Topical clindamycin for acne vulgaris: analysis of gastrointestinal events.

Purpose: Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding gastrointestinal (GI) adverse events (AEs), real-world incidence of GI AEs with topical clindamycin is unknown. This review provides background information and an overview of safety data of topical clindamycin for treating AV.Materials and Methods: Available safety data from published literature, previously unpublished worldwide pharmacovigilance data, and two retrospective cohort studies were reviewed.Results and Conclusions: According to pharmacovigilance data, the rate of GI adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). Results from two retrospective medical record studies of patients with AV indicated that physicians prescribe topical clindamycin equally to patients with or without inflammatory bowel disease history, and that rates of pseudomembranous colitis in these patients were low. In 8 published pivotal clinical trials of topical clindamycin for AV, GI AEs were reported in 1.4% of participants. Limitations include under/inaccurate reporting of AEs or prescription data and limited generalizability. This review of published case reports, worldwide pharmacovigilance data, retrospective US prescription data, and clinical trials safety data demonstrates that the incidence of colitis in patients exposed to topical clindamycin is extremely low.

Incidence of anxiety disorder among adults with hidradenitis suppurativa.

BACKGROUND: There is limited data on risk of new-onset anxiety disorders in hidradenitis suppurativa (HS) patients. OBJECTIVES: To compare the risk of new-onset anxiety disorder in patients with HS and controls, and to describe risk factors for development of anxiety among HS patients. METHODS: Retrospective cohort analysis of a US electronic health records database between 2011-2020. Adults newly diagnosed with HS at a dermatology or primary care visit and controls were included. The primary outcome was new diagnosis of generalized anxiety disorder, phobic disorders, panic disorder, or unspecified anxiety. Cox proportional hazards regression was used to compare the crude risk of any anxiety disorder between groups and assess independent association with HS while controlling for potential demographic, clinical, and healthcare-related confounders. RESULTS: Among 9,597 HS patients and 959,493 controls, the incidence rate of anxiety was 5.74 and 3.86 per 100 person-years, respectively. Crude risk among all patients was 48% higher for those with HS compared to controls (HR 1.48, 95%CI 1.40-1.55). When stratifying by index encounter type, HS patients had 2.43 (95%CI 2.13-2.77) times the risk of anxiety disorder compared to dermatology controls and 1.46 (95%CI 1.38-1.55) times the risk compared to primary care controls. Adjusted hazard ratio for HS vs. control was 1.11 (95%CI 1.05-1.17) overall, 1.26 (95%CI 1.07-1.48) in the dermatology subgroup, and 1.07 (95%CI 1.01-1.13) in the primary care subgroup. Risk factors for incident anxiety diagnosis among HS patients included depression (HR 1.69, 95%CI 1.48-1.93), female sex (HR 1.41, 95% CI 1.23-1.60), younger age (HR 0.87 per 10-year increase, 95%CI 0.84-0.90), White race, Medicaid insurance (HR 1.22, 95%CI 1.07-1.40), tobacco smoking (HR 1.16, 95%CI 1.03-1.31), and having one or more emergency department visits in the year before HS diagnosis. Absolute incidence rates of anxiety disorders were highest among HS patients who were aged 18-29 years (7.10 per 100 person-years), female (6.34 per 100 person-years), and White (6.79 per 100 person-years). CONCLUSIONS: HS is independently associated with increased risk of anxiety disorders. An increased risk remains, but is attenuated, when controlling for confounders. The relative risk may be particularly high among patients managed by dermatologists.

Outcome Measurement Instruments Used to Evaluate Dermatologic Adverse Events in Cancer Trials: A Systematic Review.

