A Retrospective Nationwide Non-Interventional Study of an Aqueous Sublingual Immunotherapy Formulation Administered with a 200-µL Dosing Pump.

BACKGROUND: Convenient dosing is a key component of treatment adherence and thus efficacy and safety. Aqueous sublingual immunotherapy (SLIT) formulations can be administered with a dosing pump that delivers 200 µL of volume per actuation. OBJECTIVE: The objective of this study was to describe the use of Staloral® 300 Rapid in its new dosing pump presentation and to evaluate the safety and satisfaction from both the patient and doctor. PATIENTS AND METHODS: We performed a retrospective non-interventional study in a population (aged 5 years or over) of individuals with allergic rhinitis or allergic asthma who were being treated with aqueous 300 index of reactivity SLIT formulations of various allergens (grass pollen, tree pollen, house dust mites). Based on a detailed, SLIT-specific, patient self-questionnaire (Quartis®) and the inspection of medical records, we assessed the characteristics of the SLIT, safety, patient satisfaction and willingness to continue SLIT. The physician's satisfaction with the treatment was measured on a 0-100 visual analogue scale. Adverse events were coded with the Medical Dictionary for Regulatory Activities. RESULTS: A total of 801 valid patients were included (52.4% male; mean ± standard deviation age: 25.9 ± 17.2 years; mean time since diagnosis: 4.56 ± 4.68 years; mean time using the previous dosing pump: 19.2 ± 13.0 months; time using the 200-µL dosing pump: 14.95 ± 3.80 months). Among the study population, 317 subjects comprised the paediatric subgroup (57%: male; mean age: 9.8 ± 2.5 years). Overall, 54 patients (6.7%) reported a total of 68 adverse events (including 51 gastrointestinal adverse events). The large majority of adverse events were mild, local and transient and did not require treatment. There were no severe adverse events. The level of patient satisfaction with the ease of SLIT administration was high (84.3% overall, and 82.6% in the paediatric subgroup). The mean ± standard deviation visual analogue scale score for physician satisfaction with the treatment was 70.6 ± 25.1 out of 100. CONCLUSIONS: Administration of 300 index of reactivity SLIT with a 200-µL dosing pump is safe, well tolerated and associated with good levels of patient satisfaction.

Hypersensitivity to alemtuzumab. A safe and effective desensitization protocol: A case report.

We describe a successful desensitization to alemtuzumab in one patient diagnosed with T-cell prolymphocytic leukaemia. Alemtuzumab treatment was initiated during infusion number 18, the patient showed cutaneous eruption with a miliary pattern, despite premedication with corticosteroids and antihistamines. The eruption returned with successive alemtuzumab infusions (infusions 19, 20 and 21), remained present for longer and was more severe with each infusion. The patient was referred to our Allergy Unit as it was necessary to maintain alemtuzumab treatment. Total immunoglobulin E level was 3 UI/ml and specific immunoglobulin E against more common pneumo-allergens, food, latex and hamster were inferior to 0.35 UI/ml. Prick test using the undiluted drug (30 mg/ml) and intradermal tests using serial dilutions (1/10, 1/100) were performed. The result of alemtuzumab skin prick test was 4 mm. The intradermal skin test result was positive at 1/100 dilution (papule: 8 mm; erythema: 12 mm). The basophil activation test with alemtuzumab was performed concluding that 10% of the basophils were activated by alemtuzumab. The patient underwent alemtuzumab desensitization according to a 12-step protocol that resolved to be safe and efficacious. Our experience may be helpful for similar clinical cases where the therapeutic options are very limited and a life-threatening condition such T-cell prolymphocytic leukaemia is present. In addition, a careful risk/benefit ratio should be considered and accurate informed consent is mandatory.

Exposición a contaminantes ambientales y patología respiratoria / Exposure to environmental contaminants & respiratory pathology

Objetivo: Tras la aparición de 5 casos con sintomatología respiratoria en una empresa aeronáutica y su exposición a diferentes sustancias químicas, nos propusimos investigar su posible relación con el medio laboral. Material y métodos: Se realizaron mediciones ambientales de polvo de aluminio, tricloroetileno y glicol, estudio alergológico con dichas sustancias además de neumoalergenos y tests epicutáneos con batería estándar europea, análisis de sangre, radiografías de tórax, mediciones de flujo pico y pruebas funcionales respiratorias, test de metacolina y electrocardiograma. Resultados: La medición del flujo pico y el test de hiperreactividad bronquial directo con metacolina fueron negativos. El estudio alergológico de las sustancias expuestas fue negativo detectándose en 3 casos resultados positivos a neumoalergenos. Conclusiones: La negatividad en las mediciones del flujo pico y el test de metacolina estando el trabajador en activo, prácticamente descartarían un cuadro de asma laboral, en la actualidad. No podemos descartar la posibilidad concomitante de un Síndrome de disfunción reactiva de la vía aérea en un momento previo al estudio. En tal caso, la existencia de una hiperreactividad bronquial inicial podría haber cedido sin llegar a objetivarse en la actualidad con metacolina. La creación de equipos multidisciplinarios es fundamental para la detección de enfermedades respiratorias de posible origen laboral

Target: After the appearance of 5 cases with respiratory symptoms in an aeronautical company and their exposal to different chemical substances, we proposed to investigate their possible link with the working environment. Material and methods: Aluminium environmental dust measurements, trichloroethylene and glycol, alergic study with these substances as well as with aero alergens and epicutaneos tests with a european standard accumulator were made, blood analysis, thorax x-rays, peak-flow measurements and functional respiratory tests, Methacholine test and electrocardiogram. Results: The peak-flow measurement and the direct bronchial hyperactivity test using metacholine were negative. The alergic tests performed were generally negative with the exception of 3 positive results concerning aero alergens test. Conclusions: The negative results of the peak-flow measurements and the metacholine test of an active worker, would practically disguard a cadre of work related asthma, at the present time. We cannot discard the concomitant possibility of a reactive disfunction syndrome via the aerial route in a precise moment of time previous to the study. In such case, the existence of an initial bronchial hyperreactivity could have yielded finally not being detectable with metacholine. The creation of multidisciplinary equipment is fundamental for the detection of respiratory diseases of possible work origin