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6. Platelet rich plasma for primary macular hole: A case series

Author

Parisi, Guglielmo, Gelormini, Francesco, Ricardi, Federico, Borrelli, Enrico, Parisi, Francesca, Belluardo, Giuseppe, Azzaro, Laura, Marolo, Paola, D’antico, Sergio, Salafia, Marika, and Reibaldi, Michele

Abstract

Objective To evaluate the anatomical and functional macular results and rate of complications following surgical treatment of primary macular hole (MH) with autologous platelet rich plasma (a-PRP) use.Design retrospective, interventional, non-randomized case seriesPartecipants and methods A cohort of 9 consecutive patients from January 1, 2019 to August 31, 2021 who underwent vitrectomy with a-PRP use for primary MH were included. Anatomical results based on spectral domain- optical coherence tomography (SD-OCT) and visual acuity were analyzed.Results 10 pseudophakic eye of 9 patients were enrolled. Six patients were female and three patients were male. The mean age was 69.9 years ± 1.48. The baseline MH minimum diameter was 486.1 μm ± 37.1, and mean pre operative best-corrected visual acuity (BCVA) was 0.91 ± 0.03 logMAR (Snellen equivalent 20/160). Mean 1 month post operative BCVA was 0.81 ± 0.57 logMAR (Snellen equivalent 20/130; p= 1.000); mean 3 month post operative BCVA was 0.66 ± 0.04 logMAR (Snellen equivalent 20/90; p= 0.006); mean 6 month post operative BCVA was 0.6 ± 0.04 logMAR (Snellen equivalent 20/80; p< 0.001). In all eyes, 10/10 (100%), there was a complete MH closure at 6 months follow up: 5 eyes (50%) with a U-type closure pattern, 4 eyes (40%) with a V-type pattern and 1 eye (10%) with an irregular foveal contour closure at 6 month follow-up. No ocular and systemic complications were reported.Conclusion The a-PRP use is a successful and promising vitreoretinal surgical technique option for primary MH

Published
2024
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15. Safety and effectiveness of tofacitinib in ulcerative colitis: Data from TOFA-UC, a SN-IBD study.

Author

Macaluso, Fabio Salvatore, D'Antonio, Elvira, Fries, Walter, Viola, Anna, Ksissa, Omar, Cappello, Maria, Muscarella, Stefano, Belluardo, Nunzio, Giangreco, Emiliano, Mocciaro, Filippo, Di Mitri, Roberto, Ferracane, Concetta, Vitello, Alessandro, Grova, Mauro, Renna, Sara, Casà, Angelo, De Vivo, Simona, Ventimiglia, Marco, and Orlando, Ambrogio

Abstract

Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC). To assess the safety and effectiveness of TOFA in clinical practice. TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included. 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response. TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Vedolizumab may be an effective option for the treatment of postoperative recurrence of Crohn's disease.

Author

Macaluso, Fabio Salvatore, Cappello, Maria, Crispino, Federica, Grova, Mauro, Privitera, Antonino Carlo, Piccillo, Giovita, Magnano, Antonio, Ferracane, Concetta, Belluardo, Nunzio, Giangreco, Emiliano, Fries, Walter, Viola, Anna, Di Mitri, Roberto, Mocciaro, Filippo, Camilleri, Salvatore, Garufi, Serena, Renna, Sara, Casà, Angelo, Maida, Marcello, and Orlando, Ambrogio

Abstract

The role of Vedolizumab (VDZ) as therapeutic option for the postoperative recurrence of Crohn's disease (CD) following ileocolonic resection is unknown. To assess the effectiveness of VDZ in this setting. All consecutive CD patients with a baseline colonoscopy at 6–12 months from the ileocolonic resection showing postoperative recurrence (Rutgeerts score ≥i2) and treated with VDZ after the baseline colonoscopy were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD). The primary outcome was endoscopic success, assessed at the first colonoscopy following initiation of VDZ and defined as reduction of at least one point of Rutgeerts score. The secondary outcome was clinical failure, assessed at one year and at the end of follow-up. Fifty-eight patients were included (mean follow-up: 24.8 ± 13.1 months). Endoscopic success was reported in 47.6% of patients. Clinical failure was reported in 19.0% of patients at one year, and in 32.8% of patients at the end of follow-up. A new resection was required in 7 patients (12.1%). VDZ may be an effective option for the treatment of postoperative recurrence of CD. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Effectiveness and safety of vedolizumab in biologically naïve patients: A real-world multi-centre study

