They also have serious side effects and can be toxic. But now a new medicine called Dupilumab has shown great promise in current clinical trials. Up to 38 percent of trial participants were completely cleared or almost cleared of their inflamed red and scaly skin patches after a week course of treatment. As a group, they experienced significant decreases in itchiness, severity of rash and improvements in depression, anxiety and quality of life.
Eczema (Atopic Dermatitis) Overview
An estimated three percent of all U. Eric Simpson, lead investigator of the phase three clinical trial, said that if all goes well, the FDA will make their decision on Dupilumab by the end of March. If approved, the drug, which is made by Sanofi and Regeneron, will hit the market shortly after that. How fast is this track?
Typically, new drugs can take up to two years to approve after a successful phase three trial. Simpson and co-investigators from around the world conducted two independent, randomized and double-blind trials to test Dupilumab in a total of 1, participants with moderate to severe atopic dermatitis, which is the most common form of eczema. The subjects were randomized into three groups: those who received a placebo injection, those who received weekly Dupilumab shots, and those who received Dupilumab shots every other week.
At the end of 16 weeks, researchers in both trials found that 36 to 38 percent of the participants who received the weekly or fortnightly shot either saw eczema lesions completely cleared from their body, or saw almost all of them cleared. Serious eczema can lead to profound misery in people who have the condition.
The itch can be so intense that people struggle to sleep or concentrate at work or school. But trial participants who received the real medicine reported improvements in sleep, anxiety, depression and quality of life after going through the trial. Outcome methodology for atopic eczema has been a relatively neglected and unstandardized area of research, with a bias toward objective measurements deemed to be important by physicians rather than patient-centered assessments.
Interpreting what a change in a score of 12 of actually means in terms of patient morbidity can be extremely difficult.
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Furthermore, these scoring systems are primarily designed for clinical trial work and are generally too time-consuming for routine use in the outpatient clinic or for monitoring patient responses in general practice. These measures potentially provide a more holistic and relevant evaluation of the impact of health care intervention. Compared with other chronic diseases such as asthma 10 , 11 and rheumatoid arthritis, 12 where patient-oriented symptom measurements have been successfully developed and incorporated into clinical practice, patient-based assessments in atopic eczema remain underused or neglected.
In our recent review of atopic eczema RCTs 93 trials , patient symptoms were assessed using a wide range of scales with no standardized scoring system identified and were restricted to an assessment of itch alone or itch and sleep disturbance in more than three quarters of the trials. We performed this study to investigate which atopic eczema symptoms are important to patients, to develop a simple patient-oriented eczema measure POEM for research purposes, and to assist health care professionals such as general practitioners, dermatologists, pediatricians, and specialist nurses caring for patients in routine clinical practice.
Patients were recruited from primary and secondary care settings using 5 local general practices and the outpatient Department of Dermatology at the University Hospital in Nottingham, England. Secondary care patients were recruited consecutively from the dermatology outpatient clinic. Ethical permission for the study was obtained from the Local Ethics Committee before commencement of the study.
Thirty-five patients were recruited from primary and secondary care settings for qualitative semistructured interviews by a single interviewer C. Identified symptoms were incorporated into a questionnaire that was administered to patients with atopic eczema at interview examples and the format of these questions are available from the authors on request. The aims of this questionnaire were 1 to establish the frequency of each symptom using a 5-point scale , because measuring symptoms that occurred very rarely or every day in most of the patients would provide poor discrimination between individuals in the final outcome measure; 2 to investigate whether some symptoms were more important than others to patients using a 5-point scale ; and 3 to assess the clarity of the questions and identify symptoms that were difficult to understand or assess as part of a questionnaire.
A 1-month recall period was used to capture relatively infrequent but important symptoms. Patients were given the opportunity to add other symptoms that they felt were important. We computed and tabulated the percentage of respondents falling into each frequency and morbidity category for each symptom. We used the Spearman rank correlation coefficient to assess the association between frequency and morbidity for each symptom. Those symptoms confirmed to be important and comprehensible in the above sample were then incorporated into a POEM allowing patients to record how frequently they experienced each symptom on a 5-point scale.
Although a 1-month recall period had been used to obtain preliminary information on the frequency of symptoms, a 1-week recall period was considered more appropriate for the final outcome measure, to monitor short-term changes in clinical trials and daily practice. The POEM was given to an additional patients recruited from the outpatient clinic.
