Kija Shah-Hosseini

Medication persistence with long-term, specific grass pollen immunotherapy measured by prescription renewal rates

Abstract Objective: We assessed medication persistence using prescription renewal rates for grass pollen specific immunotherapy (SIT) in a representative population of patients in Germany to evaluate whether the perception of superior persistence for the subcutaneous route compared to the sublingual route could be confirmed in clinical practice. Methods: Individual prescriptions for allergen immunotherapy were extracted from a national prescription database (INSIGHT Health) and followed over 3 years on a per-patient basis. However, patients’ medical history and treatment schedules were not available for analysis. Products were identified by the national drug code (PZN number) and grouped to either subcutaneous immunotherapy (SCIT) with natural extract injections, SCIT with modified allergens (allergoids) or sublingual immunotherapy (SLIT) with natural pollen extract solutions. Persistence was defined as at least one prescription of the individual drug in the respective years. Results: A total of 1409 patients started SIT in 2005 (112, 695, and 602 for natural extract SLIT, natural extract SCIT, and allergoid SCIT, respectively). In 2006, 71%, 55%, and 59% of those patients had at least one renewal prescription of natural extract SLIT, natural extract SCIT, and allergoid SCIT, respectively, as well as 51%, 34%, and 39% in 2007. In both years, persistence with natural extract SLIT was significantly higher than with natural extract SCIT (p = 0.0015 for 2006, p = 0.0003 for 2007) and allergoid SCIT (p = 0.0152 for 2006, p = 0.0111 for 2007). There were no significant differences between the two SCIT groups. Conclusion: Medication persistence with grass pollen SIT in a representative sample of patients in Germany was similar to published medication persistence in asthma and COPD patients. The sublingual application route shows significantly better persistency than the subcutaneous route with native allergens or allergoids.

Specific immunotherapy for allergic rhinitis to grass and tree pollens in daily medical practice—symptom load with sublingual immunotherapy compared to subcutaneous immunotherapy

Abstract Background. Despite strong evidence for subcutaneous and sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis, comparative data are scarce. Objectives. We performed an individual patient data meta-analysis of four observational studies to compare the effectiveness of both application routes. Methods. After individual analysis, a subsequent analysis of the total data pool was performed. Descriptive and explorative data analysis methods were used. Results. Altogether 847 patients (382 male, 453 female) aged 3–78 years (mean age 28.3 years) were treated with specific immunotherapy: 665 (78.5%) patients sublingual and 182 (21.5%) subcutaneous. The majority of patients (61.6%) in both treatment groups started specific immunotherapy due to severe rhinitis symptoms which occurred frequently or very frequently. Most patients in both treatment groups had moderate to severe conjunctivitis symptom load which occurred frequently or very frequently. Median rhinitis and conjunctivitis symptom loads decreased during both treatments to the same extent. Similar improvements in the symptom loads were observed in patients stratified for age, disease duration, and presence or absence of mild to moderate asthma. Conclusion. The effectiveness of sublingual and subcutaneous immunotherapy with pollen extracts appeared virtually equal in daily medical routine. Due to the advantageous safety profile, the sublingual application may be favorable.

Sublingual versus subcutaneous immunotherapy: patient adherence at a large German allergy center

Background Many placebo-controlled studies have demonstrated that allergen immunotherapy (AIT) is an effective therapy for treating allergies. Both commonly used routes, subcutaneous (SCIT) and sublingual immunotherapy (SLIT), require high patient adherence to be successful. In the literature, numbers describing adherence vary widely; this investigation compares these two routes of therapy directly. Methods All data were retrieved from the patient data management system of a center for dermatology, specific allergology, and environmental medicine in Germany. All 330 patients (aged 13–89 years) included in this study had commenced AIT between 2003 and 2011, thus allowing a full 3-year AIT cycle to be considered for each investigated patient. Results In this specific center, SCIT was prescribed to 62.7% and SLIT to 37.3% of all included patients. The total dropout rate of the whole patient cohort was 34.8%. Overall, SLIT patients showed a higher dropout rate (39.0%) than did SCIT patients (32.4%); however, the difference between these groups was not significant. Also, no significant difference between the overall dropout rates for men and for women was observed. A Kaplan–Meier curve of the patient collective showed a remarkably high dropout rate for the first year of therapy. Conclusion The analysis presented in this single-center study shows that most patients who discontinue AIT do so during the first year of therapy. Patients seem likely to finish the 3-year therapy cycle if they manage to adhere to treatment throughout the first year. Strategies for preventing nonadherence in AIT, therefore, need to be developed and standardized in future investigations.

