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Background: Efgartigimod, a human immunoglobulin (Ig)G1 antibody Fc fragment, blocks the neonatal Fc receptor, reducing IgGs involved in chronic inflammatory demyelinating polyneuropathy (CIDP). The multi-stage, double-blinded, placebo-controlled ADHERE (NCT04281472) and open-label extension ADHERE+ (NCT04280718) trials (interim analysis cutoff: February 16, 2024) assessed efgartigimod PH20 SC in participants with CIDP. Methods: Participants with active CIDP received open-label, weekly efgartigimod PH20 SC 1000 mg during ≤12-week run-in (stage-A). Responders were randomized (1:1) to efgartigimod or placebo for ≤48 weeks (stage-B). Participants with clinical deterioration in stage-B or who completed ADHERE entered ADHERE+. Week 36 changes from run-in baseline (CFB) in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT), Inflammatory Rasch-built Overall Disability Scale (I-RODS), and grip strength scores were evaluated. Results: Of 322 stage-A participants, 221 were randomized and treated in stage-B, and 99% entered ADHERE+. Mean CFB (SE) in aINCAT, I-RODS, and grip strength scores were -1.2 (0.15) and 8.8 (1.46) and 17.5 (2.02), respectively, at ADHERE+ Week 36 (N=150). Half the participants with clinical deterioration during ADHERE stage-B restabilized on efgartigimod from ADHERE+ Week 4. Conclusions: Interim results from ADHERE+ indicate long-term effectiveness of efgartigimod PH20 SC in clinical outcomes in participants with CIDP.
Background: Efgartigimod, a human immunoglobulin (Ig)G1 antibody Fc fragment, blocks the neonatal Fc receptor, reducing IgGs involved in chronic inflammatory demyelinating polyneuropathy (CIDP), a rare, progressive, immune-mediated disease that can lead to irreversible disability. The multi-stage, double-blinded, placebo-controlled ADHERE (NCT04281472) trial assessed efgartigimod PH20 SC in participants with CIDP. Methods: Participants with active CIDP received open-label, weekly efgartigimod PH20 SC 1000 mg during ≤12-week run-in (stage-A). Responders were randomized (1:1) to weekly efgartigimod or placebo for ≤48 weeks (stage-B). This posthoc analysis evaluated changes from run-in baseline (study enrollment) to stage-B last assessment and items of the Inflammatory Rasch-built Overall Disability Scale (I-RODS). Results: Of 322 participants who entered stage-A, 221 were randomized and treated in stage-B, and 191/221 had data for run-in baseline and post–stage-B timepoints. Mean (SE) I-RODS change at stage-B last assessment vs run-in baseline was 5.7 (1.88) and -4.9 (1.82) in participants randomized to efgartigimod and placebo, respectively. 37/97 (38.1%) and 24/92 (26.1%) participants randomized to efgartigimod and placebo, respectively, experienced ≥4-point improvements in I-RODS score. Efgartigimod-treated participants improved ≥1 point in I-RODS items of clinical interest. Conclusions: Participants who received efgartigimod in stage-B experienced improvements in I-RODS score from study enrollment to stage-B last assessment.
Clinical high-risk for psychosis (CHR-P) states exhibit diverse clinical presentations, prompting a shift towards broader outcome assessments beyond psychosis manifestation. To elucidate more uniform clinical profiles and their trajectories, we investigated CHR-P profiles in a community sample.
Methods
Participants (N = 829; baseline age: 16–40 years) comprised individuals from a Swiss community sample who were followed up over roughly 3 years. latent class analysis was applied to CHR-P symptom data at baseline and follow-up, and classes were examined for demographic and clinical differences, as well as stability over time.
