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Psoriasis: HELP
Articles by Sergio Chimenti
Based on 126 articles published since 2008

Between 2008 and 2019, S. Chimenti wrote the following 126 articles about Psoriasis.
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5 · 6
1 Guideline Consensus on the use of cyclosporine in dermatological practice. Italian Consensus Conference. 2014

Altomare, G / Ayala, F / Bardazzi, F / Bellia, G / Chimenti, S / Colombo, D / Flori, M L / Girolomoni, G / Micali, G / Parodi, A / Peris, K / Vena, G A / Anonymous1420806. ·IRCCS Galeazzi, University of Milan, Milan, Italy - giampiero.girolomoni@univr.it. ·G Ital Dermatol Venereol · Pubmed #25213388.

ABSTRACT: Cyclosporine A (CsA) efficacy and safety have been proven in various dermatoses both in adults and in children even as long-term treatment. Over the last 25 years, Italian dermatologists have gathered relevant experience about CsA treatment for psoriasis and atopic dermatitis. This paper has been developed by an Italian Consensus Conference and it is aimed at providing recommendations based on real-world clinical experience in adult patients, consistent with efficacy and safety data arising from the scientific literature. The paper is mainly focused on the analysis of the optimal therapeutic schemes for psoriasis and atopic dermatitis, in terms of doses and treatment duration, according to individual characteristics and to the severity of the disease. Moreover, it overviews ideal management, taking into account pharmacological interactions, influence of comorbidities, and the most common adverse events related to CsA treatment.

2 Guideline European S3-guidelines on the systemic treatment of psoriasis vulgaris. 2009

Pathirana, D / Ormerod, A D / Saiag, P / Smith, C / Spuls, P I / Nast, A / Barker, J / Bos, J D / Burmester, G-R / Chimenti, S / Dubertret, L / Eberlein, B / Erdmann, R / Ferguson, J / Girolomoni, G / Gisondi, P / Giunta, A / Griffiths, C / Hönigsmann, H / Hussain, M / Jobling, R / Karvonen, S-L / Kemeny, L / Kopp, I / Leonardi, C / Maccarone, M / Menter, A / Mrowietz, U / Naldi, L / Nijsten, T / Ortonne, J-P / Orzechowski, H-D / Rantanen, T / Reich, K / Reytan, N / Richards, H / Thio, H B / van de Kerkhof, P / Rzany, B. · ·J Eur Acad Dermatol Venereol · Pubmed #19712190.

ABSTRACT: Of the 131 studies on monotherapy or combination therapy assessed, 56 studies on the different forms of phototherapy fulfilled the criteria for inclusion in the guidelines. Approximately three-quarters of all patients treated with phototherapy attained at least a PASI 75 response after 4 to 6 weeks, and clearance was frequently achieved (levels of evidence 2 and 3). Phototherapy represents a safe and very effective treatment option for moderate to severe forms of psoriasis vulgaris. The onset of clinical effects occurs within 2 weeks. Of the unwanted side effects, UV erythema from overexposure is by far the most common and is observed frequently. With repeated or long-term use, the consequences of high, cumulative UV doses (such as premature aging of the skin) must be taken into consideration. In addition, carcinogenic risk is associated with oral PUVA and is probable for local PUVA and UVB. The practicability of the therapy is limited by spatial, financial, human, and time constraints on the part of the physician, as well as by the amount of time required by the patient. From the perspective of the cost-bearing institution, phototherapy has a good cost-benefit ratio. However, the potentially significant costs for, and time required of, the patient must be considered.

3 Editorial Role of Th17 in the pathogenesis of cutaneous inflammatory diseases. 2012

Chiricozzi, A / Zhang, S / Dattola, A / Gabellini, M / Chimenti, S / Nistico, S P. · ·J Biol Regul Homeost Agents · Pubmed #23034250.

ABSTRACT: Th17 cells are a new T-cell subtype characterized by the capability of producing IL-17. They are reported to be involved in a wide range of cutaneous immune-mediated conditions and, particularly in this review, we sought to elucidate the Th17 role in the pathogenesis of some common inflammatory diseases including psoriasis, allergic contact dermatitis and atopic dermatitis.

4 Review Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. 2017

Cohen, A D / Wu, J J / Puig, L / Chimenti, S / Vender, R / Rajagopalan, M / Romiti, R / de la Cruz, C / Skov, L / Zachariae, C / Young, H S / Foley, P / van der Walt, J M / Naldi, L / Prens, E P / Blauvelt, A. ·Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. · Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel. · Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, U.S.A. · Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. · University of Rome Tor Vergata, Rome, Italy. · Dermatrials Research Inc. & Venderm Innovations in Psoriasis, Hamilton, ON, Canada. · Department of Dermatology, Apollo Hospitals, Chennai, India. · Department of Dermatology, University of São Paulo, São Paulo, Brazil. · Clínica Dermacross, Santiago, Chile. · Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. · The University of Manchester, Manchester Academic Health Science Centre, Manchester, U.K. · Department of Dermatology, Salford Royal NHS Foundation Trust, Manchester, U.K. · Skin & Cancer Foundation Inc., Carlton, Vic., Australia. · Department of Dermatology, The University of Melbourne, Melbourne, Vic., Australia. · St Vincent's Hospital, Melbourne, Vic., Australia. · International Psoriasis Council, St Louis, MO, U.S.A. · Department of Dermatology, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy. · Deptartment of Dermatology, Erasmus MC, P.O. Box 5201, 3008, AE Rotterdam, the Netherlands. · Oregon Medical Research Center, Portland, OR, U.S.A. ·Br J Dermatol · Pubmed #28646580.

