P467 Maintenance of quality of life improvement in a phase 3 study of tofacitinib for patients with moderately to severely active ulcerative colitis

Abstract

Introduction Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib 10 mg twice daily (BID) improved quality of life (QoL) in the Phase 3 OCTAVE Induction 1 and 2 studies of patients (pts) with moderate to severe UC.1 Method OCTAVE Sustain (NCT01458574) was a Phase 3, 52 week, randomised, double-blind, placebo (Pbo)-controlled study in pts completing OCTAVE Induction 1 or 2 with clinical response (>=3 points and >=30% decrease from baseline (BL) Mayo score plus decrease in rectal bleeding subscore (RBSS) of >=1 or RBSS =170) and Response (>=16 point improvement from induction BL IBDQ Score) were compared by Cochran- Mantel-Haenszel chi-square test. Continuous endpoints were analysed using a linear mixed-effects model. Results OCTAVE Sustain randomised 593pts (Pbo: n=198; 5 mg BID: n=198; 10 mg BID: n=197). At Sustain BL, mean IBDQ total score ranged from 166.7-167.7, and mean SF-36 PCS and MCS ranged from 49.3-50.5 and 47.8-49.0, respectively, across groups. There was minimal change from BL at Week 24 and 52 in the total IBDQ scores in the tofacitinib groups, while there was a worsening (decrease) in the Pbo group. Both the tofacitinib 5 and 10 mg BID groups showed significant difference in change from Sustain BL in total IBDQ scores at Weeks 24 and 52 compared to Pbo (all p<0.001) (Table). Significantly more patients achieved IBDQ remission and response with both tofacitinib doses vs Pbo at all time points (all p<0.001) (Table). Mean changes from Sustain BL in SF-36 PCS and MCS and all individual domain scores showed similar benefit with both tofacitinib doses vs Pbo at Weeks 24 and 52 (all p<0.001) (Table). Conclusion For pts with moderate to severe UC and clinical response to induction therapy, significant and clinically meaningful improvements in QoL (IBDQ; SF-36) were maintained with tofacitinib 5 and 10 mg BID vs Pbo through 52 weeks maintenance therapy.