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3. Safety of Systemic Agents for the Treatment of Pediatric Psoriasis

Author

Bronckers, Inge M. G. J., Seyger, Marieke M. B., West, Dennis P., Lara-Corrales, Irene, Tollefson, Megha, Tom, Wynnis L., Hogeling, Marcia, Belazarian, Leah, Zachariae, Claus, Mahé, Emmanuel, Siegfried, Elaine, Philipp, Sandra, Szalai, Zsuzsanna, Vleugels, Ruth Ann, Holland, Kristen, Murphy, Ruth, Baselga, Eulalia, Cordoro, Kelly, Lambert, Jo, Alexopoulos, Alex, Mrowietz, Ulrich, Kievit, Wietske, and Paller, Amy S.

Published
2017
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4. A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents

Author

Bronckers, Inge M. G. J. Paller, Amy S. West, Dennis P. and Lara-Corrales, Irene Tollefson, Megha M. Tom, Wynnis L. and Hogeling, Marcia Belazarian, Leah Zachariae, Claus Mahe, Emmanuel Siegfried, Elaine Blume-Peytavi, Ulrike Szalai, Zsuzsanna Vleugels, Ruth Ann Holland, Kristen Murphy, Ruth and Puig, Lluis Cordoro, Kelly M. Lambert, Jo Alexopoulos, Alex Mrowietz, Ulrich Kievit, Wietske Seyger, Marieke M. B. and Psoriasis Investigator Grp Pediat Dermatology Res Alliance and European Working Grp Pediat

Abstract

This cohort study compares the use of methotrexate vs biologic agents in children with moderate to severe psoriasis. Question What is the association between use of methotrexate vs biologics and psoriasis severity and drug survival (rate and duration of adherence to a specific drug regimen) in pediatric patients with moderate to severe psoriasis? Findings In this cohort study including 234 pediatric patients with moderate to severe psoriasis, those receiving biologics were more likely than those treated with methotrexate to achieve a Physician Global Assessment status of clear/almost clear and 75% or more improvement of the Psoriasis Area and Severity Index rating at 6 months. In addition, biologics were associated with better drug survival rates at 1, 3, and 5 years, with comparable discontinuation rates owing to lack of response. Meaning In pediatric patients with psoriasis, treatment with biologics may be associated with a significantly greater reduction in psoriasis severity than methotrexate; nevertheless, with 35.6% of the patients achieving clear/almost clear and 40.0% reaching 75% or more improvement on the Psoriasis Area and Severity Index, methotrexate remains an effective treatment for pediatric psoriasis. Importance Few studies have compared the use of methotrexate and biologics, the most commonly used systemic medications for treatment of moderate to severe psoriasis in children. Objective To assess the real-world, 6-month reduction in psoriasis severity and long-term drug survival (rate and duration of adherence to a specific drug) of methotrexate vs biologics in plaque psoriasis in children. Design, Setting, and Participants A retrospective medical records review was conducted at 20 European and North American centers. Treatment response was based on site-reported Psoriasis Area and Severity Index (PASI) and/or Physician Global Assessment (PGA) scores at baseline and within the first 6 months of treatment. Participants included all 234 consecutively seen children with moderate to severe psoriasis who received at least 3 months of methotrexate or biologics from December 1, 1990, to September 16, 2014, with sufficient data for analysis. Data analysis was performed from December 14, 2015, to September 1, 2016. Main Outcomes and Measures PASI, with a range from 0 to 72 (highest score indicating severe psoriasis), and/or PGA, with a scale of 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), and 5 (very severe). Results Of 234 pediatric patients (103 boys [44.0%]; 131 girls [56.0%]) treated with methotrexate and/or biologics, 163 patients (69.7%) exclusively received methotrexate, 47 patients (20.1%) exclusively received biologics, and 24 children (10.2%) received methotrexate and biologics sequentially. Of the latter cohort, 23 children were treated initially with methotrexate. Mean (SD) age at initiation was 11.6 (3.7) years for methotrexate and 13.3 (2.9) years for biologics (73.2% for etanercept) (P = .002). Among patients evaluated by a scoring method at 6-month follow-up, 75% or greater improvement in PASI (PASI75) was achieved in 12 of 30 patients (40.0%) receiving methotrexate and 20 of 28 patients (71.4%) receiving biologics, and PGA was clear/almost clear (PGA 0/1) in 41 of 115 patients (35.6%) receiving methotrexate and 18 of 37 patients (48.6%) receiving biologics. Achieving PASI75 and/or PGA 0/1 between baseline and 6 months was more likely with biologics than methotrexate (PASI75: odds ratio [OR], 4.56; 95% CI, 2.02-10.27; P < .001; and PGA 0/1: OR, 2.00; 95% CI, 0.98-4.00; P = .06). Decreased mean PASI and PGA scores were associated with biologics more than with methotrexate (PASI effect, -3.13; 95% CI, -4.33 to -1.94; P < .001; and PGA effect, -0.31; 95% CI, -0.56 to -0.06; P = .02). After 1, 3, and 5 years of use, overall drug survival rates for methotrexate were 77.5%, 50.3%, and 35.9%, and for biologics, the rates were 83.4%, 64.3%, and 57.1%, respectively. Biologics were associated with a better confounder-corrected drug survival than methotrexate (hazard ratio [HR], 2.23; 95% CI, 1.21-4.10; P = .01). Discontinuation owing to lack of response was comparable (HR, 1.64; 95% CI, 0.80-3.36; P = .18). Conclusions and Relevance Methotrexate and biologics appear to be associated with improvement in pediatric psoriasis, although biologics seem to be associated with greater reduction in psoriasis severity scores and higher drug survival rates than methotrexate in the real-world setting. Additional studies directly comparing these medications should be performed for confirmation.

