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Pharmacokinetics and Concentration-Response of Dupilumab in Patients With Seasonal Allergic Rhinitis.

ABSTRACT: Patients with moderate to severe allergic rhinitis may benefit from subcutaneous immunotherapy (SCIT), despite the risk of systemic allergic reaction. Dupilumab is a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of the type 2 inflammation seen in allergic rhinitis, thereby inhibiting their signaling. In the LIBERTY Grass AID trial (NCT03558997), 16 weeks of treatment with 300 mg of dupilumab every 2 weeks plus timothy grass (TG) SCIT did not reduce TG allergen challenge nasal symptom scores compared with SCIT only but did improve tolerability of SCIT up-titration in patients with a history of grass pollen-induced seasonal allergic rhinitis. Here, we present the pharmacokinetics of functional serum dupilumab and concentration-response relationships in 52 patients enrolled in this trial. Functional dupilumab concentrations and concentrations of TG-specific IgE and IgG4 were assessed in blood samples collected from dupilumab-only and SCIT + dupilumab-treated groups. Mean functional dupilumab concentrations were similar in both groups and reached a steady state of ≈70-80 mg/L at week 5. One week after the end of treatment, TG-specific IgG4 concentrations were increased in the SCIT + dupilumab group, but not in the dupilumab-only group, over the range of dupilumab concentrations evaluated, whereas no changes were seen for TG-specific IgE concentrations. This study demonstrates that SCIT does not alter functional concentrations of serum dupilumab, and the impact of SCIT on TG-specific immunoglobulins is not affected by functional dupilumab concentrations over the range studied, indicating that maximum response was achieved in all patients.

SUBMITTER: Kamal MA

PROVIDER: S-EPMC9303412 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAcupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients.MethodsWe conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks.ResultsForty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: - 0.9 points (95% CI - 1.6 to - 0.2; p = 0.011) and VAS overall SAR symptoms: - 21.6 mm (95% CI - 36.3 to - 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI - 3.8 to - 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe.ConclusionResults of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310.

Project description:BackgroundGrass pollinosis is an important contributor to allergic diseases, with varying patterns and frequency of allergens according to the geographical location studied. Our study aims to provide a better understanding of subtropical grass pollinosis in Argentinian patients with seasonal allergic rhinitis.MethodsWe conducted a retrospective cross-sectional study involving 894 patients with seasonal allergic rhinitis from Bahía Blanca, Argentina. Skin prick tests were performed to selected pollen species belonging to three subfamilies of the Poaceae genera. Frequency of sensitization to specific grass pollen extracts, cross-reactivity of allergens assessed by skin prick test, and possible associations between allergen extracts and asthma or allergic conjunctivitis were analyzed.ResultsSensitization to the Pooideae subfamily was the most frequent, encompassing 86.8% (CI: 84.4%-88.9%) of the studied population. Positive reactions to allergen extracts from the Chloridoideae and the Panicoideae subfamilies showed smaller papule size than allergen extracts from the Pooideae subfamily (χ2(5) = 83.75, p < 0.001). Patients with a positive skin prick test (SPT) to a specific extract were more likely to present some degree of cross-reactivity to the remaining pollens when compared to patients with negative SPT to the same specific extract. Even though the proportion of patients presenting with asthma (46.9%) was higher than those with conjunctivitis (22.6%), there was only a statistically significant association between sensitization to Festuca arundinacea (φ = 0.089, p = .009), Phalaris arundinacea (φ = 0.074, p = .032) and Paspalum notatum (φ = 0.070, p = .038) and the presence of conjunctivitis.ConclusionsOur results suggest a high frequency of sensitization to grass pollen extracts from the Poaceae family among patients with seasonal allergic rhinitis. Overall, sensitization to the Pooidae subfamily was the most common, where Phalaris arundinacea presented the highest frequency.

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Pharmacokinetics and Concentration-Response of Dupilumab in Patients With Seasonal Allergic Rhinitis.

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