Results
Similar three-class solutions were yielded for both time points. Class 1 was mainly characterized by subtle, subjectively experienced disturbances in mental processes, including thinking, speech and perception (basic symptoms [BSs]). Class 2 was characterized by subthreshold positive psychotic symptoms (i.e., mild delusions or hallucinations) indicative of an ultra-high risk for psychosis. Class 3, the largest group (comprising over 90% of participants), exhibited the lowest probability of experiencing any psychosis-related symptoms (CHR-P symptoms). Classes 1 and 2 included more participants with functional impairment and psychiatric morbidity. Class 3 participants had a low probability of having functional deficits or mental disorders at both time points, suggesting that Class 3 was the healthiest group and that their mental health and functioning remained stable throughout the study period. While 91% of Baseline Class 3 participants remained in their class over time, most Baseline Classes 1 (74%) and Class 2 (88%) participants moved to Follow-up Class 3.
Conclusions
Despite some temporal fluctuations, CHR-P symptoms within community samples cluster into distinct subgroups, reflecting varying levels of symptom severity and risk profiles. This clustering highlights the largely distinct nature of BSs and attenuated positive symptoms within the community. The association of Classes 1 and 2 with Axis-I disorders and functional deficits emphasizes the clinical significance of CHR-P symptoms. These findings highlight the need for personalized preventive measures targeting specific risk profiles in community-based populations.
Coping strategies, competence, and locus of control (LOC) beliefs are important predictors of mental health (MH). However, research into their complex interactions has produced mixed results. Our study investigated them further in the previously unexplored context of clinical high-risk (CHR) of psychosis.
Methods
We tested six alternative structural equation models in a community sample (N = 523), hypothesizing a mediating role of coping and treating CHR symptoms as (i) an additional mediator or (ii) a specific outcome. Our measurement model included two latent factors of MH: (1) psychopathology (PP), consisting of presence of mental disorders, global and psychosocial functioning, and (2) self-rated health (SRH) status.
Results
In the model with the best Akaike Information Criterion and the latent factors as outcome variables, maladaptive coping completely mediated the impact of maladaptive LOC on PP and SRH. Additionally, CHR symptoms partially mediated the effect of maladaptive coping on PP and SRH in the community sample, as long as sex was not entered into the model. In the clinical sample (N = 371), the model did not support a mediation by CHR symptoms, despite significant pathways with both coping and MH outcomes; further, competence beliefs directly impacted SRH.
Conclusions
Coping strategies are an important intervention target for MH promotion, especially in the community. In clinical populations, interventions focusing on coping strategies may improve CHR symptoms, thus potentially supporting better MH, especially SRH. Additionally, due to their mostly cascading effects on MH, improving competence and LOC beliefs may also promote psychological well-being.
Mars exploration motivates the search for extraterrestrial life, the development of space technologies, and the design of human missions and habitations. Here, we seek new insights and pose unresolved questions relating to the natural history of Mars, habitability, robotic and human exploration, planetary protection, and the impacts on human society. Key observations and findings include:
– high escape rates of early Mars' atmosphere, including loss of water, impact present-day habitability;
– putative fossils on Mars will likely be ambiguous biomarkers for life;
– microbial contamination resulting from human habitation is unavoidable; and
– based on Mars' current planetary protection category, robotic payload(s) should characterize the local martian environment for any life-forms prior to human habitation.
Some of the outstanding questions are:
– which interpretation of the hemispheric dichotomy of the planet is correct;
– to what degree did deep-penetrating faults transport subsurface liquids to Mars' surface;
– in what abundance are carbonates formed by atmospheric processes;
– what properties of martian meteorites could be used to constrain their source locations;
– the origin(s) of organic macromolecules;
– was/is Mars inhabited;
– how can missions designed to uncover microbial activity in the subsurface eliminate potential false positives caused by microbial contaminants from Earth;
– how can we ensure that humans and microbes form a stable and benign biosphere; and
– should humans relate to putative extraterrestrial life from a biocentric viewpoint (preservation of all biology), or anthropocentric viewpoint of expanding habitation of space?
Studies of Mars' evolution can shed light on the habitability of extrasolar planets. In addition, Mars exploration can drive future policy developments and confirm (or put into question) the feasibility and/or extent of human habitability of space.