Published
2020

6. Real-world Methotrexate Use in a Prospective Cohort of Paediatric Patients with Plaque Psoriasis: Effectiveness, Adverse Events and Folic Acid Regimen.

Author

BRUINS, Finola M., VAN ACHT, Maartje R., BRONCKERS, Inge M. G. J., GROENEWOUD, Hans M. M., DE JONG, Elke M. G. J., and SEYGER, Marieke M. B.

Subjects
CHILD patients, FOLIC acid, PSORIASIS, METHOTREXATE
Abstract

In paediatric psoriasis, few studies have evaluated methotrexate effectiveness, adverse events and folic acid regimen. Therefore this study prospectively assessed methotrexate adverse events and effectiveness in paediatric patients with psoriasis in a real-world setting. Furthermore, gastrointestinal adverse events and methotrexate effectiveness were compared between folic acid regimens (5 mg once weekly vs 1 mg 6 times weekly). Data for paediatric patients with psoriasis treated with methotrexate from September 2008 to October 2020 were extracted from Child-CAPTURE, a prospective, daily clinical practice registry. Effectiveness was determined by Psoriasis Area and Severity Index (PASI). Comparison of persistent gastrointestinal adverse events between folic acid regimens were assessed through Kaplan-Meier analysis. A total of 105 paediatric patients with plaque psoriasis (41.0% male, mean age 14.1 years) were included. At week 24 and 48, an absolute PASI ≤ 2.0 was achieved by approximately one-third of all patients. During follow-up, 46.7% reported ≥ 1 persistent adverse events. After 1 and 2 years, approximately one-quarter of patients achieved a PASI ≤ 2.0 without persistent adverse events. Although non-significant, a possible trend towards lower occurrence of gastrointestinal adverse events was found for folic acid 1 mg 6 times weekly (p = 0.196), with similar effectiveness between folic acid regimens. These findings show that a subgroup of paediatric patients with psoriasis responded well to methotrexate treatment without considerable side-effects during a 2-year follow-up. [ABSTRACT FROM AUTHOR]

Published
2022
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7. A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents.

