Brunner, Hermine I., Nanda, Kabita, Toth, Mary, Foeldvari, Ivan, Bohnsack, John, Milojevic, Diana, Rabinovich, C. Egla, Kingsbury, Daniel J., Marzan, Katherine, Chalom, Elizabeth, Horneff, Gerd, Kuester, Rolf-Michael, Dare, Jason A., Trachana, Maria, Jung, Lawrence K., Olson, Judyann, Minden, Kirsten, Quartier, Pierre, Bereswill, Mareike, Kalabic, Jasmina, Kupper, Hartmut, Lovell, Daniel J., Martini, Alberto and Ruperto, Nicolino ORCID: 0000-0001-8407-7782 (2020). Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results. Arthritis Care Res., 72 (10). S. 1420 - 1431. HOBOKEN: WILEY. ISSN 2151-4658

Full text not available from this repository.

Abstract

Objective To evaluate safety and effectiveness of adalimumab (ADA) in polyarticular-course juvenile idiopathic arthritis (JIA) in the STRIVE registry. Methods STRIVE enrolled patients with polyarticular-course JIA into 2 arms based on treatment with methotrexate (MTX) alone or ADA with/without MTX (ADA +/- MTX). Adverse events (AEs) per 100 patient-years of observation time were analyzed by registry arm. Patients who entered the registry within 4 weeks of starting MTX or ADA +/- MTX, defined as new users, were evaluated for change in disease activity assessed by the 27-joint Juvenile Arthritis Disease Activity Score with the C-reactive protein level (JADAS-27(CRP)). Results At the 7-year cutoff date (June 1, 2016), data from 838 patients were available (MTX arm n = 301, ADA +/- MTX arm n = 537). The most common AEs were nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%) in the MTX arm and arthritis (3.9%), upper respiratory tract infection (3.5%), sinusitis, tonsillitis, and injection site pain (3.0% each) in the ADA +/- MTX arm. Rates of serious infection were 1.5 events/100 patient-years in the MTX arm and 2.0 events/100 patient-years in the ADA +/- MTX arm. AE and serious AE rates were similar in patients receiving ADA with versus without MTX. No deaths or malignancies were reported. New users in the ADA +/- MTX arm showed a trend toward lower mean JADAS-27(CRP)compared with new users in the MTX arm in the first year of STRIVE. Conclusion The STRIVE registry 7-year interim results support the idea that ADA +/- MTX is well tolerated by most children. Registry median ADA exposure was 2.47 (interquartile range 1.0-3.6) years, with 42% of patients continuing ADA at the 7-year cutoff date.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Brunner, Hermine I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nanda, KabitaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Toth, MaryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Foeldvari, IvanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bohnsack, JohnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Milojevic, DianaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rabinovich, C. EglaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kingsbury, Daniel J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marzan, KatherineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chalom, ElizabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Horneff, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuester, Rolf-MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dare, Jason A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trachana, MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jung, Lawrence K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Olson, JudyannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Minden, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Quartier, PierreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bereswill, MareikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalabic, JasminaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kupper, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lovell, Daniel J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martini, AlbertoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruperto, NicolinoUNSPECIFIEDorcid.org/0000-0001-8407-7782UNSPECIFIED
URN: urn:nbn:de:hbz:38-317602
DOI: 10.1002/acr.24044
Journal or Publication Title: Arthritis Care Res.
Volume: 72
Number: 10
Page Range: S. 1420 - 1431
Date: 2020
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 2151-4658
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DISEASE-ACTIVITY; RHEUMATOID-ARTHRITIS; PLUS METHOTREXATE; GERMAN BIOLOGICS; CLINICAL-TRIALS; DOUBLE-BLIND; CHILDREN; ETANERCEPT; VALIDATION; EFFICACYMultiple languages
RheumatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/31760

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item