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Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials CTs. International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma.
A systematic review of randomized controlled CTs of the biological agents omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab for the treatment of severe asthma was conducted. This study followed the corresponding international recommendations. We identified a total of articles, of which 37 were finally included. Women represented The mean percentage of women in these trials was The separate analysis by sex of the what does it mean control group in biology variable was only what does it mean control group in biology bkology 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex.
Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient.
This gives rise to potential gender bias in these CTs. This is an open access article distributed under the terms of the Creative Commons Attribution Licensewhich permits unrestricted use, distribution, and reproduction in any contrl, provided the original author and source are credited. Data Availability: All relevant data are within the manuscript and its Supporting Information files. Competing interests: The authors have declared that no competing what does it mean control group in biology exist.
InThe Food and Drug Administration FDA [ 3 ] published a guideline regarding the participation of women in clinical trials CTs and evaluating all clinical data by sex, but it was not reproduced in Europe [ 4 ]. Gender bias is a well-established term used in biomedical research to show the low sensitivity to gender among low women representation and absence of analysis separately by sex in CTs [ 6 — 9 ]. In Psychiatry, three studies about gender bias remarked that results were poorly stratified by sex [ 10 — 12 ].
What does it mean control group in biology epidemiologic studies mention the presence of sex disparities in asthma prevalence and severity [ 1718 ]. As children, boys have what does it mean control group in biology increased prevalence of asthma compared to girls However, bioology adolescence, there is a decline in asthma prevalence and morbidity in males congrol with an increase in females. By adulthood, women have increased asthma prevalence compared to men 9.
Over the past decade, an improved understanding of the complex pathophysiology of asthma has led to the development of new classification for phenotypes of asthma. Biological agents have demonstrated a beneficial role in certain clusters targeted at immunoglobulin E IgE or eosinophils [ 22 ]. Omalizumab was the first monoclonal antibody mAb developed for a specific subgroup of patients with uncontrolled IgE-mediated allergic asthma.
Currently, the biological mdan with monoclonal antibodies has been shown to reduce asthma exacerbations and oral corticosteroid use, and improve lung function and quality of life in appropriately selected patients [ 24 ]. Because of differences in gender, analysis of gender bias should be taken into consideration when evaluating the efficacy and safety of asthma novel therapies [ 25 ].
Thus, this systematic review aims to evaluate gender bias in published CTs of omalizumab, benralizumab, reslizumab, mepolizumab and dupilumab in severe asthma. We selected the studies that met the following inclusion criteria:. Search terms included a mixture of MeSH terms and free text keywords and synonyms combined with Boolean operators.
The search strategy is detailed in Table 1. Besides, the reference lists of selected studies were hand-searched to identify any other relevant studies. Two independent reviewers BFR and PCG screened the titles and abstracts of all eligible publications for possible inclusion. The articles included were full-length read before a final decision on inclusion. Any disagreement was settled by consensus with a third reviewer ABGG.
Reviewers independently extracted data and ABGG examined all extraction sheets to ensure their accuracy. We explicitly stated if there were any missing difference between associative and causal hypothesis from CTs. For each publication, the following variables were registered:. For the analysis of gender and sex differences and in order to characterize the gender sensitivity of the trials, we followed the Spanish recommendations for the study and evaluation of gender differences in CTs of drugs [ 27 ], the FDA guide [ 3 ] and the European Commission [ 28 ].
In the same way, the dhat was based on the SAGER guidelines [ 5 ] similar recommendations published in Shat [ 29 ] and previous publications [ 11 ]. The variables analyzed were:. We also applied a subgroup analysis for the variables: coontrol of publication, location, comparator, drug, age of patients, objectives and sample size. After the elimination of duplicates, records were screened by title and abstract.
We assessed 91 articles biolovy eligibility; 55 were excluded because they did not meet the eligibility criteria. One clinical trial [ 30 ] was identified from a post-hoc study, so 37 studies were finally included Fig 1. Table 2 indicates the characteristics of what chemicals are in human blood trials included in the study [ 30 — 66 ]. In most publications, the study drug was omalizumab 16followed by benralizumab 9mepolizumab 5dupilumab 4 and reslizumab 3.
Most trials were funded by pharmaceutical companies. The trials measured the variables of efficacy and safety 35efficacy, safety and quality of life 1 and efficacy, safety and pharmacokinetic 1. Sixteen studies included patients with severe allergic asthma and 21 with uncontrolled eosinophilic asthma. Cohtrol 3 shows the biologt characteristics of the studies. The mean percentage of female authors among all the authors was The total number of patients included in these studies was The average number of patients per study was range 61— There were participants women, what does it mean control group in biology an average number of women per study of range 29— The separate analysis by sex of the main variable was carried out in only 5 of the 37 studies included.
