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Background and Objectives: In multiple sclerosis (MS), MRI markers can measure the potential neuroprotective effects of fingolimod beyond its anti-inflammatory activity. In this study we aimed to comprehensively explore, in the real-word setting, whether fingolimod not only reduces clinical/MRI inflammatory activity, but also influences the progression of irreversible focal and whole brain damage in relapsing-remitting [RR] MS patients., Methods: The "EVOLUTION" study, a 24-month observational, prospective, single-arm, multicenter study, enrolled 261 RRMS patients who started fingolimod at 32 Italian MS centers and underwent biannual neurological assessments and annual MRI evaluations. Study outcomes included the proportions of evaluable RRMS patients achieving at 24 months: (1) no new/enlarging T 2 -hyperintense white matter (WM) lesions and/or clinical relapses; (2) a modified classification of "No Evidence of Disease Activity 4" ("modified NEDA-4") defined as no new/enlarging T 2 -hyperintense WM lesions, clinical relapses, and 6-month confirmed disability progression, and a yearly percentage lateral ventricular volume change on T 2 -FLAIR images < 2%; (3) less than 40% of active lesions at baseline and month 12 evolving to permanent black holes (PBHs)., Results: At month 24, 76/160 (47.5%; 95% confidence interval [CI] = 39.8%;55.2%) RRMS patients had no clinical/MRI activity. Thirty-nine of 170 RRMS patients (22.9%; 95% CI = 16.6%;29.3%) achieved "modified NEDA-4" status. Forty-four of 72 RRMS patients (61.1%; 95% CI = 49.8%;72.4%) had less than 40% of active WM lesions evolving to PBHs. The study confirmed the established safety and tolerability profile of fingolimod., Discussion: By comparing our results with those from the literature, the EVOLUTION study seems to indicate a neuroprotective effect of fingolimod, limiting inflammatory activity, brain atrophy and PBH development., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

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.)

Background: We aimed to explore whether erenumab, a monoclonal antibody targeting the calcitonin gene-related peptide receptor, could exert a central effect on brain network function in migraine, and investigate the persistence of such an effect following treatment discontinuation., Methods: This was a randomized, double-blind, placebo-controlled, multicenter trial with a crossover design performed in adult episodic migraine patients with previous treatment failure. Patients were randomized (1:1) to 12 weeks of erenumab 140 mg or placebo, followed by a 12-week crossover. Resting state (RS) functional connectivity (FC) changes of brain networks involved in migraine were investigated using a seed-based correlation approach., Results: Sixty-one patients were randomized to treatment. In each treatment sequence, 27 patients completed the visit at week 12. Forty-four enrolled patients, 22 in each treatment sequence, completed the study procedures with no major protocol violations. We observed a carry-over effect of erenumab during the placebo treatment and therefore data analysis was performed as a parallel comparison of erenumab vs placebo of the first 12 weeks of treatment. From baseline to week 12, compared to placebo, patients receiving erenumab showed RS FC changes within the cerebellar, thalamic and periaqueductal gray matter networks, significantly associated with clinical improvement. Compared to non-responders, patients achieving a 50% reduction in migraine days had distinct patterns of thalamic and visual network RS FC. Brain RS FC changes reversed when erenumab was stopped. A lower baseline RS FC of the pontine network identified patients responding to erenumab., Conclusion: Erenumab modulates RS FC of networks involved in migraine pathophysiology. In line with clinical response, erenumab-induced brain RS FC changes tend to reverse when treatment is stopped., (© 2023. The Author(s).)

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.)

Background: Cyclosporine A (CsA) is one of the systemic therapeutic options for moderate-to-severe psoriasis, based on its efficacy and rapidity of action. The current study investigated the response to CsA in patients with moderate-to-severe plaque psoriasis., Materials and Methods: TRANSITION was an observational, cross-sectional, multicentre study which evaluated the proportion of partial- and suboptimal-responders among patients with moderate-to-severe plaque psoriasis treated with continuous CsA for ≥12 weeks. Patients demonstrating a Psoriasis Area and Severity Index (PASI) response of ≥90, ≥75 and <90, ≥50 and <75 and <50 were defined as responders, suboptimal-responders, partial-responders, and non-responders, respectively., Results: A total of 196 patients (mean age, 46.6 years; 62.8% males) from 14 sites in Italy were evaluated. At the study visit, the mean (SD) PASI score was 4.2(5.5) compared with 15.3(7.1) prior to the last CsA cycle. For response categories, 39.8%, 22.4%, 16.8%, and 20.9% of patients were responders, suboptimal-responders, partial-responders, and non-responders to CsA treatment. Overall, 28.6% of patients permanently discontinued treatment with CsA (lack of efficacy [10.2%], poor tolerability and voluntary discontinuation [3.6% each], and other [11.7%])., Conclusion: Patients were only partially satisfied with CsA treatment, reporting measurable impact on quality of life. Only 40% patients showed a satisfactory response to CsA.