On March 13th 2020, in execution of the Law Decree 14/2020 regarding the reorganization of National Health Care related to COVID-19 emergency, all non-urgent outpatient healthcare services were suspended in Italy. The present work describes remote support and online group psychotherapy set in motion during COVID-19 emergency for outpatients with Binge Eating Disorder.
Objectives
Aim of the present work is to describe and evaluate online support and group psychotherapy for outpatients with Binge Eating Disorder during lockdown due to COVID-19 emergency. Outcomes were evaluated by remote administration of questionnaires.
Methods
20 outpatients with Binge Eating Disorder, treated by psychotherapists of Hospital Psychology Unit in Psychiatry Day Hospital of an Italian General Hospital, received remote support by phone calls and online group psychotherapy from march to may 2020. During the first two weeks, patients were supported via phone calls. From the third week on, they took part to online group psychotherapy sessions, held every week at the same day and time. Pre-post remote administration of Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) and the Questionnaire of Eating Behaviours (Scheda dei Comportamenti Alimentari, SCA) was used to evaluate outcomes. Data were analyzed by Student’s t-test.
Results
No significant difference was found, thus indicating stability of symptomatology.
Conclusions
Lockdown was a highly stressful period, in which many people lost control on eating behaviours and those with Binge Eating Disorder were expected to have an exacerbation of symptoms. Remote support and online group psychotherapy proved effective in protecting patients from a possible aggravation of their condition.
Due to the presence of artefacts in stool samples, the copromicroscopic diagnosis of Ascaris lumbricoides is not always straightforward, particularly in the case of fertilized decorticated eggs. A total of 286 stool samples from 115 schoolchildren in India and 171 adult immigrants in Italy were screened for the presence of A. lumbricoides eggs by both Kato-Katz thick smear and Mini-FLOTAC. If the outer layer of A. lumbricoides eggs was absent, two aliquots of each stool sample were preserved: one for coproculture to identify larvae after development and one to compose a pool of stool for molecular analysis. A total of 64 stool samples (22.4%) were positive for A. lumbricoides using the Kato-Katz thick smear; 36 (56.3%) of these showed mammillated A. lumbricoides eggs, 25 (39.1%) showed elements resembling fertilized decorticated eggs, while three samples (4.7%) showed both mammillated and decorticated eggs. By Mini-FLOTAC, 39 stool samples (13.6%) were positive, while decorticated A. lumbricoides-like eggs were identified as artefacts. These results were confirmed by negative coprocultures and quantitative polymerase chain reaction. Mini-FLOTAC can be used for a reliable diagnosis of A. lumbricoides, thanks to the flotation and translation features which allow a clearer view, resulting in the correct identification of A. lumbricoides eggs.
Non-alcoholic fatty liver disease (NAFLD) is becoming the most common liver disease worldwide. Prolonged fasting and excessive caloric intake are possible nutritional causes of NAFLD incurred by patients with eating disorders (ED).
Aims
Aims of this study are: identifying if eating disorders are associated with NAFLD; evaluating possible improvements of the risk of NAFLD and of psychopathology determined by integrated multidisciplinary treatment (behavioral therapy, dietary assessment and treatment, clinical care overall).
Methods
78 patients with ED received the integrated multidisciplinary treatment. Psychopathology and eating symptoms were assessed before and after treatment through Eating Disorder Inventory and Questionnaire of Eating Behaviours (QEB). The risk of NAFLD was evaluated by Fatty liver index (FLI) based on values of γGT, BMI, triglycerides and waist circumference.
Results
54% of patients with binge eating disorder in our sample has a 60-FLI, indicating a risk of NAFLD higher than 85%.
