scholarly journals Early responders within seven days of dupilumab treatment for severe asthma evaluated by patient-reported outcome: a pilot study

2021 ◽  
Vol 16 ◽  
Author(s):  
Nozomi Tani ◽  
Nobutaka Kataoka ◽  
Yusuke Kunimatsu ◽  
Yusuke Tachibana ◽  
Takumi Sugimoto ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Severe Asthma ◽  
Early Response ◽  
Patient Reported Outcome ◽  
Forced Expiratory Volume ◽  
Response To Treatment ◽  
Severe Atopic Dermatitis ◽  
Asthma Control Test ◽  
Rapid Improvement ◽  
Patient Reported

Background: The management of severe asthma-associated symptoms is essential since they are distressing to the affected patients, and also greatly impair their quality of life. Dupilumab, a monoclonal antibody, blocks interleukin (IL)-4 and IL-13 signaling, both of which are crucial in acquired and innate immunity pathways through fast signal transduction, leading to an early response to treatment. Although rapid improvement within 1–3 days after dupilumab treatment was observed in moderate-to-severe atopic dermatitis, an early response within 7 days of dupilumab treatment in severe asthma has not been reported. Methods: Twelve consecutive patients with severe asthma who were newly treated with dupilumab between July 2019 and April 2020 were retrospectively investigated. We evaluated the early response (within 7 days) of patients with severe asthma receiving dupilumab therapy. Asthma control test (ACT) and the daily ACT, which was modified from the ACT to evaluate daily symptoms associated with asthma, were adopted as patient-reported outcomes (PROs) at week 8 and within 7 days, respectively. Patients were stratified into early responders (7 days), late responders (week 8), and non-responders without significant improvement in PROs. Descriptive statistics were adopted due to the limited number of patients.Results: Four of these 12 patients were early responders, with the following baseline characteristics: body mass index, <25 kg/m2; without depression; baseline forced expiratory volume in 1 second, <1.50 L; and more than one exacerbation in 1 year. On the other hand, five were late responders, and 44.4% of the nine responders were early responders. The higher the eosinophilic count and/or FeNO did not show any relationship between the early responder and nonresponder.Conclusions: The effect of dupilumab on severe asthma in patients with atopic features could be started earlier than 2 weeks, similar to atopic dermatitis. Daily ACT may be useful in monitoring the early efficacy of dupilumab in treating severe asthma.

scholarly journals Patient Reported Outcome Measure in Atopic Dermatitis Patients Treated with Dupilumab: 52-Weeks Results

2021 ◽  
Author(s):  
Servando E. Marron ◽  
Lucia Tomas-Aragones ◽  
Carlos A. Moncin-Torres ◽  
Manuel Gomez-Barrera ◽  
Francisco Javier Garcia-Latasa de Aranibar
Keyword(s):  
Quality Of Life ◽  
Atopic Dermatitis ◽  
Clinical Practice ◽  
Stressful Life Events ◽  
Severe Disease ◽  
Patient Reported Outcome ◽  
Routine Clinical Practice ◽  
Severe Atopic Dermatitis ◽  
Patient Reported

Dupilumab is used to treat atopic dermatitis patients who have proven to be refractory to previous treatments. The aim of this study was to assess evolution and patient reported outcome measures in adult patients with moderate-to-severe atopic dermatitis treated with Dupilumab in routine clinical practice. The outcomes were evaluated and registered at baseline and weeks-16, 40 and 52. The variables evaluated were: diseases severity, pruritus, stressful life events, difficulty to sleep, anxiety and depression, quality of life, satisfaction, adherence to the treatment, efficacy and safety. Eleven patients were recruited between Nov 14th 2017 and Jan 16th 2018. Demographic variables: 90% Caucasian, 82% women. Clinical variables: Mean duration of AD =17.7 (&plusmn;12.8), 91% had severe disease severity. At baseline, SCORAD mean score = 61.7 (&plusmn;15.5); itch was reported by 100% of patients; itch Visual Analogue Scale mean range of 8 (6-10); HADS mean total score =13.9 (&plusmn;5.5); DLQI mean score =13.3 (&plusmn;8.3): EQ-5D-3L mean range = 57 (30-99). At week-52 there is a significant reduction of SCORAD scores, HADS total score and improved quality of life. &iexcl;This study confirms that Dupilumab, used for 52-weeks under routine clinical practice, maintains the improved atopic dermatitis signs and symptoms obtained at week-16, with a good safety profile.

