Summary
Background
Cutaneous reactions after severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccines are poorly characterized.
Objective
To describe and classify cutaneous reactions ...after SARS‐CoV‐2 vaccination.
Methods
A nationwide Spanish cross‐sectional study was conducted. We included patients with cutaneous reactions within 21 days of any dose of the approved vaccines at the time of the study. After a face‐to‐face visit with a dermatologist, information on cutaneous reactions was collected via an online professional survey and clinical photographs were sent by email. Investigators searched for consensus on clinical patterns and classification.
Results
From 16 February to 15 May 2021, we collected 405 reactions after vaccination with the BNT162b2 (Pfizer‐BioNTech; 40·2%), mRNA‐1273 (Moderna; 36·3%) and AZD1222 (AstraZeneca; 23·5%) vaccines. Mean patient age was 50·7 years and 80·2% were female. Cutaneous reactions were classified as injection site (‘COVID arm’, 32·1%), urticaria (14·6%), morbilliform (8·9%), papulovesicular (6·4%), pityriasis rosea‐like (4·9%) and purpuric (4%) reactions. Varicella zoster and herpes simplex virus reactivations accounted for 13·8% of reactions. The COVID arm was almost exclusive to women (95·4%). The most reported reactions in each vaccine group were COVID arm (mRNA‐1273, Moderna, 61·9%), varicella zoster virus reactivation (BNT162b2, Pfizer‐BioNTech, 17·2%) and urticaria (AZD1222, AstraZeneca, 21·1%). Most reactions to the mRNA‐1273 (Moderna) vaccine were described in women (90·5%). Eighty reactions (21%) were classified as severe/very severe and 81% required treatment.
Conclusions
Cutaneous reactions after SARS‐CoV‐2 vaccination are heterogeneous. Most are mild‐to‐moderate and self‐limiting, although severe/very severe reactions are reported. Knowledge of these reactions during mass vaccination may help healthcare professionals and reassure patients.
What is already known about this topic?
In clinical trials, COVID‐19 vaccines were associated with cutaneous adverse events, especially local injection site reactions.
Previous descriptions of cutaneous reactions beyond the injection site were case reports or mostly reported by non‐dermatologists and lacked clinical images.
What does this study add?
We describe and classify a large, representative sample of patients with unexplained skin manifestations after COVID‐19 vaccination, using consensus to define associated morphological patterns.
We describe six morphological reaction patterns and herpesvirus reactivations, and their association with demographic factors and the medical record, and provide illustrations to allow for easy recognition.
Linked Comment: V. Bataille and S. Puig. Br J Dermatol 2022; 186:15.
Plain language summary available online
Drago et al. are right to point out that our paper did not provide data on enanthems.1,2 As the data collection form did not include the description of mucous membranes, they might not have been ...explored in many patients. We have reported and included in the supplementary material a few cases that were noticed by their doctors and were the first descriptions of enanthem in COVID-19. Given the low number of cases and their nonsystematic acquisition, we avoided any analysis of these data.
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Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) ...is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities.
Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022.
Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community).
Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.
En España, aunque el Ministerio de Sanidad elabora el informe de posicionamiento terapéutico (IPT) y las condiciones de reembolso de los fármacos, las Comunidades Autónomas (CC. AA.) gestionan los servicios de salud y deciden sobre las condiciones de prescripción en su ámbito territorial. El objetivo del estudio EQUIDAD fue describir los condicionantes para la prescripción de los nuevos fármacos en Dermatología en las CC. AA. y sus posibles diferencias.
Estudio transversal realizado en abril-mayo del 2023. Dos dermatólogos con responsabilidades directivas de cada Comunidad Autónoma (C. A.) informaron sobre los condicionantes autonómicos y locales en la prescripción de los fármacos cuyo IPT para el tratamiento de enfermedades dermatológicas fue publicado en los años 2016-2022. Los datos fueron recogidos mediante un cuestionario online.
Un total de 33 investigadores de 17 CC. AA. participaron en el estudio. Se observaron inequidades entre CC. AA. para el acceso a los nuevos fármacos. Existieron condicionantes autonómicos adicionales al IPT en psoriasis en el 64,7% de las CC. AA., siendo este porcentaje menor en dermatitis atópica (35,3%) o melanoma (11,8%). El más frecuente fue el requisito de un orden de prescripción previo para el uso del fármaco. En algunas CC. AA. se detectaron además variaciones y condicionantes locales (diferencias entre centros de una misma C. A.).