Author

Macaluso, Fabio Salvatore, Fries, Walter, Renna, Sara, Viola, Anna, Muscianisi, Marco, Cappello, Maria, Guida, Laura, Siringo, Sebastiano, Camilleri, Salvatore, Garufi, Serena, Privitera, Antonino Carlo, Belluardo, Nunzio, Giangreco, Emiliano, Bertolami, Carmelo, Vassallo, Roberto, Rizzuto, Giulia, Orlando, Rosalba, Ventimiglia, Marco, and Orlando, Ambrogio

Abstract

Biologically naïve patients with inflammatory bowel disease treated with vedolizumab (VDZ) are largely underrepresented in real-world cohorts. A multi-centre, observational cohort study was performed on the effectiveness and safety of VDZ in biologically naïve subjects with Crohn’s disease (CD) and ulcerative colitis (UC). Data of consecutive biologically naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. A total of 172 consecutive patients (CD: N?=?88; UC: N?=?84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. This study demonstrates the effectiveness and safety of VDZ as a first-line biological, particularly among elderly patients.

Published
2020
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40. Propensity Score-matched Comparison of Infliximab and Adalimumab in Tumour Necrosis Factor-α Inhibitor-naïve and Non-naïve Patients With Crohn's Disease: Real-Life Data From the Sicilian Network for Inflammatory Bowel Disease.

Author

Macaluso, Fabio Salvatore, Fries, Walter, Privitera, Antonio Carlo, Cappello, Maria, Siringo, Sebastiano, Inserra, Gaetano, Magnano, Antonio, Mitri, Roberto Di, Mocciaro, Filippo, Belluardo, Nunzio, Scarpulla, Giuseppe, Magrì, Giovanni, Trovatello, Antonino, Carroccio, Antonio, Genova, Salvatore, Bertolami, Carmelo, Vassallo, Roberto, Romano, Claudio, Citrano, Michele, and Accomando, Salvatore

Abstract

Background and Aims There is an unmet need to better understand the effectiveness of different biologics in inflammatory bowel diseases. We aimed at performing a multicentre, real-life comparison of the effectiveness of infliximab [IFX] and adalimumab [ADA] in Crohn's disease [CD]. Methods Data of consecutive patients with CD treated with IFX and ADA from January 2013 to May 2017 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. We used propensity score-matching accounting for the main baseline characteristics in TNF-α inhibitor-naïve and non-naïve patients. Results A total of 632 patients [735 total treatments] were included. Among naïve patients, a clinical benefit [the sum of steroid-free remission plus clinical response] was achieved in 81.8% patients treated with ADA and in 77.6% patients treated with IFX (adjusted odds ratio [OR]: 1.23, 95% CI 0.63-2-44, p = 0.547] at 12 weeks; after 1 year, a clinical benefit was achieved in 69.2% of patients treated with ADA and in 64.5% patients treated with IFX [adjusted OR: 1.10, 95% CI 0.61–1.96, p = 0.766]. Among non-naïve patients, a clinical benefit was achieved in 61.7% of patients treated with ADA and in 68.1% of patients treated with IFX [adjusted OR: 0.72, 95% CI 0.21–2.44, p = 0.600] at 12 weeks; after 1 year, a clinical benefit was achieved in 48.9% of patients treated with ADA and in 40.4% patients treated with IFX [adjusted OR: 1.23, 95% CI 0.54–2.86, p = 0.620]. Conclusions In this propensity score-matched comparison of ADA and IFX in CD, both drugs showed high rates of clinical benefit, without significant differences between them. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population. Cardio-Sis Study Group

