Paolo Dapavo - Academia.edu (original) (raw)

Papers by Paolo Dapavo

Research paper thumbnail of Interleukin-17 vs. Interleukin-23 Inhibitors in Pustular and Erythrodermic Psoriasis: A Retrospective, Multicentre Cohort Study

Journal of Clinical Medicine

Pustular and erythrodermic psoriasis are rare and difficult-to-treat conditions. It has recently ... more Pustular and erythrodermic psoriasis are rare and difficult-to-treat conditions. It has recently been shown that interleukin (IL)-17 inhibitors can be very effective among patients with these forms of psoriasis; however, the potential of IL-23 inhibitors is largely unknown. The aim of this multicentre, retrospective study was to compare the safety, effectiveness, and drug survival of IL-17 and IL-23 inhibitors among patients affected by these rare forms of psoriasis. The study involved 27 patients with erythrodermic psoriasis and 59 with pustular psoriasis (36 with generalised pustular psoriasis and 23 with palmoplantar pustular psoriasis) treated with an IL-17 or IL-23 inhibitor. The effectiveness of the two drug classes was assessed using the disease-specific Psoriasis Area Severity Index (PASI) and the Investigator Global Assessment, which were evaluated at different time points. There was a consistent trend towards a higher rate of PASI 100 responses in the patients treated with...

Research paper thumbnail of Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

Advances in Therapy

Introduction: While several European studies have reported real-world apremilast use, patient-per... more Introduction: While several European studies have reported real-world apremilast use, patient-perceived benefits, and treatment satisfaction , local reimbursement criteria for apremilast vary and data from Italy are limited. Methods: The cross-sectional DARWIN study enrolled consecutive patients who had initiated apremilast for plaque psoriasis 6 (± 1) months prior to enrolment at a single visit across 24 Italian dermatological sites. Disease severity was assessed using body surface area (BSA) and Physician Global Assessment (PGA). Patient-reported outcomes assessed 6 (± 1) months after apremilast initiation were Dermatology Life A1 The members of the DARWIN study group are listed in Acknowledgments.

Research paper thumbnail of Drug Survival of Anti Interleukin-17 and Interleukin -23 Agents after Adalimumab Failure in Hidradenitis Suppurativa: A Pilot Study

Acta dermato-venereologica, Apr 19, 2023

Research paper thumbnail of Concomitant cutaneous graft-versus-host disease and solid organ rejection: an unreported presentation

Italian Journal of Dermatology and Venereology

Research paper thumbnail of ISID0593 - Inverse psoriasis involvement in moderate to severe psoriatic patients: A comparison between anti IL23 and anti IL17

Research paper thumbnail of Characteristics of Patients Experiencing a Flare of Generalized Pustular Psoriasis: A Multicenter Observational Study

Vaccines

Background: Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease char... more Background: Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease characterized by recurrent episodes of flares. Characteristics of patients experiencing a flare are hardly described in a real-life setting. The aim of the study is to investigate the clinical characteristics of patients experiencing a flare of GPP. Methods: Multicenter retrospective observational study on consecutive patients experiencing a flare of GPP between 2018 and 2022. Disease severity and quality of life were assessed by Generalized Pustular Psoriasis Area, Body Surface Area (BSA), and Severity Index (GPPASI), and Dermatology life quality index (DLQI) questionnaire, respectively. Visual analogue scale (VAS) of itch and pain, triggers, complications, comorbidities, pharmacological therapies, and outcome were collected. Results: A total of 66 patients, 45 (68.2%) females, mean age 58.1 ± 14.9 years, were included. The GPPASI, BSA, and DLQI were 22.9 ± 13.5 (mean ± standard deviation),...