Existe una multiplicidad de criterios tanto a nivel autonómico como local que añade restricciones adicionales a las establecidas por los IPT y que plantean una situación de inequidad entre los pacientes y los profesionales de las diferentes CC. AA. en el acceso a los nuevos fármacos.
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El Grupo de Psoriasis de la Academia Española de Dermatología y Venereología (GPs) diseño en 2017 la medida Actividad Mínima de Enfermedad en Psoriasis (AME). Se presentan los ...resultados de un estudio observacional, transversal y multicéntrico de la aplicación de esta escala a nivel nacional.
Se realizó un muestreo no aleatorizado, estratificado para alcanzar representación autonómica y provincial, de pacientes consecutivos con psoriasis (Ps) vulgar sin artritis activa. Se incluyeron 830 pacientes: 493 eran varones (59,5%), con una edad media de 51,4 años (DE=14,2), de todas las autonomías del país (excepto Ceuta y Melilla) y 44 (88%) de las 50 provincias. Se obtuvo un cuestionario recogiendo datos demográficos, DLQI, valoración subjetiva en escalas de 0 a 10 de picor, eritema, descamación y visibilidad; y el PASI y el BSA del paciente.
Más de la mitad no cumplían criterio de AME (491; 59,2%), con diferencia significativa entre regiones, por el sexo y por la edad. También había diferencias según el tratamiento realizado (p<0,001). El uso de un medicamento biológico se asoció a un mayor cumplimiento AME frente al uso de otro tipo de medicamentos (59,4 vs. 23,3%). No se observaron diferencias entre los tratamientos biológicos.
El porcentaje global de cumplimiento AME es bajo, con diferencias por la localización geográfica, el sexo, la edad y el fármaco utilizado, si bien ninguno de esos factores por separado las justifica.
In 2017, the Spanish Academy of Dermatology and Venereology Psoriasis Working Group (PWG) designed the Minimal Disease Activity (MDA) criteria to determine the level of disease activity. We hereby present the results of an observational, cross-sectional, multicenter study of the nationwide application of these criteria.
We conducted a non-randomized sampling, stratified to achieve autonomic and provincial representation of consecutive patients with psoriasis (Ps) vulgaris without active arthritis. A total of 830 patients were included: 493 men (59.5%), with a mean age of 51.4 years (SD, 14.2), from all autonomous regions of Spain (except for Ceuta and Melilla) and 44 (88%) out of the 50 provinces. A questionnaire was obtained with demographic data, DLQI, subjective assessment—on a scale from 0 to 10—of itching, erythema, desquamation, visibility, and the patients’ PASI and BSA.
More than 50% failed to meet the MDA criteria (491; 59.2%), with significant differences being reported by region, sex, and age. Additionally, significant differences were reported based on the therapy used (P<.001). The use of biological therapies was associated with higher MDA compliance compared to other therapies (59.4% vs 23.3%). No differences were reported among various biological therapies.
The overall rate of MDA compliance is low, with differences being based on geographic location, sex, age, and drug used, yet none of these factors separately justify them.
BACKGROUND AND OBJECTIVESThe negative impact of psoriasis on patient quality of life can be as important as the physical consequences of the disease. We could assume that clearance of the disease ...would also lead to an improvement in its psychosocial impact. The present study assesses the psychological state of patients with psoriasis receiving systemic treatment in a psoriasis unit, especially those with mild or no disease involvement. METHODSWe performed a cross-sectional, observational, noninterventional epidemiological study of 2 cohorts (cases and controls). The patients self-completed demographic data and 4 questionnaires (Rosenberg Self-Esteem Scale, Skindex-29, HADS, and COPE-28 questionnaire) at a single visit. RESULTSWe recruited 111 patients diagnosed with psoriasis and 109 control patients. In self-esteem, the mean and standard deviation (SD) score was 33.5 (4.8) for the psoriasis group and 33.3 (6.7) for the control group, with no significant differences. In the Skindex-29, the mean score for the psoriasis group was almost 3 times higher than that of the control group (30 vs. 11). Significant differences were found in the HADS scores of both groups (12.7 vs. 9.0, P<.001). The mean HADS-A scores were 8.0 (4.78) for the psoriasis group compared with 5.7 (3.8) for the control group (P<.001). In the case of HADS-D, the scores were 4.7 (3.9) compared with 3.2 (3.1) (P<.004), respectively. CONCLUSIONSOur findings indicate that it is necessary to assess the psychological state of patients with psoriasis, because psychological effects persist even in cases where the disease is almost totally controlled.
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