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Purpose: Limited data is available on treatment satisfaction with the management of wet age-related macular degeneration (wAMD) among patients in Italy. In this cross-sectional real-world study, treatment satisfaction with anti-vascular endothelial growth factor (anti-VEGFs) was assessed in patients with wAMD in Italy., Patients and Methods: This was a non-interventional, cross-sectional survey involving patients with wAMD receiving anti-VEGFs. The survey was administered through a virtual assistant via phone. Patients' treatment satisfaction was assessed using a newly developed Novartis Tailored Treatment Satisfaction Questionnaire (NVS TTSQ) and the validated Macular Disease Treatment Satisfaction Questionnaire (MacTSQ)., Results: Overall, 154 evaluable patients were enrolled in 5 centers across Italy. The mean (SD) age of the patients was 76.8 years (7.01). Overall treatment satisfaction score assessed by NVS TTSQ was 40.50 (7.11), with a mean of 9.97 (1.84) on the information domain and 22.98 (4.57) on the unmet need domain. Patients were satisfied with diagnosis communication (4.99 [1.30]), information provided on treatment administration (4.58 [1.49], range 0-6), the waiting room (4.40 [1.43]), and management of visits and injections at the center (5.14 [1.12]), general management of maculopathy at the center (5.22 [1.01]). Patients were not satisfied with their independence in terms of disease management (2.56 [2.45]); they would like additional information about the disease (5.38 [1.03]) and to discuss the injection procedures (4.02 [1.94]) with already-treated patients. The overall treatment satisfaction score on MacTSQ scale was 55.84 (10.13)., Conclusion: Patients with wAMD are satisfied with the overall management of their disease in Italy. However, patients would like to have more information on prognosis and management of the disease., Competing Interests: Enrico Peiretti is a scientific advisor for Bayer and Novartis. He received travel grants from Alcon, Baush and Lomb, Sifi, and Allergan. Chiara Ascardi, Marta Bartezaghi, and Lorenzo De Santi were full-time employees of Novartis Farma S.p.A., Milano, MI, Italy at the time of the study. Francesco Bandello is a consultant/advisor for Abbvie, Alimera, Bayer, Boehringer-Ingelheim, Fidia Sooft, Hofmann La Roche, Novartis, Ntc Pharma, Oxurion Nv, and Sifi. Francesco Boscia is a consultant/advisor for Alcon, Abbvie, Bayer, Novartis, Roche, and Zeiss. Monica Varano serves as an advisory board member of Abbvie, Astellas, Bayer, Biogen, Novartis, and Roche. Giovanni Staurenghi is a consultant/advisor for Abbvie, Apellis Pharmaceuticals, Inc., Annexon Bioscience, Bayer Healthcare Pharmaceuticals, Boehringer, Centervue, Inc., Genentech, Heidelberg Engineering, Hoffman La Roche, Ltd., Iveric Bio, Medscape, Novartis Pharmaceuticals, Optos, Inc., and RetinAI. He received grant support from Carl Zeiss Meditec, Centervue, Inc., Heidelberg Engineering, Hoffman La Roche, Ltd., Nidek, Inc., Novartis Pharmaceuticals, Optos, Inc., and RetinAI. He received lecture and speaker bureau fees from Carl Zeiss, Heidelberg Engineering, Hoffman La Roche, Ltd., Meditec, Nidek, Inc., and Novartis Pharmaceuticals. He also received patent royalties from Ocular Instruments Inc. The authors report no other conflicts of interest in this work., (© 2024 Peiretti et al.)

