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Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE MONO-2

Yosipovitch, Gil; Gooderham, Melinda J; Ständer, Sonja; Fonacier, Luz; Szepietowski, Jacek C; Deleuran, Mette; Girolomoni, Giampiero; Su, John C; Bushmakin, Andrew G; Cappelleri, Joseph C; Feeney, Claire; Chan, Gary; Thorpe, Andrew J; Valdez, Hernan; Biswas, Pinaki; Rojo, Ricardo; DiBonaventura, Marco; Myers, Daniela E
BACKGROUND:Abrocitinib, an oral, once-daily Janus kinase 1-selective inhibitor, improved itch severity, sleep, and work productivity versus placebo in patients with moderate-to-severe atopic dermatitis. OBJECTIVE:The aim of this study was to investigate relationships among itch, sleep, and work productivity in the phase III JADE MONO-2 clinical trial. METHODS:A repeated-measures longitudinal model was used to examine relationships between itch (using the Peak Pruritus Numerical Rating Scale [PP-NRS] or Nighttime Itch Scale [NTIS]) and sleep disturbance/loss (using the Patient-Oriented Eczema Measure sleep item and SCORing AD Sleep Loss Visual Analog Scale) and, separately, between itch and work productivity (using the Work Productivity and Activity Impairment-Atopic Dermatitis Version 2.0 questionnaire). Mediation modelling was used to investigate the effect of treatment (abrocitinib vs placebo) on work impairment via improvements in itch and sleep. RESULTS:The relationships between itch/sleep and itch/work productivity were approximately linear. PP-NRS scores of 0, 4-6, and 10 were associated with 0 days, 3-4 days, and 7 days per week of disturbed sleep, respectively. PP-NRS or NTIS scores of 0-1, 4-5, and 10 were associated with 0-10%, 20-30%, and >50% overall work impairment, respectively. Seventy-five percent of the effect of abrocitinib on reducing work impairment was indirectly mediated by improvement in itch, followed by sleep. CONCLUSION/CONCLUSIONS:These results quantitatively demonstrate that reducing itch severity is associated with improvements in sleep and work productivity. Empirical evidence for the mechanism of action of abrocitinib showed that itch severity is improved, which reduces sleep loss/sleep disruption and, in turn, improves work productivity. CLINICAL TRIAL REGISTRATION/BACKGROUND:NCT03575871.
PMID: 37624488
ISSN: 1179-1888
CID: 5599002

Coronavirus disease 2019 vaccine skin testing and graded challenges in vaccine-hesitant patients

Heffes-Doon, Ari; Horne, Nathanael; Okpara, Chinyere; Akerman, Meredith; Fonacier, Luz
PMCID:10079592
PMID: 37031774
ISSN: 1534-4436
CID: 5502732

Atopic dermatitis yardstick update

Boguniewicz, Mark; Fonacier, Luz; Guttman-Yassky, Emma; Ong, Peck Y; Silverberg, Jonathan I
PMID: 36931465
ISSN: 1534-4436
CID: 5462662

Proposed solutions by the American College of Allergy, Asthma, and Immunology and advocacy experts to address racial disparities in atopic dermatitis and food allergy

Corbett, Mark; Allen, Abby; Bobo, Nichole; Foggs, Michael B; Fonacier, Luz S; Gupta, Ruchi; Kowalsky, Rachel; Martinez, Erin; Begolka, Wendy Smith; Zachary, Cherie; Blaiss, Michael S
Atopic dermatitis (AD) and food allergies are more prevalent and more severe in people with skin of color than White individuals. The American College of Allergy, Asthma, and Immunology (ACAAI) sought to understand the effects of racial disparities among patients with skin of color with AD and food allergies. The ACAAI surveyed its members (N = 200 completed), conducted interviews with health care providers and advocacy leaders, and hosted a roundtable to explore the challenges of diagnosis and management of AD and food allergies in people with skin of color and to discuss potential solutions. Most of the survey respondents (68%) agreed that racial disparities make it difficult for people with skin of color to receive adequate treatment for AD and food allergies. The interviews and roundtable identified access to care, burden of costs, policies and infrastructure that limit access to safe foods and patient education, and inadequate research involving people with skin of color as obstacles to care. Proposed solutions included identifying ways to recruit more people with skin of color into clinical trials and medical school, educating health care providers about diagnosis and treating AD and food allergy in people with skin of color, improving access to safe foods, creating and disseminating culturally appropriate materials for patients, and working toward longer appointment times for patients who need them. Challenges in AD and food allergy in persons with skin of color were identified by the ACAAI members. Solutions to these challenges were proposed to inspire actions to mitigate racial disparities in AD and food allergy.
PMID: 36538973
ISSN: 1534-4436
CID: 5431862