Importance: Assessment of type, severity, and impact of dermatologic adverse events (DAEs) necessitates well-developed and validated clinician-reported outcome measures (ClinROMs) and patient-reported outcome measures (PROMs) that evaluate concepts specific to mucocutaneous toxic effects and that allow appropriate interpretation and comparison of DAEs across trials. Objective: To evaluate heterogeneity and quality of ClinROMs and PROMs used to assess DAEs from systemic cancer therapy. Evidence Review: Two systematic reviews were conducted by searching PubMed and Embase databases from inception through March 7, 2023, and April 12, 2023. The first search included randomized clinical trials and observational studies reporting systemic cancer treatment-induced DAEs assessed by a ClinROM or PROM. The second included studies evaluating measurement properties of frequently used ClinROM and PROM instruments. The Consensus-Based Standards for the Selection of Health Measurement Instruments risk of bias tool was used to evaluate methodologic quality of validation assessments. Findings: A total of 395 studies were included. The Common Terminology Criteria for Adverse Events (CTCAE) was utilized in 331 studies meeting inclusion criteria (83.8%). At least 1 skin-related PROM was infrequently utilized in systemic chemotherapy clinical trials (79 studies [20.0%]). Most frequently utilized PROMs were the Dermatology Life Quality Index (DLQI; 34 studies [8.6%]) and Skindex-16 (20 studies [5.1%]). Among studies capturing DAEs, 115 (29.1%) reported a nondescript term (ie, rash) as the only DAE. Eight studies described 44 property assessments of the CTCAE, DLQI, and Skindex. There were no studies evaluating content validity, intrarater reliability, or measurement error for the CTCAE, DLQI, or Skindex. There were no studies evaluating structural validity, internal consistency, and responsiveness of DLQI or Skindex. Interrater reliability and responsiveness were each assessed for 1 DAE-related component of the CTCAE. Construct validity for CTCAE, DLQI, and Skindex was evaluated in 29 (65.9%), 3 (6.8%), and 9 (20.5%) assessments, respectively. Conclusions and Relevance: In this systematic review, there was a narrow spectrum of ClinROMs and PROMs with limited validity for the measurement of DAEs in the context of systemic chemotherapy interventions in clinical trials. Report of trial DAEs often had low morphologic specificity and meaning. Based on existing gaps in measurement and report of DAEs, a frequent and impactful adverse event to chemotherapy, the framework for evaluating cutaneous toxic effects in oncology trials may need collaborative reevaluation.

Outcome Measures for the Evaluation of Treatment Response in Hidradenitis Suppurativa for Clinical Practice: A HiSTORIC Consensus Statement.

Importance: Although several clinician- and patient-reported outcome measures have been developed for trials in hidradenitis suppurativa (HS), there is currently no consensus on which measures are best suited for use in clinical practice. Identifying validated and feasible measures applicable to the practice setting has the potential to optimize treatment strategies and generate generalizable evidence that may inform treatment guidelines. Objective: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied. Evidence Review: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice. Findings: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]). Conclusions and Relevance: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.

Reducing Behavioral and Psychological Symptoms of Dementia in Acutely Ill Patients via Patient Engagement Specialists: A Pilot Feasibility Study.

Behavioral and psychological symptoms of dementia (BPSD) are common in hospitalized persons living with dementia (PLWD). This pilot aimed to test the feasibility of an innovative model of care, PES-4-BPSD (a dementia unit staffed with Patient Engagement Specialists, PES). Non-randomized pilot feasibility trial was conducted, enrolling N = 158 patients to the intervention unit (n = 79, a 10-bed dementia unit, staffed with nursing assistants, NAs, with mental health backgrounds, PES) and an enhanced control unit (n = 79, 40-bed medicine unit, staffed with NAs). All NAs/PES (N = 63) received dementia training, with completion rate of 82.5%. Overall, patients had ~1 NPI-Q (Neuropsychiatric Inventory Questionnaire) assessment/48 hr. 97% (n = 153) of PLWD exhibited at least one behavior. Average NPI-Q scores did not differ across intervention (5.36) and control (3.87) units (p = .23). Patients on the intervention unit had 88% (p = .002) shorter duration of constant observation. A dementia care unit staffed by PES is an innovative model requiring further research.

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.

Incidence and Prevalence of Diagnosed Vitiligo According to Race and Ethnicity, Age, and Sex in the US.