Purpose: Secukinumab is a fully human monoclonal antibody that inhibits interleukin (IL)-17A approved for the treatment of moderate to severe plaque psoriasis in adults and children. We compared the efficacy and safety of secukinumab in patients aged < 65 years (adult patients) versus patients aged ≥ 65 years (elderly patients) in a post-hoc analysis of the SUPREME study., Patients and Methods: Patients with moderate to severe plaque psoriasis received subcutaneous secukinumab 300 mg per week for the first 5 weeks, then 300 mg per month. We compared the following outcomes in patients aged ≥ 65 years vs < 65 years: baseline characteristics; PASI50/75/90/100 response rates (improvements ≥ 50%/75%/90%/100% in Psoriasis Area and Severity Index (PASI) from baseline); changes in Dermatology Life Quality Index (DLQI); Hospital Anxiety and Depression Scale (HAD-A, HAD-D) score changes; treatment-emergent adverse events (TEAEs)., Results: Secukinumab was slightly less effective in elderly patients than in adult patients (response rates at week 16: PASI90, 69.4% vs 80.9%, p = 0.4528; PASI100, 44.4% vs 56.7%, p = 0.8973). Elderly and adult patients showed a similar time course of changes in absolute PASI scores. Patients aged ≥ 65 years had a statistically significantly lower improvement in quality of life (mean DLQI reduction) than patients aged < 65 years at week 16 [-5.4 (±4.3) vs -8.8 (±6.9), p = 0.0065] and at week 24 [-5.3 (±4.4) vs -9.2 (±7.1), p = 0.0038]. Secukinumab treatment resulted in comparable mean reductions in anxiety and depression scores in both cohorts at 24 weeks [HAD-A, -1.3 (±3.3) vs -2.1 (±3.8), p = 0.9004; HAD-D, -1.0 (±3.3) vs -1.5 (±3.1), p = 0.4598]. The frequency of TEAEs in the two cohorts was similar (16.7% vs 14.6%, p = 0.7391)., Conclusion: Secukinumab is a valid option for the management of moderate to severe psoriasis in elderly patients., Competing Interests: M.T. has nothing to disclose; F.R. acted as speaker and consultant for Sanofi, AbbVie and Novartis, outside the submitted work; G.M. has nothing to disclose; K.H. reports personal fees from AbbVie, Almirall, Ganassini, LEO Pharma, Novartis, and Sanofi, outside the submitted work; M.P. has nothing to disclose; A.Ca. has nothing to disclose; A.P. has nothing to disclose; A.Ch. served as advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for AbbVie, Almirall, Incyte, LEO Pharma, Lilly, Janssen, Novartis, Pfizer, and Sanofi Genzyme; P.M. has nothing to disclose; F.B. has nothing to disclose; V.B. has nothing to disclose. P.D. has nothing to disclose; P.G. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for AbbVie, Almirall, Amgen, Janssen, LEO Pharma, Eli Lilly, Novartis, Pierre Fabre, Pfizer, Sandoz, Sanofi, UCB. C.Z. has nothing to disclose; C.P. has nothing to disclose; F.C. has nothing to disclose; MC.F. has served on advisory boards, received honoraria for lectures and research grants from Amgen, Almirall, AbbVie, BMS, Galderma, Kyowa Kirin, Leo Pharma, Pierre Fabre, UCB, Lilly, Pfizer, Janssen, MSD, Novartis, Sanofi-Regeneron, Sun Pharma.; S.T. acted as a speaker for AbbVie, Novartis and Janssen; P.B. has nothing to disclose; L.P. has nothing to disclose; G.G., M.B., L.C., and E.A. are employees of Novartis. AC received speaker’s/consultancy honoraria or grants for research from AbbVie, Almirall, Amgen, LEO Pharma, Novartis, Janssen, UCB, and Lilly. The authors report no other conflicts of interest in this work., (© 2023 Talamonti et al.)