Inhibition of IL-13: A New Pathway for Atopic Dermatitis

2020 ◽  
pp. 120347542098255
Author(s):  
Kayadri Ratnarajah ◽  
Michelle Le ◽  
Anastasiya Muntyanu ◽  
Steve Mathieu ◽  
Simon Nigen ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Atopic Dermatitis ◽  
Severity Index ◽  
Severe Atopic Dermatitis ◽  
Treatment Alternative ◽  
Control Groups ◽  
Rapid Improvement ◽  
Common Receptor ◽  
The Common ◽  
And Control

Dupilumab, a monoclonal antibody against the common receptor of interleukin (IL)-4 and IL-13, was the first biologic therapy approved in Canada for treatment of moderate-to-severe atopic dermatitis (AD). While it is considered safe and effective, dupilumab is not universally effective and 8%-38% of patients develop conjunctivitis, while some patients develop head and neck dermatitis. Thus, new therapeutic options are warranted. While both IL-4 and IL-13 play important roles in the pathogenesis of AD, it has been recently demonstrated that IL-13 is the primary upregulated cytokine in AD skin biopsy samples. A placebo-controlled phase 2b clinical trial evaluating the efficacy and safety of lebrikizumab, an IL-13 inhibitor, in AD demonstrated that, at 16 weeks, Eczema Area and Severity Index (EASI) 75 and Investigator’s Global Assessment (IGA) 0/1 were achieved by 60.6% and 44.6% of patients taking lebrikizumab at its highest dose (vs 24.3% and 15.3% of patients taking placebo, respectively). Moreover, treatment with lebrikizumab was associated with rapid improvement of pruritus and low rates of conjunctivitis (1.4%-3.8%). Another IL-13 monoclonal antibody, tralokinumab, was evaluated for safety and efficacy in moderate-to-severe AD. By week 12, among adults receiving 300 mg tralokinumab, 42.5% achieved EASI-75 and 26.7% achieved IGA 0/1 score (vs 15.5% and 11.8% in the placebo group, respectively). Both lebrikizumab and tralokinumab demonstrated acceptable safety profiles in AD (and non-AD) trials with adverse events often being comparable between treatment and control groups. Thus, IL-13 inhibitors may provide a safe and effective treatment alternative for patients with moderate-to-severe AD.

Patient reported outcome measures in cardiovascular disease

ESC CardioMed ◽  
2018 ◽  
pp. 1399-1402
Author(s):  
Ran Kornowski ◽  
Eli I. Lev
Keyword(s):  
Coronary Revascularization ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Clinical Encounter ◽  
Normal Function ◽  
Response To Treatment ◽  
Cardiac Events ◽  
Clinical Workflow ◽  
Patient Reported ◽  
Revascularization Procedures

The patient reported outcome measure (PROM) initiative focuses on what matters to patients following medical interventions, a perspective that is often ignored or missed by the treating physicians. PROM questionnaires encompass what occurs outside the clinical encounter, such as symptom severity, the response to treatment, undesirable side effects, returning to normal function, perceived needs, and what really matters to patients in their ordinary environment. This topic is of prime importance in cardiovascular medicine, as it encompasses chronic diseases with exacerbation and various cardiac interventions. PROMs and quality of life questionnaires have been utilized mostly in congestive heart failure syndromes and following surgical and catheter-based coronary revascularization procedures. Improved scores influenced by age or sex have been obtained following revascularization procedures. Poor PROMs are specifically related to subsequent cardiac events and all-cause mortality. Some hurdles challenging the routine use of PROMs include the feasibility of implementation into the clinical workflow and getting medical staff engaged in the project. Overcoming these challenges may enable significant improvement in patient care and patient-centred cardiovascular outcomes.

scholarly journals Development and validation of a set of patient reported outcome measures to assess effectiveness of asthma prophylaxis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yalini Guruparan ◽  
Thiyahiny S. Navaratinaraja ◽  
Gowry Selvaratnam ◽  
Nalika Gunawardena ◽  
Shalini Sri Ranganathan
Keyword(s):  
Asthma Control ◽  
Operating Characteristic ◽  
Characteristic Curve ◽  
Patient Reported Outcome ◽  
Forced Expiratory Volume ◽  
Alpha Coefficient ◽  
Focus Group Discussions ◽  
Group Discussions ◽  
Resource Limited ◽  
Patient Reported

