Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients.

BACKGROUND: In this analysis we aimed to describe Brazilian inflammatory bowel disease (IBD) patients' knowledge and perceptions regarding biosimilars and compare with viewpoints from non-Brazilian patients. METHODS: An online survey consisting of 19 questions was made available by the European Federation of Crohn's and Ulcerative Colitis Associations between July 2018 and December 2018. Only respondents who had heard of biosimilars were asked to respond to all of the questions. RESULTS: A total of 102 Brazilian IBD patients responded to the survey. The majority (78.4%) of patients had been exposed to anti-tumor-necrosis-factor drugs and 63.4% of them had heard of biosimilars. Brazilian respondents worried significantly more about biosimilars being less effective than the originator (62.5% versus 47.9%, p value 0.03) and molecular differences between biosimilars and originators (53.1% versus 31.8, p value 0.001) as compared with non-Brazilian IBD patients. The majority of Brazilian (75%) and non-Brazilian (64.1%) respondents thought that the lower cost of biosimilars should not come before their safety and efficacy (p value 0.09). In addition, 79.1% of Brazilian respondents believed that the arrival of biosimilars will have an impact on the management of IBD. CONCLUSIONS: Brazilian patients reported higher rates of misconceptions regarding biosimilars than non-Brazilian IBD patients. Although patients still worry about different aspects regarding biosimilars, they also tend to be confident that biosimilars will have an impact on the management of their disease. With the recent approval of many biosimilars in Brazil and the imminent widespread use of these drugs, our data raise awareness for the need of providing patient education to prevent negative expectations toward switching to biosimilars.

Patients' perspectives on smoking and inflammatory bowel disease: An online survey in collaboration with European Federation of Crohn's and Ulcerative Colitis Associations.

BACKGROUND: Smoking has detrimental effects on Crohn's disease (CD) activity while data on ulcerative colitis (UC) are conflicting. Little is known about the use and impact of alternative smoking products in inflammatory bowel diseases (IBD). AIM: To understand the patients' perceptions of the impact of smoking on their IBD and to assess differences between CD and UC patients. METHODS: The questionnaire was developed by Philip Morris Products SA in cooperation with European Federation of Crohn's and Ulcerative Colitis Associations. The final survey questionnaire consisted of 41 questions divided in 8 categories: (1) Subject screener; (2) Smoking history; (3) Background information; (4) IBD disease background; (5) Current disease status; (6) Current therapeutics and medications; and (7) Current nicotine/cigarettes use and awareness of the impacts of smoking on IBD. The questionnaire was submitted online from 4th November 2019 to 11th March 2020 through the European Federation of Crohn's and Ulcerative Colitis Associations website to IBD patients who were current smokers or had a history of smoking. RESULTS: In total 1050 IBD patients speaking nine languages participated to the survey. Among them, 807 (76.9%) patients declared to have ever smoked or consumed an alternative smoking product, with a higher proportion of current cigarette smokers among CD patients (CD: 63.1% vs UC: 54.1%, P = 0.012). About two-thirds of the participants declared to have ever stopped cigarette smoking and restarted (67.0%), with a significantly higher proportion among UC patients compared to CD patients (73.1% vs 62.0%, P = 0.001). We also found significant differences between CD and UC patients in the awareness of the health consequences of smoking in their disease and in the perceived impact of smoking on disease activity, for both cigarettes and alternative smoking products. CONCLUSION: This survey found significant differences between CD and UC patients in both awareness and perception of the impact of smoking on their disease. Further efforts should be done to encourage smoking cessation for all IBD patients, including UC patients.

Quality of Care Standards in Inflammatory Bowel Diseases: a European Crohn's and Colitis Organisation [ECCO] Position Paper.

The management of inflammatory bowel disease [IBD] is complex, and requires tight control of disease activity, close monitoring to avoid treatment side effects, health care professionals with expertise in IBD, and an interdisciplinary, holistic approach. Despite various efforts to standardise structures, processes, and outcomes,1-8 and due to the high variability at the local, national, and international levels, there are still no clear definitions or outcome measures available to establish quality of care standards for IBD patients which are applicable in all contexts and all countries. For this reason, the European Crohn's and Colitis Organisation [ECCO] supported the construction of a list of criteria summarising current standards of care in IBD. The list comprises 111 quality standard points grouped into three main domains [structure n = 31, process n = 42, outcomes n = 38] and is based on scientific evidence, interdisciplinary expert consensus, and patient-oriented perspectives. The list of proposed criteria is intended to represent the position of ECCO regarding the optimum quality of care that should be available to patients. Since health care systems and regulations vary considerably between countries, this list may require adaptation at local and national levels. It is recognised that not all these criteria that have been identified as optimal will be available in every unit. However, ECCO will continue its efforts to develop and coordinate projects and initiatives that will help to guarantee optimal quality of care for all IBD patients.

