Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries

Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish Registry

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The availability of methotrexate and the introduction of multiple biological agents have revolutionized the treatment of juvenile idiopathic arthritis (JIA). Several international and national drug registries have been implemented to accurately monitor the long-term safety/efficacy of these agents. This report aims to present the combined data coming from Pharmachild/PRINTO registry and the national registries from Germany (BiKeR) and Sweden.

METHODS: Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESIs). For the Swedish register, AE data were not available.

RESULTS: Data from a total of 15,284 patients were reported: 8274 (54%) from the Pharmachild registry and 3990 (26%) and 3020 (20%) from the German and the Swedish registries, respectively. Pharmachild children showed a younger age (median of 5.4 versus 7.6 years) at JIA onset and shorter disease duration at last available visit (5.3 versus 6.1-6.8) when compared with the other registries. The most frequent JIA category was the rheumatoid factor-negative polyarthritis (range of 24.6-29.9%). Methotrexate (61-84%) and etanercept (24%-61.8%) were the most frequently used synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), respectively. There was a wide variability in glucocorticoid use (16.7-42.1%). Serious AEs were present in 572 (6.9%) patients in Pharmachild versus 297 (7.4%) in BiKeR. Infection and infestations were the most frequent AEs (29.4-30.1%) followed by gastrointestinal disorders (11.5-19.6%). The most frequent ESIs were infections (75.3-89%).

CONCLUSIONS: This article is the first attempt to present a very large sample of data on JIA patients from different national and international registries and represents the first proposal for data merging as the most powerful tool for future analysis of safety and effectiveness of immunosuppressive therapies in JIA.

REGISTRY REGISTRATION: The Pharmachild registry is registered at ClinicalTrials.gov ( NCT01399281 ) and at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) ( http://www.encepp.eu/encepp/viewResource.htm?id=19362 ). The BiKeR registry is registered at ENCePP ( http://www.encepp.eu/encepp/viewResource.htm?id=20591 ).

Original languageEnglish
Pages (from-to)285
Number of pages11
JournalArthritis Research and Therapy
Volume20
Issue number1
DOIs
Publication statusPublished - Dec 27 2018

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Pharmacovigilance
Juvenile Arthritis
Registries
Pharmaceutical Preparations
Pharmacoepidemiology
Anniversaries and Special Events
Methotrexate
Safety
Antirheumatic Agents
Biological Factors
Immunosuppressive Agents
Infection
Drug-Related Side Effects and Adverse Reactions
Sweden
Glucocorticoids
Germany
Demography

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Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs : combined data of more than 15,000 patients from Pharmachild and national registries. / Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish Registry.

In: Arthritis Research and Therapy, Vol. 20, No. 1, 27.12.2018, p. 285.

Research output: Contribution to journalArticle

Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish Registry. / Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs : combined data of more than 15,000 patients from Pharmachild and national registries. In: Arthritis Research and Therapy. 2018 ; Vol. 20, No. 1. pp. 285.
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title = "Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries",
abstract = "BACKGROUND: The availability of methotrexate and the introduction of multiple biological agents have revolutionized the treatment of juvenile idiopathic arthritis (JIA). Several international and national drug registries have been implemented to accurately monitor the long-term safety/efficacy of these agents. This report aims to present the combined data coming from Pharmachild/PRINTO registry and the national registries from Germany (BiKeR) and Sweden.METHODS: Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESIs). For the Swedish register, AE data were not available.RESULTS: Data from a total of 15,284 patients were reported: 8274 (54{\%}) from the Pharmachild registry and 3990 (26{\%}) and 3020 (20{\%}) from the German and the Swedish registries, respectively. Pharmachild children showed a younger age (median of 5.4 versus 7.6 years) at JIA onset and shorter disease duration at last available visit (5.3 versus 6.1-6.8) when compared with the other registries. The most frequent JIA category was the rheumatoid factor-negative polyarthritis (range of 24.6-29.9{\%}). Methotrexate (61-84{\%}) and etanercept (24{\%}-61.8{\%}) were the most frequently used synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), respectively. There was a wide variability in glucocorticoid use (16.7-42.1{\%}). Serious AEs were present in 572 (6.9{\%}) patients in Pharmachild versus 297 (7.4{\%}) in BiKeR. Infection and infestations were the most frequent AEs (29.4-30.1{\%}) followed by gastrointestinal disorders (11.5-19.6{\%}). The most frequent ESIs were infections (75.3-89{\%}).CONCLUSIONS: This article is the first attempt to present a very large sample of data on JIA patients from different national and international registries and represents the first proposal for data merging as the most powerful tool for future analysis of safety and effectiveness of immunosuppressive therapies in JIA.REGISTRY REGISTRATION: The Pharmachild registry is registered at ClinicalTrials.gov ( NCT01399281 ) and at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) ( http://www.encepp.eu/encepp/viewResource.htm?id=19362 ). The BiKeR registry is registered at ENCePP ( http://www.encepp.eu/encepp/viewResource.htm?id=20591 ).",
author = "{Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish Registry} and Joost Swart and Gabriella Giancane and Gerd Horneff and Bo Magnusson and Michael Hofer and Еkaterina Alexeeva and Violeta Panaviene and Brigitte Bader-Meunier and Jordi Anton and Susan Nielsen and {De Benedetti}, Fabrizio and Sylvia Kamphuis and Valda Staņēviča and Maria Tracahana and Ailioaie, {Laura Marinela} and Elena Tsitsami and Ariane Klein and Kirsten Minden and Ivan Foeldvari and Haas, {Johannes Peter} and Jens Klotsche and Horne, {Anna Carin} and Alessandro Consolaro and Francesca Bovis and Francesca Bagnasco and Angela Pistorio and Alberto Martini and Nico Wulffraat and Nicolino Ruperto",
year = "2018",
month = "12",
day = "27",
doi = "10.1186/s13075-018-1780-z",
language = "English",
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journal = "Arthritis Research and Therapy",
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TY - JOUR

