Shortened Up-Dosing With 7 Injections of Subcutaneous Allergy Immunotherapy (Alutard SQ) Is Safe and Well Tolerated

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Medical care and treatment of allergic rhinitis: a population-based cohort study based on routine healthcare utilization data.

BACKGROUND: Health services research on medical care and treatment of allergic rhinitis (AR) is scarce. OBJECTIVES: To investigate the prevalence, incidence, comorbidities, and treatment of AR in a realistic setting. METHODS: A cohort of 1 811 094 German National Health Insurance beneficiaries in 2005 was followed until 2011. To avoid misclassification, the ICD-10 code for AR (J30) had to be documented at least twice to classify patients as having AR. Descriptive statistics and logistic regression models were used to describe the burden, comorbidities, and treatment of AR. RESULTS: A total of 111 394 patients (6.2%) had prevalent AR in 2005/2006. In another 60 145 individuals (3.3%), AR was newly diagnosed in 2007 to 2011 (incident cases). Patients with prevalent AR were three times more likely to develop asthma compared to patients without AR (age and sex-adjusted risk ratio (RR) 3.04; 95% confidence interval (95%CI) 2.98-3.10). Newly diagnosed recurrent depressive disorder (RR 1.61; 95%CI 1.55-1.68), anxiety disorder (RR 1.52; 95%CI 1.48-1.56), and ADHD (RR 1.21; 95%CI 1.13-1.29) were also related to prevalent AR. Approximately 20% of children and 36% of adults with AR were exclusively treated by general practitioners. Allergy immunotherapy (AIT) was prescribed for 16.4% of patients with AR. Subcutaneous immunotherapy was most frequently used (80% of AIT). CONCLUSIONS: This study highlights the significant burden of AR. Despite the established benefits of AIT to treat AR and prevent asthma, this study suggests significant undertreatment. Future research is necessary to develop and implement adequate measures to increase guideline adherence.

Tolerability of a New Fast Updosed Immunologically Enhanced Subcutaneous Immunotherapy Formulation With an Optimized Allergen to Adjuvant Ratio Under Routine Practice Conditions: A Noninterventional Observational Study

Background and objectives: A fast updosed immunologically enhanced subcutaneous immunotherapy (SCIT) formulation with an optimized allergen to aluminium hydroxide ratio was first introduced in September 2009 in Germany. A large randomized controlled trial showed that the formulation had considerable immunologic effects and good tolerability. In this open-label, uncontrolled, noninterventional study, tolerability was investigated during routine application. Patients and methods: Patients with allergic rhinoconjunctivitis and/or asthma were treated with pollen and mite allergens using a 5-injection updosing schedule (AVANZ: 300, 600, 3000, 6000 and 15 000 SQ+ units) with weekly intervals, followed by a maintenance schedule with injections of 15 000 SQ+ units. Adverse events (AEs) were recorded by physicians, and symptoms and use of symptomatic medication were analyzed before the start of therapy and after an average 8-month treatment period. Results: SCIT was documented by 362 allergists in 1036 patients between September 2009 and February 2011. AEs mainly consisted of local reactions during updosing (in 24.5% of patients). Systemic reactions were observed during updosing (8.4%) and maintenance therapy (1.7%), the most frequent of which was dyspnea. Overall, tolerability and the effect of treatment were rated as good or very good by 94.9% and 86.6% of patients and by 96.2% and 89.6% of physicians, respectively. Conclusions: In this open-label, noninterventional study, fast updosed immunologically enhanced SCIT (AVANZ) was well tolerated in a large group of patients (AU)