Research paper thumbnail of Regression of human papillomavirus-associated high-grade vaginal intraepithelial neoplasia after switching from ustekinumab to risankizumab in a psoriasis patient

Italian Journal of Dermatology and Venereology

Research paper thumbnail of Drug survival and efficacy of anti-interleukin 23 biologics in psoriasis: a comparative study on different agents

Clinical and Experimental Dermatology, Nov 29, 2022

Research paper thumbnail of “Superresponders” at biologic treatment for psoriasis: A comparative study among IL17 and IL23 inhibitors

Research paper thumbnail of Efficacy and safety of dimethylfumarate in elderly psoriasis patients: a multicentric Italian study

Journal of Dermatological Treatment, 2021

The number of psoriatic elderly patients is steadily increasing in the Western world, nevertheles... more 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 (n = 24, 29,6%) and flushes (n = 10, 12,3%). Lymphocytopenia (n = 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.

Research paper thumbnail of Long-term maintenance treatment of psoriasis: the role of calcipotriol/betamethasone dipropionate aerosol foam in clinical practice

Journal of Dermatological Treatment, 2022

Most patients with psoriasis present with localized mild-to-moderate disease. In this case, the a... more Most patients with psoriasis present with localized mild-to-moderate disease. In this case, the application of topical treatments in the first-line setting is recommended in most cases.Among different topical options, the fixed-dose combination of betamethasone dipropionate (BD) and vitamin D analogue (Cal) aerosol foam (Enstilar®, Leo Pharma) is approved as first-line topical therapy for the treatment of psoriasis in USA and the EU, due to its high efficacy and its favorable administration scheme.The PSO-LONG was the first trial to report on the long-term efficacy and safety of the Cal/DB foam treatment for the proactive management of psoriasis and now, the indications of Cal/BD foam included its use in the psoriasis maintenance treatment. However, the precise role of this treatment and the potential therapeutic schemes in the long-term management of psoriasis need further clarification.This Position Paper, authored by a group of Italian Expert Dermatologists, critically discusses the long-term management of psoriasis with Cal/BD foam in clinical practice. In particular, the biological rationale in the proactive treatment with Cal/BD foam and current evidence regarding this therapeutic approach are presented, along with its application also in patients with moderate-to-severe disease, difficult-to-treat lesions, or within combination regimens. In addition, strategies to improve adherence to long-term treatment of psoriasis are discussed.

Research paper thumbnail of The impact of the COVID ‐19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience

British Journal of Dermatology, 2020

The "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) has spread over the ... more The "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) has spread over the four continents, causing the respiratory manifestations of Coronavirus disease-19 (COVID-19) and satisfying the epidemiological criteria for a pandemic [1]. As of April 1, 2020, more than one million COVID-19 positive cases have been identified and more than 54,000 deaths have occurred worldwide [2]. In Italy, 110,574 positive cases, 49,285 hospitalized patients and 13,155 deaths out of a population of 60,359,546 inhabitants, have been reported, respectively [3]. The highest number of deaths occurred in the northern Italian regions, i.e. Lombardy, Emilia-Romagna, Veneto and Piedmont [3].

Research paper thumbnail of Evidence for a ‘window of opportunity’ in hidradenitis suppurativa treated with adalimumab: a retrospective, real‐life multicentre cohort study*

British Journal of Dermatology, 2020

Background: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for ... more Background: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for moderate-to-severe hidradenitis suppurativa (HS). No predictors of response have been identified so far. Objective: To identify clinical parameters predicting response to adalimumab and confirm its efficacy/ safety. Methods: Data of 389 HS patients treated with adalimumab in 21 Italian centres were reviewed. Sex, ages at onset/diagnosis/baseline, body mass index, smoking, phenotypes, previous treatments, concomitant antibiotics , and "therapeutic delay", defined as the time from HS onset to adalimumab initiation, were assessed. Response to adalimumab and its impact on quality of life (QoL) were evaluated using "Hidradenitis Suppurativa Clinical Response" (HiSCR) and "Dermatology Life Quality Index" (DLQI)/"Visual Analogue Scale for pain" (VAS pain), respectively. Logistic regression analysis was performed. Results: The "therapeutic delay" correlated to lack of response to adalimumab at week 16 (OR,1.92 for therapeutic delay  10 years; 95% CI,1.28-2.89; P=0.0016). HiSCR was achieved in 43.7% and 53.9% patients at week 16 and 52, respectively. Significant reductions in both DLQI and VAS pain were found between week 16 versus baseline (p<0.0001 for both) and week 52 versus baseline (p<0.0001 for both). Previous immunosuppressants inversely correlated to HiSCR at week 52 [OR=1.74, 95% CI 1.04-2.91, p=0.0342]. Conclusion: Inverse correlation between therapeutic delay and clinical response was found, supporting early adalimumab use and providing evidence for a "window of opportunity" in HS. Adalimumab efficacy and safety were confirmed, along with patients' QoL improvement. Immunosuppressants could negatively influence response to adalimumab inducing a switch to non-TNFα-driven pathways.

