Publications by authors named "Clara De Simone"

113 Publications

Impact of Body Mass Index on the Efficacy of Biological Therapies in Patients with Psoriasis: A Real-World Study.

Clin Drug Investig 2021 Sep 18. Epub 2021 Sep 18.

Istituto di Dermatologia, Università Cattolica del Sacro Cuore, L.go F. Vito 1, 00135, Rome, Italy.

Background: The efficacy of biological therapies used for the treatment of chronic plaque psoriasis can be influenced by numerous variables including  body mass index (BMI).

Objective: This study aimed to evaluate the impact of BMI on the short-term and long-term efficacy of biological therapies in clinical practice and to identify the best therapeutic options in obese patients (BMI ≥ 30 kg/m).

Methods: A multicentric retrospective study was conducted in patients who initiated a biological therapy during the period January 2006-December 2019. The proportion of patients achieving a 90% improvement of baseline Psoriasis Area and Severity Index at weeks 12 and 24 was calculated also recording the 12- and 24-month drug survival as a measure of long-term efficacy, performing multivariate analyses to assess the impact of different variables.

Results: Five hundred and four patients with psoriasis were included. After 12 and 24 weeks, the proportion of patients achieving a 90% improvement of baseline Psoriasis Area and Severity Index response was higher in patients with a BMI < 30 kg/m compared with those with a BMI ≥ 30 kg/m [54.90% vs 43.45% (p = 0.014) at week 12 and 66.84% vs 56.55% (p = 0.021) at week 24]. The Kaplan-Meier survival curves showed how obese patients had a higher probability of discontinuation due to a lack or loss of efficacy (p = 0.0192) compared with non-obese patients. The drug survival analysis also showed that BMI negatively affected the drug survival of secukinumab (odds ratio 1.27, p < 0.001) and ustekinumab (odds ratio 1.06, p = 0.050), while the long-term efficacy of adalimumab, etanercept, and ixekizumab was not influenced by BMI.

Conclusions: Obesity (BMI ≥ 30 kg/m) negatively affects the clinical response of biological drugs in psoriatic patients, with anti-interleukin drugs being more affected by BMI than anti-tumor necrosis factor drugs.
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http://dx.doi.org/10.1007/s40261-021-01080-zDOI Listing
September 2021

Beyond-Mild Psoriasis: A Consensus Statement on Calcipotriol and Betamethasone Dipropionate Foam for the Topical Treatment of Adult Patients.

Dermatol Ther (Heidelb) 2021 Sep 12. Epub 2021 Sep 12.

Department of Dermatology, Psoriasis Center, University Medical Center, Erlangen, Germany.

Introduction: There are clear treatment options for mild psoriasis where topical therapies are the mainstay, and for severe psoriasis where systemic therapy (biologic or non-biologic) is necessary. However, there is less clarity in the 'grey zone' of patients in the moderate or so-called 'beyond-mild' segment. There are frequent delays to the initiation, discontinuation, switching and dose change in treatment, and many patients fail to continue treatment because of concerns about safety or lack of efficacy. Treatment with topical therapies, such as calcipotriol and betamethasone dipropionate (Cal/BD) combinations, may be suitable for these patients.

Method: These consensus recommendations on the use of topical therapies including Cal/BD foam for beyond-mild psoriasis originated from a modified Delphi process of European clinical experts. In the process, the experts iteratively refined a series of draft statements, which had to receive ≥ 80% approval to be incorporated into the consensus.

Results: The experts identified three main themes: Cal/BD foam as monotherapy, as an add-on to non-biologic systemic therapies and as an add-on to systemic biologics. The consensus emphasises disease factors and patient preference in treatment choice, summarises the evidence base for Cal/BD foam monotherapy for flare treatment as well as long-term management, and identifies the potential for improved treatment outcomes, such as reduced time to onset of action and reduced systemic dose to minimise side effects for add-on Cal/BD therapy to non-biologic systemics. The recommendations regarding add-on Cal/BD foam to biologics are similar to those for non-biologic systemic therapies, but also include suggestions for patients on biologics who are late responders. As clinical choices of Cal/BD combination vary, we have here often used 'Cal/BD' without reference to any particular formulation.

Conclusions: These recommendations aim to give practical guidance to those treating patients with beyond-mild psoriasis, to support patients' use of topical preparations and to optimise treatment outcomes.
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http://dx.doi.org/10.1007/s13555-021-00600-1DOI 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

Anti-TNF-Related Leukocytoclastic Vasculitis in Ulcerative Colitis: A Case Report.

Int J Environ Res Public Health 2021 06 22;18(13). Epub 2021 Jun 22.

Department of Internal Medicine, Università Cattolica Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy.

