-
Something wrong with this record ?
Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate
DJ. Lovell, HI. Brunner, AO. Reiff, L. Jung, K. Jarosova, D. Němcová, R. Mouy, C. Sandborg, JF. Bohnsack, D. Elewaut, C. Gabriel, G. Higgins, I. Kone-Paut, OY. Jones, V. Vargová, E. Chalom, C. Wouters, I. Lagunes, Y. Song, A. Martini, N. Ruperto
Language English Country Great Britain
Document type Journal Article, Research Support, Non-U.S. Gov't
NLK
Directory of Open Access Journals
from 2015
Free Medical Journals
from 2015
PubMed Central
from 2015
Europe PubMed Central
from 2015
ProQuest Central
from 2015-01-01
Open Access Digital Library
from 2015-01-01
Open Access Digital Library
from 2015-01-01
Health & Medicine (ProQuest)
from 2015-01-01
ROAD: Directory of Open Access Scholarly Resources
from 2015
- MeSH
- Adalimumab administration & dosage therapeutic use MeSH
- Antirheumatic Agents administration & dosage therapeutic use MeSH
- Child MeSH
- Arthritis, Juvenile drug therapy etiology pathology MeSH
- Clinical Trials, Phase III as Topic MeSH
- Drug Therapy, Combination MeSH
- Humans MeSH
- Methotrexate administration & dosage therapeutic use MeSH
- Adolescent MeSH
- Child, Preschool MeSH
- Prognosis MeSH
- Proportional Hazards Models MeSH
- Duration of Therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
OBJECTIVES: Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment. METHODS: Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1). RESULTS: Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis). CONCLUSIONS: Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.
AbbVie Inc North Chicago Illinois USA
Clinica Pediatrica e Reumatologia PRINTO IRCCS Istituto Giannina Gaslini Genova Italy
Department of Pediatrics The Ohio State University College of Medicine Columbus Ohio USA
Department of Rheumatology 1st Faculty of Medicine Charles University Prague Czech Republic
Division of Rheumatology Children's Hospital of Los Angeles Los Angeles California USA
Institute of Rheumatology Prague Czech Republic
Pediatric Immunology University Hospital Gasthuisberg Leuven Belgium
Pediatric Rheumatology Children's Hospital of the King's Daughters Norfolk Virginia USA
Pediatric Rheumatology Lucile Packard Children's Hospital at Stanford Palo Alto California USA
Pediatric Rheumatology Saint Barnabas Medical Center Livingston New Jersey USA
Pediatric Rheumatology Unit Faculty Hospital Kosice Slovakia
Pediatric Rheumatology Univeristé Paris Descartes and Hôpital Necker Enfants Malades Paris France
Pediatric Rheumatology Walter Reed National Military Medical Center Bethesda Maryland USA
Rheumatology University Hospital Gent Gent Belgium
VIB Center for Inflammation Research Gent University Gent Belgium
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc21020425
- 003
- CZ-PrNML
- 005
- 20210830102121.0
- 007
- ta
- 008
- 210728s2020 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1136/rmdopen-2020-001208 $2 doi
- 035 __
- $a (PubMed)32665432
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Lovell, Daniel J $u Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA Daniel.lovell@cchmc.org
- 245 10
- $a Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate / $c DJ. Lovell, HI. Brunner, AO. Reiff, L. Jung, K. Jarosova, D. Němcová, R. Mouy, C. Sandborg, JF. Bohnsack, D. Elewaut, C. Gabriel, G. Higgins, I. Kone-Paut, OY. Jones, V. Vargová, E. Chalom, C. Wouters, I. Lagunes, Y. Song, A. Martini, N. Ruperto
- 520 9_
- $a OBJECTIVES: Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment. METHODS: Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1). RESULTS: Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis). CONCLUSIONS: Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.