Research paper thumbnail of Creation of a severity index for hidradenitis suppurativa that includes a validated quality‐of‐life measure: the HIDRAscore

Journal of the European Academy of Dermatology and Venereology, 2020

Background Hidradenitis suppurativa (HS) is a chronic, debilitating disease with a considerable e... more Background Hidradenitis suppurativa (HS) is a chronic, debilitating disease with a considerable effect on patient quality of life. Its clinical severity can be measured using different scoring systems; however, few of them include patient-centred parameters. Objective To create a new scoring system for HS that includes a quality-of-life instrument, the HIDRAdisk. Methods This post hoc analysis was carried out within the framework of a multicentre, longitudinal, epidemiologic study conducted over 9 months on quality-of-life aspects of HS. The new severity score was created using as reference a question from the Subject Satisfaction Questionnaire (SSQ) concerning the severity of HS as evaluated by the patient. Associated variables were selected using univariable and multivariable logistic regression models. The discriminant capabilities of the final model and of the final score were evaluated by the area under the receiver operating characteristic curve and the Hosmer-Lemeshow test. Results The study population included 308 patients with HS of any severity grade. According to the results of the regression models, the variables associated with the reference SSQ measure were number of inflammatory nodules, abscesses and draining fistulas; the HIDRAdisk score; and the number of subumbilical lesions. The HIDRAscore is obtained by the sum of the scores associated with the number of these parameters. Possible scores range from 0 to 10. Conclusion The HIDRAscore is a new scoring system for HS severity which, in addition to the clinical evaluation by the physician, includes a validated patient-reported outcome measure, the HIDRAdisk.

Research paper thumbnail of Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study

Annals of the Rheumatic Diseases, 2012

ObjectiveTo assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleu... more ObjectiveTo assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleukin-17A antibody, in patients with rheumatoid arthritis (RA).MethodsPatients (n=237) with inadequate response to methotrexate were randomly assigned to receive monthly subcutaneous injections of secukinumab 25 mg, 75 mg, 150 mg, 300 mg or placebo. The primary endpoint was the American College of Rheumatology 20% response (ACR20) at week 16.ResultsDemographics and baseline characteristics were comparable across all treatment groups. The primary efficacy endpoint was not achieved: the proportion of ACR20 responders at week 16 with secukinumab 25–300 mg was 36.0–53.7% versus placebo (34%). Disease activity score in 28 joints (DAS28)–C-reactive protein (CRP) was a secondary endpoint and clinically relevant decreases with secukinumab 75–300 mg were reported versus placebo. Serum high sensitivity CRP levels at week 16 were significantly reduced with secukinumab 75 mg, 150 mg and 300 mg doses v...

Research paper thumbnail of Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis

Journal of the European Academy of Dermatology and Venereology, 2017

Psoriasis is a common disease, which has a considerable impact on the healthcare system. Therefor... more Psoriasis is a common disease, which has a considerable impact on the healthcare system. Therefore, appropriate use of therapeutic resources is very important. Management of psoriasis in daily clinical practice is highly variable because many issues are still debated and not definitely addressed by the evidence-based medicine. Moreover, the different availability and reimbursability of drugs in each country justifies national guidelines. Expert consensus can provide helpful guidelines for optimizing patient care. A total of 20 dermatologists from different areas of Italy and with large experience in the treatment of psoriasis agreed to participate in the guidelines expert panel who aimed to reach consensus on the factors influencing psoriasis severity, the indications for systemic treatments, the parameters to be considered in the choice of treatment, and the factors to be considered in the choice of biological treatment. The recommendations for the use, screening and monitoring of systemic therapies were based on the 2015 S3 European Dermatology Forum/European Academy of Dermatology and Venereology psoriasis guidelines. Recommendations on the treatment of psoriasis in special patient populations were also agreed. The final document was discussed in a meeting moderated by a facilitator with participation of the entire group and adopting a nominal group technique to reach consensus. A statement was regarded as consented when agreement was achieved by at least 75% of the voting experts according to the Delphi procedure.

