CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study.

Background: This study compared the therapeutic equivalence of CT-P39 (an omalizumab biosimilar) and EU-approved reference omalizumab (ref-OMA) in patients with chronic spontaneous urticaria.

Methods: This double-blind, randomized, active-controlled Phase 3 study (NCT04426890) included two 12-week treatment periods (TPs). In TP1, patients received CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg.

Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52.

Introduction: SB17 is a biosimilar to reference ustekinumab (UST). We compared the efficacy, safety, and immunogenicity of SB17 to UST up to Week 52, including switching from UST to SB17.

Methods: Subjects were randomized to receive 45 mg of SB17 or UST subcutaneously up to Week 40.

A randomized phase III study to compare efficacy and safety of BAT2206 (proposed ustekinumab biosimilar) with reference ustekinumab in patients with moderate to severe plaque psoriasis.

Background: BAT2206 is a proposed biosimilar to reference ustekinumab (UST; Stelara).

Objectives: To compare the efficacy and safety of BAT2206 with UST at 2 treatment periods, ie, a 28-week initial treatment period 1 (TP1) and a 24-week secondary TP2. This article describes the results of TP1.

Airway tryptase levels inform the lack of clinical efficacy of the tryptase inhibitor MTPS9579A in asthma.

Background: Tryptase, a mast cell protease, has been identified as a potential therapeutic target in managing patients with refractory asthma. We assessed the efficacy, safety, pharmacokinetics, and pharmacodynamics of MTPS9579A, an anti-tryptase antibody, in a phase 2a randomized trial for patients with uncontrolled asthma and a phase 1c trial to understand activity within the lower respiratory tract.

Methods: Phase 2a patients (n = 134) received 1800 mg MTPS9579A or placebo intravenously every 4 weeks for 48 weeks.

A randomized, double-blind, phase III study assessing clinical similarity of SB17 (proposed ustekinumab biosimilar) to reference ustekinumab in subjects with moderate-to-severe plaque psoriasis.

Background: Ustekinumab (UST) is a safe and effective treatment for moderate-to-severe psoriasis.

Objectives: To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed UST biosimilar SB17 with reference UST in subjects with moderate-to-severe plaque psoriasis.

Methods: In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at week 0, 4, and every 12 weeks.

Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis.

Background: Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell-mediated diseases.

Objective: This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis.

Methods: In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks' blinded treatment, followed by 38 weeks' open-label treatment and 12 weeks' drug-free follow-up.

Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution: An 8-Weeks Phase III Study.

Purpose: The objective of this study was to assess the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in patients with allergic conjunctivitis (AC).

Patients And Methods: Multi-center, international, randomized, double blind, placebo-controlled, parallel-group, phase III study of adult patients with seasonal or perennial AC.

Efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases: an exploratory study.

To evaluate the efficacy/safety of bilastine in pruritus relief in patients with chronic spontaneous urticaria (CSU) or other pruritic skin diseases. In this multicenter, open-label, exploratory study (EudraCT No.: 2016-001505-17), 115 adults with CSU ( = 34), eczema/dermatitis ( = 30), prurigo ( = 25) or cutaneous pruritus ( = 26), received bilastine 20 mg once daily for 8 weeks, or in non-responder patients (<30% improvement in pruritus score at week 2), 40 mg/day from week 2.

Pharmacokinetics of a novel human intravenous immunoglobulin 10% in patients with primary immunodeficiency diseases: Analysis of a phase III, multicentre, prospective, open-label study.

Intravenous immunoglobulin (IVIG) therapy is commonly used to treat patients with primary antibody deficiency. This prospective, open-label, non-randomised, multicentre, phase III trial investigated the pharmacokinetics of a new 10% liquid IVIG product (panzyga®; Octapharma) in 51 patients aged 2-75 years with common variable immunodeficiency (n = 43) or X-linked agammaglobulinaemia (n = 8). Patients were treated with IVIG 10% every 3 (n = 21) or 4 weeks (n = 30) at a dose of 200-800 mg/kg for 12 months.

Impaired fibrinolysis and lower levels of plasma α-macroglobulin are associated with an increased risk of severe asthma exacerbations.

Recently we have reported that asthma is associated with enhanced plasma thrombin formation, impaired fibrinolysis and platelet activation. In the present study we investigated whether described prothrombotic blood alterations might predispose to thromboembolic events or asthma exacerbations. In 164 adult asthmatics we assessed clinical events during 3-year follow-up and analyzed their associations with measured at baseline prothrombotic blood parameters.

Efficacy and Safety of Human Intravenous Immunoglobulin 10% (Panzyga®) in Patients with Primary Immunodeficiency Diseases: a Two-Stage, Multicenter, Prospective, Open-Label Study.

