Publications by authors named "Martina Burlando"

54 Publications

Crushed Corticosteroid Tablets in Peristomal Pyoderma Gangrenosum: A Case Report.

J Wound Ostomy Continence Nurs 2021 Sep-Oct 01;48(5):460-462

Martina Burlando, MD, Dermatology Unit, Policlinico San Martino Hospital, Genova, Italy.

Background: Peristomal pyoderma gangrenosum (PPG) is a variant of pyoderma gangrenosum (PG). It results from a pathergy response to trauma from effluent from the ostomy or secondary to trauma caused by removal of the ostomy appliance adhesive in contact with the skin. Currently, no evidence-based guidelines for the management of PPG exist. This case study reports a dramatic response to crushed corticosteroid tablets in a patient who proved refractory to first- and second-line treatments of her PPG and several surgeries.

Case: Ms T. was a 39-year-old woman with Crohn's disease who underwent several ileostomies, developed PPG, and failed treatment with adalimumab. Her PPG was successfully treated topically with crushed prednisone tablets.

Conclusion: We found that crushed corticosteroid tablets were an effective treatment of PPG, due to the ability to reduce pain and allow adhesion of the ostomy appliance.
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http://dx.doi.org/10.1097/WON.0000000000000798DOI Listing
September 2021

A real-world economic analysis of biologic therapies for moderate-to-severe plaque psoriasis in Italy: results of the CANOVA observational longitudinal study.

BMC Health Serv Res 2021 Sep 6;21(1):924. Epub 2021 Sep 6.

A.O.U. Città della Salute e della Scienza PO Molinette, Turin, Italy.

Background: Psoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy.

Methods: The annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%).

Results: The most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: €7848 - €31,378), followed by secukinumab (range: €9015 - €33,419). Ustekinumab (range: €11,689 - €39,280) and ixekizumab (range: €11,092 - €34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (€21,375) over the other options, because of its high response rate (86% vs. 60-80%), which was achieved early in time.

Conclusion: Biologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.
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http://dx.doi.org/10.1186/s12913-021-06866-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8422702PMC
September 2021

Psoriasis, Vitiligo, and Biologic Therapy: Case Report and Narrative Review.

Case Rep Dermatol 2021 May-Aug;13(2):372-378. Epub 2021 Jul 16.

Section of Dermatology, DISSAL, University of Genoa, Ospedale-Policlinico San Martino, IRCCS, Genova, Italy.

Psoriasis and vitiligo are 2 multifactorial immune-mediated diseases, partially sharing pathogenetic underpinnings. Their coexistence in the same patient, although uncommon, is documented in the literature. Further, several cases of vitiligo induced by biological drugs in psoriatic patients are reported. However, improvements in psoriasis and pre-existing vitiligo after the introduction of biological therapy are also described. To date, anti-TNF-alpha is the most cited group of biological drugs that induce new-onset vitiligo or progression of pre-existence vitiligo in psoriatic patients. Even anti-IL-12/23 class would seem to induce vitiligo (as in our case) or even worse it. Anti-IL-17 drugs induce a progression of pre-existing vitiligo while, to date, no cases are reported in literature considering anti-IL-23 class.
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http://dx.doi.org/10.1159/000514198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339517PMC
July 2021

Efficacy and safety of dimethylfumarate in elderly psoriasis patients: a multicentric Italian study.

J Dermatolog Treat 2021 Aug 11:1-4. Epub 2021 Aug 11.

Department of Health Sciences, Section of Dermatology, University of Florence, Florence, Italy.

The number of psoriatic elderly patients is steadily increasing in the Western world, nevertheless they are frequently excluded from clinical trials and described as a high-risk group for adverse events.We conducted a retrospective multicentric study of DMF use in elderly (>65 years) psoriatic patients. DMF efficacy was evaluated up to 24 weeks by Psoriasis Area and Severity Index (PASI) score. We also evaluated drug maintenance and safety.Our study population included 81 elderly psoriatic patients treated with DMF up to 24 weeks. The PASI score at the baseline (week 0) ranged from 3,7-24 (mean ± SD, 9,8 ± 4,1), which changed after DMF administration to 4,3 ± 3,2 at week 16 and 2,7 ± 3,2 at week 24. Among 81 elderly psoriatic patients 59 (72,8%) adverse events were reported during the observation period. The most common were gastrointestinal complaints ( = 24, 29,6%) and flushes ( = 10, 12,3%). Lymphocytopenia ( = 10, 12,35%) was frequently observed.In daily practice, DMF seems to be efficacy and well tolerated in elderly psoriatic patients. DMF may be a first-line systemic treatment option to manage elderly psoriasis, provided that also the long-term safety data are closely monitored, in particular lymphocytopenia.
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http://dx.doi.org/10.1080/09546634.2021.1962000DOI Listing
August 2021