Research paper thumbnail of Risk of Reactivation of Latent Tuberculosis in Psoriasis Patients on Biologic Therapies: A Retrospective Cohort from a Tertiary Care Centre in Northern Italy

Acta dermato-venereologica, Sep 5, 2022

ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica L. Mastorino et ... more ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy" 2/8 Acta Derm Venereol 2022 ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica 3/8 L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy" Acta Derm Venereol 2022 Advances in dermatology and venereology Acta Dermato-Venereologica L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy" 6/8 Acta Derm Venereol 2022 ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica 7/8 L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy"

Research paper thumbnail of Secukinumab in Patients with Psoriasis and a Personal History of Malignancy: A Multicenter Real-Life Observational Study

Dermatology and Therapy

Introduction: There is limited evidence to guide clinicians on the treatment of psoriasis with bi... more Introduction: There is limited evidence to guide clinicians on the treatment of psoriasis with biologics in patients with a history of malignancy who are often excluded from clinical trials investigating biologics. The aim of this work is to report a multicenter real-life experience of secukinumab treatment in patients with psoriasis and a personal history of cancer. Methods: This retrospective observational study included adult patients with moderate-tosevere plaque psoriasis treated with secukinumab for at least 24 weeks and a previous diagnosis of cancer at 15 Italian referral centers. The primary endpoint of the study was tumor

Research paper thumbnail of Tildrakizumab in real‐life shows good efficacy in moderate‐to‐severe psoriasis regardless of previous use of biologic drugs and joint involvement

Research paper thumbnail of Efficacy and Safety of Risankizumab in Hidradenitis Suppurativa: A Case Series

Acta Dermato-Venereologica

Research paper thumbnail of Interleukin-17 vs. Interleukin-23 Inhibitors in Pustular and Erythrodermic Psoriasis: A Retrospective, Multicentre Cohort Study

Journal of Clinical Medicine

Pustular and erythrodermic psoriasis are rare and difficult-to-treat conditions. It has recently ... more Pustular and erythrodermic psoriasis are rare and difficult-to-treat conditions. It has recently been shown that interleukin (IL)-17 inhibitors can be very effective among patients with these forms of psoriasis; however, the potential of IL-23 inhibitors is largely unknown. The aim of this multicentre, retrospective study was to compare the safety, effectiveness, and drug survival of IL-17 and IL-23 inhibitors among patients affected by these rare forms of psoriasis. The study involved 27 patients with erythrodermic psoriasis and 59 with pustular psoriasis (36 with generalised pustular psoriasis and 23 with palmoplantar pustular psoriasis) treated with an IL-17 or IL-23 inhibitor. The effectiveness of the two drug classes was assessed using the disease-specific Psoriasis Area Severity Index (PASI) and the Investigator Global Assessment, which were evaluated at different time points. There was a consistent trend towards a higher rate of PASI 100 responses in the patients treated with...

Research paper thumbnail of Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

Advances in Therapy

Introduction: While several European studies have reported real-world apremilast use, patient-per... more Introduction: While several European studies have reported real-world apremilast use, patient-perceived benefits, and treatment satisfaction , local reimbursement criteria for apremilast vary and data from Italy are limited. Methods: The cross-sectional DARWIN study enrolled consecutive patients who had initiated apremilast for plaque psoriasis 6 (± 1) months prior to enrolment at a single visit across 24 Italian dermatological sites. Disease severity was assessed using body surface area (BSA) and Physician Global Assessment (PGA). Patient-reported outcomes assessed 6 (± 1) months after apremilast initiation were Dermatology Life A1 The members of the DARWIN study group are listed in Acknowledgments.