Purpose: To assess the efficacy and safety of panzyga® (intravenous immunoglobulin 10%) in preventing serious bacterial infections (SBIs) in patients with primary immunodeficiency diseases (PIDs), a prospective, open-label, multicenter, phase 3 study and an open-label extension study were undertaken.

Methods: Initially, the study drug (infusion rate ≤0.08 mL/kg/min) was administered at intervals of 3 or 4 weeks for 12 months, followed by 3 months of panzyga® at infusion rates increasing from 0.

Prothrombotic State in Asthma Is Related to Increased Levels of Inflammatory Cytokines, IL-6 and TNFα, in Peripheral Blood.

Recently, we have reported that asthma is associated with enhanced plasma thrombin formation and impaired fibrinolysis. The mechanisms underlying the prothrombotic state in this disease are unknown. Our aim was to investigate whether prothrombotic alterations in asthmatics are associated with inflammation.

The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis.

Background: GP2015 is a proposed etanercept biosimilar.

Objectives: To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and the etanercept originator (ETN, Enbrel ) in patients with moderate-to-severe chronic plaque-type psoriasis.

Methods: In total, 531 eligible patients were randomized 1 : 1 to self-administer GP2015 or ETN twice weekly subcutaneously.

Asthma is associated with enhanced thrombin formation and impaired fibrinolysis.

Background: There is evidence that altered blood coagulation and fibrinolysis are involved in the pathogenesis of asthma. Increased thromboembolic risk has been reported in asthmatics.

Objective: To investigate whether enhanced thrombin generation and impaired fibrinolysis occur in asthmatics.

Evaluation of the quality of life in subjects with a history of severe anaphylactic reaction to the Hymenoptera venom.

Introduction: Sensitization to the Hymenoptera venom is one of the main causes of anaphylaxis in Poland. Venom immunotherapy is the only effective treatment in such cases. Comprehensive patient care includes also education.

Assessment of remodeling in chronic obstructive pulmonary disease using imaging methods.

Introduction: While spirometry plays a key role in diagnosing chronic obstructive pulmonary disease (COPD), imaging methods including endobronchial ultrasound (EBUS) and chest computed tomography (CT) appear to be useful for investigating structural changes in the lungs.

Objectives: The aim of this study was to evaluate remodeling in COPD patients using EBUS and chest CT.

Patients And Methods: The study included 33 patients with COPD, 15 patients with severe asthma, and 15 control subjects.

[The significance of selected psychopathological and personality variables in the course of allergic and non-allergic asthma].

Aim: The aim of this study was to carry out a comparative analysis of selected psychopathological and personality variables in patients with allergic and non-allergic asthma, as well as an attempt to determine the significance and strength of these variables in the clinical picture of both forms of the disease.

Methods: In all patients structured anamnesis, basic spirometry, and dyspnea measure- ment were carried out. The level of anxiety was determined using Spielberger's questionnaire.

Increased expression of α₂ (CD49b), α₄ (CD49d) and β₁ (CD29) integrin subunits on peripheral blood T lymphocytes in clinically stable mild-to-moderate persistent asthma.

Introduction: Adhesive molecules, particularly selectins and integrins, are critical for the inflammatory cell trafficking from blood to the lungs. Among integrins, the most important for cell infiltration are those containing α₄ and β₂ subunits.

Objectives: The aim of this study was to evaluate the expression of α₁ and α₂ integrin subunits on peripheral blood T cells in asthmatic subjects, because previously we showed evidence that α₁β₁ and α₂β₁ integrins may be found on peripheral blood eosinophils in these subjects.

[Measurement of bronchoconstrictive eicosanoids in chronic obstructive pulmonary disease].

Introduction: The aim of the study was the evaluation of the concentration of 9α11β prostaglandin F(2) - a stable metabolite of prostaglandin D(2) (PGD(2)) and leukotriene E(4) (LTE(4)) in stable and exacerbated COPD patients.

Material And Methods: 29 COPD patients aged 73 ± 8.34, mean FEV1 = 48.

Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler.

Background: Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol).

The use of endobronchial ultrasonography in assessment of bronchial wall remodeling in patients with asthma.

Background: Endobronchial ultrasound (EBUS) is a new technique that enables the assessment of bronchial wall layers. The aim of the study was to verify the utility of EBUS for the assessment of bronchial wall remodeling in patients with asthma.

Methods: In 35 patients with asthma and 23 control subjects, high-resolution CT (HRCT) scanning and EBUS were used to measure bronchial wall thickness in the 10th segment of the right lung.