While clinical trials provide invaluable evidence, real-world data can offer further insight on the efficacy and safety of biologic drugs. This report aims to analyze the long-term efficacy and ...safety of ixekizumab in real-world clinical practice in our facility.
Patients with a diagnosis of psoriasis and who started treatment with ixekizumab were included in this retrospective study and followed for 156 weeks. The severity of cutaneous manifestations was evaluated using the PASI score at several time points and clinical efficacy was evaluated using PASI 75, -90 and -100 responses.
Not only PASI 75, but also PASI 90 and 100 responses showed a favorable outcome after treatment with ixekizumab. Responses at week 12 were sustained through the following three years in the majority of patients. No statistically significant difference was found between bio-naive and bio-switch patients and weight and disease duration had no impact on the efficacy of the drug. Ixekizumab had a favorable safety profile, as we observed no major adverse events. Two cases of eczema were observed and led to drug discontinuation.
This study confirms the efficacy and safety of ixekizumab in real-world clinical practice.
Heterogeneous real-world evidence can complement the more strictly regulated clinical trial data. A benefit of this is the wide range of backgrounds, comorbidities and characteristics that can give ...additional insights into treatments. Observational, retrospective studies can help to fill in the mosaic that makes up a treatments landscape. Tildrakizumab, an interleukin 23p19 inhibitor, is approved for the treatment of plaque psoriasis and has been shown to be a safe and efficacious therapy in clinical trials and emerging real-world evidence. We aimed at confirming the efficacy of tildrakizumab in patients with plaque psoriasis in a dual center setting and identifying patients' characteristics leading to better treatment response.
Patients with moderate to severe plaque psoriasis, eligible for systemic biological treatment, and treated with tildrakizumab were included in the study and the routine clinical parameters - Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and safety - were retrospectively analyzed.
The combined cohorts included 89 patients, of which 64% were naïve to biologic therapies. At the time of analysis efficacy assessment was available for 39 patients after 12 months of treatment, 73 patients after 36 weeks, 79 patients after 16 weeks and 82 patients after 4 weeks. PASI and DLQI decreased significantly over time, with 52/73 (71.2%) patients achieving PASI 100 after 36 weeks. No severe side-effects were recorded in association with tildrakizumab.
We confirmed the safety and efficacy of tildrakizumab in a real-world clinical setting. A higher proportion of patients naïve to biologics achieved a greater PASI response than patients who had previously been treated with biologics. The same was true for older patients and patients with a shorter history of disease.
Purpose skin involvement can severely alter body image thus representing a major concern for patients with Systemic Lupus Erythematosus (SLE).The aim of this study was to analyze the impact of active ...skin involvement on Health-Related Quality of Life (HRQoL), mood disorders and self-perception of disease activity in a monocentric cohort of SLE patients.Methodsa cross-sectional study including consecutive outpatients with SLE with active skin involvement. The severity of skin lesions was assessed through the CLASI index.Consecutive SLE outpatients with at least one active disease manifestation, but without active skin involvement or irreversible skin damage served as a control group.The following data have been collected: demographics, clinical and laboratory data, SLEDAI-2K and SLICC-DI. Each patient completed the following Patient-Reported Outcomes (PROs): SF-36, FACIT-F, LIT for disease burden, SLAQ for self-assessment of disease activity; the HADS for anxiety and depression was available for a subgroup of patients. Patients with skin involvement also completed the SKINDEX-16 (a questionnaire for the evaluation of HRQoL in patients with dermatological conditions).Results we enrolled 72 consecutive SLE patients, 38 with active skin lesions (‘skin group’) and 34 without active mucocutaneous manifestations or irreversible skin damage (‘no-skin group’); 88.9% were female, 94.4% Caucasians. Mean age at enrollment was 43.9 ± 12.2 years and median disease duration was 11.5 (IQR 7–18.5) years. In the ‘skin group’ the median CLASI activity score was 5 (IQR 3–7.5) and the median CLASI damage score was 1 (IQR 0–4).In the ‘no-skin group’, we found a significantly higher percentage of patients with active hematological and renal manifestations (p<0.01).No other significant differences emerged between the two groups with respect to age, disease duration, disease activity and damage, ongoing treatment and fibromyalgia.By comparing PROs results between the two groups, we found no significant differences for the SF-36, the LIT and the FACIT-F. However, although the SLEDAI score did not significantly differ between the two groups, we found that patients in the ‘skin group’ had a significantly higher score of the SLAQ questionnaire compared to patients in the ‘no-skin group’ (p<0.01).The HADS questionnaire was available for 50 patients: patients with active skin involvement presented significantly higher scores for depressive symptoms compared to patients without skin manifestations (p=0.01).Finally, among patients with active skin lesions, we did not demonstrate a significant correlation between the CLASI activity score and the scores of all PROs used, not even with the SKINDEX, which is specific for dermatological conditions.Conclusion although skin involvement is not generally considered a severe disease manifestation in SLE, it seems to be strongly associated with patients’ perception of higher disease activity and with depressive symptoms. These results underline as skin involvement still represents an unmet need in the management of patients with SLE, with a potentially negative impact on patient satisfaction with the care process.