Persistent Penicillin Allergy Label in Pharmacies after Penicillin Allergy De-labeling [Meeting Abstract]

Diaz, A M; Fonacier, L; Stern, H; Mawhirt, S; Banta, E; Sani, S
Rationale: Carrying a penicillin allergy label is associated with increased healthcare costs and adverse events. De-labeling a penicillin allergy can optimize antimicrobial stewardship and improve patient care.
Method(s): We performed an IRB-approved retrospective study of patients over 11 years-old, who were de-labeled of penicillin allergy (negative skin testing and aminopenicillin oral challenge) in our clinic between May 2019 and May 2022. Patients had their penicillin allergy removed from our electronic medical record (EMR) and were given a wallet card denoting results. A letter with fax confirmation of receipt was sent to both primary care physician and pharmacy. EMR review and phone interviews with patients and pharmacies were subsequently conducted to determine penicillin allergy status and antibiotic prescribing patterns.
Result(s): A total of 78 charts were reviewed: 68 underwent phone interviews, 9 were lost to follow up, and 1 was deceased. From these charts, 77 (99%) remained de-labeled in our EMR, whereas 24 (31%) had an active penicillin allergy listed in their pharmacy. Out of 68 patients interviewed, 66 (97%) recalled a negative penicillin allergy result, 30 (44%) took penicillins since de-labeling, 31 (46%) were not prescribed penicillins, 4 (6%) avoided penicillins, while 3 (4%) reported unknown antibiotic use.
Conclusion(s): This study demonstrates that our pencillin de-labeling protocol is effective in maintaining a non-allergic status and allowing for subsequent penicillin administration. However, the discrepancy in allergy records between our EMR and patients' pharmacies exemplifies the need to identify barriers in universally de-labeling patients.
Copyright
EMBASE:2022489344
ISSN: 1097-6825
CID: 5509742

Cutaneous Adverse Reactions Associated with COVID-19 Vaccination [Meeting Abstract]

Jin, H; Fonacier, L; Rosenblum, J
Rationale: Adverse reactions following COVID-19 vaccination are common. We sought to characterize the most common cutaneous manifestations following COVID-19 vaccine administration and identify potential predictive factors.
Method(s): A retrospective chart review was conducted for patients seen in the allergy clinic between December 2020 and May 2021 for COVID-19 vaccine counseling. Details of reactions to either mRNA COVID-19 vaccine were noted. Cutaneous findings were defined as any local reaction including pain, redness or swelling, or generalized rash.
Result(s): Twenty-four patients out of 115 patients (20.9%) had any type of cutaneous reaction after vaccination. Most were female (n=21, 87.5%). Seven of these 24 patients had a local reaction alone. Two patients had immediate onset of generalized pruritus and rash (1 of these patients had symptom resolution by the next morning, the other resolved 8 days post-vaccination). Four patients (16.7%) had a delayed (>6 hours after vaccination) generalized pruritic rash, three of which resolved within 2 weeks and one resolved after 6 weeks. Four patients with a history of chronic urticaria (CU) had a flare of urticaria following vaccination beginning 1-2 days later. One additional patient with CU had delayed pruritus only. One patient developed urticaria 1 day after receiving vaccination with persistence of urticaria beyond 6 weeks.
Conclusion(s): Cutaneous ARs were common (20%) following COVID-19 vaccination. Most rashes were delayed and resolved within 2 weeks with no additional sequelae. In this cohort, patients with a history of CU were seen to have flares of symptoms following vaccination. Cutaneous reactions were more commonly seen in women.
Copyright
EMBASE:2022488648
ISSN: 1097-6825
CID: 5509752

Corticosteroid exposure and cumulative effects in patients with eczema: Results from a patient survey