Background: The development of drugs directed against tumor necrosis factor (TNF)-α has dramatically modified the therapeutic approach to inflammatory bowel diseases: a larger use of such drugs has also led to a major knowledge about their adverse effects, especially on skin. The aim of this report was to describe a rare steroid-dependent form of leukocytoclastic vasculitis induced by an anti-TNF-α agent in a young woman with ulcerative colitis.

Case Presentation: A young girl with ulcerative colitis developed a form of leukocytoclastic vasculitis induced by an anti-TNF-α agent. Recurrent palpable purpuric lesions on her legs were the main cutaneous manifestation. Skin lesions were steroid-dependent, but improved after withdrawal of the anti-TNF-α agent and second-line immunosuppressant therapy.

Conclusions: The need to develop specific recommendations to guide the use of medications for managing skin reactions induced by anti-TNF-α drugs is herein emphasized.
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http://dx.doi.org/10.3390/ijerph18136711DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8297360PMC
June 2021

Management of patients with atopic dermatitis undergoing systemic therapy during COVID-19 pandemic in Italy: Data from the DA-COVID-19 registry.

Allergy 2021 06 9;76(6):1813-1824. Epub 2021 Mar 9.

Dermatology Unit, Department of MedicalSpecialties, Arcispedale Santa Maria Nuova-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Background: Few and small studies have described the management of immunomodulant/immunosuppressive therapies or phototherapy in atopic dermatitis (AD) patients during coronavirus disease 2019 (COVID-19) pandemic.

Methods: A national registry, named DA-COVID-19 and involving 35 Italian dermatology units, was established in order to evaluate the impact of COVID-19 pandemic on the management of adult AD patients treated with systemic immunomodulant/immunosuppressive medications or phototherapy. Demographic and clinical data were obtained at different timepoints by teledermatology during COVID-19 pandemic, when regular visits were not allowed due to sanitary restrictions. Disease severity was assessed by both physician- and patient-reported assessment scores evaluating itch intensity, sleep disturbances, and AD severity.

Results: A total of 1831 patients were included, with 1580/1831 (86.3%) continuing therapy during pandemic. Most patients were treated with dupilumab (86.1%, 1576/1831) that was interrupted in only 9.9% (156/1576) of cases, while systemic immunosuppressive compounds were more frequently withdrawn. Treatment interruption was due to decision of the patient, general practitioner, or dermatologist in 39.9% (114/286), 5.6% (16/286), and 30.1% (86/286) of cases, respectively. Fear of increased susceptibility to SARS-CoV-2 infection (24.8%, 71/286) was one of the main causes of interruption. Sixteen patients (0.9%) resulted positive to SARS-CoV-2 infection; 3 of them (0.2%) were hospitalized but no cases of COVID-related death occurred.

Conclusions: Most AD patients continued systemic treatments during COVID pandemic and lockdown period, without high impact on disease control, particularly dupilumab-treated patients.
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http://dx.doi.org/10.1111/all.14767DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014537PMC
June 2021

Severe and resistant palmar psoriasis successfully treated with risankizumab.

Ital J Dermatol Venerol 2021 May 13. Epub 2021 May 13.

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

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http://dx.doi.org/10.23736/S2784-8671.21.06972-8DOI Listing
May 2021

Factors related to the onset and recurrence of flares in hidradenitis suppurativa patients treated with adalimumab.

Ital J Dermatol Venerol 2021 May 13. Epub 2021 May 13.

Dermatology Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Background: Hidradenitis suppurativa (HS) is characterized by periodic worsening of symptoms. However, clinical parameters associated with flare are still to be established. The aim was too investigate factors associated with flare outbreak in HS patients in treatment with adalimumab.

Methods: Moderate-severe HS patients were included in this retrospective analysis. In total, 115 HS patients treated with adalimumab from 5 Italian centers were reviewed. Gender, ages at onset/baseline, therapeutic delay, family history, body mass index, smoking, comorbidities, phenotypes, body areas involved, Hurley stage, International Hidradenitis Suppurativa Severity Score System (IHS4), Dermatology Life Quality Index (DLQI) and Visual Analogue Scale for pain (pain-VAS) were collected at baseline. Flares were modelled with baseline features using univariate and multivariate Coxregression. The factors significantly correlated with flares in the univariate model were analyzed using a recurrent event survival analysis (Andersen-Gill model) to assess the relation between them and flares recurrence.

Results: During the observation period 80.9% of patients developed flares, detecting 252 flares, overall. A univariate model identified five risk factors associated with the outbreak of flares: age, therapeutic delay, groin involvement, Hurley III, higher IHS4, whereas, from multivariate model, only IHS4 resulted to be significantly correlated. Additionally, flares were positively associated with higher DLQI and pain-VAS. Finally, the Andersen-Gill model showed four factors correlated with flares recurrence: age, therapeutic delay, Hurley III and higher IHS4. The limitations are: study's retrospective design, absence of a consensus about flare definition.

