The data in clinical practice regarding the effectiveness and safety of brodalumab in psoriasis are scarce, especially at scalp and palmoplantar locations. The main objective was the percentage of ...patients achieving absolute PASI ≤3/ ≤1/ =0 for plaque psoriasis and the percentage of patients achieving an IGA 0-1/IGA 0 for the special locations at Week 52 of treatment.
Observational retrospective multicentre study in 28 Spanish Hospitals that included adult patients with plaque psoriasis treated with brodalumab, from September 2018 until March 2021.
A total of 200 patients were included. The mean baseline PASI was 10.97 (±6.28) with a mean basal scalp (n = 58) and palmoplantar (n = 40) IGA of 2.10 (±0.97) and 2.15 (±1.26), respectively. At Week 52, 93.98%/75.90%/68.67% of patients reached an absolute PASI ≤3/ ≤1/ =0 in plaque psoriasis (n = 83), with a percentage of patients achieving scalp (n = 27) and palmoplantar (n = 19) IGA 0-1/IGA 0 of 96.3%/88.9% and 100%/88.9%, respectively. Fifteen per cent of patients reported any adverse events with candidiasis being the most reported (6%), but only 6% of the adverse events required the withdrawal.
Brodalumab demonstrated high PASI and IGA responses and was well tolerated in clinical practice in plaque, scalp and palmoplantar psoriasis.
Given the high incidence of confirmed infection by SARS-CoV-2 and mortality by COVID-19 in the Spanish population, its impact was analysed among persons with Cystic Fibrosis (CF) as a group at risk ...of a worse evolution. The possible causes of the incidence observed in them are explained and how CF Units have faced this health challenge is detailed.
Retrospective descriptive observational study, for which a Spanish CF Patients with Confirmed COVID-19 Registry is created, requesting information on number of people affected between 8 March–16 May 2020 and their clinical-demographic characteristics from the CF Units participating in the European Cystic Fibrosis Society Patient Registry (ECFSPR). The accumulated incidence is calculated, compared with that of the general population. Additionally, a survey (CF-COVID19-Spain) is carried out on prevention of SARS-CoV-2 infection, workings of CF Units and possible reasons for the incidence observed.
COVID-19 was diagnosed in eight CF patients, one of whom had received a lung transplant. The accumulated incidence was 32/10000 in CF patients and 49/10000 in the general population. General death rate was 5.85/10000 while no CF patients included in the ECFSPR died. The characteristics of those affected and the results of the survey are described.
Despite being considered a disease at high risk of severe COVID-19, the low incidence and mortality in CF patients in Spain contrasts with the figures for the general population. The possible factors that would explain such findings are discussed, with the help of the results of the CF-COVID19-Spain survey.
•SARS-CoV-2 pandemic is severely hitting Spain.•Cumulative incidence among Spanish CF patients is being lower than expected.•No fatal cases were reported in our CF patients with COVID-19 included in ECFSPR.•CF-COVID19-Spain survey was useful to explain its low incidence and mild course.
Background
It has been reported that clinical evaluation consistently underestimates the severity of hidradenitis suppurativa (HS).
Objective
To determine the usefulness of ultrasound as a diagnostic ...tool in HS compared with clinical examination and to assess the subsequent modification of disease management.
Methods
Cross‐sectional multicentre study. Severity classification and therapeutic approach according to clinical vs. ultrasound examination were compared.
Results
Of 143 HS patients were included. Clinical examination scored 38, 70 and 35 patients as Hurley stage I, II and III, respectively; with ultrasound examination, 21, 80 and 42 patients were staged with Hurley stage I, II and III disease, respectively (P < 0.01). In patients with stage I classification as determined by clinical examination, 44.7% changed to a more severe stage. Clinical examination indicated that 44.1%, 54.5% and 1.4% of patients would maintain, increase or decrease treatment, respectively. For ultrasound examination, these percentages were 31.5%, 67.1% and 1.4% (P < 0.01). Concordance between clinical and ultrasound intra‐rater examination was 22.8% (P < 0.01); intra‐rater and inter‐rater (radiologist) ultrasound agreement was 94.9% and 81.7%, respectively (P < 0.01).
