Proof-of-concept study of anti-Fel d 1 IgY antibodies in cat food using the MASK-air® app.

BACKGROUND: An innovation to better manage cat-allergic patients utilises anti-Fel d 1 IgY antibodies to neutralise Fel d 1 after its production by the cat. However, there is no published study showing its clinical efficacy in humans in a home setting. A longitudinal, open-label, proof-of-concept study was carried out to approach clinical efficacy of the cat food in cat-allergic patients. METHODS: After a baseline evaluation, the cats ate only the cat food for the following 4 months. Daily evaluation of efficacy was performed for 2 weeks at baseline and after 1, 2 and 3 months of intervention for periods of 2 weeks. The MASK-air app was used daily to assess symptoms, work productivity and medications. RESULTS: Of the 49 patients screened, 42 were followed up and 33 (78.5%) reported MASK-air data at all 3 evaluation periods. The primary end point (visual analogue scale [VAS] for global allergy symptoms) was significantly improved (p < 0.0001). All symptoms (VAS nose, eye, and asthma), VAS work and the combined symptom-medication score significantly improved after 1 month. The percentage of uncontrolled days (VAS>20/100) decreased from 64% at baseline to 35% at 1 month (p < 0.0001) and 14% at 3 months. A sensitivity analysis in patients with uncontrolled disease at baseline found similar results. DISCUSSION: A cat diet containing anti-Fel d 1 antibodies was able to (i) show decreased allergic symptoms and related outcomes, (ii) inform the design and feasibility of future studies with a control arm and (iii) estimate the sample size of the study. STUDY REGISTRATION NUMBER: clinicaltrials.gov: NCT05656482.

Valitrack study: Objective evaluation of medical compression wearing time and patient activity with the Accutrack® by Sigvaris Group sensor.

INTRODUCTION: Objective measurement of compliance is mandatory to evaluate therapeutic effects and clinical benefits of medical compression stockings. This Valitrack study evaluates the Accutrack sensor equipped with an accelerometer. The evaluation is done under controlled and free conditions and during washing. RESULTS: Global accordance results are excellent: Sensitivity (98.6%) and specificity (95.2%) and 92% of patients are not disturbed by the sensors when putting on the stockings. DISCUSSION: Thanks to its specificities one sensor per patient is sufficient. Its sensitivity distinguishes still and active positions. Only hand washing remains a false positive. The Accutrack sensor objectively measures compliance and will not be a bias because 96% of patients forget it. CONCLUSIONS: Objective compliance measurement with Accutrack allows us to evaluate the efficacity of compression, the reasons of non-compliance, and the patient's actual physical activity according to its accelerometer time-stamped.