Purpose: Psoriasis, a common systemic inflammatory disorder, presents with gender-related differences in the quality of life (QoL) and treatment outcomes. This post hoc analysis from the Phase 3b SUPREME study explored gender-related differences in patient characteristics and efficacy of secukinumab 300 mg on Psoriasis Area and Severity Index (PASI) 75/90/100 and impact on QoL using the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis through week 24., Patients and Methods: The proportion of patients achieving PASI 75/90/100 was computed using a nonresponder imputation approach. Differences between cohorts were analyzed using a logistic regression model. The mean change from baseline in DLQI was computed using the Wilcoxon test., Results: Among the 433 patients (males: 71.6%), females had a higher DLQI than males at baseline (13.1 vs 9.5; P <0.0001). Males had a slightly higher response for PASI 90 than females at week 16 (80.7% vs 78.1%; P =0.0779) and 24 (83.2% vs 79.7%; P =0.0319). No differences were observed between genders in PASI 100/75 responses at week 24. Both genders showed an improvement in DLQI with secukinumab at week 24 (-10.9 vs -8.1, respectively, in females vs males; P =0.0004)., Conclusion: In summary, secukinumab was effective in the treatment of psoriasis, irrespective of gender., Competing Interests: L. Stingeni has acted as a speaker and board member for AbbVie, Eli Lilly, Novartis, Almirall, Celgene, Sanofi, and Janssen; G. Malara has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Sanofi, Novartis, Eli Lilly, and UCB Pharma; A. Conti has acted as a consultant for AbbVie, Abbott, Amgen, Celgene, Eli Lilly, Janssen Cilag, Leo Pharma, MSD, Novartis, Sandoz, Schering Plough, UCB Pharma, and Wyeth; C.G. Carrera has reported collaboration with Novartis, AbbVie, Janssen, Lilly, and Leo Pharma; M. Burlando has served as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly, and UCB Pharma; P. Malagoli has acted as a consultant or had advisory board agreements for Janssen, Amgen, AbbVie, UCB, Novartis, Lilly, Almirall, and Leo Pharma; M.L. Musumeci has served as a consultant/investigator for AbbVie, Eli Lilly, Janssen Cilag, Novartis, and Biogen; F. Bardazzi has acted as a speaker and/or consultant for Almirall, AbbVie, Celgene, Janssen, Eli Lilly, UCB Pharma, and Leo Pharma; V. Brazzelli has acted as a consultant and congress guest for Janssen Cilag SpA, Novartis, and Sanofi Genzyme; P. Amerio has received honoraria and is on the advisory board of Sanofi, Jansen, Novartis, Pfizer, Celgene, and Eli Lilly; C. De Simone has acted as a speaker and consultant for Almirall, AbbVie, Janssen, Celgene, Leo Pharma, Novartis, Eli Lilly, and UCB Pharma; S. Trevisini has served as a speaker for AbbVie, Novartis, and Janssen; A. Balato has served as speaker and/or consultant for AbbVie, Lilly, and Sanofi; M. Megna has served as a speaker or consultant for AbbVie, Eli Lilly, Novartis, Janssen, and Leo Pharma; M. Bartezaghi employees of Novartis; A. Rausa was an employee of Novartis during study conduct and manuscript submission. She approved the final version to be submitted while she was working for Novartis; E. Aloisi and R. Orsenigo are employees of Novartis; A. Costanzo has served as a speaker and consultant for AbbVie, Eli Lilly, Novartis, Almirall, Celgene, Sanofi, Janssen, and Pfizer. The authors report no other conflicts of interest in this work., (© 2023 Stingeni et al.)

Secukinumab, a fully human monoclonal antibody, neutralizes interleukin-17A, a cornerstone cytokine driving the multiple manifestations of psoriasis. This post-hoc analysis of the SUPREME study was performed to determine the sustainability of response to secukinumab in terms of Psoriasis Area and Severity Index (PASI) 90 in patients with moderate-to-severe plaque psoriasis. Based on PASI 90 response at week 16, patients were stratified as PASI 90 responders (PASI90R, n = 337) or non-responders (PASI90NR, n = 72). At week 20, 94.2% (n = 295/313) achieved PASI 90/100 response in PASI90R, with response maintained through week 48 (89.6%, n = 189/211). An increased proportion of patients achieved PASI 90/100 response in PASI90NR (week 20: 29.9%, n = 20/67; week 48: 57.1%, n = 20/35). Overall, 64.4% patients achieved absolute PASI score = 0 at week 24 with response sustained to week 48 (66.9%). Secukinumab showed sustained and stable efficacy in maintaining PASI 90 response in patients with moderate-to-severe plaque psoriasis up to week 48.

