Central reading of endoscopic findings was used for eligibility and primary and key secondary efficacy endpoint analyses. Eligible patients were randomised to XELJANZ 10 mg BID, 5 mg BID, or placebo during maintenance.¹
Patients were eligible to enter the OCTAVE Sustain trial if they had a clinical response during OCTAVE Induction 1 or 2.
Patients had a mean Total Mayo score of 3.3 at the baseline of OCTAVE Sustain (n=59 3). 45% of patients had failed previously failed TNFi; 75% corticosteroids; 70% immunosuppressant therapy.¹

The rates of mucosal healing at Week 8 were significantly higher with XELJANZ 10 mg BID vs. placebo.¹

Maintenance therapy with XELJANZ at a dose of either 5 mg or 10 mg BID was significantly more effective at Week 52 than placebo in leading to mucosal healing.¹

Mucosal healing was defined as improvement in the endoscopic appearance of the mucosa to subscore 0 or 1.¹

Adapted from Sandborn WJ et al. 2017.¹ Patients who were eligible to enter OCTAVE Sustain were randomised to receive XELJANZ 5 mg BID, 10 mg BID, or placebo for maintenance.
Patients were eligible to enter the OCTAVE Sustain trial if they had a clinical response during OCTAVE induction 1 or 2.
Patients had a mean Total Mayo score of 3.3 at the baseline of OCTAVE Sustain (n=593). 45% of patients had previously failed TNFi; 75% corticosteroids; 70% inmunosuppressant therapy.¹

Corticosteroid tapering and withdrawal while maintaining remission is a core goal of treatment in UC. Almost 40% of patients who had failed on TNFi achieved sustained steroid-free remission with XELJANZ 10 mg BID.²

Sustained steroid-free remission was defined as being in remission and using no corticosteroids for at least 4 weeks prior to the visit at both Week 24 and Week 52.²

Central Read data from the OCTAVE Sustain Study. The majority (88%) of patients in the OCTAVE Sustain trial had received XELJ ANZ during the induction trial, and 30% were in remission at maintenance-trial entry.¹

BID=twice daily; TNFi=tumour necrosis factor inhibitor.

References