In addition, all patients were asked to assess how much overall bother their eczema had caused them during the 1-week period on a scale of 0 to 10 and to rate the global severity of their eczema on a 5-point scale clear, mild, moderate, severe, or very severe. The frequency distribution of scores was computed and tabulated. Repeatability was tested by asking 50 additional patients from the outpatient clinic to complete the new patient-oriented measure twice, 24 to 48 hours apart. To minimize recall bias, patients were not informed that they would need to repeat the questionnaire.
Test-retest repeatability was analyzed using the method suggested by Bland and Altman. During development of the POEM, sensitivity of 6 of the variables was also assessed in an RCT of topical corticosteroid use in children aged years with atopic eczema.
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Of the 35 patients interviewed, 24 were recruited from secondary care and 11 from primary care settings, with eczema severities ranging from mild to very severe global assessment by a dermatologist [C. During the interview, the following 10 symptoms were identified by patients:. The questionnaire was completed by patients from secondary care and 90 patients from primary care age range, years; median age, 10 years. No additional symptoms were identified by patients in this part of the study.
The frequency of symptoms during the 1-month period is shown in Table 1. Dryness, redness, itching, and soreness were the most commonly occurring symptoms in responding patients from the hospital and community settings. No symptoms were predominantly endorsed in 1 response category only, and therefore each could potentially provide useful information in the final outcome measure. The morbidity bother caused by each symptom was strongly related to how frequently patients experienced the symptom.
For example, sleep disturbance did not bother patients whose nights were only occasionally disturbed as much as those whose sleep was disturbed regularly.
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Therefore the amount of bother caused by each symptom was assessed only in patients experiencing the symptom on most days or every day of the month Table 2. Redness was found to be particularly difficult to assess for patients with Afro-Caribbean or Asian skin type. These 2 symptoms were therefore excluded from the final outcome measure. Retention of soreness in the outcome measure would have necessitated a separate scoring system excluding soreness for children younger than 4 years. Questions concerning the remaining symptoms were completed by all patients.
The retained 7 symptoms were incorporated into a simple POEM that allowed patients to record how frequently they experienced each symptom during a 1-week period, with a maximum score of 28 Figure 1. Weighting of individual symptoms was not used to keep the measure simple and practical. An additional patients aged 12 months to 69 years; median age, 9 years completed the POEM.
Scores for the 7 symptoms are shown in Table 3 , with dryness and itching being the most common symptoms and bleeding and weeping the most infrequent. Content validity of the new scoring system was demonstrated by the fact that the measured domains were derived from patients themselves, with no further symptoms identified among the patients questioned.
Construct validity measures agreement with other related variables, in this case patient assessments of disease-related quality of life. Criterion validity ideally involves correlation against a gold standard measure. Fifty patients age range, 12 months to 62 years; median age, 8.
The Bland and Altman plot is shown in Figure 2. The mean of the differences between scores was 0. The new measure was completed by 40 new outpatients age range, years; median age, 4 years at 0, 1, and 4 weeks, as shown in Figure 3. All 7 symptoms showed a mean decrease during the 4-week period, although dryness was slower to improve than other variables such as itch.
All variables tested during the week topical corticosteroid RCT showed an improvement Figure 4 , with itching and dryness falling by more than a third.
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Scores for other variables also decreased but were generally low at baseline, reflecting the mild-to-moderate disease spectrum of patients in the trial. The POEM is a simple, valid, easily interpreted, and reproducible tool for assessing atopic eczema and monitoring aspects of the disease that are important to patients. One could argue that designing a scale containing a number of different variables is a roundabout way of assessing disease severity. Why not just ask patients for a global assessment of their disease severity?
Direct global assessments eg, mild, moderate, and severe or visual analog scales can provide a useful overview of disease severity, but a single question may be more subject to individual external influences than a scale containing a number of items that require the patients to think about their disease in more detail.
Global scales can also lack the sensitivity to detect small but clinically important changes in severity, and they do not provide information on how individual aspects of the disease change with treatment. By measuring symptom frequency rather than overall severity, the POEM can provide useful information about the pattern of relapses and remissions, the periodicity of which is more rapid than in other inflammatory skin diseases such as psoriasis and can be difficult to capture by intermittent clinical examination.
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Patient diaries for daily recording of symptoms could be used to further supplement the POEM, but were not used in the development of the outcome measure.