Research paper thumbnail of Drug Survival of Anti Interleukin-17 and Interleukin -23 Agents after Adalimumab Failure in Hidradenitis Suppurativa: A Pilot Study

Acta dermato-venereologica, Apr 19, 2023

Research paper thumbnail of Concomitant cutaneous graft-versus-host disease and solid organ rejection: an unreported presentation

Italian Journal of Dermatology and Venereology

Research paper thumbnail of ISID0593 - Inverse psoriasis involvement in moderate to severe psoriatic patients: A comparison between anti IL23 and anti IL17

Research paper thumbnail of Characteristics of Patients Experiencing a Flare of Generalized Pustular Psoriasis: A Multicenter Observational Study

Vaccines

Background: Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease char... more Background: Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease characterized by recurrent episodes of flares. Characteristics of patients experiencing a flare are hardly described in a real-life setting. The aim of the study is to investigate the clinical characteristics of patients experiencing a flare of GPP. Methods: Multicenter retrospective observational study on consecutive patients experiencing a flare of GPP between 2018 and 2022. Disease severity and quality of life were assessed by Generalized Pustular Psoriasis Area, Body Surface Area (BSA), and Severity Index (GPPASI), and Dermatology life quality index (DLQI) questionnaire, respectively. Visual analogue scale (VAS) of itch and pain, triggers, complications, comorbidities, pharmacological therapies, and outcome were collected. Results: A total of 66 patients, 45 (68.2%) females, mean age 58.1 ± 14.9 years, were included. The GPPASI, BSA, and DLQI were 22.9 ± 13.5 (mean ± standard deviation),...

Research paper thumbnail of Regression of human papillomavirus-associated high-grade vaginal intraepithelial neoplasia after switching from ustekinumab to risankizumab in a psoriasis patient

Italian Journal of Dermatology and Venereology

Research paper thumbnail of Drug survival and efficacy of anti-interleukin 23 biologics in psoriasis: a comparative study on different agents

Clinical and Experimental Dermatology, Nov 29, 2022

Research paper thumbnail of “Superresponders” at biologic treatment for psoriasis: A comparative study among IL17 and IL23 inhibitors

Research paper thumbnail of Efficacy and safety of dimethylfumarate in elderly psoriasis patients: a multicentric Italian study

Journal of Dermatological Treatment, 2021

The number of psoriatic elderly patients is steadily increasing in the Western world, nevertheles... more 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 (n = 24, 29,6%) and flushes (n = 10, 12,3%). Lymphocytopenia (n = 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.

Research paper thumbnail of Long-term maintenance treatment of psoriasis: the role of calcipotriol/betamethasone dipropionate aerosol foam in clinical practice

Journal of Dermatological Treatment, 2022

Most patients with psoriasis present with localized mild-to-moderate disease. In this case, the a... more Most patients with psoriasis present with localized mild-to-moderate disease. In this case, the application of topical treatments in the first-line setting is recommended in most cases.Among different topical options, the fixed-dose combination of betamethasone dipropionate (BD) and vitamin D analogue (Cal) aerosol foam (Enstilar®, Leo Pharma) is approved as first-line topical therapy for the treatment of psoriasis in USA and the EU, due to its high efficacy and its favorable administration scheme.The PSO-LONG was the first trial to report on the long-term efficacy and safety of the Cal/DB foam treatment for the proactive management of psoriasis and now, the indications of Cal/BD foam included its use in the psoriasis maintenance treatment. However, the precise role of this treatment and the potential therapeutic schemes in the long-term management of psoriasis need further clarification.This Position Paper, authored by a group of Italian Expert Dermatologists, critically discusses the long-term management of psoriasis with Cal/BD foam in clinical practice. In particular, the biological rationale in the proactive treatment with Cal/BD foam and current evidence regarding this therapeutic approach are presented, along with its application also in patients with moderate-to-severe disease, difficult-to-treat lesions, or within combination regimens. In addition, strategies to improve adherence to long-term treatment of psoriasis are discussed.

