Abstract Background Biologic asthma therapies reduce exacerbations and long‐term oral corticosteroids (LTOCS) use in randomized controlled trials (RCTs); however, there are limited data on outcomes among patients ineligible for RCTs. Hence, we investigated responsiveness to biologics in a real‐world population of adults with severe asthma. Methods Adults in the International Severe Asthma Registry (ISAR) with ≥24 weeks of follow‐up were grouped into those who did, or did not, initiate biologics (anti‐IgE, anti‐IL5/IL5R, anti‐IL4/13). Treatment responses were examined across four domains: forced expiratory volume in 1 second (FEV 1 ) increase by ≥100 mL, improved asthma control, annualized exacerbation rate (AER) reduction ≥50%, and any LTOCS dose reduction. Super‐response criteria were: FEV 1 increase by ≥500 mL, new well‐controlled asthma, no exacerbations, and LTOCS cessation or tapering to ≤5 mg/day. Results 5.3% of ISAR patients met basic RCT inclusion criteria; 2116/8451 started biologics. Biologic initiators had worse baseline impairment than non‐initiators, despite having similar biomarker levels. Half or more of initiators had treatment responses: 59% AER reduction, 54% FEV 1 increase, 49% improved control, 49% reduced LTOCS, of which 32%, 19%, 30%, and 39%, respectively, were super‐responses. Responses/super‐responses were more frequent in biologic initiators than in non‐initiators; nevertheless, ~40–50% of initiators did not meet response criteria. Conclusions Most patients with severe asthma are ineligible for RCTs of biologic therapies. Biologics are initiated in patients who have worse baseline impairments than non‐initiators despite similar biomarker levels. Although biologic initiators exhibited clinical responses and super‐responses in all outcome domains, 40–50% did not meet the response criteria.
En France, l'usage des bases de donnees medico-administratives dans le cadre epidemiologique est recent comparativement a d'autres pays d'Europe, du fait notamment de leur complexite, liee a leur developpement initial mene dans une optique comptable. Les travaux menes ont porte sur l'apport de ces bases de donnees a l'etude de la prise en charge et de la morbidite evitable dans l'asthme et dans l'osteoporose. Dans un premier temps, nous avons montre que ces bases de donnees permettaient au travers d'algorithmes d'identifier des nourrissons asthmatiques et leurs exacerbations, et que la prise en charge de ces nourrissons n'etait pas optimale en France, avec une forte consommation d'antibiotiques et de corticoides oraux. Nous avons prolonge ces recherches par la description de la prise en charge des asthmatiques enfants/adolescents et adultes, et les constats ont ete les memes. Une surconsommation des traitements de crise a pu etre mise en evidence, ainsi que des sous-groupes de patients a risque d'exacerbation severe. Ces resultats nous ont amene a nous interesser tout particulierement a l'adhesion aux traitements de fond. Dans une etude menee sur 5 000 patients asthmatiques, le taux de couverture par un traitement de fond etait en moyenne de 51%, et seuls 24% des patients avaient un taux de couverture superieur ou egal au taux minimal recommande (80%). Enfin, concernant l'osteoporose, nous nous sommes attaches a decrire la prise en charge des patients osteoporotiques sur une periode de 6 ans, en nous concentrant particulierement sur les changements de strategies therapeutiques
There is a need for instruments designed for patients with asthma to self-report their performance of inhaling steps. We aimed to develop an accessible and easy-to-use patient-reported tool for inhaler technique assessment, which could also serve as a training and monitoring resource for any type of inhaler device, and to evaluate its feasibility, validity, and reliability in adults with asthma. The development was based on literature review and pilot testing with clinicians and patients. The Inhaler Technique Questionnaire (InTeQ) asks about the frequency of performing five steps when using inhalers (on a five-point Likert scale). We analyzed data from adults with persistent asthma (n = 361). We examined the measurement model using Mokken scaling analysis, construct validity by assessing hypotheses on expected discrimination among known groups, and reliability based on internal consistency and reproducibility. Means of the InTeQ items were in the range of 0.23-1.61, and coefficients of homogeneity were above the cutoff point, demonstrating the unidimensionality of the scale. Known groups' global score differences were statistically significant between patients reporting having "Discussed in detail" or having "Not discussed/Only in general" the inhaler technique with their healthcare providers (p = 0.023). The Cronbach's alpha coefficient was 0.716, and the intraclass correlation coefficient was 0.775. The InTeQ is a feasible, valid, and reliable instrument for self-reporting inhaler technique on any type of device.
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