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Cardarelli, Silvia (2015) terapia con micofenolato dell'interstiziopatia polmonare associata a sclerosi sistemica - esperienza monocentrica. [Tesi di dottorato]

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Abstract (inglese)

Background
Interstitial lung disease (ILD) is the most frequent type of organ involvement and the main cause of death in systemic sclerosis (SSc). The trigger of fibrosis is an immune mediated alveolitis, thus in the last years, several immunosuppressant drugs have been put to the test, mostly cyclophosphamide (CYC), azathioprine (AZA) and mycophenolate mofetil (MMF).
Therefore, also in the Rheumatology Unit of Padua University, in recent years have been treated in with immunosuppressive therapy.
Aim
The aim of our study was to evaluate the efficacy of MMF as a first-line drug on pulmonary function in SSc-related ILD patients and compare them to a historical group of SSc patients treated with CYC followed by AZA.
Moreover, it has been assessed the safety of each immunosuppressant drugs.
Methods
Eighteen patients with SSc-related ILD have been investigated and treated with MMF as first-line therapy for two years.
Fifteen patients, instead have been treated one year with CYC and for and with AZA for the second years.
The two groups of patients have been evaluated at baseline, and then after 12 and 24 months of therapy.
The evaluation parameters were: pulmonary function tests (FVC and DLCO), HRCT score and NYHA class.
The comparison between the two groups was assessed using Pearson’s chi-square test, student t test and Wilcoxon signed rank test as statistical approaches.

Results
At baseline, patients characteristics appeared homogeneous between the two groups and non-statistically significant increase of FVC was observed in both groups at month 12 and month 24.
In the group treated with MMF no patient has deteriorated in NYHA functional class, respiratory tests showed an average stability pulmonary function and no patient has progressed in the TC score.
In the control group, treated sequentially with CYC and AZA, has no been shown significant difference in NYHA class, respiratory tests, or in score TC.
Comparing the two groups, no resounding significant difference has been highlighted. for the evaluated clinical parameters, showing similar efficacy of MMF compared to a pattern of traditional immunosuppressive therapy.
In the group treated with MMF no patients reported adverse events than can cause discontinuation of treatment, while in the control group, 2 patients had to interrupt the CYC for leukopenia, and 5 had suspended AZA, 2 for hepatotoxicity and 3 for leukopenia.
The difference between the two groups respect to adverse events was statistically significant in favor of MMF (p = 0.0046).
Conclusions
The data of our study suggest that the immunosuppressive therapy with MMF administered for a period of two years has led to a stabilization of ILD in a cohort of SSc patients, as shown by respiratory test, the HRCT score, and functional class NYHA. Similar results have been observed in another group cohort of patients treated sequentially for two years with CYC and AZA.
Besides, MMF treated group presented a significant decrease of side effects, compared to the group treated with CYC and AZA.

Abstract (italiano)

Presupposti dello studio
L’interstiziopatia polmonare (ILD) costituisce l’impegno viscerale più frequente della sclerosi sistemica (SSc) nonché la principale causa di morte. Poiché la prima fase del processo è una alveolite immunomediata che innesca poi la fibrosi, negli ultimi anni sono stati effettuati numerosi studi per dimostrare l’efficacia di farmaci immunosoppressori come terapia della interstiziopatia. Sono stati utilizzati soprattutto la ciclofosfamide (CYC), l’azatioprina (AZA) e il micofenolato mofetile (MMF). Anche molti pazienti affetti da SSc complicata da ILD afferenti all’U.O.C. di Reumatologia del complesso Azienda Ospedaliera-Università di Padova sono stati trattati negli ultimi anni con terapia immunosoppressiva.
Scopo
Scopo dello studio è stato quello di valutare gli effetti della terapia con MMF come farmaco di prima linea sulla interstiziopatia polmonare (ILD) in un gruppo di pazienti sclerodermici. Questi sono stati confrontati con gli effetti osservati utilizzando come terapia immunosoppressiva la CYC per os seguita dall’AZA in un gruppo storico di pazienti sclerodermici pure affetti da ILD. È stato inoltre valutato il profilo di sicurezza di ciascuno dei farmaci immunosoppressori impiegati.
Casistica e metodi
Sono stati indagati 18 pazienti con SSc complicata da ILD, trattati con MMF come terapia di prima linea per 2 anni confrontati con 15 pazienti trattati per un anno con CYC per os e per un secondo anno con AZA. I due gruppi di pazienti sono stati valutati al baseline, dopo 12 mesi e dopo 24 mesi di terapia. Sono stati considerati i seguenti parametri: test spirometrici (FVC e DLCO) , score HRCT e classe NYHA. Per l’analisi statistica sono stati utilizzati il test chi-quadrato, il test t di Student e il Wilcoxon signed rank test.

Risultati
I dati al baseline mostravano che i due gruppi di pazienti apparivano omogenei prima di iniziare la terapia immunosoppressiva.
Nel gruppo trattato con MMF nessun paziente è peggiorato nella classe funzionale NYHA; le prove respiratorie hanno mostrato una stabilità media della funzione polmonare e nessun paziente è progredito nello score TC.
Nel gruppo di confronto trattato sequenzialmente con CYC e AZA non si sono evidenziate variazioni significative né della classe funzionale NYHA né delle prove respiratorie né dello score TC.
Dal confronto fra i due gruppi, non è emersa nessuna differenza statisticamente significativa per i parametri clinici presi in considerazione, dimostrando un’efficacia simile del MMF rispetto ad uno schema di terapia immunosoppressiva tradizionale.
Nel gruppo trattato con MMF nessun paziente ha riportato eventi avversi tali da determinare la sospensione del trattamento, mentre nel gruppo di confronto 2 pazienti hanno dovuto sospendere la CYC per leucopenia e 5 hanno sospeso l’AZA, 2 per epatotossicità e 3 per leucopenia. La differenza fra i due gruppi per quanto riguarda gli eventi avversi è risultata statisticamente significativa a favore dell’MMF (p=0.0046).
Conclusioni
I dati del nostro studio suggeriscono che la terapia immunosoppressiva con MMF somministrato per un periodo di due anni ha portato ad una stabilizzazione della ILD in un gruppo di pazienti affetti da SSc, come dimostrato dall’andamento dei test respiratori, dello score HRCT e della classe funzionale NYHA. Risultati simili sono stati osservati in un gruppo di pazienti trattati sequenzialmente per due anni con CYC e successivamente AZA
La terapia con MMF è risultata meno gravata da effetti indesiderati in modo statisticamente significativo rispetto al gruppo di confronto trattato con CYC e AZA .

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Tipo di EPrint:Tesi di dottorato
Relatore:Cozzi, Franco
Dottorato (corsi e scuole):Ciclo 26 > Scuole 26 > SCIENZE MEDICHE, CLINICHE E SPERIMENTALI > SCIENZE REUMATOLOGICHE
Data di deposito della tesi:30 Gennaio 2015
Anno di Pubblicazione:2015
Parole chiave (italiano / inglese):sclerosi sistemica, intestiziopatia polmonare, micofenolato. systemic sclerosis, interstitial lung disease, mycophenolate.
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/16 Reumatologia
Struttura di riferimento:Dipartimenti > Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari
Codice ID:7806
Depositato il:12 Nov 2015 14:38
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