Research paper thumbnail of The impact of the COVID ‐19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience

British Journal of Dermatology, 2020

The "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) has spread over the ... more The "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) has spread over the four continents, causing the respiratory manifestations of Coronavirus disease-19 (COVID-19) and satisfying the epidemiological criteria for a pandemic [1]. As of April 1, 2020, more than one million COVID-19 positive cases have been identified and more than 54,000 deaths have occurred worldwide [2]. In Italy, 110,574 positive cases, 49,285 hospitalized patients and 13,155 deaths out of a population of 60,359,546 inhabitants, have been reported, respectively [3]. The highest number of deaths occurred in the northern Italian regions, i.e. Lombardy, Emilia-Romagna, Veneto and Piedmont [3].

Research paper thumbnail of Evidence for a ‘window of opportunity’ in hidradenitis suppurativa treated with adalimumab: a retrospective, real‐life multicentre cohort study*

British Journal of Dermatology, 2020

Background: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for ... more Background: The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for moderate-to-severe hidradenitis suppurativa (HS). No predictors of response have been identified so far. Objective: To identify clinical parameters predicting response to adalimumab and confirm its efficacy/ safety. Methods: Data of 389 HS patients treated with adalimumab in 21 Italian centres were reviewed. Sex, ages at onset/diagnosis/baseline, body mass index, smoking, phenotypes, previous treatments, concomitant antibiotics , and "therapeutic delay", defined as the time from HS onset to adalimumab initiation, were assessed. Response to adalimumab and its impact on quality of life (QoL) were evaluated using "Hidradenitis Suppurativa Clinical Response" (HiSCR) and "Dermatology Life Quality Index" (DLQI)/"Visual Analogue Scale for pain" (VAS pain), respectively. Logistic regression analysis was performed. Results: The "therapeutic delay" correlated to lack of response to adalimumab at week 16 (OR,1.92 for therapeutic delay  10 years; 95% CI,1.28-2.89; P=0.0016). HiSCR was achieved in 43.7% and 53.9% patients at week 16 and 52, respectively. Significant reductions in both DLQI and VAS pain were found between week 16 versus baseline (p<0.0001 for both) and week 52 versus baseline (p<0.0001 for both). Previous immunosuppressants inversely correlated to HiSCR at week 52 [OR=1.74, 95% CI 1.04-2.91, p=0.0342]. Conclusion: Inverse correlation between therapeutic delay and clinical response was found, supporting early adalimumab use and providing evidence for a "window of opportunity" in HS. Adalimumab efficacy and safety were confirmed, along with patients' QoL improvement. Immunosuppressants could negatively influence response to adalimumab inducing a switch to non-TNFα-driven pathways.

Research paper thumbnail of Creation of a severity index for hidradenitis suppurativa that includes a validated quality‐of‐life measure: the HIDRAscore

Journal of the European Academy of Dermatology and Venereology, 2020

Background Hidradenitis suppurativa (HS) is a chronic, debilitating disease with a considerable e... more Background Hidradenitis suppurativa (HS) is a chronic, debilitating disease with a considerable effect on patient quality of life. Its clinical severity can be measured using different scoring systems; however, few of them include patient-centred parameters. Objective To create a new scoring system for HS that includes a quality-of-life instrument, the HIDRAdisk. Methods This post hoc analysis was carried out within the framework of a multicentre, longitudinal, epidemiologic study conducted over 9 months on quality-of-life aspects of HS. The new severity score was created using as reference a question from the Subject Satisfaction Questionnaire (SSQ) concerning the severity of HS as evaluated by the patient. Associated variables were selected using univariable and multivariable logistic regression models. The discriminant capabilities of the final model and of the final score were evaluated by the area under the receiver operating characteristic curve and the Hosmer-Lemeshow test. Results The study population included 308 patients with HS of any severity grade. According to the results of the regression models, the variables associated with the reference SSQ measure were number of inflammatory nodules, abscesses and draining fistulas; the HIDRAdisk score; and the number of subumbilical lesions. The HIDRAscore is obtained by the sum of the scores associated with the number of these parameters. Possible scores range from 0 to 10. Conclusion The HIDRAscore is a new scoring system for HS severity which, in addition to the clinical evaluation by the physician, includes a validated patient-reported outcome measure, the HIDRAdisk.