ABSTRACT: The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies.

5 Review Biosimilars for psoriasis: clinical studies to determine similarity. 2017

Blauvelt, A / Puig, L / Chimenti, S / Vender, R / Rajagopalan, M / Romiti, R / Skov, L / Zachariae, C / Young, H / Prens, E / Cohen, A / van der Walt, J / Wu, J J. ·Oregon Medical Research Center, Portland, OR, U.S.A. · Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. · University of Rome Tor Vergate, Rome, Italy. · Dermatrials Research Inc., Hamilton, ON, Canada. · Venderm Innovations in Psoriasis, Hamilton, ON, Canada. · Apollo Hospitals, Chennai, India. · Department of Dermatology, University of São Paulo, São Paulo, Brazil. · Herllev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. · Manchester Academic Health Science Centre, Department of Dermatology, University of Manchester, Salford Royal Hospital, Manchester, U.K. · Department of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands. · Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. · Department of Quality Measurements and Research, Chief Physician's Office, Clalit Health Services, Tel Aviv, Israel. · International Psoriasis Council, St Louis, MO, U.S.A. · Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, U.S.A. ·Br J Dermatol · Pubmed #27639072.

ABSTRACT: Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.

6 Review Pharmacodynamic assessment of apremilast for the treatment of moderate-to-severe plaque psoriasis. 2016

Bianchi, Luca / Del Duca, Ester / Romanelli, Marco / Saraceno, Rosita / Chimenti, Sergio / Chiricozzi, Andrea. ·a Department of Systems Medicine, Division of Dermatology , University of Rome Tor Vergata , Rome , Italy. · b Division of Dermatology, Department of Clinical and Experimental Medicine , University of Pisa , Pisa , Italy. ·Expert Opin Drug Metab Toxicol · Pubmed #27376729.

ABSTRACT: INTRODUCTION: Psoriasis is a chronic inflammatory skin disease affecting 2-3% of the population. Certain systemic drugs currently available for its treatment could be associated, in the long term, with organ toxicity and adverse events, thus, clinical monitoring throughout treatment is required. Moreover, tolerability issues, parenteral administration, and barriers to patient access, such as high cost and specialist management lead to treatment failure. AREAS COVERED: Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4i). PDE is the major enzyme class responsible for the hydrolysis of cyclic adenosine monophosphate in immune cells (cAMP). With PDE4 inhibition, apremilast works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production critically involved in psoriasis. The aim of this paper is to focus the attention on apremilast pharmacodynamics effects, its efficacy and safety in treating moderate-to-severe plaque psoriasis. EXPERT OPINION: Apremilast is an effective and well-tolerated option in treating moderate-to-severe plaque psoriasis. Its safety profile and the oral administration offer significant advantages in prescribing apremilast for the treatment of psoriasis, particularly in some subsets of patients.

7 Review Tofacitinib for the treatment of psoriasis. 2016

Galluzzo, M / D'Adamio, S / Servoli, S / Bianchi, L / Chimenti, S / Talamonti, M. ·a Department of Dermatology , University of Rome 'Tor Vergata' , Rome , Italy. ·Expert Opin Pharmacother · Pubmed #27267933.

ABSTRACT: INTRODUCTION: The identification of a number of psoriasis-susceptibility genes and a better understanding of the pathogenesis of the intracellular metabolic pathways, have generated new perspectives on psoriasis treatment, in particular new compounds that inhibit certain intracellular proteins involved in the immune response. In contrast to biologic agents, these compounds block intracellular targets such as transcriptional factors or enzymes. AREAS COVERED: Tofacitinib is a small molecule that acts as a reversible, competitive inhibitor of ATP in the ATP binding site of JAK proteins, determining their inactivation, thus prevents the downstream activation of the STAT proteins, which are then unable to up-regulate the pro-inflammatory genes implicated in psoriasis. The authors present an overview of Phases I - III clinical trials of tofacitinib for psoriasis based on peer-reviewed literature. EXPERT OPINION: In clinical practice, it is important to assess the response of psoriasis to tofacitinib and identify possible clinical, genetic, and immune biomarkers to predict the response. Comorbidities associated with psoriasis, in particular metabolic syndrome and obesity, are also an important aspect of using tofacitinib in clinical practice. There are some evidences that a drug such as tofacitinib could be used to improve not only psoriasis, but also some of its important comorbidities.