Conclusions: An early treatment of HS may prevent both the disease progression and reduce the recurrence of flares.
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http://dx.doi.org/10.23736/S2784-8671.21.06966-8DOI Listing
May 2021

Effects of TNF-α inhibition on pre-clinical enthesitis: observational study on 49 psoriatic patients.

J Dermatolog Treat 2021 Mar 10:1-4. Epub 2021 Mar 10.

Department of Dermatology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy.

Background: Enthesitis is a hallmark of psoriatic arthritis (PsA) and echographic ultrasounds (US) represent a support for diagnosis of pre-clinical signs of enthesitis in asymptomatic patients at high risk for advanced forms. Early treatment with anti-TNFα could prevent permanent damage contrasting the degenerative course of the disease.

Objectives: To evaluate the effects of adalimumab on echographic and preclinical enthesitis signs in patients affected by plaque psoriasis.

Methods: 49 psoriatic patients undergoing adalimumab treatment for plaque-type psoriasis were subjected to echographic screening for identifying pre-clinical signs of enthesitis. Patients underwent clinical and ultrasonographic examination of hands, elbows and knees before starting adalimumab and after 24 and 48 weeks of treatment.

Results: We observed a reduction of the total number of echographic abnormalities and a significant decrease of the thickness of quadriceps tendons at week 24 and week 48. Furthermore, there was no evidence of significant articular damage progression during the entire study duration.

Conclusions: Entheseal ultrasonography may be used for preclinical diagnosis of PsA.Our study demonstrates that early detection and management with adalimumab leads to a block of articular damage progression. On quadriceps tendon, adalimumab has shown to be effective with a significant thickening reduction at week 24 and 48.
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http://dx.doi.org/10.1080/09546634.2021.1899112DOI Listing
March 2021

Free and total vitamin D in psoriatic patients treated with biological drugs.

Exp Dermatol 2021 Jul 5;30(7):995-996. Epub 2021 Apr 5.

Section of Dermatology, Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.

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http://dx.doi.org/10.1111/exd.14322DOI Listing
July 2021

Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis.

Eur J Dermatol 2021 Feb;31(1):3-16

Dermatology Unit "Daniele Innocenzi", Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Corso della Repubblica, 7904100 Latina, Rome, Italy.

Guselkumab, a subcutaneously administered fully human IgG1λ monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.
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http://dx.doi.org/10.1684/ejd.2021.3965DOI Listing
February 2021

Erfolgreiche Behandlung des therapierefraktären Sweet-Syndroms mit Adalimumab.

J Dtsch Dermatol Ges 2021 Jan;19(1):122-124

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

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http://dx.doi.org/10.1111/ddg.14223_gDOI Listing
January 2021

Successful Combination of Systemic Agents for the Treatment of Atopic Dermatitis Resistant to Dupilumab Therapy.

Dermatology 2021 21;237(4):535-541. Epub 2021 Jan 21.

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Dermatologia, Rome, Italy.

Background: Dupilumab, a monoclonal antibody inhibiting the signaling pathway of IL-4/IL-13, was shown to be safe and effective in the treatment of moderate/severe atopic dermatitis (AD) in several clinical trials and real-life experiences, with only a small percentage of patients showing to be resistant or to lose disease control.

Objectives: In this study, we investigated the effectiveness and safety in combining dupilumab with systemic agents or phototherapy in patients experiencing an inadequate response to dupilumab.

Methods: This retrospective, monocentric, observational study consecutively included patients aged >18 years, with moderate-severe AD, under treatment with dupilumab. In this cohort of patients, we analyzed data of subjects who experienced an inadequate response to dupilumab, even when combined with topical corticosteroids, and for whom an additional systemic treatment or phototherapy was combined to dupilumab.

Results: In this study, we included a total population of 69 patients treated with dupilumab. In 12/69 patients (17.4%) showing an inadequate response to dupilumab, a combined treatment consisting of dupilumab plus methylprednisolone (n = 5), cyclosporine (n = 4), methotrexate (n = 2), or narrow band-UVB (n = 1) was administered. Overall, after 8 weeks of combined therapy, the majority of patients (11 of 12) obtained an improvement of signs and symptoms of AD. Patients treated with combined therapy did not experience any adverse events, neither did they withdraw treatment because of the occurrence of adverse events.

Conclusions: This study suggests that the combination of dupilumab with a conventional drug or phototherapy may represent a valid therapeutic choice, maintaining a good safety profile in AD patients recalcitrant to dupilumab monotherapy.
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http://dx.doi.org/10.1159/000512890DOI Listing
January 2021

Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations.

Dermatol Ther (Heidelb) 2021 Feb 11;11(1):235-252. Epub 2021 Jan 11.

Dermatology Clinic, Department of Medical Sciences and Public Health, University of Cagliari, Via Università 40, 09124, Cagliari, Italy.