Changes in inflammatory bowel disease patients' perspectives on biosimilars: A follow-up survey.

Background and aims: The aim of this survey was to find out whether the perspectives of patients with inflammatory bowel disease concerning biosimilars have changed since the publication of our last survey carried out in 2014-2015. Methods: An online survey consisting of 19 questions was made available by the European Federation of Crohn's and Ulcerative Colitis Associations between July 2018 and December 2018. Only respondents who had heard of biosimilars were asked to respond to all of the questions. Results: In total, 1619 patients with inflammatory bowel disease responded the questionnaire. Most respondents were from Europe (79%), followed by Asia (8%), South America (7%) and Africa (5%). Some 44% of them had heard of biosimilars, and only these respondents continued to the biosimilar-specific questions. Respondents worried significantly more about biosimilars being less effective than the originator (50% in current and 39% in previous survey, p = 0.0004). However, respondents were more likely to believe that biosimilars will have an impact on the management of inflammatory bowel disease (75% in current and 62% in previous survey). Conclusions: Many patients with inflammatory bowel disease remain unfamiliar with biosimilars. Although patients still worry about different aspects regarding biosimilars, they also tend to be more confident that biosimilars will have an impact on the management of their disease. More patient education is still needed to raise awareness about biosimilars.

Enhancements in Confidence, Acceptance, and Friendship at a Summer Camp for Children With Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) affects many children and adolescents in terms of their confidence, acceptance, and ability to build friendships. New Zealand held its first summer camp for children with IBD in January 2015. We obtained feedback from the campers (ages 10-18 years) in terms of their confidence, acceptance, and quality of life. We also asked what experience was most beneficial to them, whether they made new friends with IBD, and if they would attend the camp again. Thirty-six campers responded (81.8% response rate; median age 14 years [range 10-18]; 83.3% Crohn disease; 41.7% girls). Most reported that the camp improved their confidence (86.1%), acceptance (83.3%), and overall quality of life (75.0%) relating to IBD. Moreover, most reported that meeting their fellow campers was the most beneficial experience to come from the camp (72.2%). Overall, these results emphasize the importance and relevance of such an undertaking.

Patient Perspectives on Biosimilars: A Survey by the European Federation of Crohn's and Ulcerative Colitis Associations.

BACKGROUND AND AIM: The aim of this survey was to find out the patients' perspectives concerning biosimilars. METHODS: An online survey consisting of 14 questions was made available between November 2014 and October 2015. Only respondents who had heard of biosimilars were asked to respond the final twelve questions. RESULTS: A total of 1181 patients responded. Of these, 38% had heard of biosimilars. The respondents worried about biosimilars' safety profile [47.0%], efficacy [40.3%], and molecular basis [35.0%]. Only 25.2% of the respondents had no concerns about biosimilars. Just over half [55.9%] of the respondents thought that the lower cost of the biosimilars should not come before their safety and efficacy. Only 12.5% of respondents felt that extrapolation made sense. The survey showed that 39.9% felt that patients should be systematically informed, and 26.7% felt that patient associations should be informed and able to give their opinions. It also revealed that 20.9% of the respondents would be against the idea of interchangeability if the patient was not aware; 65.7% of the respondents would want to know whether they were receiving the reference drug or the biosimilar, and have all necessary information in writing before the drug was administered. Only 31.0% of the respondents would be fully confident about biosimilars, even if they were prescribed and explained by the treating physician. CONCLUSIONS: Most patients were not familiar with biosimilars, and those who were had doubts and concerns about the biosimilars' safety and efficacy. The patients wished to be informed and involved in decision-making concerning biosimilars.

IBD and health-related quality of life -- discovering the true impact.

BACKGROUND AND AIMS: Although inflammatory bowel diseases (IBD) significantly impact the patient's quality of life, no European-level data exists on patients' perspectives. The primary objective of this survey was to obtain an international perspective of the impact of IBD on patients' lives. Secondary objectives included obtaining a better understanding of the quality of care, access to care, and differences between countries, age groups, and sub-groups of IBD. METHODS: The survey questionnaire consisted of 52 questions in six categories. The survey was translated into ten languages, tested on volunteers, and promoted across 25 national IBD associations. Data was collected anonymously online, and participation was optional. RESULTS: 4670 patients completed the survey. Most respondents received a final diagnosis within a year from noticing first symptoms, but 67% had to visit emergency clinic at least once before diagnosis. 85% had been hospitalized in the last five years. 64% felt that gastroenterologists should ask more probing questions and 54% that they did not get to tell something potentially important to their physician. Most respondents experienced symptoms weekly also in remission. Most had been absent from work due to IBD and 24% had received unfair comments about their work performance. 45% felt that IBD had negatively affected their performance in educational settings. CONCLUSIONS: The results of this survey can be used in defining strategic priorities and planning projects and awareness raising activities. The unmet needs of IBD patients can be better demonstrated and communicated to the public, health service managers and politicians.