8 Review Small molecules and antibodies for the treatment of psoriasis: a patent review (2010-2015). 2016

Chiricozzi, Andrea / Saraceno, Rosita / Novelli, Lucia / Fida, Monika / Caso, Francesco / Scarpa, Raffaele / Costa, Luisa / Perricone, Roberto / Romanelli, Marco / Chimenti, Sergio / Chimenti, Maria Sole. ·a Dermatology Department , University of Pisa , Pisa , Italy. · b Dermatology Unit, Department of Internal Medicine , University of Rome Tor Vergata , Rome , Italy. · c Rheumatology, Allergology and Clinical Immunology, Department of Internal Medicine , University of Tor Vergata , Rome , Italy. · d University Hospital Center Tirana , Tirana , Republic of Albania. · e Rheumatology Unit, Department of Clinical Medicine and Surgery , University Federico II , Naples , Italy. · f Rheumatology Unit, Department of Medicine DIMED , University of Padua, School of Medicine and Surgery , Padua , Italy. ·Expert Opin Ther Pat · Pubmed #27266423.

ABSTRACT: INTRODUCTION: Psoriasis is a chronic condition whose therapeutic armamentarium is increasingly being discussed, particularly when compared to past decades. The use of biologic agents has profoundly changed the history of this disease, as well as the management of psoriatic patients. Due to the enormous interest in psoriasis, as demonstrated within the scientific community and pharmaceuticals, new therapeutic targets have been identified and novel patented therapeutics are being tested. AREAS COVERED: This review sought to give an overview of small molecules and antibodies patented in the last five years for the treatment of psoriasis. Therapeutic agents either in the early or advanced phase of development have been described, primarily based on a systematic search using the PubMed Medline database. EXPERT OPINION: Though the recent introduction of new antipsoriatic agents has facilitated the management of long-term psoriasis, there is still a strong desire for alternative therapeutic options. Indeed, there remain unmet needs regarding safety and efficacy of psoriasis treatment that should be addressed. In this context, recently patented drugs may prove valid, interesting, and promising within the therapeutic paradigm.

9 Review Apremilast for the treatment of psoriasis. 2015

Chimenti, Maria Sole / Gramiccia, Talia / Saraceno, Rosita / Bianchi, Luca / Garofalo, Virginia / Buonomo, Oreste / Perricone, Roberto / Chimenti, Sergio / Chiricozzi, Andrea. ·University of Rome "Tor Vergata", Rheumatology, Allergology and Clinical Immunology , Rome , Italy. ·Expert Opin Pharmacother · Pubmed #26243735.

ABSTRACT: INTRODUCTION: Psoriasis is a chronic inflammatory skin disease characterized by dysregulation of the immune system and release of pro-inflammatory mediators. Drugs available for psoriasis show some limits as tolerability and route of administration. Apremilast , Otezla®, is an oral small molecule recently approved for the treatment of patients with moderate-to-severe plaque psoriasis. Compared to biologics that target a single cytokine, apremilast, degrading phosphodiesterase 4 (PDE4), interferes with cyclic anti-microbial peptides, which is involved in the transduction of intracellular signals, controlling the balance of pro-inflammatory and anti-inflammatory signals. AREAS COVERED: This review reported the latest data available from Phase I, II and III trials on apremilast for the treatment of plaque psoriasis. A focus on the clinical management of apremilast, safety and clinical efficacy based on two pivotal clinical trials (ESTEEM 1 and ESTEEM 2) currently ongoing was described. A systematic search was conducted using the PubMed Medline database for primary articles. EXPERT OPINION: Apremilast treatment was demonstrated effective and well tolerated in Phase II and III clinical trials. Several drug peculiarities, such as the low frequency of adverse events and the oral route of administration, make apremilast an innovative treatment for moderate-to-severe psoriasis.

10 Review Tofacitinib for the treatment of moderate-to-severe psoriasis. 2015

Chiricozzi, Andrea / Faleri, Sara / Saraceno, Rosita / Bianchi, Luca / Buonomo, Oreste / Chimenti, Sergio / Chimenti, Maria Sole. ·Dermatology Department, University of Rome Tor Vergata, Rome, Italy. ·Expert Rev Clin Immunol · Pubmed #25666451.

ABSTRACT: Because of the increased knowledge about the underlying cytokine network in psoriasis, selective systemic agents for the treatment of moderate-to-severe psoriasis have been developed during the past decade. The marked upregulation of JAK/STAT pathways in psoriasis and the identification of multiple key mediators in psoriasis pathogenesis that signal through JAK/STAT pathways led to investigation of JAK proteins as potential therapeutic targets for psoriasis treatment. A novel JAK-STAT inhibitor, tofacitinib, has been tested in preclinical studies for the treatment of psoriasis. Considering the satisfactory safety profile and the encouraging efficacy observed in the Phase II and Phase III trials, tofacitinib may represent an important therapeutic to be included into the psoriasis paradigm.

11 Review IL-6 as a druggable target in psoriasis: focus on pustular variants. 2014

Saggini, Andrea / Chimenti, Sergio / Chiricozzi, Andrea. ·Department of Dermatology, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy. · Department of Dermatology, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy ; Laboratory for Investigative Dermatology, The Rockefeller University, 1230 York Avenue, New York, NY 10065, USA. ·J Immunol Res · Pubmed #25126586.