Introduction: Treat-to-target strategies are used in several chronic diseases to improve outcomes. Treatment goals have also been suggested for psoriasis, but there is currently no consensus on targets, and guidance is needed to implement this strategy in clinical practice. The project 'Treat to Target Italia' was launched by a scientific board (SB) of 10 psoriasis experts to generate expert consensus recommendations.

Methods: On the basis of the published literature, their clinical experience, and the results of a survey among Italian dermatologists, the SB identified four relevant topics: (1) clinical remission; (2) quality of life; (3) abrogation of systemic inflammation; (4) safety. They drafted 20 statements addressing these four topics and submitted them to a panel of 28 dermatologists, in a Delphi process, to achieve consensus (greater than 80% agreement).

Results: Consensus was reached on all statements. Treatment goals defining clinical remission should include a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI90 response) or an absolute PASI score of less than or equal to 3. Patient's quality of life and satisfaction are important targets. If PASI targets are achieved, there should be no or very low impact of psoriasis on quality of life [Dermatology Life Quality Index (DLQI) score less than or equal to 3]. If PASI or DLQI goals are not achieved within 3-4 months, treatment should be changed. Abrogation of systemic inflammation may be crucial for preventing or delaying inflammatory comorbidities. Safety is an equally important target as efficacy.

Conclusion: These 20 consensus statements define the parameters of a treat-to-target strategy for psoriasis in Italy. It is hoped that use of these in the management of patients with psoriasis will improve treatment outcomes and patient health-related quality of life.
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http://dx.doi.org/10.1007/s13555-020-00475-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7859133PMC
February 2021

Scurvy: A Disease not to be Forgotten.

Nutr Clin Pract 2020 Dec 23. Epub 2020 Dec 23.

Department of Internal Medicine, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico - Università Cattolica del Sacro Cuore, Roma, Italy.

An 18-year-old man presented to our hospital with muscular pain, diffuse petechiae, spontaneous thigh ecchymosis, edema and pain of the right knee, bilateral pretibial subcutaneous nodules, and gingival hypertrophy and hemorrhage. His history was positive for a mixed anxiety-depressive disorder and a restrictive diet caused by self-diagnosed food allergies. Skin lesions appeared like hyperkeratotic papules with coiled hairs and perifollicular hemorrhages. A diagnosis of scurvy was made upon demonstration of low serum levels of ascorbic acid. An allergy evaluation found cross-reactivity between pollens and food, related to the presence of panallergens. Moreover, we found that our patient was also affected by celiac disease. In conclusion, scurvy should be considered in the differential diagnosis of patients with petechiae and ecchymosis, especially when food restriction, malabsorption, or psychiatric disorders are present.
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http://dx.doi.org/10.1002/ncp.10616DOI Listing
December 2020

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

Psoriasis and its management in women of childbearing age: tools to increase awareness in dermatologists and patients.

G Ital Dermatol Venereol 2020 Aug;155(4):434-440

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

Psoriasis is a common, chronic inflammatory disease with a multifactorial pathogenesis. Mean age at presentation of psoriasis is 28 years in women, which is almost the height of fertility age. Since women of childbearing potential represent a significant proportion of psoriatic patients, the impact of psoriasis and its treatment on fertility, pregnancy, and breastfeeding should be highlighted for a proper management. Therefore, when approaching to a psoriatic woman of childbearing age, Healthcare Providers should be adequately informed and ready to provide the patients with answers to the most frequently asked questions. The Italian Society of Dermatology and Venereology (SIDeMaST) has fostered a Task Force named "Psoriasis in Women of Childbearing Age" which is composed by a group of Italian female dermatologists with a high expertise in psoriasis treatment. The aims of the Task Force are to increase awareness of the disease and its treatment in patients of childbearing age among both dermatologists and women affected by psoriasis and to encourage counselling on family planning. With the aim of providing a real support for the proper management of the delicate journey to motherhood, the Italian Task Force has published two different informative booklets addressed to patients and dermatologists which focus on the main issues regarding psoriasis in women of childbearing age.
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http://dx.doi.org/10.23736/S0392-0488.20.06748-6DOI Listing
August 2020

Recalcitrant Sweet Syndrome successfully treated with adalimumab.

J Dtsch Dermatol Ges 2021 Jan 24;19(1):122-124. Epub 2020 Aug 24.

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

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http://dx.doi.org/10.1111/ddg.14223DOI Listing
January 2021

Patients' demographic and socioeconomic characteristics influence the therapeutic decision-making process in psoriasis.

PLoS One 2020 12;15(8):e0237267. Epub 2020 Aug 12.

Dermatological Clinic, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, Italy.

Background: Knowledge regarding differences in care for psoriatic patients is limited. The aim of this study was to investigate factors influencing prescription of systemic treatments for patients with psoriasis with a special focus on socioeconomic factors.