Limitations
The inability to detect lesions that measure ≤0.1 mm or with only epidermal location.
Conclusion
Ultrasound can modify the clinical staging and therapeutic management in HS by detecting subclinical disease.
Risankizumab – a humanized monoclonal antibody that targets the p19 subunit of IL-23 – has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a ...representative pool of patients are currently lacking.
To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice.
This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52.
A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index BMI >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.
Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.
Risankizumab es un anticuerpo monoclonal humanizado que se dirige a la subunidad p19 de IL-23, recientemente aprobado para el tratamiento de la psoriasis en placas moderada a grave. Actualmente faltan datos del mundo real basados en una muestra representativa de pacientes.
Evaluar la eficacia y la seguridad a medio y a largo plazo del risankizumab en pacientes con psoriasis moderada a grave en la práctica clínica habitual.
Estudio retrospectivo y multicéntrico realizado en pacientes consecutivos con psoriasis que recibieron tratamiento con risankizumab desde abril de 2020 hasta noviembre de 2022. El criterio de valoración principal fue la proporción de pacientes que alcanzaron una mejora en el Índice de Área y Severidad de la Psoriasis (Psoriasis Area and Severity Index PASI) del 100% (PASI100) en la semana 52.
Se incluyeron en el estudio un total de 510 pacientes, 198 (38,8%) mujeres y 312 (61,2%) hombres. La edad media fue de 51,7±14,4 años, y 227 (44,5%) sujetos eran obesos (índice de masa corporal IMC>30kg/m2). La puntuación media del PASI basal fue de 11,4±7,2. La proporción de pacientes que alcanzaron PASI100 en la semana 52 fue del 67,0%. A lo largo del seguimiento del estudio, el 21%, el 50,0%, el 59,0% y el 66% de los pacientes alcanzaron un PASI100 en las semanas 4, 16, 24 y 40, respectivamente. La proporción de pacientes que alcanzaron un PASI≤2 fue mayor en el grupo con un IMC≤30kg/m2 en la semana 4 (p=0,04), la semana 16 (p=0,001) y la semana 52 (p=0,002). Una proporción estadísticamente significativa mayor de pacientes alcanzó un PASI100 en el grupo sin tratamiento previo en la semana 16 y a la semana 52 (p=0,001 en cada una, respectivamente). En la semana 16, una proporción significativamente menor de sujetos alcanzó un PASI100 en el grupo con artropatía psoriásica (p=0,04). Entre la muestra total del estudio, 22 (4,3%) pacientes reportaron algún tipo de evento adverso y 20 (3,9%) abandonaron o se retiraron del tratamiento.
Risankizumab fue un tratamiento efectivo y seguro para pacientes con psoriasis moderada a grave en la práctica clínica.
Immune signatures at birth could be associated with clinical outcomes and will improve our understanding of immunity prenatal programming.
Data come from 235 newborns from the cohort study NELA. ...Production of cytokines was determined using Luminex technology. Associations between cytokine concentrations with sex and season of birth were examined by multivariate regression models.
Umbilical cord blood cells produced high levels of inflammatory cytokines, moderate levels of Th1/Th2/Tr-related cytokines, and low levels of Th17 cytokines. Compared to females, male newborn cells secreted higher levels of Th2 (peptidoglycan-stimulated IL-13, odds ratio OR = 2.26; 95% CI 1.18, 4.31, p value = 0.013) and Th17 (polyinosinic:polycytidylic acid-stimulated IL-23, OR = 1.82, 95% CI 1.01, 3.27, p value = 0.046) and lower levels of Th1 (olive-stimulated IL-2, OR = 0.56, 95% CI 0.31, 0.99, p value = 0.047) cytokines. Also, children born during warm seasons showed decreased innate cytokine response to peptidoglycan (IL-6, OR = 0.28, 95% CI 0.15, 0.52, p value < 0.001) compared to those born in cold seasons; meanwhile, adaptive immunity cytokines were more frequently secreted by children born during warm seasons in response to allergen extracts (IL-10, OR = 2.11, 95% CI 1.12, 3.96, p value = 0.020; IL-17F, OR = 3.31, 95% CI 1.83, 5.99, p value < 0.001).