ABSTRACT: Psoriasis vulgaris (PV) is a cutaneous inflammatory disorder stemming from abnormal, persistent activation of the interleukin- (IL-)23/Th17 axis. Pustular psoriasis (PP) is a clinicopathological variant of psoriasis, histopathologically defined by the predominance of intraepidermal collections of neutrophils. Although PP pathogenesis is thought to largely follow that of (PV), recent evidences point to a more central role for IL-1, IL-36, and IL-6 in the development of PP. We review the role of IL-6 in the pathogenesis of PV and PP, focusing on its cross-talk with cytokines of the IL-23/Th17 axis. Clinical inhibitors of IL-6 signaling, including tocilizumab, have shown significant effectiveness in the treatment of several inflammatory rheumatic diseases, including rheumatoid arthritis and juvenile idiopathic arthritis; accordingly, anti-IL-6 agents may potentially represent future promising therapies for the treatment of PP.

12 Review New topical treatments for psoriasis. 2014

Chiricozzi, Andrea / Pitocco, Rossella / Saraceno, Rosita / Nistico, Steven Paul / Giunta, Alessandro / Chimenti, Sergio. ·University of Rome Tor Vergata, Department of Dermatology , Via Montpellier 1, 00133 Rome , Italy +39 339 566 8320 ; +39 062 090 2742 ; chimenti@dermatologica.it. ·Expert Opin Pharmacother · Pubmed #24392930.

ABSTRACT: INTRODUCTION: Psoriasis is a common immune-mediated disorder that in 70% of cases appears in mild or mild-to-moderate form. Psoriasis is usually treated with topical medications and/or phototherapy with variable efficacy in controlling the disease. AREAS COVERED: For the past three decades, research has been focused on systemic agents for the treatment of moderate-to-severe psoriasis, particularly with the introduction of biologic agents or 'small molecules'. In parallel, novel advances in topical antipsoriatic agents have been made, experiencing a 'new era', with the development of new formulations and the identification of new therapeutic targets. These agents, having a different spectrum of action from traditional agents, are actually being tested in pre-marketing clinical trials and they may potentially represent promising treatment options that could enlarge the therapeutic armamentarium for the treatment of psoriasis. EXPERT OPINION: Future antipsoriatic topical agents show new modality of action in blocking the pathogenic process leading to psoriatic plaque formation.

13 Review Genetic markers for cardiovascular disease in psoriasis: the missing piece. 2014

Torres, Tiago / Chiricozzi, Andrea / Chimenti, Sergio / Saraceno, Rosita. · ·Mol Diagn Ther · Pubmed #24078347.

ABSTRACT: Psoriasis is a common, chronic inflammatory disease associated with serious comorbidities. Severe psoriasis has been associated with increase cardiovascular mortality, due to a higher prevalence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia and obesity, and premature atherosclerosis, as a consequence of its systemic inflammation. It is likely that there are genetic links between psoriasis, its comorbidities and cardiovascular disease. Although there are some studies performed in rheumatoid arthritis reporting some gene polymorphisms that may be associated with cardiovascular diseases and comorbidities these studies are lacking in psoriasis. Recognizing genetic markers that could predict which patients are at risk of developing psoriasis-linked cardiovascular comorbidities would facilitate screening strategies and permit an earlier management of cardiovascular risk factors, with important clinical implications.

14 Review Infliximab in psoriasis and psoriatic arthritis. 2013

Papoutsaki, Marina / Osório, Filipa / Morais, Paulo / Torres, Tiago / Magina, Sofia / Chimenti, Sergio / Costanzo, Antonio. ·Third Department of Dermatology, A. Syggros Hospital, Athens, Greece. marinapapoutsaki@hotmail.com ·BioDrugs · Pubmed #23990278.

ABSTRACT: Psoriasis is a chronic inflammatory disorder of the skin and joints. Although rarely life threatening, psoriasis can significantly impair quality of life (QOL) and cause considerable physical and psychological distress. Between 6 and 42% of patients with psoriasis develop psoriatic arthritis, which is characterized by stiffness, pain, swelling and tenderness of the joints. Nail psoriasis is highly prevalent in both plaque-type psoriasis and psoriatic arthritis and is found in approximately 50% of patients with psoriasis and in 80% of patients with psoriatic arthritis. Infliximab, a chimeric human-murine monoclonal antibody directed against tumour necrosis factor α, is approved in the USA and EU for the treatment of plaque psoriasis and psoriatic arthritis at a recommended dosage of 5 mg/kg administered by intravenous infusion at 0,2 and 6 weeks, then every 8 weeks thereafter. The EXPRESS and EXPRESS II trials demonstrated that infliximab is efficacious as induction and maintenance therapy in the treatment of moderate to severe plaque psoriasis and also improved health-related QOL. Infliximab is also efficacious in the treatment of psoriatic arthritis, as shown in the IMPACT and IMPACT II studies. Infliximab is generally well tolerated, with a similar adverse event profile in both psoriasis and psoriatic arthritis. The use of infliximab in three case reports is presented. The patients are similar to those normally seen by clinicians, and include a male patient with plaque psoriasis and a history of severe psoriatic arthritis who was corticosteroid dependent and in whom other systemic treatments were not effective or were not able to be used. This patient showed a rapid response to infliximab with no skin lesions or arthritis after 7 weeks' treatment. Infliximab was also safe and effective in the treatment of a female patient with plaque and nail psoriasis and a history of psoriatic arthritis. Importantly, this case report supports the efficacy of infliximab in psoriatic nail disease in the context of severe skin and joint involvement. Case 3 describes a young male patient with moderate plaque-type psoriasis associated with severe nail involvement and early signs of psoriatic arthritis. Treatment with infliximab improved nail psoriasis and appears to be an effective biological treatment for nail psoriasis. Importantly, ultrasound was able to diagnose joint involvement, as seen from the proliferative synovitis in the distal interphalangeal joint and mild enthesitis, despite there being no clinical evidence of psoriatic arthritis. This case report highlights the importance of early screening. If such abnormalities are detected early on in the course of psoriasis, clinicians may be able to predict which patients are more likely to develop psoriatic arthritis, and therefore offer effective and long-term treatment that may reduce the disability and impairment of daily activities that can be associated with psoriatic arthritis.

