Efficacy and Safety of bimekizumab in elderly patients: real-world multicenter retrospective study - IL PSO (Italian Landscape Psoriasis).

Purpose of the article: The aim of this multicenter observational study is to report data from real world on the use of bimekizumab in patients aged ≥ 65 years with moderate-to-severe plaque psoriasis. Elderly patients are poorly represented in clinical trials on bimekizumab for plaque psoriasis, and real-world studies are important to guide clinical choices.Materials and methods: A retrospective multicenter study was conducted in 33 dermatological outpatient clinics in Italy. Patients aged ≥ 65 years, with moderate-to-severe plaque psoriasis and treated with bimekizumab were enrolled. No exclusion criteria were applied. Bimekizumab was administered following the Italian Guidelines for the management of plaque psoriasis and according to the summary of product characteristics, in adult patients who were candidates for systemic treatments. Overall, 98 subjects were included, and received bimekizumab up to week 36. Clinical and demographic data were collected before the initiation of treatment with bimekizumab. At baseline and each dermatological examination (4, 16, and 36 weeks), clinical outcomes were measured by the following parameters: (1) PASI score; (2) site-specific (scalp, palmoplantar, genital, nail) Psoriasis Global Assessment (PGA). At each visit, the occurrence of any adverse events (AEs) was recorded, including serious AEs and AEs leading to bimekizumab discontinuation.Results: The mean PASI score was 16.6 ± 9.4 at baseline and significantly decreased to 4.3 ± 5.2 after 4 weeks (p < 0.001), and 1.1 ± 1.7 after 16 week (p < 0.001). This level of improvement was maintained after 36 weeks (p < 0.001). PASI ≤2 was recorded in 36 (36.7%) at week 4, 68% and 69.4% at week 16 and 36, respectively. By week 16, 86/98 (87.8%) patients reached PASI75, 71/98 (72.4%) obtained PASI90, and 52/98 (53.1%) PASI100. Binary logistic regression tests showed a significant association of PASI100 by week 4 with lower PASI at baseline. PASI 100 at 16 or 36 weeks was not associated with baseline PASI, obesity, age, gender, previously naïve state, and presence of psoriatic arthritis. Patients naïve to biologics at baseline had similar response to bimekizumab as non-naïve subjects.Conclusions: Bimekizumab is a suitable option for elder patients as it is effective, tolerated and has a convenient schedule.

Effectiveness of guselkumab in patients with facial and/or genital psoriasis: Interim analysis results at Week 12 from the GULLIVER study.

BACKGROUND: Facial (FP) and genital psoriasis (GP) significantly affect patients' quality of life. Despite the advances in treatments, limited data on efficacy and safety are available on these difficult-to-treat areas. Guselkumab is an interleukin (IL)-23 inhibitor which has been proven effective in treating patients with moderate-to-severe plaque psoriasis. OBJECTIVES: The aim of this interim analysis was to report the efficacy and safety of guselkumab in the treatment of patients with FP and/or GP. MATERIALS AND METHODS: GULLIVER is a 52-week Italian observational study to evaluate the effectiveness and safety of guselkumab in a real-life setting in patients with FP and/or GP. Adult patients with facial and/or genital moderate-to-severe psoriasis (sPGA score ≥ 3) were included. The primary endpoint of this analysis was the percentage of patients achieving a facial or genital sPGA score of 0 (clear) or 1 (almost clear), at Week 12. The change in the score of the facial or genital sPGA components in patients with a score ≥3 for each sPGA component was assessed. PASI score in patients with a baseline PASI above or below 10 was evaluated. RESULTS: Overall, 351 patients were included in the study; 83.3% of FP and 76.5% of GP patients achieved the primary endpoint. Similar response rates were observed for the facial or genital sPGA components in patients with a baseline facial or genital sPGA score ≥3 in each component. Among patients with a baseline PASI score >10, mean PASI score improved from 19.0 (SD 8.3) to 2.2 (SD 4.8). Forty-four AEs were observed in 32 patients; two mild and transient AEs (fatigue and nausea) were considered treatment related. No SAEs were observed. CONCLUSIONS: Guselkumab, showing to be effective and safe in treating FP and GP, may be a valid therapeutic option for patients with psoriasis localized in these difficult-to-treat areas.

