlecitinib ± 4-week loading dose (200/50 mg, 100/50 mg, 30 mg, or 10 mg) or placebo for 24 weeks (dose-ranging period). Patients subsequently received ritlecitinib 200/50 mg daily in a 24-week extension period. The primary efficacy endpoint was percent change from baseline in Facial-Vitiligo Area Scoring Index at week 24. RESULTS: A total of 364 patients were treated in the dose-ranging period. Significant differences from placebo in percent change from baseline in Facial-Vitiligo Area Scoring Index were observed for the ritlecitinib 50 mg groups with (-21.2 vs 2.1; P < .001) or without (-18.5 vs 2.1; P < .001) a loading dose and ritlecitinib 30 mg group (-14.6 vs 2.1; P = .01). Accelerated improvement was observed after treatment with ritlecitinib 200/50 mg in the extension period (n = 187). No dose-dependent trends in treatment-emergent or serious adverse events were observed across the 48-week treatment. LIMITATIONS: Patients with stable vitiligo only were excluded. CONCLUSIONS: Oral ritlecitinib was effective and well tolerated over 48 weeks in patients with active nonsegmental vitiligo.

Validity of Lichen Planus and Lichen Planopilaris Case Identification Using Diagnostic Codes from a Clinical Database.

BACKGROUND: Case identification strategies to conduct population-based studies have not been developed for lichen planus (LP) or lichen planopilaris (LPP). OBJECTIVES: The aim of this study was to assess the validity of using diagnostic codes to establish both a cutaneous (non-oral) LP cohort and an LPP cohort from a large clinical database. METHODS: A retrospective chart review was performed to determine whether patients with ICD-9 or ICD-10 codes for LP and ICD-10 codes for LPP are confirmed cases of LP and LPP. Validation samples were used to estimate the positive predictive value (PPV) of three case definitions any LP, non-oral LP, and LPP defined as: at least one code by any physician, at least two codes by any physician, and at least one code by a dermatologist. RESULTS: Among the 199 reviewed LP charts, 166 and 123 were confirmed cases of any LP and non-oral LP, respectively. The PPVs for any LP were: 83.4% (166/199) for one code by any physician, 84.6% (77/91) for two codes by any physician, and 95.1% (97/102) for one code by a dermatologist. The PPVs for non-oral LP were: 61.8% (123/199) for one code by any physician, 70.3% (64/91) for two diagnoses by any physician, and 86.3% (88/102) for one diagnosis by a dermatologist. Of the 139 patients with at least one code for LPP, 122 were confirmed cases of LPP. The case definition for one LPP code applied by any physician had a PPV of 87.8% (122/139) to identify a true case of LPP, whereas two diagnoses by any physician had a PPV of 96.2% (76/79) and a diagnosis by a dermatologist had a PPV of 93% (107/115). CONCLUSIONS: Diagnosis codes for LP and LPP, restricted by the diagnosing physician's specialty, may be used to accurately identify case cohorts of overall LP, non-oral LP, or LPP in large clinical databases.

Biologic Vs Conventional Therapies: Comparing Risk of Psoriasis-Associated Comorbidities.

Psoriasis is associated with multiple comorbidities. In this retrospective cohort analysis, we compared the comorbidities in patients who received biologic treatments with those who received conventional treatments. Our data indicates that biologics may be associated with lower rates of comorbidities in comparison to conventional therapy. J Drugs Dermatol. 2023;22(5): doi:10.36849/JDD.7119.

Meeting Patient Expectations of Topical Psoriasis Treatment: Evidence Supporting the Use of Fixed-Combination Halobetasol/Tazarotene Lotion.

Discordance between patient and clinician treatment goals and expectations can present a challenge to implementation of effective therapeutic plans. Because topical treatments are commonly used for plaque psoriasis, both as monotherapy and adjuncts to other treatment modalities, providers need to understand the concerns of patients with psoriasis regarding use of topical products. Psoriasis is a complex and chronic disease with treatment needs that may change over time, influencing patient treatment goals and expectations of efficacy. When these expectations are not met and patient concerns are unaddressed, dissatisfaction may lead to nonadherence, which in turn can prevent patients from achieving relief from the signs and symptoms of psoriasis that affect their quality of life. Here, we detail how current topical treatments meet patient expectations and needs, with particular attention given to combination regimens using corticosteroids. This review shows that once-daily application of halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) not only has a rapid onset of treatment effect and proven efficacy, but also has a remittive effect. In addition, HP/TAZ has a favorable safety profile, with low rates of irritation and local skin reactions in clinical studies. The dual mechanisms of action related to 2 active ingredients, once-daily use, and the favorable clinical findings suggest that HP/TAZ may address patient concerns and promote treatment adherence.J Drugs Dermatol. 2023;22(2):132-138. doi:10.36849/JDD.7367.