15 Review Profile of certolizumab and its potential in the treatment of psoriatic arthritis. 2013

Chimenti, Maria Sole / Saraceno, Rosita / Chiricozzi, Andrea / Giunta, Alessandro / Chimenti, Sergio / Perricone, Roberto. ·Unit of Rheumatology, Allergology, and Clinical Immunology, University of Rome Tor Vergata, Rome, Italy. maria.sole.chimenti@uniroma2.it ·Drug Des Devel Ther · Pubmed #23620660.

ABSTRACT: Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy associated with psoriasis (PsO). PsA could be considered an enthesal disease because of the link between mechanical stress (entheses) and immunologically active tissue (synovium). Evidence of efficacy of anti-tumor necrosis factor alpha (TNF-α) is supported by reduction of histological vascularity and immune cell infiltrates in synovial tissue after treatment. Certolizumab pegol (CZP) is a polyethylene glycolylated (PEGylated) Fab' fragment of a humanized monoclonal antibody that binds and neutralizes human TNF-α. The PEG moiety of the Fab fragment, markedly increases the half-life of CZP and confers to the drug a unique structure that differs from the other anti-TNF-α agents tested for the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis, nonradiographic spondyloarthritis, PsO, and PsA. In contrast to other anti-TNF-α agents, CZP did not mediate increased levels of apoptosis, suggesting that these mechanisms are not essential for the anti-TNF-α efficacy in Crohn's disease. As CZP, infliximab, and adalimumab, but not etanercept, almost completely inhibited lipopolysaccharide-induced interleukin-1 beta release from monocytes, this cytokine-production inhibition may be relevant for drug efficacy. Due to these characteristics, it has been demonstrated in clinical studies that CZP effectively improves signs and symptoms of arthritis and physical function and skin manifestations of PsO, with a safety profile similar to rheumatoid arthritis. This drug can be considered as a valid treatment in patients affected by PsA. The efficacy and tolerability profiles suggest CZP as a suitable antipsoriatic drug in the treatment of PsA.

16 Review Etanercept provides an effective, safe and flexible short- and long-term treatment regimen for moderate-to-severe psoriasis: a systematic review of current evidence. 2013

Strohal, Robert / Chimenti, Sergio / Vena, Gino Antonio / Girolomoni, Giampiero. ·Department of Dermatology and Venereology, Federal Academic Teaching Hospital of Feldkirch, Feldkirch, Austria. robert.strohal@lkhf.at ·J Dermatolog Treat · Pubmed #22812568.

ABSTRACT: The treatment of psoriasis requires long-lasting intervention. Conventional treatments for psoriasis comprise topical, phototherapeutic and systemic modalities, such as methotrexate or cyclosporine. Biological therapies are advocated by treatment guidelines for the use in moderate-to-severe psoriasis, when conventional treatments have failed, are contraindicated or are associated with severe adverse events. Etanercept is an anti-TNF recombinant fusion protein that has emerged as a standard biologic treatment option for moderate-to-severe psoriasis. The present review summarizes data from pivotal and post-marketing randomized controlled etanercept trials to treat moderate-to-severe psoriasis for 24 weeks and longer. During the first 12 weeks, etanercept can be administered in different dosing regimens: 50 mg twice weekly (BIW) and 50 mg once weekly. Although both regimens are effective, it has been shown that the 50 mg BIW dosage leads to higher response rates at week 24. In addition, after 24 weeks' treatment etanercept provides the unique possibility of continuous or intermittent long-term treatment programmes. The medium- to long-term efficacy of etanercept was consistent, regardless of whether etanercept therapy was interrupted or continuous. Taking the chronic nature of psoriasis into account, this flexibility in dosing regimen bestows a key advantage in facilitating individualisation of long-term treatment according to patient needs.