FLI (p: 0.003) and yGT (p: 0.006) were significantly lower after treatment, thus indicating an improvement in the risk of NAFLD. Four of the eight EDI's subscales improved: Drive for thinness (p: 0.008), Interoceptive awareness (p < 0.001), Bulimia (p: 0.001), Ineffectiveness (p: 0.014). Two of the three SCA's subscales improved: Binge Eating (p: 0.001) and Food Restriction (p: 0.016).
Conclusions
the association between NAFLD and eating disorders was shown together with the efficacy of the multidisciplinary treatment. The risk index FLI and γGT were reduced by the therapy but should be monitorized over time.
To demonstrate the complex correlation existing in patients with eating disorders between hormonal alterations and psychopathological symptomatology, that has been little studied until now.
Methods
60 women aged between 16 and 35 years and diagnosed with Anorexia Nervosa and Bulimia Nervosa according to the DSM-IV were assessed using the SCL-90-R, EDI, BAT and DES II. A blood sample was taken from each patient in the morning, on the seventh day of the menstrual cycle or on the corresponding day from the women with amenorrhea; the following hormone levels were measured: TSH, FT3, FT4, LH, FSH, 17-beta-estradiol, cortisol, DHEAS. Pearson's Correlation Coefficient has been used to test the correlation between hormonal level and test scores.
Results
Positive correlations exist between BMI and FT3 and LH, which decrease when BMI decreases. We can observe positively significant correlations between LH and FSH levels and the BAT scale scores.No one significant correlation was found between hormonal levels and dissociative symptoms as measured by DES. With regard to EDI, the following psychopathological features correlate with hormonal assessment: the wish to be thin, body dissatisfaction and perfectionism.
Conclusions
Our findings suggest a significant correlation between psychopathological features we considered and hormonal readings, especially LH, FSH, TSH, FT3. When these hormonal readings decrease, the patients’ self-ratings and their body dissatisfaction decrease. That attributes a protective meaning to the dietary symptom akin to an effective measure that relieves the person's feelings of inadequacy.
Even if obesity isn’t a psychiatric disorder included in the DSM IV-TR, it is associated with a high prevalence of psychopatological features. Mainly obese patients on a waiting list for bariatric surgery are affected by psychiatric disorders more often than non-obese individuals.
Objective:
To estimate the prevalence of psychopatology in obese patients on a waiting list for weight loss surgery.
Aim:
To demonstrate the importance of a multidisciplinary approach to bariatric surgery that includes a psychodiagnostic evaluation.
Methods:
Forty-seven patients on a waiting list for bariatric surgery were assessed using the SCL-90-R.
Results:
In a high rate of patients (83%) was identified a significantly altered value at least in one of the SCL-90-R subscales. Mainly the 80.85% has expressed a psychological distress through physical symptoms (SOM), the 63.82% had a deflection of mood (DEP), the 61.7% had a higher ability to perceive both internal and external stimuli (IS); suspiciousness (PAR) occurred in 59.57% of patients (PAR).
Conclusions:
Our results suggest a high rate of psychopatological alterations in patients on a waiting list for weight loss. These individuals try to manage their emotions through the relationship with food, and the body become a way to express themselves. Therefore the early detection and the treatment of the psychopatological features associated with obesity could have a role to improve the therapeutic outcome, and a multidisciplinary approach could represent an essential element to reach a global resolution of both clinical and mental features of patients.
The original cognitive-behavioural model of bulimia nervosa (CBT-BN) proposes that specific dysfunctional cognitions and behavioural factors maintain BN, and has provided the basis for the widely used cognitive-behavioural therapy (CBT) of BN. However, Fairburn et al. (2003) noted that among treatment completers with BN, only 40% achieved full remission of the bulimic symptomatology. The enhanced CBT-BN model (CBT-E) proposed by the authors describes how four additional factors (i.e., clinical perfectionism, low self esteem, mood intolerance and interpersonal difficulties) interact with the core psychopathology of BN (i.e., over-evaluation of eating, weight, and shape and their control) to maintain the disorder.
