The introduction of personalized medicine (PM) has been a milestone in the history of medical therapy, because it has revolutionized the previous approach of treating the disease with that of treating the patient. It is known today that diseases can occur in different genetic variants, making specific treatments of proven efficacy necessary for a given endotype. Allergic diseases are particularly suitable for PM, because they meet the therapeutic success requirements, including a known molecular mechanism of the disease, a diagnostic tool for such disease, and a treatment blocking the mechanism. The stakes of PM in allergic patients are molecular diagnostics, to detect specific IgE to single‐allergen molecules and to distinguish the causative molecules from those merely cross‐reactive, pursuit of patient's treatable traits addressing genetic, phenotypic, and psychosocial features, and omics, such as proteomics, epi‐genomics, metabolomics, and breathomics, to forecast patient's responsiveness to therapies, to detect biomarker and mediators, and to verify the disease control. This new approach has already improved the precision of allergy diagnosis and is likely to significantly increase, through the higher performance achieved with the personalized treatment, the effectiveness of allergen immunotherapy by enhancing its already known and unique characteristics of treatment that acts on the causes.

Disclosure of potential conflict of interest K. Niespodziana receives grant support (grant no. P29398) from the Austrian Science Foundation (FWF). K. F. Chung has received honoraria for participating in advisory board meetings of GlaxoSmithKline (GSK), AstraZeneca, Novartis, Merck, Boehringer Ingelheim, and Teva regarding treatments for asthma and chronic obstructive pulmonary disease and has also been renumerated for speaking engagements. A. Custovic reports personal fees from Novartis,

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease which affects &#x3e;24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. <b><i>Results:</i></b> Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were −7.78 (95% CI: −8.1701 to −7.3967; <i>p</i> &#x3c; 0.001) and −7.52 (−7.9053 to −7.1320; <i>p</i> &#x3c; 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. <b><i>Conclusions:</i></b> TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

There are results of a comparative phase III clinical study on the efficiency and safety of the biosimilar drug Genolar ® (Generium JSC, Russia) and the reference drug Xolair ® (Novartis Pharma AG, Switzerland) ((NCT04607629). The study is aimed to establish the clinical equivalence of the compared drugs for additional therapy of patients with moderate and severe bronchial asthma (BA) are considered in the article. Methods. The study enrolled 191 patients aged 18 to 75 years with a moderate to severe atopic asthma for ≥ 1 year, the symptoms of which were insufficiently controlled by therapy corresponding to the 4 th stage of treatment (GINA, 2017) for ≥ 2 months before the screening. Patients were divided into the two groups in a ratio of 2 : 1 with the block randomization. 127 patients of the Group 1 were administered Genolar ® for 52 weeks ± 3 days; 64 patients of the Group 2 were administered Xolair ® for 26 weeks ± 3 days. The dose and frequency of the compared drugs administration were determined based both the initial IgE concentration (IU/mL) measured before treatment and the current body weight (kg) of the patient. The recommended omalizumab dose was 75 to 600 mg once every 2 or 4 weeks. The primary efficacy endpoint was the patients' percentage with a physician evaluation of "excellent" or "good" on the Global Evaluation of Treatment Effectiveness (GETE) scale after 26 weeks of comparative treatment. Results. According to the data analysis results, the patients' proportion with a GETE score of "excellent" or "good" after 26 weeks of therapy were no statistically significant differences between the groups in both investigated populations (PP-population (per protocol) and FAS-population (full analyses set)) (p > 0.05). Primary efficacy endpoint data analysis showed that the patients' proportion of the PP population with a GETE score of "excellent" or "good" was 57.4% of the Group 1 and 45.2% of the Group 2 (p = 0.132). The calculated one-sided 95% CI in order to test the study statistical hypothesis showed that the investigated drug Genolar ® (Generium JSC, Russia) is "non-inferior" than the reference drug. The PP population onesided 95% CI was from -0.5 to 25.0% (p = 0.116), the FAS population one was from -1.1 to 24.2% (p = 0.134). According to the safety analysis results, the comparability of the investigated and reference drugs in terms of the frequency of the adverse events was demonstrated. The analysis results of the anti-drug antibodies to omalizumab detection revealed the antibody production absence in response to the administration of the studied drugs. Conclusion. The clinical study results have proved the equivalence of the biological analogue Genolar ® (Generium JSC, Russia) and the reference drug Xolair ® (Novartis Pharma AG, Switzerland).

Allergen-specific immunotherapy (AIT) is a safe, effective treatment for respiratory allergies (such as moderate-to-severe allergic rhinoconjunctivitis) that are not controlled by symptomatic medications. The indications and contraindications for AIT have been defined in international guidelines and consensus statements. However, some of these contraindications are not evidenced- based but have been deduced from the theoretical risk of an interaction between AIT disease-modifying effect and immune or inflammatory comorbidities. In the absence of clinical trial evidence, the accumulation of experience as case reports can narrow the spectrum of absolute contraindications. The majority of international guidelines list HIV infection as a contraindication to AIT. Here, we describe two cases of safe, effective sublingual birch pollen AIT in HIV-positive patients undergoing concomitant antiretroviral therapy. A 32-year-old female and a 63-year-old male sensitized to tree pollen and with clinically confirmed birch pollen allergy underwent pre- and co-seasonal sublingual birch pollen AIT for three and two pollen seasons, respectively. The therapy was associated with a marked reduction in the frequency and intensity of allergic symptoms, and the reduced use of (symptomatic) rescue medication. Mild, local, treatment-emergent adverse events were noted throughout the course of treatment but resolved spontaneously. No serious adverse events were reported. In particular, there were no obvious harmful effects on the patients’ immune status or viral load. Hence, sublingual birch pollen AIT proved to be effective and safe in two HIV-positive patients.