17 Review Complete resolution of erythrodermic psoriasis in an HIV and HCV patient unresponsive to antipsoriatic treatments after highly active antiretroviral therapy (Ritonavir, Atazanavir, Emtricitabine, Tenofovir). 2012

Chiricozzi, Andrea / Saraceno, Rosita / Cannizzaro, Maria Vittoria / Nisticò, Steven P / Chimenti, Sergio / Giunta, Alessandro. ·Department of Dermatology, University of Rome 'Tor Vergata', Rome, Italy. chiricozziandrea@gmail.com ·Dermatology · Pubmed #23295963.

ABSTRACT: BACKGROUND: Psoriasis is a chronic, inflammatory disease affecting 2-3% of the worldwide population, and it may worsen with HIV or be detected as HIV cutaneous manifestation. HIV-related psoriasis shows a severe and prolonged clinical course with more frequent exacerbations. The management of this condition is challenging because immunomodulating and immunosuppressant agents may have variable and partial efficacy, and therefore, antiretroviral treatment represents a potential adjunctive therapeutic option. RESULTS: In the case we report, the HIV test was shown to be crucial for driving the therapeutic approach. Indeed, antiretroviral agents have been proven to be effective in the treatment of HIV+ psoriasis as first-line therapy. CONCLUSION: The HIV test should be considered in high-risk patients affected by severe psoriasis and resistant to conventional and biological treatments.

18 Review Safety of anti-TNFα agents in the treatment of psoriasis and psoriatic arthritis. 2012

Girolomoni, Giampiero / Altomare, Gianfranco / Ayala, Fabio / Berardesca, Enzo / Calzavara-Pinton, Piergiacomo / Chimenti, Sergio / Peserico, Andrea / Puglisi Guerra, Antonio / Vena, Gino Antonio. ·Department of Dermatology, University of Verona, Italy. giampiero.girolomoni@univr.it ·Immunopharmacol Immunotoxicol · Pubmed #22296031.

ABSTRACT: CONTEXT: The efficacy and favorable safety profile of anti-tumor necrosis factor (TNF) agents in the treatment of psoriasis and psoriatic arthritis (PsA) are supported by several randomized controlled studies and meta-analyses. However, some concerns on the long-term safety of these drugs still exist, as these studies generally included small patient numbers and were performed in selected patient populations. OBJECTIVE: This review presents and discusses current evidence on the safety of anti-TNFα agents in patients with psoriasis and PsA, with a focus on European registry studies and case reports of particular importance. METHODS: Key studies on the safety of anti-TNFα agents in the treatment of adult patients with psoriasis or PsA were identified by a MEDLINE search (last updated 10 November 2011) based on several interrelated queries, with a focus on European registries. Other studies and case reports were included if deemed relevant. Studies concerning other conditions, such as rheumatoid arthritis (RA), were included as appropriate when data in psoriatic disease were unavailable or insufficient. RESULTS: Available data on the safety of anti-TNFα agents such as etanercept in psoriasis and PsA appear reassuring, even if some concerns still exist. Most notably, data suggest a higher incidence of infection and lymphoma amongst patients treated with the anti-TNFα monoclonal antibodies infliximab and adalimumab compared with etanercept. CONCLUSION: The overall safety profile of monoclonal antibodies in patients with psoriasis, PsA and RA seems less favorable than that of etanercept, particularly in terms of risk of infection and hepatotoxicity.

19 Review Psoriasis, from pathogenesis to therapeutic strategies: IL-21 as a novel potential therapeutic target. 2012

Botti, Elisabetta / Spallone, Giulia / Caruso, Roberta / Monteleone, Giovanni / Chimenti, Sergio / Costanzo, Antonio. ·Department of Dermatology University of Rome Tor Vergata Viale Oxford 81, 00133, Rome, Italy. ·Curr Pharm Biotechnol · Pubmed #22250707.

ABSTRACT: Psoriasis is a common (1-3% of the population worldwide), multifactorial, immune-mediated chronic skin disease. In psoriasis pathogenesis an over-reaction of local innate immune response initiates inflammation with subsequent involvement of adaptive immune response leading to the production of a panel of cytokines, chemokines and growth factors leading to epidermal hyperplasia. Recently, IL-21 has been involved in this process as this cytokine is overexpressed in psoriatic skin and can cause epidermal hyperplasia and inflammation when injected intradermally into mice. Moreover blockade of IL-21 with a human antibody against IL-21 reduces the epidermal thickness and the expression of Th1 and Th17 genes in the well-characterized model of human psoriasis-xenograft mouse. Therefore, the inhibition of this cytokine may be therapeutically effective in the treatment of psoriasis. Here we will review recent data on psoriasis pathogenesis focusing on the role of IL-21 as novel therapeutic target.

20 Review Efalizumab. 2011

Talamonti, Marina / Spallone, Giulia / Di Stefani, Alessandro / Costanzo, Antonio / Chimenti, Sergio. ·University of Rome Tor Vergata, Department of Dermatology, 00133 Rome, Italy. ·Expert Opin Drug Saf · Pubmed #21214420.