Author

Bronckers, Inge M. G. J., Paller, Amy S., West, Dennis P., Lara-Corrales, Irene, Tollefson, Megha M., Tom, Wynnis L., Hogeling, Marcia, Belazarian, Leah, Zachariae, Claus, Mahé, Emmanuel, Siegfried, Elaine, Blume-Peytavi, Ulrike, Szalai, Zsuzsanna, Vleugels, Ruth Ann, Holland, Kristen, Murphy, Ruth, Puig, Lluís, Cordoro, Kelly M., Lambert, Jo, and Alexopoulos, Alex

Published
2020
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9. Safety of Systemic Agents for the Treatment of Pediatric Psoriasis

Author

Bronckers, Inge M G J, Seyger, Marieke M B, West, Dennis P, Lara-Corrales, Irene, Tollefson, Megha, Tom, Wynnis L, Hogeling, Marcia, Belazarian, Leah, Zachariae, Claus, Mahé, Emmanuel, Siegfried, Elaine, Philipp, Sandra, Szalai, Zsuzsanna, Vleugels, Ruth Ann, Holland, Kristen, Murphy, Ruth, Baselga, Eulalia, Cordoro, Kelly, Lambert, Jo, Alexopoulos, Alex, Mrowietz, Ulrich, Kievit, Wietske, Paller, Amy S, Bronckers, Inge M G J, Seyger, Marieke M B, West, Dennis P, Lara-Corrales, Irene, Tollefson, Megha, Tom, Wynnis L, Hogeling, Marcia, Belazarian, Leah, Zachariae, Claus, Mahé, Emmanuel, Siegfried, Elaine, Philipp, Sandra, Szalai, Zsuzsanna, Vleugels, Ruth Ann, Holland, Kristen, Murphy, Ruth, Baselga, Eulalia, Cordoro, Kelly, Lambert, Jo, Alexopoulos, Alex, Mrowietz, Ulrich, Kievit, Wietske, and Paller, Amy S

Abstract

Importance: Use of systemic therapies for moderate to severe psoriasis in children is increasing, but comparative data on their use and toxicities are limited.Objective: To assess patterns of use and relative risks of systemic agents for moderate to severe psoriasis in children.Design, Setting, and Participants: A retrospective review was conducted at 20 centers in North America and Europe, and included all consecutive children with moderate to severe psoriasis who used systemic medications or phototherapy for at least 3 months from December 1, 1990, to September 16, 2014.Main Outcomes and Measures: The minimal core data set included age, sex, severity of psoriasis, systemic interventions, monitoring, adverse events (AEs), and reason for discontinuation.Results: For 390 children (203 girls and 187 boys; mean [SD] age at diagnosis, 8.4 [3.7] years) with psoriasis who used 1 or more systemic medications, the mean interval between diagnosis and starting systemic therapy was 3.0 years. Methotrexate was used by 270 patients (69.2%), biologic agents (primarily etanercept) by 106 (27.2%), acitretin by 57 (14.6%), cyclosporine by 30 (7.7%), fumaric acid esters by 19 (4.9%), and more than 1 medication was used by 73 (18.7%). Of 270 children taking methotrexate, 130 (48.1%) reported 1 or more AEs associated with methotrexate, primarily gastrointestinal (67 [24.8%]). Folic acid 6 days per week (odds ratio, 0.16; 95% CI, 0.06-0.41; P < .001) or 7 days per week (OR, 0.21; 95% CI, 0.08-0.58; P = .003) protected against gastrointestinal AEs more than once-weekly folic acid, regardless of the total weekly dosage. Methotrexate-associated hepatic transaminase elevations were associated with obesity (35 of 270 patients [13.0%]), but a folic acid regimen was not. Injection site reactions occurred in 20 of 106 patients (18.9%) treated with tumor necrosis factor inhibitors, but did not lead to discontinuation of treatment. Having 1 or more AEs related to

Published
2017

11. A cross-sectional study in young adults with psoriasis: potential determining factors in quality of life, life course and work productivity.

Author

Bronckers, Inge M. G. J., van Geel, Maartje J., van de Kerkhof, Peter C. M., de Jong, Elke M. G. J., and Seyger, Marieke M. B.