Methods And Findings: This was a non-interventional, cross-sectional study, conducted in 18 Italian University and/or hospital centers with psoriasis-specialized units. Questionnaires evaluating demographic and socioeconomic characteristics were administered to participants. Overall, 1880 consecutive patients affected by mild-to-severe psoriasis were recruited. Univariate and multivariable logistic regression analyses of systemic therapy prescription, with a special focus on biologics, accounting for the above mentioned characteristics were performed. Our analysis showed that all analyzed patients' characteristics were significantly associated with biological therapy compared to non-biological systemic one. Particularly, women were less likely to receive biologics than men (OR = 0.66; 95% CI, 0.57-0.77). Elderly patients (≥65 years) and subjects with a BMI ≥30 had lower odds to receive biologics respect to adults (≥35-64 years) (OR = 0.33; 95% CI, 0.25-0.40), and subjects with BMI≥25<30 (OR = 0.64; 95% CI, 0.53-0.77), respectively. Northern and Southern patients were both less likely to receive biologics than Central patients (OR = 0.75; 95% CI, 0.63-0.89, and OR = 0.56; 95% CI,0.47-0.68, respectively). Lower economic profile and never reading books were both associated with decreased odds of receiving biological therapy.

Conclusions: This study shows that sex, age, comorbidities, and socioeconomic characteristics influence the prescription of systemic treatments in psoriasis, highlighting that there are still unmet needs influencing the therapeutic decision-making process that have to be addressed.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237267PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423114PMC
October 2020

Association Between Patient- and Physician-Reported Outcomes in Patients with Moderate-To-Severe Plaque Psoriasis Treated with Biologics in Real Life (PSO-BIO-REAL).

Dermatol Ther (Heidelb) 2020 Oct 6;10(5):1099-1109. Epub 2020 Aug 6.

Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy.

Introduction: Clinical trials have shown that psoriasis patients who achieve complete skin clearance are more likely to report no impairment in health-related quality of life (HRQoL) and no psoriasis symptoms versus patients who achieve almost complete skin clearance. However, real-world data are lacking. The objective of this study was to estimate the real-world proportion of moderate-to-severe psoriasis patients on biologic treatment who achieved a Psoriasis Symptom Inventory (PSI) total score of 0 (PSI 0; no symptoms) and a Dermatology Life Quality Index (DLQI) score of 0/1 (DLQI 0/1; no impact on HRQoL), and to study the relationship between patient-reported symptoms and HRQoL versus physician-reported psoriasis severity (Psoriasis Area and Severity Index [PASI]).

Methods: The PSO-BIO-REAL study was a multinational, prospective, real-world, non-interventional study that included patients aged ≥ 18 years with moderate-to-severe plaque psoriasis who had initiated biologic therapy (either biologic-naïve or had switched biologics [biologic-experienced]). Psoriasis symptoms were evaluated using the PSI, and HRQoL was assessed using the DLQI. Assessments were conducted at baseline and at 6 and 12 months after initiating biologic treatment. Associations between PSI and DLQI with PASI were evaluated using Spearman correlation coefficients. Post-hoc analyses evaluated individual PSI items and the association to PASI response, DLQI and PSI by index biologic.

Results: At 12 months, 25.5% of patients achieved PSI 0, and 51.2% achieved DLQI 0/1, with greater proportions achieving these scores among biologic-naïve than among biologic-experienced patients. There was a moderate-to-strong correlation between PSI and DLQI scores and PASI scores, with 64.8% of patients with absolute PASI 0 and 19.4% with absolute PASI > 0 ≤ 2 achieving PSI 0 (6 and 12 months pooled). Achievement of response varied by index biologic.

Conclusion: This study demonstrates that in a real-world setting patients' QoL improves with skin clearance. The results also demonstrate that the correlation between skin clearance and improvements in HRQoL (DLQI) and psoriasis symptoms (PSI) is not complete, which highlights the importance of considering both patient- and physician-reported outcomes in the assessment of psoriasis treatment outcomes.
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http://dx.doi.org/10.1007/s13555-020-00428-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7477065PMC
October 2020

The Safety of Radiotherapy in the Treatment of Primary Cutaneous B-Cell Lymphoma: A Multidisciplinary Systematic Review.

Front Oncol 2020 14;10:1133. Epub 2020 Jul 14.

Institute of Dermatology, Università Cattolica, Rome, Italy.