INDIVIDUAL ARTICLE: An Algorithm for the Management of Atopic Dermatitis in People With Skin of Color.

BACKGROUND: Variations in the epidemiology, clinical presentation, and disease course in skin of color (SOC) atopic dermatitis (AD) patients have been reported that may impact treatment approach and skincare recommendations. METHODS: The project used a modified Delphi hybrid process comprising face-to-face discussions and an online review process. A panel of physicians (advisors) who treat SOC patients with AD used information from literature searches, expert opinions, and their experience to develop a practical algorithm to improve outcomes for SOC patients with AD. RESULTS: The algorithm for SOC patients with AD aims to inform dermatologists and other healthcare professionals caring for these patients. The first section of the algorithm addresses education and behavioral measures. Treatment adherence is a considerable challenge in chronic inflammatory conditions such as AD, making education essential. The second section discusses the assessment of the skin condition. The third section informs on treatment and maintenance measures for AD. Treatment and maintenance of AD in patients with SOC should be proactive, effectively control inflammation longitudinally, include effective skin barrier protective strategies, and consider cultural practices. CONCLUSION: Robust comparative studies are needed to better understand racial/ethnic variations in AD. The algorithm supports educating healthcare professionals and patients to foster individualized treatment, prevention, and adjunctive skincare approaches across diverse patient populations. J Drugs Dermatol. 2023;22:8(Suppl 2):s3-10.

Genomic Epidemiology and Transmission Dynamics of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Congregate Healthcare Facilities in Santa Clara County, California.

BACKGROUND: Outbreaks of SARS-CoV-2 in long-term care facilities (LTCFs) cause significant morbidity and mortality. Mapping viral transmission within and between facilities by combining genomic sequencing with epidemiologic investigations enables targeting infection-control interventions. METHODS: We conducted weekly surveillance of residents and staff in LTCFs in Santa Clara County, California, with ≥1 confirmed COVID-19 case between March and July 2020. Positive samples were referred for whole-genome sequencing. Epidemiological investigations and phylogenetic analyses of the largest outbreaks (>30 cases) were carried out in 6 LTCFs (Facilities A through F). RESULTS: Among the 61 LTCFs in the county, 41 had ≥1 confirmed case during the study period, triggering weekly SARS-CoV-2 testing. The 6 largest outbreaks accounted for 60% of cases and 90% of deaths in LTCFs, although the bed capacity of these facilities represents only 11% of the LTCF beds in the county. Phylogenetic analysis of 196 whole-genome sequences recovered from those facilities showed that each outbreak was monophyletic, with staff and residents sharing a common viral lineage. Outbreak investigations revealed that infected staff members often worked at multiple facilities, and in 1 instance, a staff member infected while working in 1 facility was the likely index case in another. CONCLUSIONS: We detected a pattern of rapid and sustained transmission after a single introduction of SARS-CoV-2 in 6 large LTCF outbreaks, with staff playing a key role in transmission within and between facilities. Infection control, testing, and occupational policies to reduce exposure and transmission risk for staff are essential components to keeping facility residents safe.

Severe Acute Respiratory Syndrome Coronavirus 2 and Respiratory Virus Sentinel Surveillance, California, USA, May 10, 2020-June 12, 2021.

State and local health departments established the California Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Respiratory Virus Sentinel Surveillance System to conduct enhanced surveillance for SARS-CoV-2 and other respiratory pathogens at sentinel outpatient testing sites in 10 counties throughout California, USA. We describe results obtained during May 10, 2020‒June 12, 2021, and compare persons with positive and negative SARS-CoV-2 PCR results by using Poisson regression. We detected SARS-CoV-2 in 1,696 (19.6%) of 8,662 specimens. Among 7,851 specimens tested by respiratory panel, rhinovirus/enterovirus was detected in 906 (11.5%) specimens and other respiratory pathogens in 136 (1.7%) specimens. We also detected 23 co-infections with SARS-CoV-2 and another pathogen. SARS-CoV-2 positivity was associated with male participants, an age of 35-49 years, Latino race/ethnicity, obesity, and work in transportation occupations. Sentinel surveillance can provide useful virologic and epidemiologic data to supplement other disease monitoring activities and might become increasingly useful as routine testing decreases.

The contribution of itch and skin severity improvements to the Dermatology Life Quality Index in patients with atopic dermatitis in baricitinib phase III trials.

