Persistence of tofacitinib treatment in patients with ulcerative colitis who entered the open-label, long-term extension study, octave open in remission or with a clinical response

Introduction: Drug survival in open-label, long-term extension (OLE) studies may provide important information on the long-term efficacy and tolerability of a therapy. Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. Efficacy and safety were demonstrated in three Phase 3, randomized, PBO-controlled studies in patients (pts) with moderate to severe UC. A Phase 3, OLE study (OCTAVE Open, NCT01470612) included pts from OCTAVE Induction 1 & 2 and OCTAVE Sustain. Methods: Data on the persistence of tofacitinib treatment in the OLE study for pts who had a clinical response at Week (Wk) 52 of treatment with tofacitinib 5 or 10 mg BID, or PBO, in OCTAVE Sustain were evaluated. Data were analyzed for all responder pts and by remission status: responders who were also in remission (remitters; assigned to tofacitinib 5 mg BID per OLE study protocol), and responders who were not in remission (responders/non-remitters) at OLE baseline (assigned to tofacitinib 10 mg BID per OLE study protocol) (Figure 1). Duration of treatment in the OLE study varied by pt. Results: At baseline of the OLE study, there were 280 pts with a clinical response (all responders) which included 164 remitters and 116 responders/non-remitters who were treated for a maximum of 7 years in the OLE study (Table 1). Of these, 118 (42.1%) pts discontinued the OLE study (68/164 [41.5%] among remitters and 50/116 [43.1%] among responders/non-remitters) with a median time to discontinuation of 291 wks. Overall, the estimated 2-and 5-year tofacitinib persistence rates in the all-responder population were 73.9% and 54.5%, respectively. These rates were numerically higher in remitters (76.8% and 56.9%, respectively) vs responders/non-remitters (69.8% and 50.0%, respectively). During the OLE study, 43 (26.2%) remitters increased tofacitinib dose from 5 to 10 mg BID, and 15 (12.9%) responders/non-remitters decreased tofacitinib dose from 10 to 5 mg BID. Conclusion: With up to 7 years of follow-up, treatment persistence to tofacitinib was highest amongst pts who were responders/remitters compared with responders/non-remitters and the majority of pts continued to be on treatment at 5 years. Analyses are post hoc and limited by sample size. Further research will help to understand the reasons for continuation or discontinuation of tofacitinib treatment in pts with UC.