Importance: Vitiligo has substantial psychosocial consequences. Yet its burden is poorly established. Objective: To estimate incidence and prevalence of diagnosed vitiligo across age, sex, and racial and ethnic subgroups in the US. Design, Setting, and Participants: This analysis comprising a cohort study and cross-sectional study included electronic health records for health care-seeking children, adolescents, and adults across 4 US census regions. Data for the incidence analysis were obtained from January 1, 2015, through December 31, 2019, and data for the prevalence analysis were obtained from January 1 through December 31, 2019. Data were analyzed from December 13, 2022, to June 8, 2023. Main Outcomes and Measures: The main outcomes were incidence (per 100 000 person-years [PY]) and prevalence of diagnosed vitiligo overall and by age, race and ethnicity, and sex. Results: A total of 2 980 778 patients with vitiligo were included in the incidence analysis (mean [SD] age, 41.5 [24.0] years; 57.0% female; 1.4% Asian American; 12.9% Black; 1.5% Hispanic/Latino; 77.3% White; 6.9% other or multiracial) and 1 057 534 in the prevalence analysis (mean [SD] age, 43.4 [24.7] years; 57.5% female; 1.7% Asian American, 14.7% Black, 1.4% Hispanic/Latino; 75.7% White; 6.6% other or multiracial). Age- and sex-adjusted overall incidence rate (IR) of diagnosed vitiligo was 22.6 per 100 000 PY (95% CI, 21.5-23.8 per 100 000 PY), and prevalence was 0.16% (95% CI, 0.15%-0.17%). Sex-adjusted IR was highest among patients aged 60 to 69 years (25.3 per 100 000 PY; 95% CI, 22.2-28.6 per 100 000 PY), and prevalence was highest among patients aged 70 years or older (0.21%; 95% CI, 0.19%-0.23%). The highest age-adjusted IR was observed among Asian American patients (41.2 per 100 000 PY; 95% CI, 28.2-58.2 per 100 000 PY), followed by Hispanic/Latino patients (37.3 per 100 000 PY; 95% CI, 25.7-52.4 per 100 000 PY), patients reporting other or multiple races (31.1 per 100 000 PY; 95% CI, 25.9-37.1 per 100 000 PY), Black patients (29.6 per 100 000 PY; 95% CI, 26.0-33.6 per 100 000 PY), and White patients (18.7 per 100 000 PY; 95% CI, 17.5-20.0 per 100 000 PY). The highest age-adjusted prevalence was observed among Hispanic/Latino patients (0.29%; 95% CI, 0.20%-0.39%), followed by Asian American patients (0.27%; 95% CI, 0.19%-0.35%), patients reporting other or multiple races (0.24%; 95% CI, 0.20%-0.28%), Black patients (0.22%; 95% CI, 0.19%-0.24%), and White patients (0.13%; 95% CI, 0.12%-0.14%). Conclusions and Relevance: This cross-sectional study found that vitiligo diagnosis was more common in older patients, Hispanic/Latino patients, and Asian American patients.

Prevalence of Crohn Disease Among Pediatric Patients With Hidradenitis Suppurativa.

This cross-sectional study compares the prevalence of Crohn disease among US pediatric patients with and without hidradenitis suppurativa.

A Multicenter Retrospective Cohort Study to Characterize Patients Hospitalized With Multisystem Inflammatory Syndrome in Adults and Coronavirus Disease 2019 in the United States, 2020-2021.

BACKGROUND: The diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated multisystem inflammatory syndrome in adults (MIS-A) requires distinguishing it from acute coronavirus disease 2019 (COVID-19) and may affect clinical management. METHODS: In this retrospective cohort study, we applied the US Centers for Disease Control and Prevention case definition to identify adults hospitalized with MIS-A at 6 academic medical centers from 1 March 2020 to 31 December 2021. Patients MIS-A were matched by age group, sex, site, and admission date at a 1:2 ratio to patients hospitalized with acute symptomatic COVID-19. Conditional logistic regression was used to compare demographic characteristics, presenting symptoms, laboratory and imaging results, treatments administered, and outcomes between cohorts. RESULTS: Through medical record review of 10 223 patients hospitalized with SARS-CoV-2-associated illness, we identified 53 MIS-A cases. Compared with 106 matched patients with COVID-19, those with MIS-A were more likely to be non-Hispanic black and less likely to be non-Hispanic white. They more likely had laboratory-confirmed COVID-19 ≥14 days before hospitalization, more likely had positive in-hospital SARS-CoV-2 serologic testing, and more often presented with gastrointestinal symptoms and chest pain. They were less likely to have underlying medical conditions and to present with cough and dyspnea. On admission, patients with MIS-A had higher neutrophil-to-lymphocyte ratio and higher levels of C-reactive protein, ferritin, procalcitonin, and D-dimer than patients with COVID-19. They also had longer hospitalization and more likely required intensive care admission, invasive mechanical ventilation, and vasopressors. The mortality rate was 6% in both cohorts. CONCLUSIONS: Compared with patients with acute symptomatic COVID-19, adults with MIS-A more often manifest certain symptoms and laboratory findings early during hospitalization. These features may facilitate diagnosis and management.

Porcine xenograft and second intention healing on the lower extremities after Mohs surgery: a descriptive case series.

