732 Laboratory Parameters Related to Monitoring in Patients With Ulcerative Colitis Treated With Tofacitinib for up to 3 Years in the OCTAVE Open-Label, Long-Term Extension Study

Abstract

INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Monitoring of liver enzymes, lipids, absolute neutrophil count (ANC), absolute lymphocyte count (ALC), and hemoglobin (Hg) is recommended in patients (pts) with UC treated with tofacitinib. 1 METHODS: Changes in laboratory parameters (liver enzymes, lipids, ANC, ALC, and Hg) from baseline at Month 36 were investigated in pts with moderately to severely active UC treated with tofacitinib in OCTAVE Open, an ongoing Phase 3, open-label, long-term extension (OLE) study (NCT01470612; data as of Sep 2018, database not locked). Pts who completed or demonstrated treatment failure in the OCTAVE Sustain maintenance study, or those who were non-responders after completing OCTAVE Induction 1 or 2, were eligible for the OLE study. Pts in remission at the end of OCTAVE Sustain were assigned to tofacitinib 5 mg twice daily (BID); all other pts were assigned to tofacitinib 10 mg BID in the OLE study. The proportions of pts with laboratory values meeting protocol criteria for discontinuation (Table 1), with investigator-defined hyperlipidemia treatment-emergent adverse events (TEAEs), and with a change in lipid-lowering agent (LLA), were evaluated. RESULTS: For pts treated with tofacitinib 5 and 10 mg BID, changes from OLE study baseline in liver enzymes, lipids, ANC, ALC, and Hg at Month 36 and the proportion of pts meeting protocol criteria for discontinuation are presented in the Table 1. Hyperlipidemia TEAEs were experienced by 1.7% and 1.2% of pts treated with tofacitinib 5 and 10 mg BID, respectively. Furthermore, 8.0% and 6.6% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had a new LLA added, and 2.3% and 1.7% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had their LLA dose increased. CONCLUSION: No major changes from OLE study baseline were observed in the laboratory parameters recommended for monitoring in pts treated with tofacitinib up to Month 36. In addition, the proportions of pts meeting protocol criteria for discontinuation for liver enzymes, ANC, ALC, or Hg, with hyperlipidemia TEAEs or with a change in LLA, were evaluated and were low in both tofacitinib treatment groups. Due to the dose assignment in the OLE study, the pt populations in the treatment arms differ in terms of their baseline remission status.