Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials

Background: Psoriasis is a chronic, immune-mediated skin disease that may occur at any age. Prevalence in children ranges between 0.5 and 1.0% across Europe. Approximately 10–20% of paediatric psoriasis patients are moderate-to-severe in severity and may require the use of systemic therapy.Objective...

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Main Authors: Vito Di Lernia, Laura Macca, Lucia Peterle, Ylenia Ingrasciotta, Gianluca Trifirò, Claudio Guarneri
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-04-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2022.847308/full
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author Vito Di Lernia
Laura Macca
Lucia Peterle
Ylenia Ingrasciotta
Gianluca Trifirò
Claudio Guarneri
author_facet Vito Di Lernia
Laura Macca
Lucia Peterle
Ylenia Ingrasciotta
Gianluca Trifirò
Claudio Guarneri
author_sort Vito Di Lernia
collection DOAJ
description Background: Psoriasis is a chronic, immune-mediated skin disease that may occur at any age. Prevalence in children ranges between 0.5 and 1.0% across Europe. Approximately 10–20% of paediatric psoriasis patients are moderate-to-severe in severity and may require the use of systemic therapy.Objective: Recently, newer targeted, systemic therapies have been licensed for treatment of moderate-to-severe paediatric psoriasis. The objective of this study was to evaluate the short-term efficacy of available antipsoriatic systemic drugs in children with a narrative synthesis of key efficacy from randomized clinical trials.Methods: A systematic review of literature was performed on Medline and embase databases and the Cochrane Central Register of Controlled Trials. Randomized clinical trials investigating the efficacy of treatments licensed by the US Food and Drug Administration and/or the European Medicines Agency for paediatric and adolescent psoriatic population were retrieved and analyzed. Data from this literature review was assessed in line with GRADE (grading of recommendations, assessment, development and evaluations). The short-term (12-16 weeks) clinical efficacy from baseline was evaluated according to the Psoriasis Area and Severity Index (PASI) 75 and 90 compared to baseline. Illustrative comparative risks, relative risk (RR) and the number needed to treat (NNT) for response on PASI 75 and PASI 90 were extracted.Results: A total of five relevant studies were identified on two TNF-alpha blockers (etanercept and adalimumab), the IL12/23 inhibitor ustekinumab and two IL-17 inhibitors (ixekizumab, secukinumab). Comparators were placebo (3 studies), placebo and etanercept (1 study) methotrexate (1 study). All examined drugs resulted efficacious. The probability to achieve PASI 75 and PASI 90 was higher for the IL-12/23 and IL-17 inhibitors. Overall, the anti-IL17s and the anti-IL12/23 antibodies showed a more favourable NNT for PASI 75, whereas IL-17 inhibitors for PASI 90.Conclusion: The approved biological therapies may be beneficial for the treatment of moderate to severe plaque psoriasis in children and adolescents. Since psoriasis is a chronic and often challenging condition with no definitive solution, systematic evaluations of long-term efficacy, drug survival and adverse effects may help careful, individualized, patient-centered clinical decision making.
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spelling doaj.art-1e90a780d1714986a5e3ff54f738bd0a2022-12-21T23:36:19ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-04-011310.3389/fphar.2022.847308847308Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical TrialsVito Di Lernia0Laura Macca1Lucia Peterle2Ylenia Ingrasciotta3Gianluca Trifirò4Claudio Guarneri5Dermatology Unit, Arcispedale S. Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, ItalyDepartment of Clinical and Experimental Medicine, Section of Dermatology, University of Messina, Messina, ItalyDepartment of Clinical and Experimental Medicine, Section of Dermatology, University of Messina, Messina, ItalyDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, Section of Pharmacology, University of Messina, Messina, ItalyDepartment of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Verona, ItalyDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, Section of Dermatology, University of Messina, Messina, ItalyBackground: Psoriasis is a chronic, immune-mediated skin disease that may occur at any age. Prevalence in children ranges between 0.5 and 1.0% across Europe. Approximately 10–20% of paediatric psoriasis patients are moderate-to-severe in severity and may require the use of systemic therapy.Objective: Recently, newer targeted, systemic therapies have been licensed for treatment of moderate-to-severe paediatric psoriasis. The objective of this study was to evaluate the short-term efficacy of available antipsoriatic systemic drugs in children with a narrative synthesis of key efficacy from randomized clinical trials.Methods: A systematic review of literature was performed on Medline and embase databases and the Cochrane Central Register of Controlled Trials. Randomized clinical trials investigating the efficacy of treatments licensed by the US Food and Drug Administration and/or the European Medicines Agency for paediatric and adolescent psoriatic population were retrieved and analyzed. Data from this literature review was assessed in line with GRADE (grading of recommendations, assessment, development and evaluations). The short-term (12-16 weeks) clinical efficacy from baseline was evaluated according to the Psoriasis Area and Severity Index (PASI) 75 and 90 compared to baseline. Illustrative comparative risks, relative risk (RR) and the number needed to treat (NNT) for response on PASI 75 and PASI 90 were extracted.Results: A total of five relevant studies were identified on two TNF-alpha blockers (etanercept and adalimumab), the IL12/23 inhibitor ustekinumab and two IL-17 inhibitors (ixekizumab, secukinumab). Comparators were placebo (3 studies), placebo and etanercept (1 study) methotrexate (1 study). All examined drugs resulted efficacious. The probability to achieve PASI 75 and PASI 90 was higher for the IL-12/23 and IL-17 inhibitors. Overall, the anti-IL17s and the anti-IL12/23 antibodies showed a more favourable NNT for PASI 75, whereas IL-17 inhibitors for PASI 90.Conclusion: The approved biological therapies may be beneficial for the treatment of moderate to severe plaque psoriasis in children and adolescents. Since psoriasis is a chronic and often challenging condition with no definitive solution, systematic evaluations of long-term efficacy, drug survival and adverse effects may help careful, individualized, patient-centered clinical decision making.https://www.frontiersin.org/articles/10.3389/fphar.2022.847308/fullpsoriasispaediatricchildhoodtreatmenttherapy
spellingShingle Vito Di Lernia
Laura Macca
Lucia Peterle
Ylenia Ingrasciotta
Gianluca Trifirò
Claudio Guarneri
Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials
Frontiers in Pharmacology
psoriasis
paediatric
childhood
treatment
therapy
title Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials
title_full Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials
title_fullStr Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials
title_full_unstemmed Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials
title_short Efficacy of Systemic Biologic Drugs in Pediatric Psoriasis: Evidence From Five Selected Randomized Clinical Trials
title_sort efficacy of systemic biologic drugs in pediatric psoriasis evidence from five selected randomized clinical trials
topic psoriasis
paediatric
childhood
treatment
therapy
url https://www.frontiersin.org/articles/10.3389/fphar.2022.847308/full
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