Aims
The goal of this study was to examine (a) the validity of the CBT-E model and (b) whether each of the four hypothesized maintenance factors intensifies the core psychopathology-bulimic symptomatology relationship in a clinical sample.
Methods
Data were analysed from 362 adults seeking treatment for BN (n = 167) or atypical BN (n =195) at four Italian specialized care centres, using latent variable structural equation modeling approach.
Results
Both the measurement and the structural model were good fits for the data. All four hypothesized factors exacerbated the core psychopathology-bulimic symptomatology relationship. Core psychopathology explained approximately 47.7% of the variance of bulimic symptomatology. The inclusion of the direct effects and interaction terms increased the explained variance of bulimic symptomatology to 64%.
Conclusions
Overall, results supported the validity of the CBT-E model and highlighted the importance of assessment and treatment of the four maintenance processes included in the CBT-E model.
Psoriasis is a multifactorial chronic infiammatory skin disease that often occurs in patients with overweight or obesity; obesity makes psoriasis less susceptible to therapy and a moderate weight loss improves drug response. Many studies shows connections between obesity and eating disorders, but few studies investigated the link between eating disorders and psoriasis.
Objectives:
To evaluate the presence of eating disorders and psychopathological traits in patients affected by psoriasis compared with a control population, and correlate this data with different features of cutaneous disease and BMI.
Aims:
To suggest the importance of a psychological support that could reduce the occurrence of loss of control over food.
Methods:
We enrolled 100 consecutive psoriatic outpatients and a control group of 100 selected non psoriatic outpatients, matched by BMI to the study group. The assessment battery was composed by the Psoriasis Area and Severity Index (PASI) score, the EDI and SCL-90R.
Results:
Most of EDI and SCL-90R subscales resulted more altered in psoriatic population compared to the controls (p < .001 for IA and ID, and p < .05 for GSI). Moreover, we noticed an association between the progressive weight gain and the impairment of most of EDI subscales, indicating the presence of an ED in only psoriasis group (p < .01).
Conclusion:
Psoriasis is associated with psychopathological traits and symptoms commonly associated with eating disorders. A multidisciplinary approach could have an important role to reduce the loss of control over food, to loss weight and to improve the drug response.
Given the poor compliance of schizofrenic patients to antipsychotic therapies, are been developed drugs in long-acting formulation that for their pharmacokinetic ensures prolonged therapeutic activities. Currently, we consider that their efficacy depends on hereditary tracts, influencing both pharmacodynamic and pharmacokinetic parameters.
Objective
Investigate relationships between clinical efficacy and genetic polymorphims of long-acting drugs’ pharmacodynamic targets.
Methods
Seventy-eight psychotic patients, treated with atypical long-acting antipsychotics (olanzapine pamoate, paliperidone palmitate, risperidon and aripiprazole), were examined. We carried out a blood sampling to evaluate dopaminergic DRD2 and glutamatergic GRM3 genetic receptors polymorphisms. PANSS and BPRS scales were used to assess clinical condition.
Results
Regarding the GRM3 genes, the study of rs2228595 and rs6465084 polymorphisms showed a prevalence of wild type genotypic frequency of 81.2% and 56.2%, respectively. The prevalence of the patients with mutated heterozygote genotype (rs6465084 polymorphisms) resulted high (40.6%). Considering rs1989796 e rs274622 polymorphisms, the sample showed a prevalence of mutated heterozygote genotype in the 53.1% e 45.3%, respectively, with a percentage of 43.7% of patients with a mutation in homozygosis. Considering the rs146812 polymorphism, the 53.1% of patients resulted with a wild type genotype. Finally, findings showed a prevalence of 56.2% for the mutated heterozygote genotype in the DRD2 rs6277 polymorphism. The genotypic categorization analysis demonstrated a significative association between the GRM3 rs274622 polymorphism and higher BPRS scores.
Conclusions
The relationship between rs274622 polymorphism and worse clinical conditions could indicate a major resistance to long-acting antipsychotics in patients with genotypic frequency CT (mutated heterozygosis) for this polymorphism.