ABSTRACT: INTRODUCTION: Conventional systemic therapies for psoriasis are associated with serious toxicities that can limit long-term use. In recent years, biological therapies have offered the possibility of long-term therapy with improved safety and efficacy for the treatment of psoriasis. Biological therapies can be classified into three categories: the T-cell modulating agents (alefacept and efalizumab), the inhibitors of TNF-α (adalimumab, etanercept, infliximab) and the inhibitors of IL-12 and -23 (ustekinumab). Efalizumab is a humanized recombinant monoclonal IgG1 antibody. It targets multiple stages in the immunopathogenesis of psoriasis: initial T-cell activation, migration of T-cells into dermal and epidermal tissues, and T-cell reactivation. On 19 February 2009, the Committee for Medicinal Products for Human Use (CHMP) recommended the suspension of the marketing authorisation for efalizumab. AREAS COVERED: Numerous clinical trials have demonstrated the efficacy, safety and health-related quality of life benefits of efalizumab in patients with moderate-to-severe chronic plaque psoriasis. Efalizumab was approved by the FDA in November 2003 and by the European Medicines Evaluation Agency in September 2004 for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. Recently, three cases of progressive multifocal leukoencephalopathy were described in patients on long-term (> 3 years) efalizumab therapy, leading to its withdrawal from the market. EXPERT OPINION: Although initially favorable, the safety profile of efalizumab revealed the appearance of severe adverse events in long-term treated patients. Therefore, post-marketing surveillance is essential for correct evaluation of drug potential.

21 Review Psoriasis: from pathogenesis to novel therapeutic approaches. 2011

Monteleone, Giovanni / Pallone, Francesco / MacDonald, Thomas T / Chimenti, Sergio / Costanzo, Antonio. ·Gastroenterology Unit, Internal Medicine Department, University Tor Vergata of Rome, 00133 Rome, Italy. gi.monteleone@med.uniroma2.it ·Clin Sci (Lond) · Pubmed #20846119.

ABSTRACT: Psoriasis is one of the commonest chronic inflammatory disorders. Its cause is unknown, but a wealth of studies indicate that the disease results from a complex and dynamic interplay between genetic and environmental factors that trigger an excessive inflammatory response in the skin. Dendritic cells and effector T-cells are central in the development of the psoriastic lesion, and cytokines produced by these cells stimulate keratinocytes to proliferate and increase the migration of inflammatory cells into the skin, promoting epidermal hyperplasia and inflammation. Understanding the immunology of the psoriatic plaque has led to new therapeutic options and novel candidates for immunomodulation, and has changed the ways psoriatic patients are managed.

22 Review Calcipotriene/betamethasone in the treatment of psoriasis: a review article. 2009

Saraceno, Rosita / Gramiccia, Talia / Frascione, Pasquale / Chimenti, Sergio. ·Policlinico Tor Vergata-University of Rome Tor Vergata, Department of Dermatology, Viale Oxford 81, 00133 Rome, Italy. rositasaraceno@yahoo.it ·Expert Opin Pharmacother · Pubmed #19663634.

ABSTRACT: Plaque-type psoriasis is a chronic and immune-mediated skin disease affecting approximately 1-3% of the Caucasian population. Most cases are of mild or moderate severity and benefit from local treatment that represents the mainstay therapy. Topical corticosteroids and vitamin D(3) analogues remain the option of choice. Optimization of these treatments is made by the combination of calcipotriene and betamethasone dipropionate. This formulation combines the keratinocyte differentiation and antiproliferative action of the vitamin D(3) analogues with the anti-inflammatory effect of steroids enhancing effectiveness while reducing the side-effect profile of the single topical agent. In this article, we highlight the advantages of the association of calcipotriene and betamethasone in the treatment of localized plaque-type, scalp and nail psoriasis.

23 Review Etanercept provides a more physiological approach in the treatment of psoriasis. 2008

Altomare, Gianfranco / Ayala, Fabio / Berardesca, Enzo / Chimenti, Sergio / Giannetti, Alberto / Girolomoni, Giampiero / Lotti, Torello / Martini, Patrizia / Peserico, Andrea / Guerra, Antonio Puglisi / Vena, Gino A. ·Department of Dermatology, University of Milan, Italy. ·Dermatol Ther · Pubmed #18837727.

ABSTRACT: Psoriasis is a common chronic inflammatory disease affecting the skin and joints. Moderate to severe psoriasis is traditionally treated with systemic treatments, which can be effective but are often associated with relevant adverse effects, even when administered intermittently or rotationally. Biologic therapies may provide high and consistent efficacy over time, long-term safety, and simple administration schedules compared with nonbiologic therapies, and can be used in patients intolerant and/or resistant to these therapies. TNF-antagonists have a definite advantage over other biologic agents (e.g., T-cell targeting drugs) in the early and late manifestations of joint involvement. TNF-antagonists are a class of drugs with distinct pharmacokinetic and pharmacodynamic properties, and different safety profiles. Etanercept provides a more "physiological" mechanism of action compared to anti-TNF antibodies. Etanercept has less dramatic effects on TNF homeostasis although it has been proved to be highly effective in blocking psoriatic joint erosions. It maintains stable efficacy over time on skin psoriasis, also when used intermittently. Moreover, etanercept has been shown to be not immunogenic, and it only slightly increases the risk of granulomatous infections compared to anti-TNF antibodies. According to the "physiologic" paradigm of selection among TNF-antagonists linked to more or less physiologic mechanism of action, etanercept appears to be the anti-TNF of choice for treating most patients with moderate to severe plaque psoriasis and psoriatic arthritis, possibly even at an early stage.