Moreover, none of the studies analyzed secondary variables between the subpopulation of men ahat women. Only 1 of the 37 trials discussed results separated by sex. Pregnancy was an exclusion criterion in 11 trials. None of the included studies analyzed any of the other gender or sex-related variables. Table 4 bjology the proportion of women and sex-related characteristics in the different subgroups of the CTs. Moreover, they were published between and and aimed at efficacy and safety evaluation.
The results of the current study show that, in general, the proportion of women included in the CTs of omalizumab, benralizumab, reslizumab, mepolizumab and dupilumab in severe asthma was higher This percentage of females included in the studies is similar to the percentage of women with severe asthma reflecting a low gender bias regarding the inclusion of women in these CTs [ 67 ].
However, the separate analysis by sex of the main variable was carried out in only 5 of the 37 studies included, only 1 of the 37 trials discussed results separated by sex and no study included the concept of gender in the text. Additionally, the mean percentage of female authors among biopogy the authors was low, just Possible explanations for this fact could be that mAb are the most recent iin for asthma, and consequently international recommendations [ 27 — 29 cannot connect to shared printer windows 10 error 709 would have had an impact on the design of the CTs.
A potential reason why sex and gender considerations were not included is that sex and other demographic information such as age what does it mean control group in biology race would have been analyzed as a covariate in some of these trials. However, guidelines recommend the inclusion of this valuable information in published studies [ 3 — 5 ]. Additionally, none of the trials followed a hormonal interaction approach to analyze the potential interaction with drugs such as hormonal contraceptives.
Several studies have causation meaning that asthma affects men and women differently [ 17 — 19 ]. According to The Prevention and Incidence of Asthma and Mite Allergy PIAMA study [ 69 ], a unique study that recruited more than women and assessed more than of their children, exists a sex disparity in asthma: until puberty, asthma is more common and severe in boys, but after puberty, this disease becomes more common in women.
Some recent articles have found an association between asthma and female sex hormones that could explain this fact [ 20 ]. Although the relationship remains unclear, the main hypothesis is that estrogen fluctuations directly modulate immune pathways crucial in asthma pathogenesis because of the anti-inflammatory action of these hormones [ 18 ].
In spite of all these reasons, none of the CTs analyzed the interaction between hormone replacement therapy and the study drug or investigate the effects of the phase of the menstrual cycle on the response to the drug. This fact goes against international recommendations what does it mean control group in biology could respond to a possible attempt to avoid increases in the final cost of trials. Furthermore, we found that more than half of the trials did not state whether pregnancy was a reason for exclusion.
Even so, it is proved that there is a connection between pregnancy and asthma severity, but with a variable effect [ 70 ]. The CTs of the five mAb approved for the treatment of severe asthma were included in this study. Nevertheless, the percentage of women included in the CTs of the different drugs varied between them. However, in the two latest CTs of omalizumab, conducted both inan analysis by sex of the main outcome was performed.
In contrast, the most recent CTs of benralizumab included the highest percentage of women, two of them analyzed the main outcome by sex and one discussed the results based on sex. It could be explained by the presence of common research authors in these studies. We should also mention that we included CTs carried out just in children, comtrol, or both. It is remarkable that a clinical study that enrolled more than inner-city children, adolescents and young adults 6—20 years old [ 58 ] was the only one that brought up socio-economical aspects from the participants, although the percentage of women was below the average.
Besides, another publication included males and premenarchal females grroup 6 to 12 years [ 49 ]. In this case, despite the interest in the effects of the phase of the menstrual cycle on the response to the drug, sex-related variables were not included in the design. The main strength of this work is that it is the first systematic review performed on the recently whaat mAb used in severe asthma which tries what does ancestry dna tell you reddit assess gender of bias in CTs.
What does it mean control group in biology, two of the largest health databases that incorporate articles from the highest-impact medical journals, PubMed and EMBASE, were employed without date and language restrictions, and both CTs conducted in adults and children were included. The main limitation was that the exclusion of post-hoc trials could prevent the inclusion of studies that subsequently evaluated variables based on sex.
Moreover, pilot studies were excluded because our study assesses variables that are generally evaluated at the end biklogy the clinical trial and preliminary results from pilot studies were commonly included in larger What does it mean control group in biology. Similarly, short reports and letters to the editor were excluded due to the absence of complete data from CTs. The design of the study was limited to variables that were included in the CTs such as location or the phase of the study, but we did not analyze other relevant variables such as race or socioeconomic status.
Additionally, ,ean cutoff for adult and pediatric age has been established at the age of 12, since most CTs distinguish between patients older or younger than 12 years. However, some adolescents may not reach puberty until they are not over the age of In conclusion, women represented more than half of the patients recruited in CTs of mAb for the treatment of severe asthma.
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