Author

Verdecchia P, Staessen JA, Achilli A, DE SIMONE, GIOVANNI, Ganau A, Mureddu G, Pede S, Porcellati C, Fornari G, Repaci S, Castellani C, Achilli P, Jaspers C, Cucchiara G, Panzano C, Angeli F, Aillon C, Sclavo MG, Scherillo M, Raucci D, Di Donato M, Cas LD, Faggiano P, Porcu M, Calamida R, Pistia L, Vancheri F, Alletto M, Curcio M, Pettinati G, Ieva M, Muscella A, Guerrieri M, Denbek C, Gulizia M, Francese GM, Perticone F, Iemma G, Fariello R, Sala N, Mezzetti A, Pierdomenico SD, Bucci M, Benemio G, Gattobigio R, Sacchi N, Cocchieri M, Prosciutti L, Battocchi P, Garognoli O, Arcelli G, Pirelli S, Emanuelli C, Braschi GB, Abrignani M, De Ferrari G, Ponremoli R, Igidbashian D, Marini R, Scarpino L, Mandorla S, Buccolieri M, Picchi L, Casolo G, Pardini M, Marracci G, STRAZZULLO, PASQUALE, GALLETTI, FERRUCCIO, BARBATO, ANTONIO, Cavallini C, Borgioni C, Seghieri G, Cipollini F, Arcangeli E, Boddi W, Palermo C, Savelli F, Lembo G, Vecchione C, Malatino L, Belluardo P, Zoccali C, Leonardis D, Mallamaci F, Lacchè A, Gentile C, Boccanelli A, Mureddu GF, Santini M, Colivicchi F, Ficili S, Uguccioni M, Nardozi C, Tedeschi A, Martin G, Zanata G, Mos L, Dialti V, Martina S, Renna A, Farina G, Tripodi E, Miserrafiti B, Scali R, Stornello M, Valvo E, Bernardinangeli M, Proietti G, Poddighe G, Biscottini B, Panciarola R, Boccali A, Veglio F, Rabbia F, Caserta M, Chiatto M, Stefenelli C, Cioffi G, Bonazza G, Scabbia EV, Bottoni D., Verdecchia, P, Staessen, Ja, Achilli, A, DE SIMONE, Giovanni, Ganau, A, Mureddu, G, Pede, S, Porcellati, C, Fornari, G, Repaci, S, Castellani, C, Achilli, P, Jaspers, C, Cucchiara, G, Panzano, C, Angeli, F, Aillon, C, Sclavo, Mg, Scherillo, M, Raucci, D, Di Donato, M, Cas, Ld, Faggiano, P, Porcu, M, Calamida, R, Pistia, L, Vancheri, F, Alletto, M, Curcio, M, Pettinati, G, Ieva, M, Muscella, A, Guerrieri, M, Denbek, C, Gulizia, M, Francese, Gm, Perticone, F, Iemma, G, Fariello, R, Sala, N, Mezzetti, A, Pierdomenico, Sd, Bucci, M, Benemio, G, Gattobigio, R, Sacchi, N, Cocchieri, M, Prosciutti, L, Battocchi, P, Garognoli, O, Arcelli, G, Pirelli, S, Emanuelli, C, Braschi, Gb, Abrignani, M, De Ferrari, G, Ponremoli, R, Igidbashian, D, Marini, R, Scarpino, L, Mandorla, S, Buccolieri, M, Picchi, L, Casolo, G, Pardini, M, Marracci, G, Strazzullo, Pasquale, Galletti, Ferruccio, Barbato, Antonio, Cavallini, C, Borgioni, C, Seghieri, G, Cipollini, F, Arcangeli, E, Boddi, W, Palermo, C, Savelli, F, Lembo, G, Vecchione, C, Malatino, L, Belluardo, P, Zoccali, C, Leonardis, D, Mallamaci, F, Lacchè, A, Gentile, C, Boccanelli, A, Mureddu, Gf, Santini, M, Colivicchi, F, Ficili, S, Uguccioni, M, Nardozi, C, Tedeschi, A, Martin, G, Zanata, G, Mos, L, Dialti, V, Martina, S, Renna, A, Farina, G, Tripodi, E, Miserrafiti, B, Scali, R, Stornello, M, Valvo, E, Bernardinangeli, M, Proietti, G, Poddighe, G, Biscottini, B, Panciarola, R, Boccali, A, Veglio, F, Rabbia, F, Caserta, M, Chiatto, M, Stefenelli, C, Cioffi, G, Bonazza, G, Scabbia, Ev, and Bottoni, D.