Antecedentes y objetivos: En septiembre del 2009 fue introducida en Alemania una nueva formulación de inmunoterapia subcutánea (SCIT), de inicio rápido, con una relación de alérgeno /hidróxido de aluminio optimizada para mejorar su actividad. Sus efectos sobre el sistema inmune y su adecuada tolerancia han sido bien establecidos mediante un gran estudio controlado y aleatorizado. Mediante un estudio abierto, no controlado, de práctica en vida real, se ha estudiado la tolerancia de esta nueva inmunoterapia. Pacientes y Métodos: Se seleccionaron pacientes diagnosticados de rinoconjuntivitis alérgica con o sin asma, siendo tratados con extracto de pólenes o ácaros, siguiendo una pauta de inicio rápida en 5 administraciones (AVANZ®: 300, 600, 3000, 6000 and 15 000 unidades SQ+) en intervalos semanales, seguidos de un mantenimiento de 15 000 unidades SQ+. Los médicos participantes registraron los efectos adversos del tratamiento (AEs) y también se registraron el consumo de medicación de rescate y la sintomatología, antes de iniciar el tratamiento y tras un periodo medio de tratamiento de 8 meses. Resultados: En el estudio participaron 362 alergólogos y 1036 pacientes que realizaron los registros entre septiembre del 2009 y febrero del 2011. Se observó algún efecto adverso, predominantemente reacciones locales, en el 24,5% de los pacientes. Con respecto a los efectos adversos sistémicos, ocurrieron en el 8,4% de los pacientes en el periodo de inicio, y en un 1,7% de los pacientes en el periodo de mantenimiento. El efecto sistémico más frecuente fue la disnea. En conjunto, la tolerancia fue calificada como buena o muy buena por el 94,9% de los pacientes y el 96,2% de los médicos. En el mismo sentido calificaron el efecto del tratamiento el 86,6% y 89,6% respectivo. Conclusiones: Este estudio en vida real, abierto y no controlado, realizado en un gran número de pacientes, confirma que la inmunoterapia optimizada y rápida AVANZ tiene una buena tolerancia (AU)

Tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with an optimized allergen to adjuvant ratio under routine practice conditions: a noninterventional observational study.

BACKGROUND AND OBJECTIVES: A fast updosed immunologically enhanced subcutaneous immunotherapy (SCIT) formulation with an optimized allergen to aluminium hydroxide ratio was first introduced in September 2009 in Germany. A large randomized controlled trial showed that the formulation had considerable immunologic effects and good tolerability. In this open-label, uncontrolled, noninterventional study, tolerability was investigated during routine application. PATIENTS AND METHODS: Patients with allergic rhinoconjunctivitis and/or asthma were treated with pollen and mite allergens using a 5-injection updosing schedule (AVANZ: 300, 600, 3000, 6000 and 15 000 SQ+ units) with weekly intervals, followed by a maintenance schedule with injections of 15,000 SQ+ units.Adverse events (AEs) were recorded by physicians, and symptoms and use of symptomatic medication were analyzed before the start of therapy and after an average 8-month treatment period. RESULTS: SCIT was documented by 362 allergists in 1036 patients between September 2009 and February 2011. AEs mainly consisted of local reactions during updosing (in 24.5% of patients). Systemic reactions were observed during updosing (8.4%) and maintenance therapy (1.7%), the most frequent of which was dyspnea. Overall, tolerability and the effect of treatment were rated as good or very good by 94.9% and 86.6% of patients and by 96.2% and 89.6% of physicians, respectively. CONCLUSIONS: In this open-label, noninterventional study, fast updosed immunologically enhanced SCIT (AVANZ) was well tolerated in a large group of patients.

Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio.