- 650 _2
- $a adalimumab $x aplikace a dávkování $x terapeutické užití $7 D000068879
- 650 _2
- $a mladiství $7 D000293
- 650 _2
- $a antirevmatika $x aplikace a dávkování $x terapeutické užití $7 D018501
- 650 _2
- $a juvenilní artritida $x farmakoterapie $x etiologie $x patologie $7 D001171
- 650 _2
- $a dítě $7 D002648
- 650 _2
- $a předškolní dítě $7 D002675
- 650 _2
- $a klinické zkoušky, fáze III jako téma $7 D017326
- 650 _2
- $a kombinovaná farmakoterapie $7 D004359
- 650 _2
- $a trvání terapie $7 D000081206
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a methotrexát $x aplikace a dávkování $x terapeutické užití $7 D008727
- 650 _2
- $a prognóza $7 D011379
- 650 _2
- $a proporcionální rizikové modely $7 D016016
- 650 _2
- $a výsledek terapie $7 D016896
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Brunner, Hermine I $u Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA
- 700 1_
- $a Reiff, Andreas O $u Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, California, USA $u Division of Rheumatology, Children's Hospital of Los Angeles, Los Angeles, California, USA
- 700 1_
- $a Jung, Lawrence $u Department of Rheumatology, Children's National Medical Center for Cancer and Immunology Research, Washington, District of Columbia, USA
- 700 1_
- $a Jarosova, Katerina $u Institute of Rheumatology, Prague, Czech Republic $u Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic
- 700 1_
- $a Němcová, Dana $u Department of Pediatrics and Adolescent Medicine, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic
- 700 1_
- $a Mouy, Richard $u Pediatric Rheumatology, Univeristé Paris-Descartes and Hôpital Necker-Enfants Malades, Paris, France
- 700 1_
- $a Sandborg, Christy $u Pediatric Rheumatology, Lucile Packard Children's Hospital at Stanford, Palo Alto, California, USA
- 700 1_
- $a Bohnsack, John F $u Department of Pediatrics, Division of Allergy, Immunology and Pediatric Rheumatology, University of Utah, Salt Lake City, Utah, USA
- 700 1_
- $a Elewaut, Dirk $u Rheumatology, University Hospital Gent, Gent, Belgium $u VIB Center for Inflammation Research, Gent University, Gent, Belgium
- 700 1_
- $a Gabriel, Christos $u Pediatric Rheumatology, Children's Hospital of the King's Daughters, Norfolk, Virginia, USA
- 700 1_
- $a Higgins, Gloria $u Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA
- 700 1_
- $a Kone-Paut, Isabelle $u Department of Paediatric Rheumatology and CEREMAI, Hôpital De Bicêtre, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, Paris, France
- 700 1_
- $a Jones, Olcay Y $u Pediatric Rheumatology, Walter Reed National Military Medical Center, Bethesda, Maryland, USA
- 700 1_
- $a Vargová, Veronika $u Pediatric Rheumatology Unit, Faculty Hospital, Kosice, Slovakia
- 700 1_
- $a Chalom, Elizabeth $u Pediatric-Rheumatology, Saint Barnabas Medical Center, Livingston, New Jersey, USA
- 700 1_
- $a Wouters, Carine $u Pediatric Immunology, University Hospital Gasthuisberg, Leuven, Belgium
- 700 1_
- $a Lagunes, Ivan $u AbbVie Inc, North Chicago, Illinois, USA
- 700 1_
- $a Song, Yanna $u AbbVie Inc, North Chicago, Illinois, USA
- 700 1_
- $a Martini, Alberto $u Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI),, Università degli Studi di Genova, Genoa, Italy
- 700 1_
- $a Ruperto, Nicolino $u Clinica Pediatrica e Reumatologia-PRINTO, IRCCS Istituto Giannina Gaslini, Genova, Italy
- 773 0_
- $w MED00188812 $t RMD open $x 2056-5933 $g Roč. 6, č. 2 (2020)
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/32665432 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20210728 $b ABA008
- 991 __
- $a 20210830102121 $b ABA008
- 999 __
- $a ok $b bmc $g 1691074 $s 1140871
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2020 $b 6 $c 2 $e - $i 2056-5933 $m RMD open $n RMD Open $x MED00188812
- LZP __
- $a Pubmed-20210728
