Treat to target (drug-free) inactive disease in DMARD-naive juvenile idiopathic arthritis: 24-month clinical outcomes of a three-armed randomised trial
Hissink Muller, Petra; Brinkman, Danielle M.C.; Schonenberg-Meinema, Dieneke; Van Den Bosch, Wytse Bastiaan; Koopman-Keemink, Yvonne; Brederije, Isabel C.J.; Bekkering, Peter W.; Kuijpers, Taco W.; Van Rossum, Marion; Van Suijlekom-Smit, Lisette W.A.; Van Den Berg, J. Merlijn; Boehringer, Stefan; Allaart, Cornelia F.; Ten Cate, R.
(2019) Annals of the Rheumatic Diseases, volume 78, issue 1, pp. 51 - 59
(Article)
Abstract
Question: Which is the best strategy to achieve (drug-free) inactive disease in juvenile idiopathic arthritis (JIA)? Methods: In a randomised, single-blinded, study in disease-modifying anti-rheumatic drug (DMARD)-naive patients with JIA, three treatment-strategies were compared: (1) sequential DMARD-monotherapy (sulfasalazine or methotrexate (MTX)), (2) combination therapy MTX + 6 weeks prednisolone and
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(3) combination therapy MTX +etanercept. Treatment-to-target entailed 3-monthly DMARD/biological adjustments in case of persistent disease activity, with drug tapering to nil in case of inactive disease. After 24 months, primary outcomes were time-to-inactive-disease and time-to-flare after DMARD discontinuation. Secondary outcomes were adapted ACRPedi30/50/70/90 scores, functional ability and adverse events. Results: 94 children (67 % girls) aged median (IQR) 9.1 (4.6-12.9) years were enrolled: 32 in arms 1 and 2, 30 in arm 3. At baseline visual analogue scale (VAS) physician was mean 49 (SD 16) mm, VAS patient 53 (22) mm, erythrocyte sedimentation rate 12.8 (14.7), active joints median 8 (5-12), limited joints 2.5 (1-4.8) and Childhood Health Assessment Questionnaire score mean 1.0 (0.6). After 24 months, 71% (arm 1), 70% (arm 2) and 72% (arm 3) of patients had inactive disease and 45% (arm 1), 31% (arm 2) and 41% (arm 3) had drug-free inactive disease. Time-to-inactive-disease was median 9.0 (5.3-15.0) months in arm 1, 9.0 (6.0-12.8) months in arm 2 and 9.0 (6.0-12.0) months in arm 3 (p=0.30). Time-to-flare was not significantly different (overall 3.0 (3.0-6.8) months, p=0.7). Adapted ACR pedi-scores were comparably high between arms. Adverse events were similar. Conclusion: Regardless of initial specific treatments, after 24 months of treatment-to-target aimed at drug-free inactive disease, 71% of recent-onset patients with JIA had inactive disease (median onset 9 months) and 39% were drug free. Tightly controlled treatment-to-target is feasible. Trial registration number: 1574.
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Keywords: inactive disease, juvenile idiopathic arthritis, treatment strategy study, treatment-to-target, Rheumatology, Immunology and Allergy, Immunology, General Biochemistry,Genetics and Molecular Biology
ISSN: 0003-4967
Publisher: BMJ Publishing Group
Note: Publisher Copyright: © © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
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