BACKGROUND: Subcutaneous immunotherapy (SCIT) traditionally includes an updosing phase injecting increasing doses of allergen over a period of several weeks, followed by a maintenance phase. To establish shorter and more convenient updosing schedules, a fast updosed immunologically enhanced SCIT formulation has been developed by optimizing the allergen/adjuvant (aluminium hydroxide) ratio. METHODS: In a randomized, controlled, parallel-group trial, patients with grass pollen induced rhinoconjunctivitis with/without asthma were treated with an immunologically enhanced SCIT formulation (AVANZ, ALK, Denmark). The trial included updosing with five injections (300, 600, 3000, 6000 and 15,000 SQ+) injected either in weekly interval (Group 1) or in 3-4 days interval (Group 2) followed by two maintenance injections (15,000 SQ+), approximately 10 weeks treatment. The immunological effects (primary endpoint) and tolerability (secondary endpoint) of the updosing schedules were evaluated. RESULTS: Four hundred patients were treated (Group 1: 201, Group 2: 199). In both groups, an immunological response with statistically significant increases in levels of IgE-blocking factor, IgG(4) and IgE (P < 0.001), was induced from baseline to end of trial. Most frequently reported adverse events were local injection site reactions such as injection site swellings (Group 1: 30% of patients, Group 2: 41% of patients). Other frequently reported adverse events included systemic reactions (Group 1: 21% of patients, Group 2: 33% of patients), primarily mild to moderate allergic rhinitis and urticaria. CONCLUSIONS: Fast updosed immunologically enhanced SCIT with an optimized allergen/adjuvant ratio induced significant immunological effects and had an acceptable safety profile. Clinical efficacy will be investigated in future clinical trials.

[Bilateral nasal remission spectroscopy allows the side separated continuous measurement of changes in swelling of the nasal mucosa]. / Schwellungsänderungen in der Nase: Die bilaterale nasale Remissionsspektroskopie zum seitengetrennten Echtzeit-Monitoring.

INTRODUCTION: In earlier studies optical transmission spectroscopy showed that continuous monitoring of changes in the swelling of the nasal mucosa is possible. However, independent measurement in both sides of the nose cannot be achieved by this method. With the aim of achieving real-time monitoring of endonasal swelling separately for both nostrils we developed the new method of bilateral nasal remission spectroscopy for this pilot study. MATERIALS AND METHODS: In nasal remission spectroscopy, light at a wavelength of 790 nm (close to the isobestic point of hemoglobin) is beamed into each side of the nose, and the light that is backscattered by the internal nasal tissue is measured continuously on the same nasal side. To evaluate the principle of this new method a pilot study was conducted in five healthy probands subjected to a one-sided (unilateral) nasal histamine provocation test (0.14 ml, 2 mg/ml). RESULTS: In each proband single-sided nasal histamine provocation led to an increase in light extinction on the provoked side by an average of 0.18 optical densities (OD). In four of the five probands a slight increase (0.04 OD) in light extinction was observed on the other side of the nose. CONCLUSION: Nasal remission spectroscopy seems to allow single-side, continuous monitoring on both sides of the nose. Therefore, the method could also be suitable for use in studies of the nasal cycle, as well as for objectivisation of nasal allergen provocation tests.

[High duplication of an internal jugular vein]. / Hohe inkomplette Duplikatur einer Vena jugularis interna.

The internal jugular vein is an important landmark in most cervical operations. The surgeon should know the exact position and possible variations to prevent complications. We report on a duplicated internal jugular vein, which is a rare anatomic anomaly and discuss aetiology and appearance of this malformation and the possible affecting of the accessory nerve.

[Documentation of endonasal changes in blood volume using optical rhinometry]. / Dokumentation von endonasalen Blutvolumenänderungen mittels optischer Rhinometrie.

BACKGROUND: In optical rhinometry, the nose is transilluminated with light and the light absorption by the nasal tissue is measured continuously. Using this method, a real time documentation of changes in nasal blood volume is possible. The method has been evaluated using the nasal allergen provocation test. In this study, the ability of optical rhinometry to detect changes in the nasal blood volume due to various posture changes is examined. METHODS: Optical rhinometry was tested on ten healthy probands, with several examinations being performed on each. RESULTS: By bending the neck, lying down or stopping breathing, stronger light extinction was found. Standing up quickly caused a sudden but short decrease in light extinction. A small amount of exercise, such as making a fist several times, decreased light extinction. Harder exercise on an ergometer led to a stronger decrease in light extinction. In the Valsalva maneuver, an increase in light extinction for the duration of the maneuver was observed. Changes in breathing through the nose or mouth or counting from 1 to 100 had no influence. CONCLUSIONS: Using the new method of optical rhinometry, it is possible to detect changes in endonasal blood volume caused by changes of intrathoracic pressure, changes in posture or physical exercise, non-invasively and in real time. This technique can therefore be used for further research on the regulation of the nasal blood flow.