Pruritic Erythematous Macules in a Patient with Systemic Sarcoidosis: A Quiz.

Acta Derm Venereol 2021 Aug 31;101(8):adv00531. Epub 2021 Aug 31.

Department of Dermatology, Di.S.Sal., University of Genoa, San Martino Polyclinic Hospital IRCCS, Largo Rosanna Benzi 10, IT-16132 Genoa, Italy.

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http://dx.doi.org/10.2340/00015555-3878DOI Listing
August 2021

Dimethyl fumarate titration for the systemic treatment of moderate-to-severe plaque psoriasis.

Drugs Context 2021 31;10. Epub 2021 May 31.

Dermatology Department, DissaL, Policlinico San Martino IRCCS, Genova, Italy.

Background: Dimethyl fumarate (DMF) is an oral systemic agent approved for the treatment of moderate-to-severe psoriasis vulgaris. It has a favourable tolerability profile, but it is associated with a high incidence of mild and reversible adverse events. The aim of the article is to describe a clinical experience aimed at increasing tolerability.

Patients And Methods: A group of patients was treated with DMF with a titration schedule, according to clinical practice, although a personalization of the step-up timing was allowed. The highest dose was the minimal effective dose or the maximal tolerated doses.

Results: DMF treatment was effective in reducing the disease severity and improving the quality of life. DMF was well tolerated as only mild, mainly gastrointestinal, adverse events occurred in these patients. In addition, the up-titration schedule seemed to provide a reduced incidence of adverse events compared with the fixed dose.

Conclusion: Our experience suggested that the recommended up-titration schedule of DMF, adjusted and personalized according to patient needs and physician opinion, provided a relevant clinical benefit and was well tolerated.
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http://dx.doi.org/10.7573/dic.2020-12-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8177959PMC
May 2021

Treatment of moderate-to-severe plaque psoriasis with tildrakizumab in the real-life setting.

Drugs Context 2021 21;10. Epub 2021 May 21.

Division of Dermatology, Department of Health and Science (DissaL), Policlinico San Martino Hospital, IRCCS, Genova, Italy.

Background: Tildrakizumab is a high-affinity, humanized IgG1κ monoclonal antibody targeting the p19 subunit of IL-23, which is a key regulatory cytokine in psoriasis. Based on evidence from clinical trials, tildrakizumab is approved for the treatment of moderate-to-severe plaque psoriasis in patients eligible for systemic therapy.

Methods: We report our clinical experience with 26 patients followed up to 24 weeks.

Results: No adverse event was observed and no patient discontinued tildrakizumab. Whilst no patient had a Psoriasis Area and Severity Index (PASI) score of <5 at baseline, at week 4, 8 (32%) patients had a PASI score of <3 and 6 of these had a PASI score of 0. At week 12, 19 (79%) patients had a PASI score of <5 and, among these, 18 had a PASI score of <3 of whom 16 had a PASI score of 0. At week 24, 22 (96%) patients had a PASI score of <3 and 20 (87%) had a PASI score of 0. Quality of life was improved after 4 weeks and through the whole period of observation.

Conclusion: Our experience in the real-life setting confirms the efficacy and safety of tildrakizumab as demonstrated by clinical trials.
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http://dx.doi.org/10.7573/dic.2021-2-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8152773PMC
May 2021

Atypical and Rare Forms of Cutaneous Lupus Erythematosus: The Importance of the Diagnosis for the Best Management of Patients.

Dermatology 2021 Jun 3:1-10. Epub 2021 Jun 3.

Section of Dermatology, Department of Health Sciences, University of Genoa, Genoa, Italy.