With data from three monotherapy baricitinib phase III randomized clinical trials (RCTs), we conducted a posthoc mediator analysis to assess whether changes in itch or skin severity mediated the treatment effect over placebo on changes in health-related quality of life. In this analysis, baricitinib demonstrated significant improvement in the Dermatology Life Quality Index for which itch mediated approximately half of the changes at weeks 4 and 16.

Evolving Concepts in Psoriasis: Special Considerations for Patients With Skin of Color, Skin Barrier Dysfunction, and the Role of Adjunctive Skin Care.

BACKGROUND: Despite considerable advances in our understanding of the pathogenesis and treatment of psoriasis, data pertaining to racial/ethnic variations, effects on barrier function, and the potential role of adjunctive skin care are relatively limited. Knowledge gaps in the clinical presentation, quality-of-life impact, and approach to treating psoriasis in patients with skin color contribute to disparities in care. In addition, small studies suggest that using skincare products can reduce psoriasis symptoms, improve barrier function, and result in higher patient satisfaction, yet patients with psoriasis may underuse skincare products. This manuscript seeks to offer insights into these knowledge gaps and their potential treatment implications. METHODS: A structured literature search followed by a panel discussion and an online review process explored best clinical practices in treating psoriasis patients with skin of color and providing expert guidance for skincare use, including gentle cleansers and moisturizers. RESULTS: Racial/ethnic differences in genetic factors, clinical presentation, and disease burden in psoriasis have been reported. Underrecognition of these differences contributes to racial/ethnic health disparities for psoriasis patients in the US. Several studies have shown a greater quality-of-life impact with psoriasis among patients with skin of color. Although the published data are limited, some studies have identified differences in skin barrier properties and suggest a role for adjunctive skin care in the management of psoriasis. CONCLUSION: Further study is needed to understand racial/ethnic population variations in psoriasis and develop strategies to reduce disparities in care. Addressing alterations in skin barrier function observed in psoriasis may help to improve treatment outcomes and patient satisfaction. J Drugs Dermatol. 2022;21(10):1054-1060. doi:10.36849/JDD.7090.

Improving Rosacea Outcomes in Skin of Color Patients: A Review on the Nuances in the Treatment and the Use of Cleansers and Moisturizers.

BACKGROUND: While rosacea is a common inflammatory condition that affects diverse populations, published data in skin of color (SOC) are limited. This review explored nuances in clinical presentation and treatment considerations in SOC patients with rosacea and the role of cleansers and moisturizers in the management of rosacea in these populations. METHODS: A panel reviewed and discussed aspects of rosacea in SOC and possible implications for treatment and maintenance. The outcome of these discussions, coupled with the panel's expert opinion and experience was used to define draft statements. After group discussions and an online review process, the panel agreed on the inclusion and wording of five statements. RESULTS: Studies and anecdotal clinical experience suggest that rosacea is more common in SOC populations than previously reported. The clinical presentation of rosacea across diverse skin types includes the spectrum of clinical subtypes observed in other populations; however, clinical features may be less conspicuous in individuals with higher skin phototypes and the index of suspicion may be lower in SOC populations. To avoid underdiagnosis, dermatologists should consider rosacea in the differential diagnosis of any patient presenting with a history of skin sensitivity, central facial erythema, papules, and pustules. The compromised barrier in rosacea contributes to skin sensitivity. Studies including Chinese rosacea patients showed that using a moisturizer and sunscreen negatively correlated with rosacea development. CONCLUSIONS: The use of skincare could improve rosacea symptomatology. These products are recommended before and during prescription therapy and as part of a maintenance regimen as adjuncts. J Drugs Dermatol. 2022;21(6):574-580. doi:10.36849/JDD.6838.

Long-Term Skin Clearance With Brodalumab in Patients With Psoriasis and Inadequate Response to Prior Biologics.

BACKGROUND: Despite the emergence of multiple biologic drug options for psoriasis, unmet treatment needs remain. Biologic therapies can vary in their effectiveness and adverse events, and many patients experience a loss of treatment effect over time. After lack of response, treatment may be switched to a biologic with a different mechanism of action. Brodalumab, a human interleukin-17 (IL-17) receptor A antagonist, is approved for the treatment of adult patients with moderate-to-severe psoriasis with inadequate response or loss of response to prior systemic therapies. Because brodalumab targets the IL-17 receptor instead of the ligand itself, it not only targets a broader set of IL-17 isoforms but also may be effective in patients who received prior IL-17 inhibitors or failed to respond to anti–IL-17 treatment. This is supported by long-term evidence from clinical trials and real-world studies of patients receiving brodalumab who were previously treated with IL-17 inhibitors. Additionally, brodalumab produces reliable treatment effects after use of biologics with other mechanisms of action, such as tumor necrosis factor α and IL-12/IL-23 inhibitors, as well as after the use of multiple biologic therapies. For patients with psoriasis with inadequate response to one or more biologic therapies, brodalumab is an option that has the ability to lead to long-term skin clearance. J Drugs Dermatol. 2022;21(3):364-370. doi:10.36849/JDD.6743.

