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. 2019 Aug 23;106(6):1319–1327. doi: 10.1002/cpt.1543

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© 2019 AbbVie Inc. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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Simulated and observed American College of Rheumatology (ACR) responses (nonresponder imputation (NRI)) at week 12 in (a) methotrexate (MTX)‐inadequate responders (IRs)/conventional synthetic disease‐modifying antirheumatic drugs (csDMARD)‐IR and (b) anti‐TNF‐IR/biologics‐IR patients in phase III trials. Gray symbols and error bars represent the simulated median and 90% prediction intervals for 15 mg and 30 mg q.d. extended‐release regimens based on exposure–response analyses of the phase II studies BALANCE I and II. Black symbols represent the observed responses in phase III trials. q.d., once daily.