Conjunctival Provocation Tests: A Predictive Factor for Patients' Seasonal Allergic Rhinoconjunctivitis Symptoms

BACKGROUND No parameters currently exist that can reliably predict the impact of preseasonal immunotherapy on the symptoms occurring during the season. OBJECTIVE The purpose of our studies was to prove a correlation between preseasonal conjunctival allergen challenge and coseasonal primary clinical endpoints using the total combined score, ie, a combination of symptoms and medication score, as the primary outcome parameter. METHODS Twelve weeks before both the birch and the grass pollen seasons, 2 separate prospective, double-blind, randomized, controlled studies were conducted followed by posttrial observations for each study during the active season. In the studies, patients who reacted to conjunctival allergen challenge were treated with sublingual immunotherapy tablets that contain either birch and/or alder or grass pollen allergoids. RESULTS In all, 158 patients were included in the grass and 160 in the tree pollen study; of these, 100 and 109 patients, respectively, took part in the posttrial observations. When comparing patients with and without a positive reaction in the final conjunctival allergen challenge, the results revealed a significant difference in the total combined score (grass: P < .001; birch: P = .025). The same applied to the rescue medication score (P = .005; P = .025). A significant difference regarding the rhinoconjunctivitis symptom score was shown in the grass pollen study (P = .002), and the difference of well days was significant in the tree pollen study (P = .049). CONCLUSION When comparing patients based on their reaction to allergen challenge after immunotherapy, each study leads to similarly significant results. Therefore, conjunctival allergen challenge can be used effectively as a parameter to predict allergic rhinoconjunctivitis symptoms during the season in patients treated with preseasonal sublingual immunotherapy tablets. Whether this can be transferred to untreated patients needs to be determined.

A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite allergic patients.

In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose.

Clinical Efficacy of a Spray Containing Hyaluronic Acid and Dexpanthenol after Surgery in the Nasal Cavity (Septoplasty, Simple Ethmoid Sinus Surgery, and Turbinate Surgery)

Background. This prospective, controlled, parallel-group observational study investigated the efficacy of a spray containing hyaluronic acid and dexpanthenol to optimise regular treatment after nasal cavity surgery in 49 patients with chronic rhinosinusitis. Methods. The control group received standard therapy. Mucosal regeneration was determined using rhinoscopy sum score (RSS). Pre- and postoperative nasal patency was tested using anterior rhinomanometry. The participants were questioned about their symptoms. Results. Regarding all RSS parameters (dryness, dried nasal mucus, fibrin deposition, and obstruction), mucosal regeneration achieved good final results in both groups, tending to a better improvement through the spray application, without statistically significant differences during the whole assessment period, the mean values being 7.04, 5.00, 3.66, and 3.00 (intervention group) and 7.09, 5.14, 4.36, and 3.33 (control group). No statistically significant benefit was identified for nasal breathing, foreign body sensation, and average rhinomanometric volume flow, which improved by 12.31% (control group) and 11.24% (nasal spray group). Conclusion. The investigational product may have additional benefit on postoperative mucosal regeneration compared to standard cleaning procedures alone. However, no statistically significant advantage could be observed in this observational study. Double-blind, controlled studies with larger populations will be necessary to evaluate the efficacy of this treatment modality.

A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragées) in patients with acute rhinosinusitis.