Lupus erythematosus (LE) is an autoimmune disease with a wide range of clinical and cutaneous manifestations. Along with the well-known typical cutaneous manifestations of LE, some cutaneous manifestations are rarer, but still characteristic, enabling the dermatologist and the general practitioner who know them to suspect cutaneous LE (CLE) and investigate a possible underlying systemic involvement. Indeed, not infrequently a skin manifestation is the first presentation of systemic LE (SLE), and >75% of SLE patients show signs of skin disease during the course of the illness. Especially, SLE involvement occurs in cases of acute CLE, while it is uncommon in subacute CLE and rare in chronic CLE. This review aims to concentrate especially on atypical cutaneous manifestations of LE to enable the clinician to diagnose even the rarest forms of CLE.
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http://dx.doi.org/10.1159/000515766DOI Listing
June 2021

Bulky Condyloma Acuminata following Ustekinumab Treatment for Plaque Psoriasis: A Case Report.

Case Rep Dermatol 2021 Jan-Apr;13(1):244-247. Epub 2021 Apr 21.

Section of Dermatology, DISSAL, San Martino-IST Polyclinic Hospital, University of Genoa, Genoa, Italy.

Ustekinumab is a fully human monoclonal antibody targeting the pro-inflammatory cytokines interleukin (IL)-12 and IL-23 approved for the treatment of psoriasis and psoriatic arthritis. We report a case of a patient treated for chronic plaque psoriasis with ustekinumab who developed bulky condyloma acuminata shortly after initiating the treatment. Although ustekinumab has already been described in literature associated with other forms of human papilloma virus skin infections, this is the first case to our knowledge in which ustekinumab is associated with genital warts.
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http://dx.doi.org/10.1159/000509178DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138217PMC
April 2021

Secukinumab Exhibits Sustained and Stable Response in Patients with Moderate-to-Severe Psoriasis: Results from the SUPREME Study.

Acta Derm Venereol 2021 04 27. Epub 2021 Apr 27.

Department of Biomedical Sciences, Humanitas University, IRCCS Istituto Clinico Humanitas, IT-20089 Rozzano-Milan, Italy. E-mail:

Secukinumab, a fully human monoclonal antibody, neutralizes interleukin-17A, a cornerstone cytokine driving the multiple manifestations of psoriasis. This post-hoc analysis of the SUPREME study was performed to determine the sustainability of response to secukinumab in terms of Psoriasis Area and Severity Index (PASI) 90 in patients with moderate-to-severe plaque psoriasis. Based on PASI 90 response at week 16, patients were stratified as PASI 90 responders (PASI90R, n = 337) or non-responders (PASI90NR, n = 72). At week 20, 94.2% (n = 295/313) achieved PASI 90/100 response in PASI90R, with response maintained through week 48 (89.6%, n = 189/211). An increased proportion of patients achieved PASI 90/100 response in PASI90NR (week 20: 29.9%, n = 20/67; week 48: 57.1%, n = 20/35). Overall, 64.4% patients achieved absolute PASI score=0 at week 24 with response sustained to week 48 (66.9%). Secukinumab showed sustained and stable efficacy in maintaining PASI 90 response in patients with moderate-to-severe plaque psoriasis up to week 48.
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http://dx.doi.org/10.2340/00015555-3816DOI Listing
April 2021

COVID-19 "second wave" and vaccines: the dermatologists' perspective.

Int J Dermatol 2021 Jul 25;60(7):889-890. Epub 2021 Mar 25.

Di.S.Sal. Section of Dermatology, University of Genoa, Genoa, Italy.

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http://dx.doi.org/10.1111/ijd.15547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251220PMC
July 2021

Considerations on inhibition of IL-23 in psoriatic women of childbearing potential.

Dermatol Ther 2021 05 17;34(3):e14931. Epub 2021 Mar 17.

Di.S.Sal. Section of Dermatology, University of Genoa, Genoa, Italy.

Lack of safety data on pregnant women determines difficulty in choosing the correct biologic agent to treat psoriasis in women of childbearing potential. Studies have postulated a role of IL-23 in unexplained recurrent spontaneous abortions. This gives rise to consideration about use of anti-IL-23 drugs in treatment of psoriasis in women of childbearing potential.
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http://dx.doi.org/10.1111/dth.14931DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8244100PMC
May 2021

Spastic quadriplegia following intradermal use of hydrogen peroxide in the tardive curettage procedure for the treatment of a giant congenital nevus.

