Tofacitinib in Patients with Ulcerative Colitis: health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies

Background and Aims: Tofacitinib is an oral, small molecule Janus kinase [JAK] inhibitor that is being investigated for ulcerative colitis [UC]. We evaluated health‐related quality of life [HRQoL] in tofacitinib UC Phase 3 studies. Methods: Patients ≥ 18 years old in OCTAVE Induction 1 [N = 598] and 2 [N = 541] with moderately to severely active UC 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. Results: In OCTAVE Induction 1 and 2, mean changes from baseline IBDQ were greater with tofacitinib 10 mg BID at Week 8 [28.9 and 31.5] versus placebo [15.4 and 17.2; p < 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 < 0.01]. In OCTAVE Sustain atWeek 52, changes in IBDQ were maintained with tofacitinib 5 mg [‐1.3] and 10 mg BID [0.6], and larger with placebo [‐20.2; p < 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 < 0.0001] at Week 52 in OCTAVE Sustain. Conclusions: 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. ClinicalTrials.gov registration numbers: NCT01465763, NCT01458951 and NCT01458574.