This study evaluated whether secukinumab treatment for patients with moderate to severe plaque psoriasis correlates with improvements in symptoms of anxiety and depression. SUPREME was a 24-week, phase IIIb, multicentre, prospective study conducted across 50 centres in Italy with an extension period of up to 72 weeks. Assessments used were: Psoriasis Area Sever-ity Index (PASI), Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A), and HADS - Depression (HADS-D) scores and Dermatology Quality Life Index (DLQI). Compared with baseline, a significantly greater proportion of patients who reported moderate to severe clinical symptoms of anxiety or depression (HADS-A or HADS-D ≥ 11) were free of moderate to severe symptoms at weeks 16 and 48. The PASI and DLQI scores reduced over time with secukinumab treatment. Psoriasis treatment with secukinumab for 48 weeks resulted in significantly improved skin clearance and a parallel improvement in symptoms of anxiety and depression, assessed by HADS.

Background: A significant proportion of patients with severe asthma may also suffer from nasal polyposis, which is commonly defined as chronic rhinosinusitis with nasal polyps (CRSwNP), the presence of which may adversely affect asthma treatment outcomes. The biologic agent omalizumab is effective as add-on therapy in patients with severe allergic asthma. The aim of this post hoc analysis of the PROXIMA study was to compare the efficacy of omalizumab between patients with severe allergic asthma, with and without comorbid CRSwNP., Methods: PROXIMA was a prospective observational 2-part study conducted in Italy in adult patients with severe allergic asthma, where, in the second part, patients eligible for add-on omalizumab initiated treatment for 12 months. Patient baseline data such as comorbidities and history of exacerbations were collected. Outcomes were asthma control (Asthma Control Questionnaire [ACQ]), lung function (forced expiratory volume in 1 s [FEV 1 ]) and exacerbation rate. The post hoc analysis compared these outcomes between the cohort with comorbid CRSwNP and the cohort without CRSwNP., Results: Of 123 patients included in this analysis, 17 (13.8%) were in the CRSwNP cohort. There was no significant difference between cohorts in baseline clinical characteristics or in change from baseline at 12 months in ACQ values,  % of predicted FEV 1 or annual asthma exacerbation rate, although results were numerically in favor of the CRSwNP cohort versus the non-CRSwNP cohort. The proportion of patients who achieved an improvement in all three outcomes was numerically greater in the CRSwNP cohort (35.7% vs 23.0%)., Conclusions: In an observational real-world setting, add-on omalizumab for severe allergic asthma was effective in improving asthma control, lung function and in reducing exacerbations, including in those patients with CRSwNP., Competing Interests: Competing interestsEnrico Heffler is an advisory board member and speaker for Novartis, AstraZeneca, Sanofi-Genzyme, GSK, Teva, Circassia, and Nestlè Purina. Fabiana Saccheri and Marta Bartezaghi are employees of Novartis. Giorgio Walter Canonica has received research grants, as well as lecture or advisory board fees, from A. Menarini, Alk-Abello, Allergy Therapeutics, Anallergo, AstraZeneca, MedImmune, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, Danone, Faes, Genentech, Guidotti-Malesci, GlaxoSmithKline, Hal Allergy, Merck, MSD, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi, Genzyme/Regeneron, Stallergenes, UCB Pharma, Uriach Pharma, Teva, Thermo Fisher, and Valeas., (© The Author(s) 2020.)