Newborns showed specific cytokines signatures influenced by sex and season of birth.
There is a limited number of population-based studies on the immune status at birth and the influence of prenatal and perinatal factors on it. Characterization of cytokine signatures at birth related to the prenatal environment could improve our understanding of immunity prenatal programming. Newborns exhibit specific unstimulated and stimulated cytokine signatures influenced by sex and season of birth. Unstimulated and stimulated cytokine signatures in newborns may be associated with the development of related clinical outcomes later in life.
The prevalence of asthma is considerably high among women of childbearing age. Most asthmatic women also often have other atopic disorders. Therefore, the differentiation between patients with atopic ...diseases without asthma and asthmatics with coexisting diseases is essential to avoid underdiagnosis of asthma and to design strategies to reduce symptom severity and improve quality of life of patients. Hence, we aimed for the first time to conduct an analysis of volatile organic compounds in exhaled breath of women of childbearing age as a new approach to discriminate between asthmatics with other coexisting atopic diseases and non-asthmatics (with or without atopic diseases), which could be a helpful tool for more accurate asthma detection and monitoring using a noninvasive technique in the near future. In this study, exhaled air samples of 336 women (training set (n = 211) and validation set (n = 125)) were collected and analyzed by thermal desorption coupled with gas chromatography-mass spectrometry. ASCA (ANOVA (analysis of variance) simultaneous component analysis) and LASSO + LS (least absolute shrinkage and selection operator + logistic regression) were employed for data analysis. Fifteen statistically significant models (p-value < 0.05 in permutation tests) that discriminated asthma with other coexisting atopic diseases in women of childbearing age were generated. Acetone, 2-ethyl-1-hexanol and a tetrahydroisoquinoline derivative were selected as discriminants of asthma with other coexisting atopic diseases. In addition, carbon disulfide, a tetrahydroisoquinoline derivative, 2-ethyl-1-hexanol and decane discriminated asthma disease among patients with other atopic disorders. Results of this study indicate that refined metabolomic analysis of exhaled breath allows asthma with other coexisting atopic diseases discrimination in women of reproductive age.
Secukinumab is a first-in-class interleukin 17A monoclonal antibody that has demonstrated an excellent safety and efficacy profile in phase 3 studies.
To evaluate the effectiveness of secukinumab in ...daily clinical practice and to understand the clinical and epidemiologic characteristics of patients treated with secukinumab in clinical settings.
In this multicenter prospective observational study, we recruited adult patients with moderate-to-severe plaque psoriasis from 12 hospitals in Spain during January-December 2016. These patients were treated with secukinumab and prospectively followed at 12-week intervals for 52 weeks.
In total, 158 patients were recruited to the study. A Psoriasis Area and Severity Index (PASI) score improvement ≥75% over baseline (PASI-75) was achieved by 57%, 83.5%, 89%, and 78.5% of patients at weeks 4, 12, 24, and 52, respectively. PASI-90 was achieved in 27.8%, 62%, 64.6%, and 63.2% of patients at weeks 4, 12, 24, and 52, respectively; PASI-75 and PASI-90 responders were significantly more common among patients with a body mass index <30 kg/cm2 and patients without previous biologic therapy failures.
Observational study. Time from onset of psoriasis was not evaluated.
Secukinumab is a safe treatment with effectiveness rates similar to those found in its phase 3 studies. These rates endure up to a year from start of treatment.
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