Comparative Effectiveness and Durability of Biologics in Clinical Practice: Month 12 Outcomes from the International, Observational Psoriasis Study of Health Outcomes (PSoHO).

INTRODUCTION: Given the chronic nature of psoriasis (PsO), more studies are needed that directly compare the effectiveness of different biologics over long observation periods. This study compares the effectiveness and durability through 12 months of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis in a real-world setting. METHODS: The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of 1981 adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. The study compares the effectiveness of anti-IL-17A biologics with other approved biologics and provides pairwise comparisons of seven individual biologics versus ixekizumab. The primary outcome was defined as the proportion of patients who had at least a 90% improvement in Psoriasis Area and Severity Index score (PASI90) and/or a score of 0 or 1 in static Physician Global Assessment (sPGA). Secondary objective comparisons included the proportion of patients who achieved PASI90, PASI100, a Dermatology Life Quality Index (DLQI) score of 0 or 1, and three different measures of durability of treatment response. Unadjusted response rates are presented alongside the primary analysis, which uses frequentist model averaging (FMA) to evaluate the adjusted comparative effectiveness. RESULTS: Compared to the other biologics cohort, the anti-IL-17A cohort had a higher response rate (68.0% vs. 65.1%) and significantly higher odds of achieving the primary outcome at month 12. The two cohorts had similar response rates for PASI100 (40.5% and 37.1%) and PASI90 (53.9% and 51.7%) at month 12, with no significant differences between the cohorts in the adjusted analyses. At month 12, the response rates across the individual biologics were 53.5-72.6% for the primary outcome, 27.6-48.3% for PASI100, and 41.7-61.4% for PASI90. CONCLUSIONS: These results show the comparative effectiveness of biologics at 6 and 12 months in the real-world setting.

Osteoartrosis de ATM: recuperar la función / TMJ Osteoarthrosis: recover function

Objetivo: evaluar la rehabilitación funcional de la ATM en pacientes con osteoartrosis, con abordaje neuromuscular. La osteoartrosis se caracteriza por la degeneración del cartílago articular y la cortical ósea, que conduce a dolor e inmovilidad. Se incluyó a 8 mujeres entre 20 y 42 años de edad con dolor en la región orofacial, signos de oclusión disfuncional e imágenes compatibles con trastornos degenerativos en ATM. Clínicamente se evaluó el dolor y la oclusión y, mediante tecnología electrónica, se obtuvieron datos objetivos de los movimientos de apertura-cierre y lateralidades, la velocidad de apertura-cierre mandibulares y de los ruidos articulares. Las mediciones fueron realizadas al inicio y al finalizar el tratamiento de estabilización mandibular con una ortosis neuromuscular. Para determinar la significación estadística se utilizaron el Student`s test de comparaciones múltiples y el análisis de varianza, ANOVA, de un factor. Las diferencias entre medias se consideraron significativas con p <0.05. Los resultados demostraron ausencia de dolor en el 100% de los casos al primer mes de tratamiento. Se incrementaron la apertura bucal (6,73 mm promedio), ambas lateralidades (P=0.0023), velocidad en apertura y en cierre (no estadísticamente significativo). Después de estabilizar la mandíbula se redujo la frecuencia de los ruidos. En conclusión, la oclusión dental disfuncional es el principal factor etiológico de la artrosis de la ATM. El establecimiento de una oclusión fisiológica produce la descompresión de la ATM, aumenta el rango de los movimientos mandibulares y disminuye significativamente el dolor (AU)