Background: Patients with severe allergic asthma (SAA) when treated with omalizumab may exhibit different extent of response. Identifying biomarkers that can predict the extent of treatment effectiveness in patients can be useful in personalizing omalizumab treatment., Methods: Patients from the longitudinal phase of the PROXIMA study were selected for this ancillary study. After 12 months of omalizumab treatment, patients were categorized according to their response to treatment as: "clinical responder" (Asthma Control Questionnaire [ACQ] total score <1 at Month 12 and/or with a reduction in number of exacerbation versus the previous year); "functional responder" (an increment of ≥0.1 L in forced expiratory volume in 1 s [FEV 1 ] at Month 12 versus baseline); and "super responder" (among clinical responders group, who also showed a functional response). Plasma galectin-3 (GAL-3) levels were quantified using a micro titer plate-based enzyme linked immunosorbent assay kit., Results: The Majority of patients (86.36%) in sub-study population were identified as clinical responders. Of the total patients identified as clinical responders, 64.86% were identified as super responders . A statistically significant difference in the baseline plasma GAL-3 levels between responders and non-responders was observed only in the functional responders group ( P  = 0.0446). Patients with plasma GAL-3 level of ≥11 ng/mL had a greater probability of being a super responder ( P  = 0.0118) or a functional responder ( P  = 0.0032)., Conclusion: Our findings support the use of plasma GAL-3 as a predictive marker to stratify responders and identify super responders and functional responders to omalizumab treatment in patients with severe allergic asthma using less invasive sample like plasma., Competing Interests: AMR, PLM, LDF, RR, DDS, GWC have no competing interests. FS and MB are employees of Novartis., (© 2019 The Authors.)

Background: Data on the prevalence of perennial versus seasonal allergic asthma in Italy are lacking; moreover, there is limited evidence on the effect of omalizumab on patient-reported outcomes in Italian patients with severe allergic asthma. PROXIMA, an observational, multicenter study, was designed to assess the prevalence of perennial versus seasonal allergic asthma (cross-sectional phase) and the effect of omalizumab on improving illness perception, quality of life (QoL) and asthma control of Italian patients with severe allergic asthma (longitudinal phase)., Methods: The study included a cross-sectional phase ( n  = 357) and a longitudinal phase ( n  = 123): during the longitudinal phase, patients received omalizumab (75-600 mg subcutaneously every month) and were followed-up for 12 months. The primary parameter of cross-sectional phase was prevalence of perennial allergic asthma and that of longitudinal phase was proportion of patients with asthma control (assessed using asthma control questionnaire [ACQ]). Secondary parameters assessed were patients' disease perception, level of asthma control, exacerbation rate during both cross-sectional and longitudinal phases, and patients' compliance to and persistence with omalizumab, and patients' QoL during the longitudinal phase., Results: Most patients (95.8%) had perennial allergies; 81% had polysensitization. Of 99 patients in the per-protocol set, 95 (95.96% [95% CI: 89.98-98.89%]) achieved asthma control (ACQ < 4) at both 6 and 12 months of omalizumab treatment; ACQ score decreased after 6 and 12 months ( P  < 0.0001). Omalizumab treatment resulted in a significant improvement in QoL and patients' illness perception and 87% decrease in exacerbation rate. The compliance rate with omalizumab was high (73.2%). No new safety signals were identified during treatment., Conclusion: This study demonstrated that in severe allergic asthma, omalizumab improves patient-reported outcomes such as patients' illness perception and QoL, while confirming improvement of asthma control and exacerbation rate reduction in Italian patients., Competing Interests: The study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki and the AIFA Guideline for classification and management of observational studies on drugs. All patients provided informed consent before participating in the study.Not applicable.Giorgio Walter Canonica reports having received research grants as well as lecture or advisory board fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, Glaxo Smith Kline, Mundipharma, Novartis, Sanofi-Aventis, Teva. Paola Rottoli reports receiving personal fees and other from Roche, personal fees from Boehringer Ingelheim, grants and personal fees from Novartis, personal fees from TEVA, other from Menarini, from null, outside the submitted work. Bruno Macciocchi reports receiving grants from Boehringer Ingelheim. Pierachille Santus reports receiving personal fees from Astra Zeneca, grants and personal fees from Boehringer ingelheim, grants from Almirall, grants and personal fees from Chiesi Farmaceutici, personal fees from Guidotti, personal fees from GSK, personal fees from Zambon Italia, outside the submitted work. Marta Bartezaghi and Laura Rigoni are the employees of Novartis.