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. 2020 Jun 6;7(3):553–580. doi: 10.1007/s40744-020-00209-4

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© The Author(s) 2020

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Fig. 1 — Mean (standard error [SE]) change from baseline in alanine aminotransferase (a), aspartate aminotransferase (b), hemoglobin (c), absolute lymphocyte count (d), absolute neutrophil count (e), creatinine (f), and creatine kinase (g), and mean (SE) percentage change from baseline in absolute CD16+56 (h), high-density lipoprotein-cholesterol (i), low-density lipoprotein-cholesterol (j), total cholesterol (k), and triglycerides (l), up to month 30. The dashed line represents the time between the baseline (month 0) and month 1 or month 3, as baseline refers to the baseline visit of the qualifying study for patients who enrolled within the 14-day window from the last visit of the qualifying study, or the baseline visit of this long-term extension (LTE) study for patients who enrolled outside of the 14-day window from the last visit of the qualifying study. Data are presented to month 30 because sample sizes were too small (N ≤ 50) for meaningful analysis beyond this point. N is the number of patients evaluable at each time point. Only evaluable patients at a visit of interest were included in the analysis and missing values were not imputed. ^aAverage dosing was based on an average total daily dose (ATDD) of tofacitinib: patients who received an ATDD < 15 mg/day were assigned to the average tofacitinib 5 mg twice daily (BID) group; patients who received an ATDD ≥ 15 mg/day were assigned to the average tofacitinib 10 mg BID group. ^bThe constant tofacitinib 5 mg BID group included all patients who started OPAL Balance on tofacitinib 5 mg BID and stayed on tofacitinib 5 mg BID (as per sponsor’s smoothing algorithm) until switching to tofacitinib 10 mg BID or discontinuing the study. Assessments (including exposure and adverse events) after dose switch to tofacitinib 10 mg BID were excluded from the analysis. Δ change from baseline, ALC absolute lymphocyte count, ALT alanine aminotransferase, ANC absolute neutrophil count, AST aspartate aminotransferase, ATDD average total daily dose, BID twice daily, HDL high-density lipoprotein, LDL low-density lipoprotein

Fig. 1 — Mean (standard error [SE]) change from baseline in alanine aminotransferase (a), aspartate aminotransferase (b), hemoglobin (c), absolute lymphocyte count (d), absolute neutrophil count (e), creatinine (f), and creatine kinase (g), and mean (SE) percentage change from baseline in absolute CD16+56 (h), high-density lipoprotein-cholesterol (i), low-density lipoprotein-cholesterol (j), total cholesterol (k), and triglycerides (l), up to month 30. The dashed line represents the time between the baseline (month 0) and month 1 or month 3, as baseline refers to the baseline visit of the qualifying study for patients who enrolled within the 14-day window from the last visit of the qualifying study, or the baseline visit of this long-term extension (LTE) study for patients who enrolled outside of the 14-day window from the last visit of the qualifying study. Data are presented to month 30 because sample sizes were too small (N ≤ 50) for meaningful analysis beyond this point. N is the number of patients evaluable at each time point. Only evaluable patients at a visit of interest were included in the analysis and missing values were not imputed. ^aAverage dosing was based on an average total daily dose (ATDD) of tofacitinib: patients who received an ATDD < 15 mg/day were assigned to the average tofacitinib 5 mg twice daily (BID) group; patients who received an ATDD ≥ 15 mg/day were assigned to the average tofacitinib 10 mg BID group. ^bThe constant tofacitinib 5 mg BID group included all patients who started OPAL Balance on tofacitinib 5 mg BID and stayed on tofacitinib 5 mg BID (as per sponsor’s smoothing algorithm) until switching to tofacitinib 10 mg BID or discontinuing the study. Assessments (including exposure and adverse events) after dose switch to tofacitinib 10 mg BID were excluded from the analysis. Δ change from baseline, ALC absolute lymphocyte count, ALT alanine aminotransferase, ANC absolute neutrophil count, AST aspartate aminotransferase, ATDD average total daily dose, BID twice daily, HDL high-density lipoprotein, LDL low-density lipoprotein