Objective: to evaluate the functional rehabilitation of the TMJ in patients with osteoarthritis, with a neuromuscular approach. Osteoarthrosis is characterized by degeneration of articular cartilage and bone cortex, which leads to pain and immobility. Eight women between 20 and 42 years of age with pain in the orofacial region, signs of dysfunctional occlusion, and images consistent with degenerative TMJ disorders were included. Clinically, pain and occlusion were evaluated and, using electronic technology, objective data were obtained on the opening-closing movements and lateralities, the opening-closing speed of the jaws and joint noises. Measurements were made before and at the end of the mandibular stabilization treatment with a neuromuscular orthosis. To determine the statistical significance, the Student`s multiple comparisons test and the analysis of variance, ANOVA, of one factor were used. The differences between means were considered significant with p <0.05. The results showed absence of pain pain in 100% of cases in the first month of treatment. Mouth opening (6.73 mm average), both lateralities (P = 0.0023), opening and closing speed (not statistically significant) were increased. After stabilizing the jaw the noise frequency value was reduced. In conclusion, dysfunctional dental occlusion is the main etiologic factor of TMJ osteoarthritis. Establishing a physiological occlusion causes TMJ decompression, increases the range of mandibular movements, and significantly decreases pain (AU)

Asimetrías faciales como factor etiopatogénico de cefaleas y dolor facial / Facial asymmetries as etiopathogenic factors of headache and facial pain

El objetivo de este estudio fue demostrar la hipótesis sobre la coexistencia de asimetría morfológica con actividad muscular asimétrica, y deesta última con disfunción cráneomandibular y cefalea tensional y dolor facial, para incorporar datos semiológicos al diagnóstico tempranoy tratamiento precoz de las disfunciones cráneo-cérvico mandibulares. Participaron del estudio 66 alumnos de la F.O.U.B.A. con signos y/o síntomas de disfunción cráneomandibular. El diagnóstico de dolor se realizó mediante cuestionarios siguiendo los criterios diagnósticos de la Internacional Headache Society. La determinación de asimetría se realizó midiendo segmentos y ángulos trazados en telerradiografíade frente para tejidos duros y fotografía de cara de frente para tejidos blandos. Se evaluó la función muscular mediante electromiografía de superficie (EMGS); y la dinámica del sistema estomatognático mediante el método magnetométrico. El análisis de regresión logística múltiple resultó significativo al nivel p=0.01. En el análisis de las variables individuales y el dolor se encontró correlación estadísticamente significativa entre la asimetría de tejidos duros y la presencia de cefalea tensional y/o dolor facial. El organismo intenta equilibrar las diferencias morfológicas, esto explicaría las asimetrías cruzadas entre tejidos duros, blandos y actividad muscular comocompensaciones funcionales. Concluimos diciendo que ante la presencia de cefalea tensional y/o dolor facial debemos considerar la asimetríafacial de tejidos duros como posible factor etiológico predisponente aunque no se observe asimetría en tejidos blandos por acción compensatoria de la dinámica muscular. La etiología mixta, oclusal y postural, de las asimetrías faciales requiere del trabajo interdisciplinario odontólogo-médico-kinesiólogo-psicólogo-fonoaudiólogo para un óptimo diagnóstico y tratamiento

The aim of this study was to test the hypothesis on the coexistence of morphological asymmetry with asymmetric muscle activity, and this one with craniomandibular dysfunction and tension headache and facial pain, to incorporate semiological data to early diagnosis and treatment for TMJD (temporo mandibular jaw dysfunction). Study participants were 66 students from the Faculty of Dentistry of the University of Buenos Aires with TMJD signs and / or symptoms. The diagnosis of pain was conducted by questionnaires following the diagnostic criteria of the International Headache Society. The asymmetry determination was performed by measuring segments and angles in cephalometric frontal tracings for hard tissues and frontal picture for soft tissues. Muscle function was evaluated by surface electromyography (SEMG) and stomatognathic system dynamics by magnetometric method. The multiple logistic regression analysis was significant at p = 0.01. In the analysis of individual variables and pain we found statistical correlation between the asymmetry of hard tissues and the presence of tension headache and / or facial pain. The body tries to balance the morphological differences; this would explain the asymmetries cross between hard tissues, soft and functional muscle activity as offsets. We conclude saying that in the presence of tension headache and/or facial pain, the hard tissue facial asymmetry should be considered as a possible etiologic factor predisposing even asymmetry is not observed in soft tissue because of compensatory action of muscle dynamics. The mixed etiology, occlusal and postural of the facial asymmetries, requires interdisciplinary work dentist-doctor-physiotherapist,-psychologist-speech therapist, for optimal diagnosis and treatment.