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: A high treatment burden with nebulised therapies in cystic fibrosis (CF) patients is the major limitation for treatment compliance; moreover, studies on treatment compliance with inhaled antibiotics are limited. This study assessed compliance to TOBI ® Podhaler™ (TIP) treatment in CF patients with chronic Pseudomonas aeruginosa (Pa) infections in a real-world setting using the Italian Treatment Adherence CF Questionnaire (ITA-CFq)., Methods: This longitudinal, multicentre, cohort study included 2 follow-up (FU) visits: FU-1 at 3-months±15-days from the baseline visit and FU-2 at the end of third TIP cycle (or 6-months after enrolment, whichever occurred first). The effect of TIP on quality-of-life (QoL) and treatment satisfaction were evaluated using Cystic Fibrosis Questionnaire-Revised (CFQ-R) and Treatment Satisfaction Questionnaire for Medication (TSQM), respectively. Overall compliance to treatments was assessed using ITA-CFq., Results: Eighty-two patients (mean age, 24.8 ± 7.9 years), including 22 paediatric patients (age, <18 years), were enrolled in the study; 56 (68.3%) patients, including 17 paediatric patients, completed the study. At baseline, the mean compliance score to aerosol antibiotic treatment was 7.8 ± 3.2; upon introducing TIP, the compliance score improved to 9.4 ± 1.2 at the FU-1 and thereafter remained stable at 9.5 ± 1.2. TSQM was higher for the convenience domain (74.2 ± 17.1 at enrolment and slightly improved to 77.8 ± 15.9 at FU-2) following TIP initiation. No substantial effect of TIP was observed on the QoL when measured using the revised CFQ-R. The safety profile was in line with previous findings., Conclusion: TIP was convenient to use and led to improved treatment adherence in CF patients with chronic Pa-infection., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: We designed the PROXIMA study (Patient-Reported Outcomes and Xolair(®) In the Management of Asthma) to determine the proportion of patients with severe asthma sensitive to perennial allergens, and to evaluate asthma control and treatment adherence up to 12 months in patients treated with omalizumab in Italian population. In addition, an ancillary study was designed to explore protein biomarkers and characterize them in relation to severe allergic asthma and treatment effects by proteomic approach., Methods: PROXIMA is an observational, multicenter, cross-sectional and prospective cohort study conducted at 25 centers in Italy, in outpatient settings. The study consists of two phases: 1) a cross-sectional phase plans to enroll 600 patients with severe allergic asthma, in step 4 therapy as per GINA guidelines, aged ≥18 years, needing a step up in therapy, and 2) a longitudinal phase on patients who will start omalizumab add-on therapy per clinician's judgment at baseline visit (approximately 180-240 patients). The primary variable of the cross-sectional phase is the proportion of patients with severe asthma presenting with perennial form of allergy (skin prick test or in vitro test). The primary variable of longitudinal phase is proportion of patients who achieve disease control (assessed by Asthma Control Questionnaire [ACQ]) with omalizumab at 6 months, and maintain it at 12 months. Secondary variables are patient compliance to omalizumab, patient-reported perception of cognitive and emotional impact of the illness, assessed by Brief Illness Perception Questionnaire (Brief IPQ) and the health related quality of life evaluated by the EuroQoL 5D-3 L (EQ-5D-3 L). Safety endpoints will be recorded during the course of the study. Patients participating in the longitudinal phase will be enrolled for ancillary study if they provide additional informed consent. Protein species in complex mixtures will be identified using innovative MudPIT (Multidimensional Protein Identification Technology) method., Conclusions: The results of this observational study will provide estimate of patient population allergic to perennial allergens in Italy and information on patient-reported outcomes with omalizumab therapy in a real-world setting. The exploratory proteomic analysis on asthma biomarkers could eventually provide new data to identify responder patients to anti IgE therapy.