T1 - Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs

T2 - combined data of more than 15,000 patients from Pharmachild and national registries

AU - Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish Registry

AU - Swart, Joost

AU - Giancane, Gabriella

AU - Horneff, Gerd

AU - Magnusson, Bo

AU - Hofer, Michael

AU - Alexeeva, Еkaterina

AU - Panaviene, Violeta

AU - Bader-Meunier, Brigitte

AU - Anton, Jordi

AU - Nielsen, Susan

AU - De Benedetti, Fabrizio

AU - Kamphuis, Sylvia

AU - Staņēviča, Valda

AU - Tracahana, Maria

AU - Ailioaie, Laura Marinela

AU - Tsitsami, Elena

AU - Klein, Ariane

AU - Minden, Kirsten

AU - Foeldvari, Ivan

AU - Haas, Johannes Peter

AU - Klotsche, Jens

AU - Horne, Anna Carin

AU - Consolaro, Alessandro

AU - Bovis, Francesca

AU - Bagnasco, Francesca

AU - Pistorio, Angela

AU - Martini, Alberto

AU - Wulffraat, Nico

AU - Ruperto, Nicolino

PY - 2018/12/27

Y1 - 2018/12/27

N2 - BACKGROUND: The availability of methotrexate and the introduction of multiple biological agents have revolutionized the treatment of juvenile idiopathic arthritis (JIA). Several international and national drug registries have been implemented to accurately monitor the long-term safety/efficacy of these agents. This report aims to present the combined data coming from Pharmachild/PRINTO registry and the national registries from Germany (BiKeR) and Sweden.METHODS: Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESIs). For the Swedish register, AE data were not available.RESULTS: Data from a total of 15,284 patients were reported: 8274 (54%) from the Pharmachild registry and 3990 (26%) and 3020 (20%) from the German and the Swedish registries, respectively. Pharmachild children showed a younger age (median of 5.4 versus 7.6 years) at JIA onset and shorter disease duration at last available visit (5.3 versus 6.1-6.8) when compared with the other registries. The most frequent JIA category was the rheumatoid factor-negative polyarthritis (range of 24.6-29.9%). Methotrexate (61-84%) and etanercept (24%-61.8%) were the most frequently used synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), respectively. There was a wide variability in glucocorticoid use (16.7-42.1%). Serious AEs were present in 572 (6.9%) patients in Pharmachild versus 297 (7.4%) in BiKeR. Infection and infestations were the most frequent AEs (29.4-30.1%) followed by gastrointestinal disorders (11.5-19.6%). The most frequent ESIs were infections (75.3-89%).CONCLUSIONS: This article is the first attempt to present a very large sample of data on JIA patients from different national and international registries and represents the first proposal for data merging as the most powerful tool for future analysis of safety and effectiveness of immunosuppressive therapies in JIA.REGISTRY REGISTRATION: The Pharmachild registry is registered at ClinicalTrials.gov ( NCT01399281 ) and at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) ( http://www.encepp.eu/encepp/viewResource.htm?id=19362 ). The BiKeR registry is registered at ENCePP ( http://www.encepp.eu/encepp/viewResource.htm?id=20591 ).

AB - BACKGROUND: The availability of methotrexate and the introduction of multiple biological agents have revolutionized the treatment of juvenile idiopathic arthritis (JIA). Several international and national drug registries have been implemented to accurately monitor the long-term safety/efficacy of these agents. This report aims to present the combined data coming from Pharmachild/PRINTO registry and the national registries from Germany (BiKeR) and Sweden.METHODS: Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESIs). For the Swedish register, AE data were not available.RESULTS: Data from a total of 15,284 patients were reported: 8274 (54%) from the Pharmachild registry and 3990 (26%) and 3020 (20%) from the German and the Swedish registries, respectively. Pharmachild children showed a younger age (median of 5.4 versus 7.6 years) at JIA onset and shorter disease duration at last available visit (5.3 versus 6.1-6.8) when compared with the other registries. The most frequent JIA category was the rheumatoid factor-negative polyarthritis (range of 24.6-29.9%). Methotrexate (61-84%) and etanercept (24%-61.8%) were the most frequently used synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), respectively. There was a wide variability in glucocorticoid use (16.7-42.1%). Serious AEs were present in 572 (6.9%) patients in Pharmachild versus 297 (7.4%) in BiKeR. Infection and infestations were the most frequent AEs (29.4-30.1%) followed by gastrointestinal disorders (11.5-19.6%). The most frequent ESIs were infections (75.3-89%).CONCLUSIONS: This article is the first attempt to present a very large sample of data on JIA patients from different national and international registries and represents the first proposal for data merging as the most powerful tool for future analysis of safety and effectiveness of immunosuppressive therapies in JIA.REGISTRY REGISTRATION: The Pharmachild registry is registered at ClinicalTrials.gov ( NCT01399281 ) and at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) ( http://www.encepp.eu/encepp/viewResource.htm?id=19362 ). The BiKeR registry is registered at ENCePP ( http://www.encepp.eu/encepp/viewResource.htm?id=20591 ).

U2 - 10.1186/s13075-018-1780-z

DO - 10.1186/s13075-018-1780-z

M3 - Article

C2 - 30587248

VL - 20

SP - 285

JO - Arthritis Research and Therapy

JF - Arthritis Research and Therapy

SN - 1478-6354

IS - 1

ER -