24 Review Adalimumab for the treatment of severe psoriasis and psoriatic arthritis. 2008

Papoutsaki, Marina / Costanzo, Antonio / Chimenti, Maria-Sole / Chimenti, Sergio. ·University of Rome Tor Vergata, Department of Dermatology, Viale Oxford 81, 00133 Rome, Italy. marinapapoutsaki@hotmail.com ·Expert Opin Biol Ther · Pubmed #18294106.

ABSTRACT: BACKGROUND: Psoriasis is a chronic, genetically determined, immunomediated, inflammatory skin disease affecting approximately 2 - 3% of the Caucasian population. Systemic treatment is required in moderate to severe plaque-type psoriasis forms or psoriatic arthritis. However, cumulative organ toxicity, lack of efficacy over time and other underlying diseases may limit long-term use of conventional treatments. OBJECTIVES: TNF-alpha, serves a key role in potentiating inflammatory responses associated with both psoriasis and psoriatic arthritis. Adalimumab is a fully human anti-TNF-alpha monoclonal antibody; approved for the treatment of psoriatic arthritis and, more recently, for plaque-type psoriasis. METHODS: This review reports the latest progresses made in the clinical use of 'biologic' drugs for psoriasis focusing on the clinical management of adalimumab in the treatment of plaque psoriasis and psoriatic arthritis. RESULTS: Adalimumab was shown to be effective in treating both psoriasis and psoriatic arthritis with a rapid onset of action and a good safety profile.

25 Clinical Trial Quality of life and patient benefit following transition from methotrexate to ustekinumab in psoriasis. 2017

Augustin, M / Blome, C / Paul, C / Puig, L / Luger, T / Lambert, J / Chimenti, S / Girolomoni, G / Kragballe, K / Naessens, D / Bergmans, P / Smirnov, P / Barker, J / Reich, K. ·Institute for Health Services Research in Dermatology and Nursing (IVDP), German Center for Health Services Research in Dermatology (CVderm), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany. · Department of Dermatology, Paul Sabatier University, Toulouse, France. · Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. · University of Münster, Münster, Germany. · Department of Dermatology, Ghent University Hospital, Ghent, Belgium. · University of Rome, Rome, Italy. · Department of Dermatology, University of Verona, Verona, Italy. · Århus University, Århus, Denmark. · Janssen Cilag NV, Beerse, Belgium. · Janssen-Cilag BV, Tilburg, The Netherlands. · Janssen Pharmaceutica NV, Moscow, Russia. · St John's Institute of Dermatology, King's College, London, UK. · Dermatologikum, Hamburg, Germany. ·J Eur Acad Dermatol Venereol · Pubmed #27515070.

ABSTRACT: BACKGROUND: TRANSIT (NCT01059773) compared immediate and gradual transition from methotrexate to ustekinumab in psoriasis patients via multiple measures, including patient-reported outcomes. OBJECTIVE: To evaluate patient perception of treatment benefits in TRANSIT. METHODS: A total of 489 psoriasis patients received ustekinumab, with immediate cessation of methotrexate (Arm 1) or 4 weeks' overlap with decreasing methotrexate dose (Arm 2). Ustekinumab was administered at weeks 0, 4, 16, 28 and 40. Dermatology Life Quality Index (DLQI), EuroQol 5-item (EQ-5D), visual analogue scale (VAS) valuation technique and patient benefit index (PBI) were employed. Mean global PBI and sub-scores were calculated from the sum of the benefit items weighted by their respective relevance at baseline. Patient-relevant benefit was defined as PBI ≥1 (scale: 0 [no benefit] to 4 [maximum benefit]). Correlations of global PBI with Psoriasis Area and Severity Index (PASI) and DLQI were examined. RESULTS: Relationships between PBI and clinical data were evaluable in 340 patients. The most important treatment goals at baseline included: 'be healed of all skin defects', 'have confidence in therapy', 'get better skin quickly' and 'regain control of the disease'. Benefit in PBI global score was achieved at week 4 by 93% of patients in Arm 1 and 91% in Arm 2. Global PBI scores increased in both Arms between weeks 4 and 52. Global PBI correlated weakly with PASI change from baseline (correlation coefficient range: -0.22 to -0.40), and moderately with DLQI (-0.29 to -0.54). Overall DLQI score was lower than baseline at all times; and the percentage of patients with an overall score of 0 or 1 increased with time. Correspondingly, EQ VAS scores increased with time. DLQI and EQ VAS results were similar between arms. CONCLUSIONS: Regardless of the strategy for transitioning from methotrexate, ustekinumab was associated with rapid and sustained improvement in patient-reported outcomes. PBI appears a suitable tool for assessing patient-relevant treatment benefits in psoriasis patients.