G Ital Dermatol Venereol 2020 Dec;155(6):780-782

Department of Legal Medicine, IRCCS San Martino University Hospital, Genoa, Italy.

The possible transformation of a giant congenital melanocytic nevi (GCMN) in malignant melanoma estimated from 0.05% to 40% depend on the size of the lesions. Many are the surgical procedures proposed, including: full or partial-thickness excisions, dermabrasion, curettage in the first weeks of life and laser treatment. The curettage technique has been proposed in the literature for the treatment of GCMN in the first few weeks of life and defined as a relatively atraumatic surgery procedure without general complications. The authors report the first case in the literature of embolization due to use of subcutaneous peroxide infiltration before a tardive curettage procedure in a newborn case of GCMN resulting in spastic quadriplegia with dystonic reaction. Consequently, a lawsuit, due to this medical malpractice, has been opened.
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http://dx.doi.org/10.23736/S0392-0488.16.05231-7DOI Listing
December 2020

Italian expert-based recommendations on the use of photo(chemo)therapy in the management of mycosis fungoides: Results of an e-Delphi consensus.

Photodermatol Photoimmunol Photomed 2021 Jul 1;37(4):334-342. Epub 2021 Feb 1.

SOD Clinica di Dermatologia, Azienza Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.

Background: Phototherapy is a mainstay for the treatment of MF. However, there is scarce evidence for its use, mostly due to the lack of a unified schedule.

Aims: The primary aim of this study was to establish the first structured, expert-based consensus regarding the indications and technical schedules of NB-UVB and PUVA for MF. The secondary aim was to determine the consensus level for each specific item.

Materials & Methods: E-delphi study. Item-specific expert consensus was defined as the number of "Totally Agree" results to ≥80% of the panelists. Cronbach alpha index ≥0.7 was used as a measure of homogeneity in the responses among questions related to the same topic.

Results: Overall, there was a high homogeneity among responders (0.78). On specific topics, the highest grade was observed for technical items (0.8) followed by indications for early (0.73) and advanced stages (0.7).

Conclusions: Items related to the most canonical indications of phototherapy and to treatment schedules showed the highest agreements rates. There is consensus about the use of standardized treatment schedules for the induction and consolidation phases for NB-UVB and PUVA in MF.
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http://dx.doi.org/10.1111/phpp.12658DOI Listing
July 2021

Can Methotrexate be a successful treatment for unresponsive generalized annular elastolytic giant cell granuloma? Case report and review of the literature.

Dermatol Ther 2021 01 30;34(1):e14705. Epub 2020 Dec 30.

DISSAL Department of Dermatology, University of Genova Ospedale Policlinico San Martino IRCCS, Genoa, Italy.

Annular elastolytic giant cell granuloma (AEGCG) is a rare granulomatous skin disorder, characterized by erythematous plaques with elevated borders and hypopigmented center, occurring mainly on sun exposed-skin. Histologically it presents with elastophagocytosis and elastolysis. There is no established first line treatment for AEGCG, especially for the generalized form. In a small number of cases, antimalarial drugs and tranilast, associated to topical or oral steroids, have been proposed to treat generalized AEGCG with partial benefits. We herein present the case of a patient with AEGCG aged 74 years, who was unresponsive to classical therapies, and then successfully treated with methotrexate.
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http://dx.doi.org/10.1111/dth.14705DOI Listing
January 2021

Six months into the pandemic. A review of skin manifestations in SARS-CoV-2 infection.

Dermatol Ther 2021 Jan 14;34(1):e14641. Epub 2020 Dec 14.

Department of Dermatology, University of Genoa, Genoa, Italy.

During the COVID-19 pandemic, various cutaneous manifestations have been described as associated with SARS-CoV2 infection. It is debated if skin lesions could represent a diagnostic or prognostic indicator. Specifically, it is unclear whether skin lesions may be used to perform an early diagnosis and/or to predict worse outcomes. In this review, we described the cutaneous signs so far reported as COVID-19-related and discussed their incidence, clinico-pathological features, and diagnostic and prognostic value.
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http://dx.doi.org/10.1111/dth.14641DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883133PMC
January 2021

Comparison of short- and long-term effectiveness of ixekizumab and secukinumab in real-world practice.