Objective:To investigate the bioecological relationship between Chagas disease peridomestic vectors and reptiles as source of feeding.Methods:In a three-story building,triatomines were captured by ...direct search and electric vacuum cleaner search in and outside the building.Then,age structure of the captured Triatoma maculata(T.maculata) were identified and recorded.Reptiles living in sympatric with the triatomines were also searched.Results:T.maculata were found living sympatric with geckos(Thecadactylus rapicauda) and they bit residents of the apartment building in study.A total of 1 448 individuals of T.maculata were captured within three days,of which 74.2%(1 074 eggs) were eggs,21.5%were nymphs at different stages,and 4.3%were adults.Conclusions:The association of T.maculata and T.rapicauda is an effective strategy of colonizing dwellings located in the vicinity of the habitat where both species are present;and therefore,could have implications of high importance in the intradomiciliary transmission of Chagas disease.
Background & objectives: Since the beginning of the year 2020, the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) impacted humankind adversely in almost all spheres ...of life. The virus belongs to the genus Betacoronavirus of the family Coronaviridae. SARS-CoV-2 causes the disease known as coronavirus disease 2019 (COVID-19) with mild-to-severe respiratory illness. The currently available diagnostic tools for the diagnosis of COVID-19 are mainly based on molecular assays. Real-time reverse transcription-polymerase chain reaction is the only diagnostic method currently recommended by the World Health Organization for COVID-19. With the rapid spread of SARS-CoV-2, it is necessary to utilize other tests, which would determine the burden of the disease as well as the spread of the outbreak. Considering the need for the development of such a screening test, an attempt was made to develop and evaluate an IgG-based ELISA for COVID-19.
Methods: A total of 513 blood samples (131 positive, 382 negative for SARS-CoV-2) were collected and tested by microneutralization test (MNT). Antigen stock of SARS-CoV-2 was prepared by propagating the virus in Vero CCL-81 cells. An IgG capture ELISA was developed for serological detection of anti-SARS-CoV-2 IgG in serum samples. The end point cut-off values were determined by using receiver operating characteristic (ROC) curve. Inter-assay variability was determined.
Results: The developed ELISA was found to be 92.37 per cent sensitive, 97.9 per cent specific, robust and reproducible. The positive and negative predictive values were 94.44 and 98.14 per cent, respectively.
Interpretation & conclusions: This indigenously developed IgG ELISA was found to be sensitive and specific for the detection of anti-SARS-CoV-2 IgG in human serum samples. This assay may be used for determining seroprevalence of SARS-CoV-2 in a population exposed to the virus.
to determine central corneal thickness in normal subjects, glaucomatous patients and ocular hypertension patients, to evaluate if the central corneal thickness is related to the presence of glaucoma ...or ocular hypertension. Furthermore, we aim to verify the relationship between central corneal thickness and severity of glaucomatous visual field loss.
comparative study including 150 eyes of 150 subjects, separated into three groups: normal (47 eyes), ocular hypertension (35) and glaucomatous (68). This last group was subdividided in three subgroups depending on the Hodapp-Parrish-Anderson criteria for scoring Humphrey visual field defects (initial, moderate and advanced). We evaluated the visual field, the central corneal thickness measured by pachymetry and the intraocular pressure measured by Goldmann tonometry. Results were analysed using the Student's t-test for normally distributed independent samples.
the central corneal thickness was 526+/-25 microns (mean +/-standard deviation (SD)) in glaucomatous patients, 560+/-27 microns in ocular hypertension patients, and 556+/-27 microns in the normal group. Statistical significance could be found between the glaucomatous group of patients and the other groups (p< 0.01), but not between the ocular hypertension group and normal subjects (p= 0.4). The comparison between central corneal thickness of the subgroup with advanced damage of the visual field and the two other subgroups was also statistically significant (p< 0.01), but not between the subgroups of initial damage and moderate damage (p= 0.7).
the central corneal thickness in glaucomatous patients is lower than in normal subjects and in ocular hypertension patients. Patients classified as having advanced damage in their visual field have significantly lower central corneal thickness measurements than patients classified as having initial or moderate damage.
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