Primary cutaneous B-cell lymphomas (PCBCL) are rare types of extranodal non-Hodgkin's lymphoma. The choice of treatment usually depends on the variant of PCBCL, number, size, and location of the lesions, involved body surface area as well as patient's age and health condition. The efficacy of radiotherapy (RT) in the treatment of PCBCL has been widely reported conversely, data about the acute and late skin toxicity, patient's treatment satisfaction and quality of life are scarce. A systematic search using PubMed, Scopus, and Cochrane library was performed to identify full original articles analyzing the safety of RT in patients with PCBCL with the primary outcome to assess the acute and late skin toxicity. Secondary outcomes were complete remission, disease free survival, and overall survival. The literature search resulted in 276 articles including eight studies assessing the safety of RT for the treatment of PCBCL. Most patients (median 73%, range 11.9-99.9%) were recorded as having acute skin toxicity of grade 1-2, while acute grade 3-4 toxicity occurred in a median of 8% (range 4-23%) of patients. A median of 20% (range 4-54%) of patients had late skin toxicity of grade 1-2. No late grade 3-4 toxicity was reported. Only one study evaluated patient's satisfaction showing that the 97% of patients were satisfied with radiation therapy. This systematic review confirms the safety of RT in the treatment of PCBCL. Patients with a PCBCL should be managed in highly specialized centers in the context of a multidisciplinary team including dermatologist, hematologist, pathologist, and radiation oncologist.
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http://dx.doi.org/10.3389/fonc.2020.01133DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7372591PMC
July 2020

The impact of COVID-19 pandemic in a cohort of Italian psoriatic patients treated with biological therapies.

J Dermatolog Treat 2020 Aug 4:1-5. Epub 2020 Aug 4.

Dermatology, Università Cattolica del Sacro Cuore, Rome, Italy.

Background: The beginning of 2020 has been marked by COVID-19 pandemic, with a strong impact on several national health systems worldwide.

Objective: To describe the impact of COVID-19 pandemic in a cohort of Italian psoriatic patients treated with biologics.

Methods: A telephone survey was conducted in May 4-10 2020 about the Italian lockdown period (March 9-May 3 2020) in a cohort of psoriatic patients treated with biologics, asking about any exposure to COVID-19, disease status, continuation of therapy, work activity and psychological status through Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS) and Brief Resilience Scale (BRS).

Results: 226 patients were interviewed, with no COVID-19 positive cases. Sixty-three of 226 (27.9%) described worsening of the disease with a correlation to drug withdrawal [43/226 (19%)]. Correlation was also found between the worsening of psoriasis and HADS anxiety, HADS depression, BRS and PSS abnormal scores considered both as categorical and continuous variables. No correlation was found between worsening of psoriasis and work activity.

Conclusion: Uncertainty about whether biologics could increase the risk of SARS-CoV-2 infection led to drug withdrawal with subsequent worsening of psoriasis. Moreover, psychological status also had a direct influence on the clinical course of the disease.
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http://dx.doi.org/10.1080/09546634.2020.1800578DOI Listing
August 2020

New JAK inhibitors for the treatment of psoriasis and psoriatic arthritis.

G Ital Dermatol Venereol 2020 Aug 15;155(4):411-420. Epub 2020 Jun 15.

Institute of Dermatology, Sacred Heart Catholic University, Rome, Italy.

Psoriasis is a common inflammatory skin disease that can be associated with various pathological conditions among which arthritis is a frequent comorbidity. Based on the current pathogenetic model, development of psoriasis is mainly driven by the IL-23/IL-17A axis. Though the therapeutic armamentarium is expanding in the latest years, new therapies are needed because of the lack or loss of response or intolerance/contraindication to the currently approved drugs. The most recently developed drugs for the treatment of psoriasis and psoriatic arthritis specifically target cytokines, cytokine receptors, and intracellular signaling transducers that are involved in the pathogenesis of psoriasis. Janus kinase (JAK) pathway transduces signals of multiple cytokines, such as TNF-α, IL-23, IL-12, IFN, IL-6, IL-17, that have resulted crucial in the induction and maintenance of psoriasis inflammation. Thereby, JAK-1, JAK-3, TYK-2 belonging to the JAK family, have been identified as valid therapeutic targets in the treatment of psoriasis. Nowadays, different JAK inhibitors have been investigated in clinical trials showing promising results in terms of efficacy and safety. In this review, we systematically collected publications and data related to JAK inhibitors used in psoriasis and psoriatic arthritis providing the state-of-the-art on this new class of molecules in the treatment of these diseases.
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http://dx.doi.org/10.23736/S0392-0488.20.06658-4DOI Listing
August 2020

Clinical and Ultrasonographic Profile of Adalimumab-treated Hidradenitis Suppurativa Patients: A Real-life Monocentric Experience.

Acta Derm Venereol 2020 Jun 11;100(13):adv00172. Epub 2020 Jun 11.