There is limited data on benefits of healing after Mohs surgery using porcine xenografts (PXs) compared to second intention (SI). This case series sought to describe healing time, scar size, cosmetic outcome, pain, and infection rates in patients treated with PX or SI for wounds on lower extremities. 14 patients were enrolled. Six patients received treatment with SI, and eight patients received PX. 11 patients (4 SI, 7 PX) completed follow-up visit after 3 months (79% follow-up rate) when primary outcome measure was assessed. 64% of patients took > 3 months to heal. 72% of patients healed within 6 months post-surgery. Scars contracted by > 50% in 7/11 patients completing follow-up. In SI group, 3/5 patients self-reported pain level > 1 out of 10 at 1-week post-surgery compared to 3/8 in the PX group. Two patients in each group developed post-operative wound infection and three patients in PX group experienced other adverse events. These results suggest that healing with PX or SI resulted in small scar size, low post-operative pain level, and low rate of adverse events. Both groups had longer healing times than expected.

Overall and Racial and Ethnic Subgroup Prevalences of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis.

Importance: Prevalences of alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) are poorly established. Objective: To estimate overall and subgroup prevalences of AA and its subtypes. Design, Setting, and Participants: This cross-sectional study using electronic records comprising the Explorys database (Watson Health, IBM Corporation) included children, adolescents, and adults seeking healthcare across the 4 census regions in the US between January 1, 2019, and December 31, 2019. The statistical analysis was conducted between July 21, 2022, and December 22, 2022. Main Outcomes and Measures: Prevalent cases of AA, AT, and AU. Results: Of the 1 093 176 patients who met inclusion criteria, 1812 had at least 1 code for AA, 1216 female (67%) and 596 male (33%) patients. Overall age-and-sex standardized prevalences among adults and among children and adolescents were observed to be 0.18% and 0.10%, respectively. The age-standardized prevalence ratio in women to men was 1.32. Standardized prevalence was highest in those aged 30 to 39 (297 per 100 000; 95% CI, 263-335) and 40 to 49 (270 per 100 000; 95% CI, 240-303) years. The highest standardized prevalence was observed among Asian patients (414 per 100 000; 95% CI, 306-548), followed by patients reporting another race or multiple races (314 per 100 000; 95% CI, 266-368), Black (226 per 100 000; 95% CI, 199-255), and Hispanic/Latino (212 per 100 000; 95% CI, 129-328) patients. White patients had the lowest standardized prevalence (168 per 100 000; 95% CI, 157-179) among racial and ethnic subgroups. Relative to White patients, standardized prevalence ratios for Asian, Black, and Hispanic/Latino patients were 2.47 (95% CI, 2.17-2.81), 1.35 (95% CI, 1.26-1.44), and 1.26 (95% CI, 1.03-1.55), respectively. Cases of AT and AU comprised approximately 9% of patients diagnosed with AA. Conclusions and Relevance: The findings of this cross-sectional study suggest that there is a significant burden of AA, AT, and AU in the US in which people of color, particularly Asian Americans, appear to be disproportionately affected.

Quality of Life and Treatment Adherence in Patients with Vulvar Lichen Sclerosus.

BACKGROUND: Vulvar lichen sclerosus (VLS) is a chronic, relapsing, inflammatory dermatosis that has significant impact on patients' quality of life (QoL). While disease severity and associated QoL impact have been studied, factors associated with treatment adherence and their relation to QoL in VLS remain unexplored. OBJECTIVE: The objectives of this study were to describe demographics, clinical characteristics, and skin-related QoL in VLS patients and to assess the relationship between QoL and treatment adherence. METHODS: This was a cross-sectional, single institution, electronic survey study. The relationship between adherence, measured using the validated Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) scale, and skin-related QoL, using the Dermatology Life Quality Index (DLQI) score, was assessed using Spearman correlation. RESULTS: Of 28 survey respondents, 26 provided complete responses. Among 9 patients classified as adherent and 16 classified as nonadherent, mean DLQI total score was 1.8 and 5.4, respectively. Spearman correlation between summary nonadherence score and DLQI total was 0.31 (95% CI: -0.09-0.63) overall and 0.54 (95% CI: 0.15-0.79) when patients who reported missing doses due to asymptomatic disease were excluded. Most frequently reported factors preventing treatment adherence included application/treatment time (43.8%) and asymptomatic or well-controlled disease (25%). CONCLUSIONS: Though Qol impairment was relatively small in both our adherent and nonadherent groups, we identified important factors preventing treatment adherence, with the most common being application/treatment time. These findings may help dermatologists and other providers generate hypotheses as to how to facilitate better treatment adherence among their patients with VLS, with the goal of optimizing QoL.