Insights in Skin of Color Patients With Atopic Dermatitis and the Role of Skincare in Improving Outcomes.

BACKGROUND: Research on the role of race and ethnicity in the pathophysiology of atopic dermatitis (AD) is limited. Variations in the epidemiology, clinical presentation, and disease course in skin of color SOC AD patients have been reported. This manuscript seeks to offer insights into distinct features of AD in populations with (SOC) and provide recommendations on the role of skincare in treating AD amongst diverse populations. METHODS: A literature review followed by panel discussions and an online review process explored best clinical practices in treating AD patients with SOC and providing expert guidance for skincare use, including gentle cleansers and moisturizers. RESULTS: Some studies have identified differences in skin barrier properties in racial/ethnic groups affected by AD that may have implications for barrier function. Variations in the clinical presentation – including morphology, severity, and distribution – of AD in populations with SOC have been reported. Epidemiologic studies suggest a higher prevalence among self-identified Blacks/African Americans and greater health care utilization for AD among both Blacks/African Americans and Asian/Pacific Islanders. Pigmentary sequelae, including hyper- hypo- and depigmentation is a distinct feature of AD in patients with SOC that may contribute to the quality of life impact of the disorder. Xerosis may be more stigmatizing in SOC due to greater visibility of scale and dryness in the context of melanin-rich skin. Racial/ethnic variations in the prevalence of pruritus have also been reported, which may in turn have implications for AD in SOC. Treatment and maintenance of AD in patients with SOC should be proactive, effectively control inflammation longitudinally, include effective skin barrier protective strategies, and consider cultural practices. CONCLUSION: Robust comparative studies are needed to better understand racial/ethnic variations in AD. Further research will help to tailor patient education and foster individualized approaches to treatment, prevention, and adjunctive skin care across the diverse spectrum of patient populations. J Drugs Dermatol. 2022;21(5):462-470. doi:10.36849/JDD.6609.

Introduction, Transmission Dynamics, and Fate of Early Severe Acute Respiratory Syndrome Coronavirus 2 Lineages in Santa Clara County, California.

We combined viral genome sequencing with contact tracing to investigate introduction and evolution of severe acute respiratory syndrome coronavirus 2 lineages in Santa Clara County, California, from 27 January to 21 March 2020. From 558 persons with coronavirus disease 2019, 101 genomes from 143 available clinical samples comprised 17 lineages, including SCC1 (n = 41), WA1 (n = 9; including the first 2 reported deaths in the United States, with postmortem diagnosis), D614G (n = 4), ancestral Wuhan Hu-1 (n = 21), and 13 others (n = 26). Public health intervention may have curtailed the persistence of lineages that appeared transiently during February and March. By August, only D614G lineages introduced after 21 March were circulating in Santa Clara County.

Epidemiologic Findings from Case Investigations and Contact Tracing for First 200 Cases of Coronavirus Disease, Santa Clara County, California, USA.

In January 2020, Santa Clara County, California, USA, began identifying laboratory-confirmed coronavirus disease among residents. County staff conducted case and contact investigations focused on households and collected detailed case demographic, occupation, exposure, and outcome information. We describe the first 200 test-positive cases during January 31-March 20, 2020, to inform future case and contact investigations. Probable infection sources included community transmission (104 cases), known close contact with a confirmed case-patient (66 cases), and travel (30 cases). Disease patterns across race and ethnicity, occupational, and household factors suggested multiple infection risk factors. Disproportionately high percentages of case-patients from racial and ethnic subgroups worked outside the home (Hispanic [86%] and Filipino [100%]); household transmission was more common among persons from Vietnam (53%). Even with the few initial cases, detailed case and contact investigations of household contacts capturing occupational and disaggregated race and ethnicity data helped identify at-risk groups and focused solutions for disease control.

Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5).

BACKGROUND: Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults. OBJECTIVE: To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy. METHODS: Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with ≥2-point improvement. RESULTS: At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P < .001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P < .001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies. LIMITATIONS: Short-term clinical trial results may not be generalizable to real-world settings. CONCLUSION: Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.