Subjects
*YOUNG adults, *QUALITY of life, *PSORIASIS, *DISEASE duration, *PRODUCTIVE life span, *CROSS-sectional method
Abstract

Background: Psoriasis can have a substantial impact on health-related quality of life (HRQoL), life course, and work productivity. Young adulthood is a critical, sensitive period of development that includes major life changing decisions. The impact of psoriasis on this vulnerable population is yet unknown. Objectives: To assess QoL, life course, and work productivity in young adults with psoriasis and identify characteristics influencing these patient-reported outcomes (PRO). Methods: An explorative, cross-sectional study was performed in psoriasis patients aged 18–30 years. Individuals completed a set of questionnaires regarding their health status (DLQI, SF-36, EQ-5D), achievement of developmental milestones (COLQ), and work productivity (WPAI-PSO, PRODISQ). Results: Seventy-five patients (22 males, 53 females; median age [IQR], 21.0 [8.0]). Median PASI and BSA, respectively, were 4.4 [4.9] and 4.5 [8.4]. Young adults experienced feelings of embarrassment, impairments in physical health and work productivity, and difficulties in social development. Patients with more severe psoriasis, longer disease duration, higher body mass index (BMI), female patients and patients closer to their thirties tended to be more affected. Conclusion: In the young adult psoriasis population, substantial QoL impairments were found. Female patients, patients with high BMI, or long disease duration in particular tended to experience more difficulties. These exploratory findings indicate the need for further studies in young adults to detect potential clinical predictors for severe HRQoL impairments. [ABSTRACT FROM AUTHOR]

Published
2019
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12. Nail Involvement as a Predictor of Disease Severity in Paediatric Psoriasis: Follow-up Data from the Dutch ChildCAPTURE Registry.

Author

BRONCKERS, Inge M. G. J., BRUINS, Finola M., VAN GEEL, Maartje J., GROENEWOUD, Hans M. M., KIEVIT, Wietske, VAN DE KERKHOF, Peter C. M., PASCH, Marcel C., DE JONG, Elke M. G. J., and SEYGER, Marieke M. B.

Subjects
*PSORIASIS, *INTRAMEDULLARY rods, *CROSS-sectional method, *INTRAMEDULLARY fracture fixation
Abstract

Little is known about the relationship between nail psoriasis and psoriasis severity in children, and there has been no longitudinal assessment of psoriasis severity related to nail psoriasis. The aim of this study was to assess whether nail psoriasis could serve as a predictor for a more severe disease course. De-identified data were obtained from the ChildCAPTURE registry, a daily clinical practice cohort of children with psoriasis, from September 2008 to November 2015. Cross-sectional analyses were performed at baseline. Longitudinal data until 2-year follow-up were analysed by linear mixed models. Nail psoriasis was present in 19.0% of all 343 patients at baseline and cross-sectionally associated with higher Psoriasis Area and Severity Index (PASI) (p = 0.033). Longitudinal analysis demonstrated higher PASI (p < 0.001) during 2-year follow-up in patients with nail involvement at baseline. These findings suggest that nail psoriasis is a potential clinical predictor for more severe disease course over time in paediatric psoriasis. [ABSTRACT FROM AUTHOR]

Published
2019
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13. [Terbinafine resistance explains treatment failure in a patient with tinea corporis].

Author

Buil JB, Bronckers IMGJ, Driessen RJB, Do Nguyen Dan T, Melchers WJG, and Verweij PE

Subjects
Antifungal Agents therapeutic use, Drug Resistance, Fungal, Humans, Terbinafine therapeutic use, Treatment Failure, Tinea drug therapy, Tinea epidemiology, Tinea microbiology
Abstract

Background: Tinea corporis is a superficial fungal infection of the limbs, chest or back caused by dermatophytes. Local antifungal treatment is often sufficient to treat tinea corporis. Systemic treatment may be needed in more severe cases, in immunocompromised patients or when treatment failure is documented. Treatment failure is relative common and frequent causes are low compliance, low systemic antifungal drug concentrations, reduced penetration of topical agents or an immunocompromised status. Recently, antifungal resistance has been documented in dermatophytes., Case Description: We describe a patient with terbinafine treatment failure caused by antifungal drug resistance., Conclusion: The frequency of terbinafine resistance in the Netherlands is unknown as no surveillance is performed. Recent reports from both India and European countries indicate that antifungal resistance should be considered in patients with terbinafine treatment failure.

Published
2021

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