Expert Opin Biol Ther 2021 Feb 20;21(2):279-286. Epub 2021 Jan 20.

Institute of Dermatology, Università Cattolica Del Sacro Cuore , Rome, Italy.

: Although secukinumab and ixekizumab both act by inhibiting IL-17A, some scientific evidence suggests that there are differences in efficacy between the two agents. : The aim of this study was to compare the short- and long-term effectiveness of ixekizumab and secukinumab in clinical practice. : A retrospective study was conducted on a cohort of 245 psoriatic patients receiving secukinumab or ixekizumab during the period from September 2016 to December 2019. The proportion of patients achieving PASI75, PASI90, and PASI100 at weeks 12 and 24 was calculated. We recorded the 12- and 24-month drug survival as a measure to assess long-term effectiveness. : A higher proportion of patients in the secukinumab group achieved PASI75, 90, and 100 at 12 weeks. The Kaplan-Meier survival curve for any reason of discontinuation showed no differences between the two groups. Instead, the multivariate analysis for ineffectiveness, adjusted for potential confounders, showed a lower drug survival rate in the secukinumab group, with an adjusted HR of 2.57 (95% CI 1.05-6.28, p 0.038). : This real-life study demonstrated that ixekizumab and secukinumab are both highly effective in short- and long-term treatment of psoriasis, even though few differences exist concerning speed of action and long-term effectiveness.
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http://dx.doi.org/10.1080/14712598.2021.1849133DOI Listing
February 2021

The HLA-Cw6 Dilemma: Is It Really an Outcome Predictor in Psoriasis Patients under Biologic Therapy? A Monocentric Retrospective Analysis.

J Clin Med 2020 Sep 28;9(10). Epub 2020 Sep 28.

Di.S.Sal. Section of Dermatology, University of Genoa, Via Pastore 1, 16132 Genoa, Italy.

HLA-Cw6 is one of the most strongly associated psoriasis susceptibility alleles. Data regarding correlation between HLA-Cw6 status and biologic treatment outcomes are divergent. The aim of our study in our cohort of psoriatic patients was to explore if the HLA-Cw6 status influences the response rate to biologic therapies at 16 and 48 weeks. One hundred and one psoriatic patients eligible for biologic therapies were enrolled. HLA-C*06 alleles were detected from their blood samples. The effectiveness of antipsoriatic treatments was reported as 90% Psoriasis Area and Severity Index reduction (PASI90). All biologics showed efficacy at week 16, without significant differences between one another. HLA-Cw6 status did not seem to affect baseline characteristics, or treatment response at week 16. At week 48, IL-12/23 and IL-17 targeting drugs were more effective on Cw6-positive patients than on Cw6-negative patients. Conversely, TNF-targeting drugs seemed to be more effective on Cw6- negative patients than on Cw6-positive patients. The HLA-Cw6 test could well deserve to be integrated into the clinical laboratory work-up supporting the choice of the correct biologic.
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http://dx.doi.org/10.3390/jcm9103140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7600180PMC
September 2020

Comedonal variant of chronic cutaneous lupus erythematosus causing mutilation of the earlobe.

JAAD Case Rep 2020 Sep 11;6(9):843-844. Epub 2020 Jun 11.

University of Genoa, DiSSal Section of Dermatology, San Martino Polyclinic Hospital IRCCS, Genoa, Italy.

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http://dx.doi.org/10.1016/j.jdcr.2020.06.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452277PMC
September 2020

Acetazolamide: a new trigger for bullous pemphigoid?

Eur J Dermatol 2020 Jun;30(3):321-322

Di.S.SAL Section of Dermatology, University of Genoa, Via Pastore 1, GenoaItaly, Section of Dermatology, IRCCS San Martino Policlinic Hospital, GenoaItaly.

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http://dx.doi.org/10.1684/ejd.2020.3773DOI Listing
June 2020

A survey of psoriasis patients on biologics during COVID-19: a single centre experience.

J Dermatolog Treat 2020 May 25. Epub 2020 May 25.

Dermatology Unit, DissaL, Policlinico San Martino-IRCCS Hospital, Genoa, Italy.

