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Data show clinically meaningful improvement in IBDQ score and MCS score in patients treated with UST.
Investigators, led by William J. Sandborn, MD, University of California San Diego, found in a long-term extension of the IM-UNITI study, ustekinumab (UST) therapy maintained a clinically meaningful improvement in health-related quality of life (HRQoL).
Previous data from the IM-UNITI study found subcutaneous UST was safe and effective for maintenance therapy in patients with moderate to severe Crohn’s disease who responded to UST induction therapy.
The study was presented online at the Digestive Disease Week Annual Meeting.
The study included patients who completed the Week 44 IM-UNITI study safety and efficacy evaluations, who were then eligible to continue regimen in the LTE study.
The regime included UST 90mg every 12 weeks (q12w) or UST 90mg every 8 weeks (q8w).
Investigators assessed the HRQoL using the Inflammatory Bowel Disease Questionnaire (IBDQ), which included 32-tems with 4 dimensions (bowel symptoms, systemic symptoms, emotional function, social function) and a total score of 32 to 224.
They also used the Medical Outcomes Study 36-Item Short Form (SF-36), a mental component score (MCS) and physical component score (PCS) summary, each score 0 – 100. A higher score indicated better quality of life.
Investigators defined clinically meaningful improvement as an IBDQ change ≥16 points or change in SF-36 MCS or PCS score ≥5 points.
Further, data for treated patients from both randomized and nonrandomized populations were summarized through week 252.
For patients who had treatment failure between week 44 and week 252, investigators had their induction baseline carried forward and patients with insufficient data had their last value carried forward.
Further, the team analyzed binary endpoints using a nonresponder imputation approach, where the two groups of patients with treatment failure or insufficient data were not considered to have achieved clinically meaningful improvement.
Sandborn and colleagues found the mean IBDQ scores and SF-36 scores at maintenance baseline were comparable in both UST regimens.
The team noted the improvements in IBDQ and SF-36 scores were maintained at week 252 in both UST regiments, with further improvement observed in IBDQ bowel and emotional symptom scores.
Data show from baseline to week 252, the percentage of patients who achieved clinically meaningful improvement in IBDQ total score was 40.8% for UST 90 mg q12w and 43.2% for 90 mg q8w.
Data also show clinically meaningful improvement in both UST regiments in SF-36 PCS (90 mg q12w, 37.5%; 90 mg q8w, 37.7%), as well as MCS scores (90 mg q12w, 33.9%; 90 mg q8w, 31.0%).
“Long-term (5 years) treatment with UST 90 mg q12w or 90 mg q8w was effective at maintaining improvements in HRQoL that were achieved during UST induction therapy in patients with CD,” investigators wrote.
The study, “Long-Term (5-Year) Maintenance of Clinically Meaningful Improvements in Health-Related Quality of Life,” was presented online at DDW.