Introduction: In the IM-UNITI study, subcutaneous ustekinumab (UST) was safe & efficacious for maintenance in moderately to severely active CD patients who responded to UST induction therapy. In the IM-UNITI LTE, UST maintained clinically meaningful improvement in HRQoL through Week (W) 140. We present the final HRQoL results for patients receiving UST in LTE study through 5 years (W252).

Methods: Patients completing the W44 IM-UNITI study safety & e ficacy evaluations were eligible to continue in the LTE (UST 90 mg every 12W [Q12W] or UST 90 mg Q8W; placebo not evaluated). HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) & Medical Outcomes Study 36-Item Short Form (SF-36). Clinically meaningful improvement was defined as an IBDQ change ≥ 16 points or change in SF-36 mental component summary (MCS) or physical component summary (PCS) score ≥ 5 points. Data for all treated patients from randomized/nonrandomized populations were summarized through W252. For continuous endpoints, patients with treatment failure between W44-W252 had induction baseline (BL) values carried forward and patients with insu ficient data had last value carried forward. Binary endpoints were analyzed using a nonresponder imputation approach.

Results: Mean IBDQ & SF-36 scores (tables) at maintenance BL were comparable for both UST regimens. At W252, for both UST regimens, improvements in IBDQ & SF-36 scores that were achieved by maintenance BL were maintained; further improvement was observed in IBDQ bowel & emotional symptoms scores. From BL to W252, clinically meaningful improvement in IBDQ total score was achieved (Q12W: 40.8%; Q8W: 43.2%). Clinically meaningful improvement was also observed in SF- 36 PCS (Q12W: 37.5%; Q8W: 37.7%) and MCS scores (Q12W: 33.9%; Q8W: 31.0%).

Conclusions: Long-term (5 years) treatment with UST 90 mg (Q12W/Q8W) was effective at maintaining improvements in HRQoL that were achieved during UST induction therapy in CD patients.