Disclosure of interest
The authors have not supplied their declaration of competing interest.
Our objective was to measure the efficacy of ivermectin (IVM) and benzimidazoles (BZ, i.e. fenbendazole and albendazole) in 15 cattle farms in western France and southern Italy. A total of 11 groups were treated with IVM and 11 with BZ. Efficacy was assessed by calculating the percentage of faecal egg count reduction (%FECR) using the pre- and post-treatment arithmetic means. Anthelmintic resistance was considered to be present when the %FECR was <95% and the lower limit of the 95% confidence interval <90%. For IVM, the percentages of FECR ranged from 73% to 100%. Lack of efficacy to IVM was detected in two farms out of four in France, but was not detected in any of the seven farms in Italy. For BZ, the percentages of FECR ranged from 95% to 100%. No case of BZ resistance was detected in the five farms in France and the six farms in Italy.
Well-controlled intrauterine development is an essential condition for many aspects of normal adult physiology and health. This process is disrupted by poor maternal nutrition status during pregnancy. Indeed, physiological adaptations occur in the fetus to ensure nutrient supply to the most vital organs at the expense of the others, leading to irreversible consequences in tissue formation and differentiation. Evidence indicates that maternal undernutrition in early life promotes changes in key hormones, such as glucocorticoids, growth hormones, insulin-like growth factors, estrogens and androgens, during fetal development. These alterations can directly or indirectly affect hormone release, hormone receptor expression/distribution, cellular function or tissue organization, and impair tissue growth, differentiation and maturation to exert profound long-term effects on the offspring. Within the male reproductive system, maternal protein malnutrition alters development, structure, and function of the gonads, testes and prostate gland. Consequently, these changes impair the reproductive capacity of the male offspring. Further, permanent alterations in the prostate gland occur at the molecular and cellular level and thereby affect the onset of late life diseases such as prostatitis, hyperplasia and even prostate cancer. This review assembles current thoughts on the concepts and mechanisms behind the developmental origins of health and disease as they relate to protein malnutrition, and highlights the effects of maternal protein malnutrition on rat prostate development and homeostasis. Such insights on developmental trajectories of adult-onset prostate disease may help provide a foundation for future studies in this field.
A minimal model for predator-prey interaction in a composite environment is presented and analysed. We first consider free migrations between two patches for both interacting populations, and then the particular cases where only one-directional migration is allowed and where only one of the two populations can migrate. Our findings indicate that in all cases the ecosystem can never disappear entirely, under the model assumptions. The predator-free equilibrium and the coexistence of all populations are found to be the only feasible stable equilibria. When there are only one-directional migrations, the abandoned patch cannot be repopulated. Other equilibria then arise, with only prey in the second patch, coexistence in the second patch, or prey in both patches but predators only in the second one. For the case of sedentary prey, with predator migration, the prey cannot thrive alone in either of the two environments. However, predators can survive in a prey-free patch due to their ability to migrate into the other patch, provided prey is present there. If only the prey can migrate, the predators may be eliminated from one patch or from both. In the first case, the patch where there are no predators acts as a refuge for the survival of the prey.
Anadara demiri (Piani, 1981) is an alien species in the Mediterranean Sea extending its range from Turkey westernly to the Adriatic Sea, where it is locally abundant. The species was first identified as Arca amygdalum Philippi, 1847 in the 1970s. The locus typicus of A. amygdalum is China. This first identification has never been discussed and the species has been thought to be of Indo-Pacific origin to date. However, in the Indo-Pacific province no Anadara shows any similarity with A. demiri. Morphological and molecular data suggest A. demiri is closely related to Anadara transversa (Say, 1822), a common species of the eastern coasts of North America. Anadara demiri is hence considered a junior synonym of A. transversa and the origin of this immigration has to be searched in the southern range of this species, maybe the Gulf of Mexico coasts of Florida.