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http://dx.doi.org/10.1080/09546634.2020.1770165DOI Listing
May 2020

Erythema multiforme after initiation of anti interleukin-12/23 (ustekinumab) treatment for plaque psoriasis.

JAAD Case Rep 2020 May 29;6(5):386-387. Epub 2020 Apr 29.

Section of Dermatology, DISSAL, San Martino-IST Polyclinic Hospital, University of Genoa, Genoa, Italy.

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http://dx.doi.org/10.1016/j.jdcr.2020.03.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7200193PMC
May 2020

Deferred time of delivery of biologic therapies in patients with stabilized psoriasis leads to a 'perceived satisfaction': a multicentric study.

J Dermatolog Treat 2020 Apr 29:1-5. Epub 2020 Apr 29.

Department of Experimental, Diagnostic and Specialty Medicine, Division of Dermatology, University of Bologna, Bologna, Italy.

Thanks to their specificity of action, biologic drugs often lead to complete clearance of psoriatic lesions. In order to maintain its effectiveness, biological therapies cannot be discontinued. The aim of the study was to investigate the effect of widening the administration window of four biologic drugs, thus improving the quality of life of psoriatic patients and satisfying their desire to feel free from the disease, without loss of effectiveness. We performed a multicentric cohort study considering patients with moderate-severe plaque psoriasis and/or arthropathic psoriasis treated with infliximab, adalimumab, etanercept or ustekinumab. The study group included patients with stabilized psoriasis in which the administration regimen of the biologic drug was deferred. The control group included psoriatic patients treated according the product monograph. The percentage of relapses in case of deferred administration intervals was comparable to that of standard administration intervals. The delayed administration modality got a good psychological consensus from the patients themselves, that reported a greater 'perceived satisfaction'. A consistent economic advantage was reported in case of prolonged administration intervals. The administration of biologic drugs with prolonged intervals maintains the same effectiveness as standard administration and produces a 'perceived satisfaction' in psoriatic patients.
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http://dx.doi.org/10.1080/09546634.2020.1759769DOI Listing
April 2020

Active pharmacovigilance program in patients affected by psoriasis and inflammatory bowel diseases
.

Int J Clin Pharmacol Ther 2020 Apr;58(4):208-213

Objective: To help identify adverse events (AEs) in new biologic therapies and to spread the culture of pharmaceutical surveillance among patients affected by psoriasis or inflammatory bowel disease (IBD).

Materials And Methods: This active pharmacovigilance program provided all patients with telephone follow-ups (FU), carried out by a clinical pharmacologist for a total duration of 1 year. Collected AEs were classified according to the MedDRA dictionary.

Results: 21 patients with psoriasis and 10 patients with IBD were enrolled. In our sample, the AEs reported were frequent but mild, underlining the crucial role of active pharmacovigilance in detecting minor AEs rarely spontaneously reported by the patients.

Conclusion: According to our experience, a multidisciplinary team is recommended to manage complex therapies improving AE reporting and promoting greater therapeutic adherence.
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http://dx.doi.org/10.5414/CP203628DOI Listing
April 2020

Cutaneous manifestations of HAV, HBV, HCV.

Ital J Dermatol Venerol 2021 Feb 4;156(1):5-12. Epub 2019 Dec 4.

Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.

Hepatotropic viral infections are a relevant global health problem and present multiple extrahepatic manifestations in addition to hepatic disease. Along with generic cutaneous symptoms correlated to the cholestatic liver disease that may arise during the infection, some cutaneous manifestations of hepatotropic viral infections are characteristic, enabling to suspect the underlying infection. This review will present the principal cutaneous manifestations of hepatotropic virus infection. Cutaneous manifestations are rare in HAV infections: these include urticaria, panniculitis, scarlatiniform eruption, evanescent skin rash, maculopapular prolonged rash, serum sickness-like illness rash, cutaneous vasculitis, cryoglobulinemia. The commonest cutaneous manifestation associated to HBV infection is serum sickness-like syndrome. Polyarteritis nodosa (PAN) is among the most common and serious cutaneous manifestations of HBV infection. In children, HBV infection may acutely manifest as papular acrodermatitis of childhood (Gianotti-Crosti Syndrome), with non-pruritic, non-coalescing, round papules. Patients with chronic HBV infection may also develop mixed cryoglobulinemia, that is, inter alia, the most documented extrahepatic manifestation of HCV infection. Cutaneous lichen planus has been associated to HBV and HCV infection. As for oral lichen planus, the association with HBV and HCV is more debated. Interestingly, patients with oral lichen planus with HCV have a higher risk of developing oral squamous cell carcinoma. Dermatologists should be aware of the possible cutaneous manifestations associated to viral hepatitis.
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http://dx.doi.org/10.23736/S0392-0488.19.06488-5DOI Listing
February 2021

Ixekizumab Effectiveness and Safety in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Multicenter, Retrospective Observational Study.