Abstract Objectives: In this observational study, data on the efficacy, effects on quality of life and tolerability of the topical formulation SNS01 (Ectoin Rhinitis nasal spray) were compared to those of BNO-101 (Sinupret forte dragées) in patients with acute rhinosinusitis in the ear, nose, and throat (ENT) clinical setting. Design and methods: Patients with the diagnosis of acute rhinosinusitis were included in this non-interventional study with a treatment duration of 14–16 days. They received either a herbal phytotherapeutic dragée (control) or an ectoine-based nasal spray (investigational product), each to be taken according to the instructions for use (IFU) and summary of product characteristics (SPC). At each visit, the physician performed a nasal endoscopy, recorded the Sinusitis Symptom Score and checked for adverse events. During the entire treatment period, patients recorded the Sinusitis Symptom Score in patient diaries. In addition, patients receiving the nasal spray filled out a questionnaire to assess the tolerability of the treatment. To investigate effects on quality of life patients were asked to fill out the German version of a sinusitis-specific HRQL (health related quality of life) questionnaire. Clinical trial registration: NCT01684540. Results: Patient diary entries, the assessment of the Sinusitis Symptom Score and the HRQL questionnaire demonstrated that the ectoine nasal spray was as effective as the phytotherapeutic dragées in treating acute rhinosinusitis. After two weeks of treatment, the assessments of both the patients’ diaries and physicians’ record forms indicated statistically significant improvement (p ≤ 0.001) in the symptom scores of the two groups (57.8% improvement for ectoine and 49.3% improvement for the phytotherapeutic dragées compared to baseline). Also, overall scores of 80 in the sensory questionnaire confirmed the good tolerability of the nasal spray. Correspondingly, HRQL improved significantly over the course of the treatment in both groups. Conclusion: SNS01 and BNO-101 demonstrated comparable effects in the treatment of acute rhinosinusitis. Limitations: Following German regulations, this trial was set up as an observational ‘non-interventional’ study, which does not allow for a placebo group or randomization of patients. Although the grade of evidence delivered by the study data is thus reduced from Ib to IIa, it does, however, reflect a realistic view of the most common clinical practice.

Optimum treatment strategies for polyallergic patients – analysis of a large observational trial

Abstract Objectives: To document the effectiveness and safety of sublingual allergen immunotherapy (SLIT) with a five-grass pollen tablet (Oralair) and compare different treatment options in a broad, non-selected population of patients in a real-world clinical setting. Research design and methods: This was a 2 year, open, prospective, multicenter, single-arm, non-interventional study. Patients with a history of clinically relevant allergic symptoms caused by grass pollen, confirmed by skin prick testing, received treatment with the five-grass pollen tablet. Concomitant treatment with symptomatic medication and/or additional SLIT or subcutaneous immunotherapy (SCIT) was permitted. Twelve-month data are presented here. Effectiveness was assessed comparing a combined rhinoconjunctivitis (RC) score derived from the severity of rhinitis and conjunctivitis symptoms under treatment with retrospective data of the previous year. Results: A total of 1408 patients participated in the study, of whom 434 were children/adolescents and 962 polyallergic. Compared with the grass pollen season preceding five-grass pollen tablet treatment, a statistically significant reduction of 49.9% was achieved in RC score for the total population (p < 0.001), and an improvement in overall health was perceived by 90.9% of patients. The overall population of polyallergic patients derived similar benefits from treatment with the five-grass pollen tablet as monoallergic patients. The percentage reduction in RC score was larger in polyallergic patients taking no additional therapy (60.2%) than in those taking concomitant symptomatic medication (38.1%) or allergen immunotherapy (AIT) (50.8%). Within the last of these groups, RC score improved by 47.6% among patients receiving additional SCIT, versus 54.8% with additional SLIT. Adverse drug reactions, reported in 15.3% of study participants, were mostly local in nature and mild or moderate in intensity. Conclusions: After 1 year of treatment, polyallergic patients responded similarly to the five-grass pollen tablet as monoallergic patients. For polyallergic patients in whom additional treatment was needed, a second SLIT may be more beneficial than a SCIT or symptomatic co-medication.

PD14 - Non-interventional 2-year study of sublingual immunotherapy in children and adolescents with allergic rhinoconjunctivitis caused by grass pollen

Background The aim of this non-interventional study was to document the impact of a sublingual allergen immunotherapy (AIT) with Oralair 5-grass pollen tablets (Stallergenes, France) on symptom severity, use of symptomatic medication and tolerability in patients with grass pollen-induced allergic rhinoconjunctivitis (RC) over 2 years of routine medical practice treatment. This poster focuses on the subgroups of children (4-11 yrs) and adolescents (12-17 yrs).

Ultra-short-course booster is effective in recurrent grass pollen-induced allergic rhinoconjunctivitis

A relevant proportion of allergic rhinoconjunctivitis (ARC) patients experience recurrent symptoms after successfully completing allergen immunotherapy (AIT). This prospective, controlled, noninterventional study used internationally standardized instruments to determine the clinical effects of a preseasonal, ultra‐short‐course booster AIT on clinical outcome parameters.