Clinical Gastroenterology and Hepatology Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis  Bruce E. Sands, Pam R. Taub, Alessandro Armuzzi, Gary S. Friedman, Michele Moscariello, Nervin Lawendy, Ronald D. Pedersen, Gary Chan, Chudy I. Nduaka, Daniel Quirk, Leonardo Salese, Chinyu Su, Brian G. Feagan  Clinical Gastroenterology and Hepatology  DOI: 10.1016/j.cgh.2019.04.059 Copyright © 2019 AGA Institute Terms and Conditions

Figure 1 Mean changes from baseline in lipids and hsCRP at week 8: (A) total cholesterol; (B) HDL-c; (C) LDL-c; (D) hsCRP; (E) Pearson correlation of changes in hsCRP and BMI with lipid increases at week 8. *P < .05, **P < .001, ***P < .0001 vs placebo. Pearson correlation coefficients and P values were calculated for changes from baseline in hsCRP at week 8 with week 8 changes from baseline in lipids. Phase 2 induction data are not included. BID, twice daily. Clinical Gastroenterology and Hepatology DOI: (10.1016/j.cgh.2019.04.059) Copyright © 2019 AGA Institute Terms and Conditions

Figure 2 Mean change from baseline in lipid concentrations over 61 weeks: (A) total cholesterol; (B) HDL-c; (C) LDL-c; (D) triglycerides; (E) total cholesterol/HDL-c ratio; (F) LDL-c/HDL-c ratio. Dashed line indicates the end of induction studies. Phase 2 induction data are not included. BID, twice daily; ind, induction; main, maintenance. Clinical Gastroenterology and Hepatology DOI: (10.1016/j.cgh.2019.04.059) Copyright © 2019 AGA Institute Terms and Conditions

Supplementary Figure 1 Overview of the OCTAVE program. Final complete efficacy assessment at week 8 of 52. Treatment continued up to week 9 of 53. Clinical response in OCTAVE Induction 1 and 2 was defined as a decrease from baseline total Mayo score of ≥3 points and ≥30%, plus a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1. Study A3921139 is ongoing. Remission was defined as a total Mayo score of ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0. BID, twice daily. Clinical Gastroenterology and Hepatology DOI: (10.1016/j.cgh.2019.04.059) Copyright © 2019 AGA Institute Terms and Conditions

Supplementary Figure 2 Mean change from baseline in lipid concentrations over 8 weeks in induction: (A) total cholesterol; (B) HDL-c; (C) LDL-c; (D) triglycerides; (E) total cholesterol/HDL-c ratio; (F) LDL-c/HDL-c ratio. BID, twice daily; HDL-c, high-density lipoprotein cholesterol; LDL-c, low-density lipoprotein cholesterol. Clinical Gastroenterology and Hepatology DOI: (10.1016/j.cgh.2019.04.059) Copyright © 2019 AGA Institute Terms and Conditions