Institute of Dermatology, Catholic University, Largo Agostino Gemelli 8, IT-00168 Rome, Italy. E-mail: Institute of Dermatology, Catholic University, Largo Agostino Gemelli 8, IT-00168 Rome, Italy. E-mail:

Ultrasonography has proven useful for diagnosis and treatment monitoring in patients with hidradenitis suppurativa. The aim of this study was to assess the clinical response to adalimumab using ultrasound findings. This prospective study collected data on demographic features, disease severity, and hidradenitis suppurativa findings from patients with hidradenitis suppurativa treated with adalimumab. Generalized estimating equations investigated relationships between disease severity measures and clinical/demographic variables. The study included a total of 41 patients with hidradenitis suppurativa who were treated with adalimumab for a mean period of 50.8 ± 32.2 weeks; range 6-108 weeks). Clinical improvement was observed during adalimumab therapy, with a progressively greater number of patients achieving HiSCR50 response (36.4% at week 52). Disease duration was identified as the most relevant clinical variable affecting disease severity and treatment response. Treatment response was also influenced by treatment duration, with a 4% greater likelihood of achieving HiSCR50 response at each time-point. At the ultrasound examination, subcutaneous involvement of hidradenitis suppurativa lesions was identified as a predictive negative factor for clinical response to adalimumab (HiSCR50 achievement).
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http://dx.doi.org/10.2340/00015555-3520DOI Listing
June 2020

TNF-α inhibitors biosimilars as first line systemic treatment for moderate-to-severe chronic plaque psoriasis.

Expert Rev Clin Immunol 2020 06 4;16(6):591-598. Epub 2020 Jun 4.

Department of Medicine, Section of Dermatology and Venereology, University of Verona , Verona, Italy.

Introduction: Biologics have revolutionized the therapy of moderate-to-severe plaque psoriasis. Despite their greater efficacy over conventional systemic therapies their high cost has represented a burden for health-care systems, which limited their use. The availability of biosimilars at low cost is changing the place in therapy of biologics for psoriasis.

Areas Covered: The role of TNF- α inhibitors in the management of plaque psoriasis, their efficacy and safety profile are presented. Phase 3 clinical trials and real-life data from the use of TNF- α inhibitor biosimilars in the treatment of plaque psoriasis are also reviewed in detail. Furthermore, arguments in favor of the use of TNF- α inhibitor biosimilars as a first-line therapy in moderate-to-severe plaque psoriasis are discussed.

Expert Opinion: An increasing amount of data show that biosimilars represent a safe and effective alternative to the originator biologics. In the face of ever-increasing health-care costs, switching to biosimilars and starting naïve patients on the best-value biologic can reduce expenditure for patients and payers while maintaining a high-quality care. Moreover, as the cost of biosimilars is approaching the cost of conventional systemic treatments, TNF-α inhibitors biosimilars may represent a first-line systemic treatment for psoriasis patients because they are effective and safe.
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http://dx.doi.org/10.1080/1744666X.2020.1771182DOI Listing
June 2020

Disease Severity Is Associated with Alexithymia in Patients with Atopic Dermatitis.

Dermatology 2020 5;236(4):329-335. Epub 2020 May 5.

Institute of Dermatology, Catholic University, Rome, Italy.

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disorder that is associated with higher rates of psychological disorders, but limited evidence supported the association with alexithymia, a psychoaffective dysfunction.

Objectives: This study was aimed to investigate the occurrence of alexithymia in AD patients, compared to healthy subjects.

Methods: This cross-sectional study assessed AD severity by the Eczema Area and Severity Index (EASI) score, sleeplessness and itch by a numeric rating scale (NRS), and alexithymia by the 20-item Toronto Alexithymia Scale (TAS-20) score. The association between disease characteristics and alexithymia was evaluated through several logistic regression models.

Results: 202 AD patients and 240 healthy subjects were included in this study. The alexithymic personality trait (TAS-20 ≥51) was more frequently observed among AD patients compared to the control group (62.4% [126/202] vs. 29.2% [70/240], p < 0.0001). In particular, alexithymia (TAS-20 score ≥61) was detected in a significantly higher number of AD patients than in the controls (27.7% [56/202] vs. 7.5% [18/240]; p < 0.0001), whereas borderline alexithymia was detected in 34.6% (70/202) of AD patients compared to 21.7% of healthy controls. Alexithymia was more common among severe AD patients (43.6%) compared to mild AD patients (15.6%) and correlated with itch intensity and sleep disturbances. Among clinical variables, ordered logistic regression analyses revealed disease severity as predictor of alexithymia. Indeed, univariate analysis showed EASI score, sleep NRS, and itch NRS being significantly associated with alexithymia, while a multivariate model identified increased EASI score values as predicting factor.

Conclusion: This study described alexithymia in AD patients correlating its occurrence with clinical AD severity markers (EASI score, itch, and sleeplessness) and identifying the increase in EASI score as predicting factor.
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http://dx.doi.org/10.1159/000507246DOI Listing
April 2021

Dupilumab improves clinical manifestations, symptoms, and quality of life in adult patients with chronic nodular prurigo.

J Am Acad Dermatol 2020 Jul 27;83(1):39-45. Epub 2020 Mar 27.

