Tofacitinib ( Xeljanz ) is an oral, small molecule Janus kinase [ JAK ] inhibitor that is being investigated for ulcerative colitis [ UC ].
Researchers have evaluated health-related quality of life [ HRQoL ] in Tofacitinib UC phase 3 studies.
Patients ( greater than or equal to 18 years old ) in OCTAVE Induction 1 [ N = 598 ] and 2 [ N = 541 ] with moderately to severely active ulcerative colitis were randomised [ 1:4 ] to placebo or Tofacitinib 10 mg twice daily [ BID ] for 8 weeks.
Subsequently, OCTAVE Sustain re-randomised [ 1:1:1 ] clinical responders [ N = 593 ] from induction studies to placebo, Tofacitinib 5 mg BID, or 10 mg BID, for 52 weeks.
Inflammatory Bowel Disease Questionnaire [ IBDQ ] and SF-36v2 Health Survey [ SF-36v2 ] assessed HRQoL.
In OCTAVE Induction 1 and 2, mean changes from baseline IBDQ were greater with Tofacitinib 10 mg BID at week 8 [ 40.7 and 44.6 ] versus placebo [ 21.0 and 25.0; p less than 0.0001 ]; mean changes from baseline SF-36v2 Physical and Mental Component Summaries [ PCS/MCS ] were also greater with 10 mg BID [ PCS: 6.8 and 6.8; MCS: 6.8 and 7.6 ] versus placebo [ PCS: 2.5 and 4.6; MCS: 3.5 and 4.4; p less than 0.01 ].
In OCTAVE Sustain at week 52, changes in IBDQ were maintained with Tofacitinib 5 mg [ 3.7 ] and 10 mg BID [ 4.8 ], and larger with placebo [ -26.5; p less than 0.0001 ].
Changes in SF-36v2 PCS/MCS were also maintained with 5 mg [ PCS: 0.0; MCS: -1.0 ] and 10 mg BID [ PCS: 0.3; MCS: 0.1 ] versus placebo [ PCS: -5.2; MCS: -6.7; p less than 0.0001 ] at week 52 in OCTAVE Sustain.
In conclusion, Tofacitinib 10 mg BID induction therapy significantly improved HRQoL versus placebo at week 8.
Improvements were maintained through 52 weeks’ maintenance therapy with Tofacitinib 5 mg and 10 mg BID. ( Xagena )
Panes J et al, Journal of Crohn's and Colitis 2018; 12: 145–156