Abstract

The hypothesis that a therapeutic strategy aimed at lowering systolic blood pressure (SBP) below 130 mm Hg is superior to a conventional strategy targeted at below 140 mm Hg in hypertensive subjects has never been tested in randomized intervention studies. The Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica (Cardio-Sis) is a multi-centre study in non-diabetic, treated hypertensive subjects aged >55 years with uncontrolled SBP (>or=150 mm Hg) and at least one additional cardiovascular risk factor (ClinicalTrials.gov identifier: NCT00421863). Subjects are randomized to an SBP goal

Published
2008

46. The real-world effectiveness of vedolizumab on intestinal and articular outcomes in inflammatory bowel diseases.

Author

Macaluso, Fabio Salvatore, Orlando, Rosalba, Fries, Walter, Scolaro, Mariangela, Magnano, Antonio, Pluchino, Dario, Cappello, Maria, Morreale, Gaetano Cristian, Siringo, Sebastiano, Privitera, Antonino Carlo, Ferracane, Concetta, Belluardo, Nunzio, Alberghina, Nadia, Ventimiglia, Marco, Rizzuto, Giulia, Renna, Sara, Cottone, Mario, and Orlando, Ambrogio

Abstract

Background The effectiveness of vedolizumab in real-world practice is under evaluation, while its role in inflammatory bowel disease-associated spondyloarthritis is still unclear. Aims To report real-world data about the effectiveness of vedolizumab on intestinal and articular symptoms after 10 and 22 weeks of treatment. Methods Web-based data from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD) were extracted to perform a prospective multicentre observational study. Results 163 patients (84 with Crohn's disease and 79 with ulcerative colitis) were included. At week 10, a steroid-free remission was achieved in 71 patients (43.6%), while at week 22 a steroid-free remission was obtained in 40.8% of patients. A response on articular symptoms was reported after 10 weeks of treatment in 17 out of 43 (39.5%) patients with active spondyloarthritis at baseline, and in 10 out of 22 (45.4%) patients at week 22. The only factor associated with articular response was the coexistence of clinical benefit on intestinal symptoms (at week 10: OR 8.471, p  = 0.05; at week 22: OR 5.600, p  = 0.08). Conclusions Vedolizumab showed good effectiveness after 10 and 22 weeks of treatment. A subset of patients reported improvement also on articular symptoms, probably as a consequence of the concomitant control of gut inflammation. [ABSTRACT FROM AUTHOR]

Published
2018
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47. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population

Author

VERDECCHIA P, CARDIO SIS STUDY G. R. O. U. P., Staessen, Ja, Achilli, A, DE SIMONE, G, Ganau, A, Mureddu, G, Pede, S, Porcellati, C, Fornari, G, Repaci, S, Castellani, C, Achilli, P, Jaspers, C, Cucchiara, G, Panzano, C, Angeli, F, Aillon, C, Sclavo, Mg, Scherillo, M, Raucci, D, DI DONATO, M, Cas, Ld, Faggiano, P, Porcu, M, Calamida, R, Pistia, L, Vancheri, F, Alletto, M, Curcio, M, Pettinati, G, Ieva, M, Muscella, A, Guerrieri, M, Denbek, C, Gulizia, M, Francese, Gm, Perticone, F, Iemma, G, Fariello, R, Sala, N, Mezzetti, A, Pierdomenico, Sd, Bucci, M, Benemio, G, Gattobigio, R, Sacchi, N, Cocchieri, M, Prosciutti, L, Battocchi, P, Garognoli, O, Arcelli, G, Pirelli, S, Emanuelli, C, Braschi, Gb, Abrignani, M, DE FERRARI, G, Ponremoli, R, Igidbashian, D, Marini, R, Scarpino, L, Mandorla, S, Buccolieri, M, Picchi, L, Casolo, G, Pardini, M, Marracci, G, Strazzullo, P, Galletti, F, Barbato, A, Cavallini, C, Borgioni, C, Seghieri, G, Cipollini, F, Arcangeli, E, Boddi, W, Palermo, C, Savelli, F, Lembo, G, Vecchione, C, Malatino, Lorenzo, Belluardo, P, Zoccali, C, Leonerdis, D, Mallamaci, F, Lacchè, A, Gentile, C, Boccanelli, A, Mureddu, Gf, Santini, M, Colivicchi, F, Ficili, S, Uguccioni, M, Nardozi, C, Tedeschi, A, Martin, G, Zanata, G, Mos, L, Dialti, V, Martina, S, Renna, A, Farina, G, Tripodi, E, Miserrafiti, B, Scali, R, Stornello, M, Valvo, E, Bernardinangeli, M, Proietti, G, Poddighe, G, Biscottini, B, Panciarola, R, Boccali, A, Veglio, F, Rabbia, F, Caserta, M, Chiatto, M, Stefenelli, C, Cioffi, G, Bonazza, G, Scabbia, Ev, and Bottoni, D.

