C0364 - Assessment of Health-Related Quality of Life and Patient-Reported Outcomes With Tofacitinib Treatment Stratified by Age in Patients From the OCTAVE Ulcerative Colitis Clinical Program

Introduction: Tofacitinib is an oral small molecule JAK inhibitor for the treatment of UC. Consistent with previous studies in patients (pts) with inflammatory bowel disease (IBD) and the general population, analyses from the tofacitinib OCTAVE UC clinical program demonstrated that older age was associated with poorer health outcomes in pts with UC.¹ To further understand the relationship between age and risk/benefit of tofacitinib, this post hoc analysis assessed HRQoL and pt-reported outcomes (PROs) stratified by age among pts enrolled in the tofacitinib OCTAVE UC clinical program.

Methods: Data up to Week (W)8 of the Phase (P)3 induction studies (OCTAVE Induction 1&2 [NCT01465763; NCT01458951]), W52 of the P3 maintenance study (OCTAVE Sustain [NCT01458574]), and Month 48 of the open-label, long term extension (OLE) study (OCTAVE Open [NCT01470612]) were analyzed. Proportions of pts with an IBD Questionnaire (IBDQ) total score ≥ 170 (i.e., IBDQ remission; cut-off generally corresponds to clinical remission), and mean changes from induction study baseline in the Mayo stool frequency subscore (SFS) and rectal bleeding subscore (RBS), stratified by age, were evaluated.

Results: The age distribution of pts who enrolled in the OCTAVE UC clinical program was generally similar across the studies and treatment groups.¹ In OCTAVE Induction 1&2 and OCTAVE Sustain, proportions of pts who received tofacitinib treatment and who had an IBDQ total score ≥ 170 were generally higher than those who received placebo (PBO), regardless of age (Figure a–b). In OCTAVE Open, proportions of pts treated with tofacitinib 5 mg BID and with an IBDQ total score ≥ 170 were generally similar among the age groups (Figure c). A trend toward better HRQoL with older age was observed in the tofacitinib 10 mg BID group (Figure d). In OCTAVE Induction 1&2, pts who received tofacitinib 10 mg BID had a greater change from baseline in SFS and RBS compared with PBO, regardless of age. In OCTAVE Sustain and OCTAVE Open, there was no consistent trend for change from baseline in SFS among age and treatment groups, and similar changes from baseline in RBS were observed across age groups among tofacitinib-treated pts (Table).

Discussion: Tofacitinib demonstrated consistent efficacy for achieving IBDQ remission and was associated with improvements in PROs across all age groups. This analysis was limited by the small number of pts in each age group.

Reference

1. Lichtenstein GR et al. Inflamm Bowel Dis. 2022; in press