Biological drugs such as Adalimumab, Etanercept and Ustekinumab are valid therapies for the treatment of chronic inflammatory skin diseases. Ustekinumab and Adalimumab are specific monoclonal antibodies respectively for the Interleukin 12-23 (IL12-23) and the Tumor Necrosis Factor-alpha (TNF-alpha). Etanercept is a fusion protein for TNF-alpha. These drugs have significant therapeutic efficacy in the short term. However, they are used for chronic therapies, so can lose their effectiveness. Purpose of the study was the comparative evaluation of the clinical effectiveness of these biological drugs in patients with Psoriasis (PSO) and Psoriatic Arthritis (PSA), and the evaluation of therapeutic switch between biological drugs. The retrospective study was done in cooperation between Pharmacy and Dermatology Units of the University Hospital "A. Gemelli "in Rome. Patients with moderate to severe psoriasis were studied, including all of them that have receveid treatment with one of three biologic drugs in the period from 01/01/2010 to 31/12/2014. The effectiveness analysis was realized by monitoring the index of PASI (Psoriasis Area Severity Index) at baseline and at 4 weeks, and verifying the achievement of PASI:75 (75% reduction of skin lesions on the body surface), respectively at 12 weeks for Adalimumab and Etanercept, and 16 weeks for Ustekinumab. The study showed the clinical effectiveness and safety profile of Adalimumab, Etanercept and Ustekinumab in the treatment of Psoriasis and Psoriatic Arthritis. Also, biological drugs represent a valid therapeutic alternative, if the first adopted biological drug loses effectiveness. In fact, patients who have made the switch of the drug at the end of the study, have continued to maintain the PASI:75.
I farmaci biologici quali Adalimumab, Etanercept ed Ustekinumab sono valide terapie per il trattamento di patologie infiammatorie croniche della pelle. Ustekinumab ed Adalimumab sono anticorpi monoclonali specifici rispettivamente per l’Interleukina 12-23 (IL12-23) e per il Tumor Necrosis Factor-alfa(TNF-alfa). Etanercept è una proteina di fusione specifica per il TNF-alfa. Questi farmaci hanno notevole efficacia terapeutica in tempi brevi, tuttavia, essendo destinati a terapie croniche, può riscontrarsi perdita di efficacia. Obiettivo dello studio è stata la valutazione comparata dell’efficacia clinica dei suddetti biologici in pazienti con Psoriasi (PSO) e Psoriasi Artropatica (PSA), e la valutazione di switch terapeutici tra un biologico e l’altro. Lo studio osservazionale, retrospettivo, è stato eseguito in collaborazione tra le U.O.C. (Unità Operativa Complessa) di Farmacia e Dermatologia del Policlinico Universitario “A. Gemelli” di Roma. Ai fini dello studio sono stati considerati i pazienti con psoriasi da moderata a grave, indipendentemente dall’età, che nel periodo compreso tra il 01/01/2010 e il 31/12/2014 hanno ricevuto la terapia con uno dei tre farmaci biologici. L’analisi dell’efficacia è stata condotta monitorando l’indice di PASI (Psoriasis Area Severity Index) al tempo zero ed a 4 settimane, e verificando il raggiungimento del PASI:75 (riduzione del 75% delle lesioni cutanee sulla superficie corporea) rispettivamente a 12 settimane per Adalimumab e Etanercept, ed a 16 settimane per Ustekinumab. Lo studio ha confermato l’efficacia clinica e il profilo di sicurezza di Adalimumab, Etanercept ed Ustekinumab nel trattamento della Psoriasi e Psoriasi Artropatica. Inoltre, è emerso che i farmaci biologici rappresentano una valida alternativa terapeutica, qualora il primo biologico adottato perda efficacia. Infatti, i pazienti che hanno effettuato lo switch del farmaco, al termine dello studio osservazionale, hanno continuato a mantenere il PASI:75.
VALUTAZIONE CLINICA COMPARATA DELL’EFFICACIA TERAPEUTICA DEGLI INIBITORI DEL TNF-ALFA E DELL’INTERLEUKINA 12-23 NEL TRATTAMENTO DELLE PATOLOGIE INFIAMMATORIE CRONICHE CUTANEE
DI CARLO, CIRINO
2014/2015
Abstract
Biological drugs such as Adalimumab, Etanercept and Ustekinumab are valid therapies for the treatment of chronic inflammatory skin diseases. Ustekinumab and Adalimumab are specific monoclonal antibodies respectively for the Interleukin 12-23 (IL12-23) and the Tumor Necrosis Factor-alpha (TNF-alpha). Etanercept is a fusion protein for TNF-alpha. These drugs have significant therapeutic efficacy in the short term. However, they are used for chronic therapies, so can lose their effectiveness. Purpose of the study was the comparative evaluation of the clinical effectiveness of these biological drugs in patients with Psoriasis (PSO) and Psoriatic Arthritis (PSA), and the evaluation of therapeutic switch between biological drugs. The retrospective study was done in cooperation between Pharmacy and Dermatology Units of the University Hospital "A. Gemelli "in Rome. Patients with moderate to severe psoriasis were studied, including all of them that have receveid treatment with one of three biologic drugs in the period from 01/01/2010 to 31/12/2014. The effectiveness analysis was realized by monitoring the index of PASI (Psoriasis Area Severity Index) at baseline and at 4 weeks, and verifying the achievement of PASI:75 (75% reduction of skin lesions on the body surface), respectively at 12 weeks for Adalimumab and Etanercept, and 16 weeks for Ustekinumab. The study showed the clinical effectiveness and safety profile of Adalimumab, Etanercept and Ustekinumab in the treatment of Psoriasis and Psoriatic Arthritis. Also, biological drugs represent a valid therapeutic alternative, if the first adopted biological drug loses effectiveness. In fact, patients who have made the switch of the drug at the end of the study, have continued to maintain the PASI:75.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/19221