Abstract Background In the local setting, asthma control is assessed by symptoms and signs elicited by clinicians because of the limited availability of spirometry. Hence, we intended to develop a patient reported outcome measure (PROM) with more holistic interpretation that could also serve as a tool to measure the asthma control in resource limited settings. Therefore, this study was carried out in Northern Sri Lanka to develop and validate the Asthma Control PROM (AC-PROM) Tamil to measure the effectiveness of asthma prophylaxis based on symptoms, exacerbation and limitation of activity which could also serve as an easy measure of asthma control to the provider. Methods The AC-PROM Tamil was developed in 3 steps: item generation, item reduction and psychometric evaluation. Items were generated through thematic analysis from focus group discussions among patients with asthma. Items were converted to an interviewer administered questionnaire in Tamil in the format of 5-point Likert scale. Item reduction was done by two rounds of online Delphi surveys among 10 experts and an exploratory factor analysis among 200 patients with asthma. The face and content validity were assessed by a panel of experts during Delphi survey and patients during the pre-test of the tool. Criterion validity of the tool was assessed against the forced expiratory volume in one second of 187 patients with asthma. The cut-off value to assess the asthma control was determined by receiver operating characteristic curve. Reliability was verified by Cronbach’s alpha coefficient. Results From thematic analysis of focus group discussions 10 items were generated. One item was removed during Delphi survey. Exploratory factor analysis indicated removal of another item with 8 items categorised into two factors. Cronbach’s alpha coefficient of factors 1 and 2 were 0.821 and 0.903 respectively, indicating good reliability. Observations made by experts and responses made by patients were incorporated to improve the clarity and relevance of the items. Criterion validity was demonstrated by significant correlation between the AC-PROM Tamil and forced expiratory volume in one second (r = 0.66, p = 0.001). The cut-off value of the AC-PROM Tamil to detect asthma control was 28.5 with 79% (95% CI 71.3–86.9) sensitivity and 71% (95% CI 61.9–79.6) specificity. The AC-PROM Tamil showed moderate accuracy (the area under the receiver operating characteristic curve = 0.796; 95% CI 0.73–0.86). Response rate of the AC-PROM Tamil was 100% and time taken to complete was 3–4 min. Conclusion The AC-PROM Tamil is a simple, feasible and reasonably accurate tool to assesses the effectiveness of asthma prophylaxis, particularly in resource limited settings.

scholarly journals Influence of dupilumab on the economic burden of severe asthma and atopic dermatitis

2020 ◽  
pp. 15-26
Author(s):  
I. S. Krysanov ◽  
V. S. Krysanova ◽  
O. I. Karpov ◽  
V. Yu. Ermakova
Keyword(s):  
Atopic Dermatitis ◽  
Severe Asthma ◽  
Economic Burden ◽  
Weighted Average ◽  
Indirect Costs ◽  
Current Treatment ◽  
Severe Atopic Dermatitis ◽  
Local Conditions ◽  
Economic Burden Of Disease

The prevalence of comorbidity — asthma and atopic dermatitis — is not understood well yet. More severe processes decreasing quality of life and increasing a social-economic burden of disease are occurred in such kind comorbidity.Aim: an evaluation of economic burden of non-control severe asthma in combination with severe atopic dermatitis in the local conditions.Materials and methods. Analysis has been performed for adult patients; the bottom-up approach of costs evaluation was used. Direct medical and non-medical as well as indirect costs were calculated for two models: Model 1 — current practice of the treatment, Model 2 — treatment with Dupilumab. Results. Model 1 — Weighted average expenditures for one patient were 3,1 mln RUR, indirect costs were dominated (76 % from the total), severe atopic dermatitis had 15 % of total. Model 2 (with Dupilumab) — Dupilumab has decreased the total weighted average cost on 903 905 RUR. The total economic burden of comorbidity was 17,6 bln RUR in the current treatment option, and 12,4 bln RUR in Dupilumab hand (different is 5,2 bln RUR, or burden decrease is expected on 29,2 %).Conclusion. The wider introduction of Dupilumab into clinical practice, which allows achieving control in the treatment of severe asthma and severe atopic dermatitis, should reduce treatment costs and reduce the socio-economic burden of these diseases as a result.

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