[Endocranial complications in otitis media: what you need to remember]. / Kopfschmerz, Schwindel, Meningismus, Krampfanfall. Steckt vielleicht eine Otitis media dahinter?

Thanks to the potency of antibiotics, life-threatening complications of otitis media are rare. In many cases, however, the symptomatology is veiled, and the course of the disease tends to be protracted. Secondary symptoms may preponderate and often mask those associated with the ear itself. If a case of otitis media fails to clear up, or mastoiditis develops, or sensorineural deafness, vertigo, headaches, seizures, or meningism occur, the possibility of an otogenous complication must immediately be considered and the patient submitted to diagnostic imaging without delay, so as to ensure early surgical treatment of a possible lesion in the ear.

Optical measurement of nasal swellings.

We introduce a new optical method to noninvasively and continuously measure the swelling process of the nasal mucosa whereby we use light of different wavelengths in the red and near-infrared range which is transilluminated through the nasal tissue and whose extinction is recorded as a function of time. From the temporal and spectral extinction data, we are able to extract characteristic parameters that describe the swelling process quantitatively by means of a regression-type parameter estimation algorithm. The method has been applied to the nasal allergen provocation test and verified on a limited number of volunteers.

Titanium clip prosthesis.

OBJECTIVE: Prostheses for the reconstruction of a defective ossicular chain should be stable and firmly anchored to the ossicular remnants. This will prevent a defective connection from causing diminished sound transmission efficiency and will keep the prosthesis from tilting or even losing contact, which would result in a sound transmission block. Through temporal bone experimentation, we have consequently developed a very lightweight titanium prosthesis, which is fastened onto the stapes head with a clip mechanism. METHODS: When temporal bone experiments using laser Doppler vibrometry confirmed that the prosthesis functioned well acoustically and when luxation experiments proved that it could be safely used without the risk of stapes dislocation, the prosthesis was used in a clinical application within an observational study. The University of Dresden Otorhinolaryngological Hospital as well as seven surgeons from five other hospitals participated in the study. RESULTS: The results of 133 operations showed that, in over 90% of the cases, the prosthesis could be implemented without problems and with good mechanical stability. The first acoustical results obtained during the first year from 49 patients showed a sound transmission improvement range from 12 dB to 14 dB. CONCLUSION: With the clip prosthesis, it seems possible to further improve defective middle ear function, which would allow the patient to regain social hearing after middle ear reconstruction. The reliability of the fastening is an innovation. Revision operations showed a stable prosthesis-stapes complex in the middle of a recurring cholesteatoma and the prosthesis could always be easily pulled from the stapedial suprastructure.

[Optical Rhinometry. Continuous, direct measurement of swelling of the nasal mucosa with allergen provocation. Real-time monitoring of the nasal provocation test using optical rhinometry]. / Die optische Rhinometrie. Kontinuierliche, direkte Messung der Schwellung der Nasenschleimhaut bei Allergenprovokation.

BACKGROUND: Various methods exist for measuring swelling of the nasal mucosa. This is necessary in order to make the nasal provocation test objective. With the new method of optical rhinometry, it is possible to measure swelling of the mucosa directly from outside of the nose in real-time. The measurement is carried out with monochromatic near-infrared light of different wavelengths, the intensity change of which are recorded and displayed during the swelling. MATERIALS AND METHODS: With the help of a specially developed prototype of an optical rhinometer, we carried out measurements on 15 subjects having positive nasal provocation tests with histamine and allergens, negative provocation tests with allergens in non-allergics, negative provocation tests with control solution, and decongestion with xylometazoline. RESULTS: We found significant differences between positive and negative provocation tests ( P<0.01). Decongestion was different from all other groups ( P<0.01). Nasal congestion subjectively reported by the subject always correlated with the optical rhinometry findings. CONCLUSION: The objective assessment of nasal swelling using optical rhinometry seems reliable. The course of the endonasal swelling can thereby be monitored in real-time. The measurement is largely independent of the cooperation of the patient. The swelling is measured directly and not indirectly via air flow resistance.