Am J Clin Dermatol 2020 Jun;21(3):441-447

Department of Advanced Biomedical Sciences, University of Naples Federico II, Via Pansini 5, 80131, Naples, Italy.

Background: Ixekizumab (anti-IL-17A) is a biological agent used for the treatment of moderate-to-severe psoriasis. Real-life data on the effectiveness and safety of ixekizumab are currently scarce.

Objective: The objective of this study was to evaluate the effectiveness and safety of ixekizumab in a cohort of psoriatic and psoriatic arthritis patients.

Methods: We conducted a retrospective study involving 201 patients affected by moderate-to-severe psoriasis and treated with ixekizumab at seven Italian University centers. Data analysis focused on 110 patients who started ixekizumab at baseline and completed at least 24 weeks of treatment.

Results: Significant reduction of mean (± standard deviation) baseline Psoriasis Area Severity Index (PASI) score (14.3 ± 5.8) was detected at 4 weeks of ixekizumab therapy (4.9 ± 4.2, p < 0.001), with a further significant improvement at weeks 12 and 24 (1.9 ± 2.9 and 0.9 ± 1.6, respectively) (p < 0.001). Our analysis showed 90%, 72%, and 57% of patients achieving PASI 75, 90, and 100 responses (75%, 90%, and 100% reduction in PASI score), respectively, after 24 weeks' therapy. For patients with arthritis (28%), a significant reduction in the mean (± standard deviation) baseline Disease Activity Score (DAS)-28 score (4.6 ± 5.1) was detected at week 4 (2.5 ± 3.9, p < 0.01), with a further significant improvement at weeks 12 and 24 (2.1 ± 1.2 and 1.4 ± 0.9, respectively) (p < 0.001). The bio-naïve group showed significantly higher PASI 90 and 100 response rates at week 12 than the bio-exposed one (p < 0.05). This trend in terms of PASI 100 response was also maintained at week 24 (p < 0.05). Furthermore, PASI 90 responses were significantly higher in anti-interleukin (IL)-17A-naïve patients at week 24 than in anti-IL-17A-experienced ones (p < 0.05). The dropout rate for adverse events (AEs) was as low as 2% (2/110), while AEs that did not cause treatment interruption were observed in 6% (7/110). Patients withdrawing from the study were defined as non-responders according to the non-responder imputation method. The retrospective design of the study does not allow missing data to be retrieved or homogeneous patient selection.

Conclusions: The present study illustrates ixekizumab in real-world clinical practice, confirming its usefulness and safety in the management of psoriasis and psoriatic arthritis.
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http://dx.doi.org/10.1007/s40257-019-00490-2DOI Listing
June 2020

Primary cutaneous melanoma: correlation between clinical and histologic aspects in a retrospective Italian study.

G Ital Dermatol Venereol 2019 Oct;154(5):519-522

Section of Dermatology, Department of Health Sciences, San Martino University Hospital IRCCS, University of Genoa, Genoa, Italy.

Background: In Italy, the incidence of new cases of melanoma is roughly 10,000 cases per year, with an average rate of mortality of 5-6 per 100,000 population per year respectively. The objective of this retrospective study was to evaluate the epidemiological incidence of primitive melanoma, including the incidence of multiple melanomas occurring in the same patient. Furthermore, we studied all histological different types of melanoma focusing on the presence of an association nevus-melanoma.

Methods: A clinical epidemiologic retrospective study from January 2010 to March 2015 was recorded. For each lesion, mitotic rate, Breslow's index, ulceration, presence of regression, vascular and perineural invasion, lymphocytic infiltrate, microsatellitosis and presence of pre-existencing nevus were also studied.