Published
2008

48. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population

Author

Cardio Sis Study Group, Verdecchia, P, Staessen, Ja, Achilli, A, de Simone, G, Ganau, A, Mureddu, G, Pede, S, Porcellati, C, Fornari, G, Repaci, S, Castellani, C, Achilli, P, Jaspers, C, Cucchiara, G, Panzano, C, Angeli, F, Aillon, C, Sclavo, Mg, Scherillo, M, Raucci, D, Di Donato, M, DEI CAS, Livio, Faggiano, P, Porcu, M, Calamida, R, Pistia, L, Vancheri, F, Alletto, M, Curcio, M, Pettinati, G, Ieva, M, Muscella, A, Guerrieri, M, Denbek, C, Gulizia, M, Francese, Gm, Perticone, F, Iemma, G, Fariello, R, Sala, N, Mezzetti, A, Pierdomenico, Sd, Bucci, M, Benemio, G, Gattobigio, R, Sacchi, N, Cocchieri, M, Prosciutti, L, Battocchi, P, Garognoli, O, Arcelli, G, Pirelli, S, Emanuelli, C, Braschi, Gb, Abrignani, M, De Ferrari, G, Ponremoli, R, Igidbashian, D, Marini, R, Scarpino, L, Mandorla, S, Buccolieri, M, Picchi, L, Casolo, G, Pardini, M, Marracci, G, Strazzullo, P, Galletti, F, Barbato, A, Cavallini, C, Borgioni, C, Seghieri, G, Cipollini, F, Arcangeli, E, Boddi, W, Palermo, C, Savelli, F, Lembo, G, Vecchione, C, Malatino, L, Belluardo, P, Zoccali, C, Leonardis, D, Mallamaci, F, Lacchè, A, Gentile, C, Boccanelli, A, Mureddu, Gf, Santini, M, Colivicchi, F, Ficili, S, Uguccioni, M, Nardozi, C, Tedeschi, A, Martin, G, Zanata, G, Mos, L, Dialti, V, Martina, S, Renna, A, Farina, G, Tripodi, E, Miserrafiti, B, Scali, R, Stornello, M, Valvo, E, Bernardinangeli, M, Proietti, G, Poddighe, G, Biscottini, B, Panciarola, R, Boccali, A, Veglio, F, Rabbia, F, Caserta, M, Chiatto, M, Stefenelli, C, Cioffi, G, Bonazza, G, Scabbia, Ev, and Bottoni, D.

Published
2008

49. BENEFITS FROM A COMPUTER-AIDED DETECTION DEVICE IN COLONOSCOPY (ACCENDO-COLO) – AN INTERIM ANALYSIS OF AN ITALIAN MULTICENTER RANDOMIZED CLINICAL TRIAL.

Author

Salvi, Daniele, Pecere, Silvia, Cesaro, Paola, Ciuffini, Cristina, Milluzzo, Sebastian Manuel, Quadarella, Alessandro, Piccirelli, Stefania, Pesatori, Eugenia Vittoria, Belluardo, Nicoletta, Ferrari, Clarissa, Olivari, Nicola, Codazzi, Manuela, Gerardi, Viviana, Grazioli, Leonardo Minelli, Barbaro, Federico, Papparella, Luigi Giovanni, Petruzziello, Lucio, Costamagna, Guido, and Spada, Cristiano

Published
2023
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