Barta, Kelly; Fonacier, Luz S; Hart, Mary; Lio, Peter; Tullos, Kathryn; Sheary, Belinda; Winders, Tonya A
BACKGROUND:Individuals with eczema may have substantial lifetime corticosteroid exposure, increasing the risk of corticosteroid-related side effects. OBJECTIVE:To conduct a patient survey evaluating corticosteroid exposure and its cumulative effects in individuals with eczema. METHODS:The multinational online survey was conducted between November 5, 2020, and January 11, 2021. Participants were aged 18 years or older and a patient (n = 1889) or a caregiver of a child (n = 271) diagnosed with having eczema by a medical professional. RESULTS:All participants reported using corticosteroids. Average duration of topical corticosteroid (TCS) use was 15.3 years in adults and 3.6 years in children; 75% used TCS 1 to 2 times a day and 50% applied TCS 15 to 30 days/mo. Frequency and duration could not be determined by varying prescription TCS potencies. Oral corticosteroid use was reported by 36% of the participants (23% for eczema), with a lifetime average of 8.4 courses in adults and 8.1 courses in children. Corticosteroids for non-eczema atopic conditions were reported by 49% of the participants. In participants using TCS, 83% of adults and 64% of children experienced worsening symptoms over time. Development of new symptoms and conditions increased with a greater number of corticosteroid treatments and longer duration of TCS use but may have been owing to eczema progression. Symptoms consistent with topical steroid withdrawal syndrome after TCS discontinuation were reported by many participants. CONCLUSION/CONCLUSIONS:Reported substantial corticosteroid exposure throughout their lifetime eczema experience placed participants at risk of negative outcomes. Corticosteroids are a critical component of eczema treatment for many patients. However, careful corticosteroid prescribing practices and monitoring are needed to avoid side effects. When possible, corticosteroid-sparing strategies should be explored.
PMID: 36191848
ISSN: 1534-4436
CID: 5361652

Contact Dermatitis of a Surgical Wound

Kahwash, Basil M; Fonacier, Luz
PMID: 36357052
ISSN: 2213-2201
CID: 5357482

Epidemiology and Burden of Sleep Disturbances in Atopic Dermatitis in US Adults

Silverberg, Jonathan Ian; Chiesa-Fuxench, Zelma; Margolis, David; Boguniewicz, Mark; Fonacier, Luz; Grayson, Mitchell; Simpson, Eric; Ong, Peck
BACKGROUND:The relationship between atopic dermatitis (AD) severity, sleep disturbance (SD), and health-related outcomes is not fully elucidated. OBJECTIVE:The aim of the study was to determine the prevalence of SD in adult AD and its relationship with AD severity and health outcomes among the US population. METHODS:A cross-sectional, US population-based survey study of 2893 adults was performed. RESULTS:Among adults meeting the UK Diagnostic Criteria for AD, 255 (40.7%) reported 1 or more, 67 (11.1%) reported 3 to 4, and 57 (9.5%) reported 5 to 7 nights of SD in the past week; 475 (79.7%) reported at least some trouble sleeping in the past 3 days. Moderate and severe Patient-Oriented Scoring AD, Patient-Oriented Eczema Measure, and Numeric Rating Scale-itch and Numeric Rating Scale-skin pain scores were associated with more severe SD compared with those without AD. More frequent and severe SDs were associated with higher Dermatology Life Quality Index, lower 12-item Short-Form Health Survey, and higher Hospital Anxiety and Depression Scale (HADS) scores. Significant mediation by SD severity was observed between Patient-Oriented Eczema Measure and Numeric Rating Scale-itch with Dermatology Life Quality Index, 12-item Short-Form Health Survey physical and mental component scores, HADS-anxiety and HADS-depression scores, diagnosed anxiety, and heart disease. CONCLUSIONS:Atopic dermatitis and AD severity are associated with SDs. Sleep disturbances considerably impact quality of life and other health outcomes in adults with AD.
PMID: 33675326
ISSN: 2162-5220
CID: 5383832

Capturing total steroid burden in patients with atopic dermatitis and asthma

Fonacier, Luz; Banta, Erin; Mawhirt, Stephanie; Noor, Irum; Feldman, Eleanor; Armstrong Martin, Robert; Akerman, Meredith; Sani, Sonam
PMID: 36065113
ISSN: 1539-6304
CID: 5332372