Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven‐Year Interim Results

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 (...

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Published inArthritis care & research (2010) Vol. 72; no. 10; pp. 1420 - 1430
Main Authors 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, Ruperto, Nicolino
Format Journal Article
LanguageEnglish
Published Atlanta Wiley Subscription Services, Inc 01.10.2020
John Wiley and Sons Inc
Subjects
Arthritis
Immunotherapy
Methotrexate
Monoclonal antibodies
Nausea
Original
Patients
Pediatrics
Respiratory tract diseases
Sinusitis
TNF inhibitors
Tonsillitis
Vomiting
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Summary: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‐27CRP). 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‐27CRP 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.
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Clinicaltrials.gov identifier: NCT00783510.
Dr. Brunner has received speaking and/or consulting fees from AbbVie, AstraZeneca, Centocor, Bristol Myers Squibb, Boehringer Ingelheim, Pfizer, Regeneron, Hoffman La‐Roche, Novartis, Takeda, UCB, and Genentech (less than $10,000 each). Dr. Nanda has received consulting fees from Novartis (less than $10,000). Dr. Foeldvari has received consulting fees from AbbVie (less than $10,000). Dr. Bohnsack has received consulting fees from Novartis and Regeneron (less than $10,000 each). Dr. Milojevic has received consulting fees from Genentech and Novartis (less than $10,000 each). Dr. Rabinovich has received consulting fees from AbbVie (less than $10,000) and has received research support from AbbVie, Hoffmann‐La Roche, Janssen Research and Development, Sobi, and UCB. Dr. Kingsbury has received research support from AbbVie. Dr. Marzan has received research grants from AbbVie and Novartis. Dr. Chalom has received speaking fees from AbbVie (less than $10,000). Dr. Horneff has received speaking fees from AbbVie, Bristol Myers Squibb, Novartis, Sobi, Pfizer, and Roche (less than $10,000 each) and research grants from AbbVie, Pfizer, MSD, Novartis, and Roche. Dr. Kuester has received registry support from AbbVie and Wyeth/Pfizer. Dr. Dare has received research support from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. Dr. Trachana received speaking fees from Novartis, Pfizer, Roche, and Vianex (less than $10,000 each) and research grants from AbbVie, Pfizer, and Novartis. Dr. Jung has received consulting fees from Novartis and Bristol Myers Squibb (less than $10,000 each) and research support from AbbVie, Bristol Myers Squibb, and UCB Biosciences. Dr. Olson has received research support from AbbVie, Bristol Myers Squibb, CARRA, and Sobi. Dr. Minden has received consulting and/or speaking fees from AbbVie, Chugai, and Sanofi (less than $10,000 each) and research grants from AbbVie, Novartis, Pfizer, and Roche/Chugai. Dr. Quartier has received consulting and/or speaking fees from AbbVie, Bristol Myers Squibb, Eli Lilly and Company, Novartis, Novimmune, Pfizer, Roche, Sobi, and MedImmune (less than $10,000 each), has received research support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, Roche, and Sanofi, and is part of a data safety monitoring board for Sanofi. Ms Bereswill, Dr. Kalabic, and Dr. Kupper are full‐time employees of AbbVie and hold stock or stock options. Dr. Lovell has received speaking fees from Genentech and Bristol Meyers Squibb (less than $10,000 each) and consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Genentech, Hoffman La‐Roche, Novartis, Pfizer, Regeneron, UBC, and Xoma (less than $10,000 each; paid to the Cincinnati Children’s Hospital Medical Center), and has served on a data and safety monitoring board for Forest Research. Dr. Martini has received consulting fees from Janssen, Novartis, and Pfizer (less than $10,000 each), has served as a consultant on behalf of the Istituto Giannina Gaslini for AbbVie, Boehringer Ingelheim, Novartis, and R‐Pharm, and has received contributions from Bristol Myers Squibb, Hoffman‐La Roche, Janssen, Novartis, Pfizer, and Sobi for the coordination activity of the PRINTO network. Dr. Ruperto has received consulting and/or speaking fees from Ablynx, AbbVie, AstraZeneca‐MedImmune, Biogen, Boehringer, Bristol Myers Squibb, Eli Lilly and Company, EMD Serono, GlaxoSmithKline, Hoffmann‐La Roche, Janssen, Merck, Novartis, Pfizer, R‐Pharma, SanofiServier, Sinergie, Sobi, and Takeda (less than $10,000 each). No other disclosures relevant to this article were reported.
The STRIVE Registry is sponsored by AbbVie.
ISSN:2151-464X
2151-4658
DOI:10.1002/acr.24044