Institute of Dermatology, Catholic University, Rome, Italy; Dermatology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Background: Chronic nodular prurigo (CNPG) is a multifactorial skin disease characterized by itchy papules and nodules, usually resistant to standard treatment and associated with markedly impaired quality of life.

Objective: To describe dupilumab effectiveness and tolerability in treating adult patients with CNPG refractory to both topical and systemic therapies.

Methods: Retrospective, multicenter study including adult patients affected by CNPG, who were treated with dupilumab for at least 16 weeks.

Results: Twenty-seven CNPG patients showed clinical improvement in terms of skin lesions, itch, sleeplessness, and quality of life. A consistent proportion of patients (24/27; 88.9%) had at least 16-week continuous treatment and achieved Investigator Global Assessment score 1 (11/24; 45.8%). An increased number of patients achieved at least a 2-grade reduction in Investigator Global Assessment score (19/24; 79.2%). Numeric rating scale values for itch and sleeplessness decreased from 8.9 to 2.7 and from 8.2 to 1.7, respectively (P < .001) after 16-week therapy. Ten patients achieved 36 weeks of continuous treatment while maintaining clinical efficacy.

Limitations: Major limitations included lack of validated assessment tools at the initial data collection, a limited cohort of treated patients, and a short-term observation period.

Conclusion: Dupilumab was proven effective in reducing itch and improving CNPG skin lesions.
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http://dx.doi.org/10.1016/j.jaad.2020.03.049DOI Listing
July 2020

Autoantibody Profile of a Cohort of 54 Italian Patients with Linear IgA Bullous Dermatosis: LAD-1 Denoted as a Major Auto-antigen of the Lamina Lucida Subtype.

Acta Derm Venereol 2020 02 29;100(4):adv00070. Epub 2020 Feb 29.

Section of Dermatology, Department of Health Sciences (Di.S.Sal.), University of Genoa, 16132 Genoa, Italy.

Linear IgA bullous dermatosis (LABD) is characterized by presence of multiple IgA autoantibodies, and a comparatively lesser number of IgG antibodies, directed against different hemidesmosomal antigens. The main autoantigens are LAD-1, LABD-97, BP180 and BP230, type VII collagen and laminin 332. We retrospectively studied the serology of 54 Italian patients with LABD using enzyme-linked immunosorbent assay (ELISA), immunoblotting assay, and indirect immunofluorescence on monkey oesophagus and salt-split skin. Among these, indirect immunofluorescence of salt-split skin elicits the greatest sensitivity. Sixty-three percent of the sera were observed to be positive, with a lamina lucida pattern observed in 48%, a sub-lamina densa pattern in 2% and a mixed pattern in 13% of the cases. IgA reactivity to LAD-1 on immunoblotting was found in 52% of sera, to BP180-NC16A by ELISA in 32% and to BP230 in 26%. Only 17% of patients possessed circulating IgG autoantibodies. LAD-1 was determined to be a major autoantigen of the lamina lucida subtype. Combined serological assays demonstrated a high sensitivity (82%), suggesting that this approach could support diagnosis when a biopsy is not feasible or direct immunofluorescence results are negative.
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http://dx.doi.org/10.2340/00015555-3415DOI Listing
February 2020

Apremilast for the treatment of hidradenitis suppurativa associated with psoriatic arthritis in multimorbid patients: Case report and review of literature.

Medicine (Baltimore) 2020 Jan;99(5):e18991

Introduction: Hidradenitis suppurativa is a complex, chronic, difficult to treat condition belonging to the spectrum of cutaneous immune-mediated inflammatory diseases. Systemic treatment options for moderate-severe disease are limited to TNF-alpha antagonists and other biologic agents, with limited clinical evidence.

Patient Concerns: We report two adult patients with severe hidradenitis suppurativa presenting concomitant psoriatic arthritis and multiple medical comorbidities. Both were ineligible or resistant to adalimumab, the only biologic drug approved for the treatment of hidradenitis.

Diagnosis: Both patients were diagnosed with severe Hurley III-stage disease and psoriatic arthritis, showing resistance to first-line systemic treatments and a complex comorbidity profile.

Interventions: Patients underwent treatment with apremilast, an oral phosphodiesterase-4 inhibitor, approved for the treatment of psoriatic arthritis.

Outcomes: After 16 weeks of treatment, a clinically relevant improvement of inflammatory lesions, skin- and arthritis-related pain, and patient-reported outcomes was achieved in both patients. Apremilast was well tolerated and continued up to 48 weeks of treatment.

Conclusion: We report the "real-life" use of apremilast in the treatment of multimorbid patients with hidradenitis suppurativa and review its potential role in the management of this severe condition.
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http://dx.doi.org/10.1097/MD.0000000000018991DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7004578PMC
January 2020

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
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