A randomized double-blind placebo-controlled pilot study to assess the efficacy of a 24-week topical treatment by latanoprost 0.1% on hair growth and pigmentation in healthy volunteers with androgenetic alopecia.

BACKGROUND: Latanoprost is a prostaglandin analogue used to treat glaucoma. It can cause adverse effects, such as iridial and periocular hyperpigmentation, and eyelash changes including pigmentation and increased thickness, length, and number. Latanoprost has been used to treat eyelash alopecia, but knowledge on its effects on human scalp hair growth is not available. OBJECTIVE: The primary objectives were to assess the efficacy of latanoprost on hair growth and pigmentation. The secondary objectives were to assess the effect on scalp pigmentation; investigate the treatment duration needed to affect hair growth, hair pigmentation, and scalp pigmentation; and assess safety of latanoprost. METHODS: Sixteen men with mild androgenetic alopecia (Hamilton II-III) were included. Latanoprost 0.1% and placebo were applied daily for 24 weeks on two minizones on the scalp. Measurements on hair growth, density, diameter, pigmentation, and anagen/telogen ratio were performed throughout the study. RESULTS: At 24 weeks, an increased hair density on the latanoprost-treated site was observed compared with baseline (n = 16, P < .001) and placebo-treated site (P = .0004). LIMITATIONS: Only young men with mild androgenetic alopecia were included. The results may not be applicable to other patient groups. Choice of investigational site may have affected the results. CONCLUSIONS: Latanoprost significantly increased hair density (terminal and vellus hairs) at 24 weeks compared with baseline and the placebo-treated area. Latanoprost could be useful in stimulating hair follicle activity and treating hair loss.

Effect of baby swimming and baby lotion on the skin barrier of infants aged 3-6 months.

BACKGROUND: Skin care is important especially in infancy as the skin barrier matures during the first year of life. We studied the effects of baby swimming and baby lotion on the skin barrier function of infants. SUBJECTS AND METHODS: 44 infants aged 3-6 months were included in this mono-center prospective study. The healthy infants swam four times and were randomized to group(L) : baby lotion was applied after swimming all over the body and to group(WL) : no lotion was used. Transepidermal water loss, stratum corneum hydration, skin-pH and sebum were measured on four body regions using non-invasive methods. RESULTS: In group(L), sebum and pH remained stable. In group(WL), significant decrease in sebum was noted on forehead and thigh, and for pH on thigh and buttock. Group(L) had fewer infants with at least one adverse event compared to group(WL). Location-dependent gender differences in skin barrier function were observed. CONCLUSIONS: Reaction of skin barrier function to baby swimming and skin care regimens showed typical regional variability between body areas. Influence of baby lotion on skin barrier and gender differences in skin functional parameters were demonstrated for the first time in healthy infants participating in baby swimming.

[Gender: new methodological approaches in guideline development]. / Gender: Neue methodische Herausforderungen bei der Leitlinienentwicklung.

Gender and diversity have a strong impact on health and illness as evidenced by sex and gender differences in the onset and progression of diseases as well as in diagnosis, therapy, and therapeutic outcome. The number of sex/gender-specific studies in medicine has increased steadily in recent years, indicating sex (biological) and gender (social) differences in numerous diseases. Despite this evidence, however, sex/gender differences are rarely considered in medical practice or in health systems, suggesting a delay in transferring such research into evidence-based medical treatment. Similarly, quality improvement guidelines in medical care do not systematically integrate the sex/gender perspective. Against this backdrop, this paper seeks to enumerate the necessary components of a guideline development and evaluation process that systematically integrates sex/gender differences in addition to providing a sex/gender-based methodological approach. The latter is illustrated by a pilot study in which four international guidelines on depression were selected. The sex/gender appropriateness of these guidelines was analysed using two methods: first, sex/gender-relevant words were counted; and second, relevant sex/gender differences were summarised based on a systematic literature review and then compared with the information given in the guidelines. The findings of the pilot study revealed that although strong evidence exists on sex/gender differences in depression, such research was rarely implemented in the guidelines. Given the scope and potential of guidelines to improve the quality of health care, it is essential that they consider the crucial role of sex/gender differences. To date, sex/gender differences have been insufficiently addressed in guideline development and evaluation when they should be an integral component of the process.