[Modeling light distribution in nasal tissue structures]. / Modellierung der Lichtausbreitung in nasalen Gewebestrukturen.

There are different applications in the field of optical diagnostics in which the theories explaining the light transport in tissue do not lead to simple solutions for complicate geometric conditions. In these cases the Monte Carlo method provides a powerful tool to solve this problem statistically. In order to simulate the light transport in the nasal region a model was created which includes the structure depending on the swelling of the mucous membrane as well as the Monte Carlo model. Using this model it is possible to evaluate the measured values qualitatively. However, due to the long distance between light source and detector the statistical error becomes a major problem for reliable statements.

[Normal sense of smell in Kallmann syndrome. A case report]. / Normosmie bei Kallmann-Syndrom Ein Fallbericht.

BACKGROUND: Kallmann's syndrome (KS) was first mentioned in 1944 as an association of anosmia and hypogonadotropic hypogonadism. Causes are multiple genetic defects the most common of which is the x-linked KS appearing mostly in men. However, autosomal dominant and autosomal recessive forms have also been described. PATIENT: We present a case of KS with normosmia (male, 39 years of age). All symptoms of hypogonadotropic hypogonadism were present. RESULTS: Psychophysical olfactory testing revealed left-sided anosmia with right-sided normosmia which was confirmed by electrophysiological measures of olfactory function. Magnetic resonance imaging indicated aplasia of the left olfactory tract and bulb, whereas the right-sided structures appeared to be normal. CONCLUSIONS: As indicated in this case with lateralized anosmia and contralateral normosmia, overall olfactory function strongly depends on the "best" nostril. Therefore, in many clinical situations, lateralized olfactory testing appears to be extremely important.

[Necrotizing lymphadenitis (Kikuchi-Fujimoto disease) as a rare cause of cervical lymphadenopathies. Diagnosis and differential diagnosis]. / Nekrotisierende Lymphadenitis (M. Kikuchi-Fujimoto) als seltene Ursache zervikaler Lymphadenopathien. Diagnose und Differentialdiagnose.

BACKGROUND: The ENT specialist is often confronted with the inquiry as to the cause of lymph node enlargements. Common causes include inflammations, neoplastic, or autoimmune diseases. We report on three cases of Kikuchi-Fujimoto disease as a benign self-limiting lymphadenopathy of unknown etiology, which is usually found in young women between 20 and 30 years of age. Main symptoms are indolent or light tender, enlarged lymph nodes in the neck area. The correct diagnosis requires the histologic examination of the lymph node. Even for the experienced pathologist the differential diagnosis of malignant systemic disorders can be difficult. PATIENTS: Three female patients suffering from Kikuchi-Fujimoto disease were treated in our department between September 1997 and March 1998. RESULTS: All patients showed indolent and enlarged lymph nodes in the neck. In one case we were able to diagnose an acute cytomegalovirus infection; in another case an acute Epstein-Barr virus infection. After 3-5 months the symptoms disappeared spontaneously in all patients. In two of the three cases, histologic lymph node examination revealed T-cell lymphoma and Hodgkin's disease and in one case led to initial chemotherapeutic treatment. As a result of a second histologic examination, both diagnoses were reviewed and Kikuchi-Fujimoto disease was diagnosed. Chemotherapy was discontinued. CONCLUSIONS: Kikuchi-Fujimoto disease is a benign, self-limiting lymphadenopathy which is usually diagnosed in young women. Distinguishing Kikuchi-Fujimoto disease from malignant systemic disorders may even be difficult for pathologists using histological examination techniques and requires close cooperation between the ENT specialist and the pathologist. In order to minimize the risk of misdiagnosis and incorrect treatment, the ENT specialist should inform the pathologist about the differential diagnosis of Kikuchi-Fujimoto disease in such cases.