Research paper thumbnail of Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study

Annals of the Rheumatic Diseases, 2012

ObjectiveTo assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleu... more ObjectiveTo assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleukin-17A antibody, in patients with rheumatoid arthritis (RA).MethodsPatients (n=237) with inadequate response to methotrexate were randomly assigned to receive monthly subcutaneous injections of secukinumab 25 mg, 75 mg, 150 mg, 300 mg or placebo. The primary endpoint was the American College of Rheumatology 20% response (ACR20) at week 16.ResultsDemographics and baseline characteristics were comparable across all treatment groups. The primary efficacy endpoint was not achieved: the proportion of ACR20 responders at week 16 with secukinumab 25–300 mg was 36.0–53.7% versus placebo (34%). Disease activity score in 28 joints (DAS28)–C-reactive protein (CRP) was a secondary endpoint and clinically relevant decreases with secukinumab 75–300 mg were reported versus placebo. Serum high sensitivity CRP levels at week 16 were significantly reduced with secukinumab 75 mg, 150 mg and 300 mg doses v...

Research paper thumbnail of Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis

Journal of the European Academy of Dermatology and Venereology, 2017

Psoriasis is a common disease, which has a considerable impact on the healthcare system. Therefor... more Psoriasis is a common disease, which has a considerable impact on the healthcare system. Therefore, appropriate use of therapeutic resources is very important. Management of psoriasis in daily clinical practice is highly variable because many issues are still debated and not definitely addressed by the evidence-based medicine. Moreover, the different availability and reimbursability of drugs in each country justifies national guidelines. Expert consensus can provide helpful guidelines for optimizing patient care. A total of 20 dermatologists from different areas of Italy and with large experience in the treatment of psoriasis agreed to participate in the guidelines expert panel who aimed to reach consensus on the factors influencing psoriasis severity, the indications for systemic treatments, the parameters to be considered in the choice of treatment, and the factors to be considered in the choice of biological treatment. The recommendations for the use, screening and monitoring of systemic therapies were based on the 2015 S3 European Dermatology Forum/European Academy of Dermatology and Venereology psoriasis guidelines. Recommendations on the treatment of psoriasis in special patient populations were also agreed. The final document was discussed in a meeting moderated by a facilitator with participation of the entire group and adopting a nominal group technique to reach consensus. A statement was regarded as consented when agreement was achieved by at least 75% of the voting experts according to the Delphi procedure.

Research paper thumbnail of Risk of Reactivation of Latent Tuberculosis in Psoriasis Patients on Biologic Therapies: A Retrospective Cohort from a Tertiary Care Centre in Northern Italy

Acta dermato-venereologica, Sep 5, 2022

ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica L. Mastorino et ... more ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy" 2/8 Acta Derm Venereol 2022 ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica 3/8 L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy" Acta Derm Venereol 2022 Advances in dermatology and venereology Acta Dermato-Venereologica L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy" 6/8 Acta Derm Venereol 2022 ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica 7/8 L. Mastorino et al. "Psoriasis and risk of TB reactivation in biologic drug therapy"

Research paper thumbnail of Secukinumab in Patients with Psoriasis and a Personal History of Malignancy: A Multicenter Real-Life Observational Study

Dermatology and Therapy

Introduction: There is limited evidence to guide clinicians on the treatment of psoriasis with bi... more Introduction: There is limited evidence to guide clinicians on the treatment of psoriasis with biologics in patients with a history of malignancy who are often excluded from clinical trials investigating biologics. The aim of this work is to report a multicenter real-life experience of secukinumab treatment in patients with psoriasis and a personal history of cancer. Methods: This retrospective observational study included adult patients with moderate-tosevere plaque psoriasis treated with secukinumab for at least 24 weeks and a previous diagnosis of cancer at 15 Italian referral centers. The primary endpoint of the study was tumor

Research paper thumbnail of Tildrakizumab in real‐life shows good efficacy in moderate‐to‐severe psoriasis regardless of previous use of biologic drugs and joint involvement

Research paper thumbnail of Efficacy and Safety of Risankizumab in Hidradenitis Suppurativa: A Case Series

Acta Dermato-Venereologica