Results: Five hundred eighty primitive cutaneous melanomas (CMs) were removed from 525 patients with an incidence of 18-20 new melanomas/100,000 habitants/year. Eighty percent of these were at stage T0-1. Among other melanomas, SSM was the predominant subtype (85% of cases). Only 18 cases had lymph node metastases and 13 (2%) lymph node and/or distant metastases (stage IV) at time of diagnosis. Mitotic figures were present in 25% of cases (143 cases out of 580) without significant gender differences.

Conclusions: The incidence of new melanomas founded is close to the CM's incidence in US population in 2016 with a high percentage of superficial melanomas highlighting the importance of prevention campaigns. The presence of melanoma on a preexisting nevus in only 16% of cases allow to conclude that this association is overestimated in literature. On the contrary the high incidence of a second melanoma in the 7% of cases in a relatively short period of survey leads to the conclusion that this data is underestimated.
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http://dx.doi.org/10.23736/S0392-0488.17.05598-5DOI Listing
October 2019

Biological therapy in genital psoriasis in women.

Dermatol Ther 2020 01 4;33(1):e13110. Epub 2019 Dec 4.

DISSAL Department of Dermatology, Ospedale Policlinico San Martino, Genoa, Italy.

Genital psoriasis (GenPs) is a frequent manifestation of psoriasis, causing distress, especially in women. We prospectively studied a population of 74 psoriatic women with severe and generalized psoriasis eligible to biologic therapy, to examine which biologic therapy is more effective on GenPs and to study possible associations between PASI severity and GenPs. Overall, 25/74 (34%) had GenPs: 6 received Ixekizumab, 7 Ustekinumab, 8 Adalimumab, 2 Secukinumab, 1 Etanercept, 1 Certolizumab. Therapies were administered based on PASI severity, independently from the presence of GenPs. Side effects, PASI score, sPGA-G scale for GenPs were recorded at time 0 and after 6 month of therapy. The mean sPGA-G scale value was 2.8 before treatment. After biologic therapy, all patients except one, improved of at least one point. Mostly, patients treated with anti-IL17 (Secukinumab, Ixekizumab) and anti-IL12/23 (Ustekinumab) improved. Mean PASI ranged from 10 to 16.3 before treatment. After 6 months of therapy, 4 anti-TNFα patients, 6 anti-IL17 and 1 anti-IL12/23, reached PASI 90. At time 0, no correlation between PASI and sPGA-G was visible (Pearson r = 0.10, p = .620). From our data, GenPs apparently responds favorably to IL17A inhibitors, but further studies, based on larger numbers of patients, are needed.
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http://dx.doi.org/10.1111/dth.13110DOI Listing
January 2020

Narrow-band imaging: a useful tool for early recognition of oral lichen planus malignant transformation?

Eur J Dermatol 2019 Oct;29(5):500-506

Di.S.Sal. Section of Dermatology, University of Genoa, San Martino Policlinic Hospital, Largo Rosanna Benzi 10, Genoa, Italy.

Background: Oral lichen planus (OLP) lesions have an overall malignant transformation rate of 1.37%. In patients with chronic disease, the diagnosis of malignancy relies on histopathological examination guided by clinical suspicion. Narrow-band imaging (NBI) is a promising endoscopic technique which, using a filtered light with specific wavelengths, can highlight microvascular abnormalities associated with subclinical neoplastic changes of the upper aerodigestive tract epithelium.

Objectives: This study aimed to analyse the value of NBI in selecting patients for biopsy before the emergence of clinical changes, allowing early detection of oral malignancies arising from OLP.

Materials And Methods: A prospective study was conducted, enrolling 32 consecutive patients with a histological diagnosis of OLP with no previous diagnosis of oral cancer or other oral inflammatory diseases. Patients with suspicious NBI lesions underwent biopsies, while other patients were included in the follow-up.

Results: Two patients were judged positive at NBI evaluation and squamous cell carcinoma was diagnosed after histological examination. None of the other patients developed clinical features of malignancies during follow-up.

Conclusion: NBI evaluation may increase the accuracy of detection of subclinical neoplastic transformation in OLP lesions and further encourage clinicians to perform biopsies in selected cases.
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http://dx.doi.org/10.1684/ejd.2019.3638DOI Listing
October 2019
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