DDW ePoster Library

LONG-TERM (5-YEAR) MAINTENANCE OF CLINICALLY MEANINGFUL IMPROVEMENT IN HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE TREATED WITH USTEKINUMAB IN THE IM-UNITI LONG-TERM EXTENSION STUDY
DDW ePoster Library. Sandborn W. 05/22/21; 320378; Sa576
Dr. William Sandborn
Dr. William Sandborn
Contributions
Abstract

Number: Sa576
LONG-TERM (5-YEAR) MAINTENANCE OF CLINICALLY MEANINGFUL IMPROVEMENT IN HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE TREATED WITH USTEKINUMAB IN THE IM-UNITI LONG-TERM EXTENSION STUDY

Society: AGA
Track: Inflammatory Bowel Diseases
Category: Immunology‚ Microbiology & Inflammatory Bowel Diseases

Author(s): William J. Sandborn1, Subrata Ghosh2, Chenglong Han3, Christopher Gasink4, Bin Zou5, Brian G. Feagan61 University of California San Diego, La Jolla, California, United States; 2 University of Birmingham, Birmingham, Birmingham, United Kingdom; 3 Janssen Global Services, Malvern, Pennsylvania, United States; 4 Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, United States; 5 Janssen Research and Development LLC, Spring House, Pennsylvania, United States; 6 Robarts Clinical Trials, London, Ontario, Canada

Background: In the IM-UNITI study, subcutaneous (SC) ustekinumab (UST) was safe and efficacious for maintenance therapy in patients with moderately to severely active Crohn's disease (CD) who responded to UST induction therapy. In the long-term extension (LTE) of IM-UNITI, UST therapy maintained clinically meaningful improvement in health-related quality of life (HRQoL) through Week (Wk) 140. Here, we present the final HRQoL results for patients who received UST in the LTE study through 5 years (Wk252).
Methods: Patients who completed the Wk44 IM-UNITI study safety and efficacy evaluations were eligible to continue their regimen in the LTE study (UST 90 mg every 12 weeks [q12w] or UST 90 mg every 8 weeks [q8w]; placebo group not evaluated in this analysis). HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a 32-item questionnaire with 4 dimensions (bowel symptoms, systemic symptoms, emotional function, and social function [total score 32 to 224]) and the Medical Outcomes Study 36-Item Short Form (SF-36; mental and physical component summary [MCS and PCS] scores, each scored 0 to 100); higher scores indicate better quality of life. Clinically meaningful improvement was defined as an IBDQ change ≥16 points or change in SF-36 MCS or PCS score ≥5 points. Data for all treated patients from randomized and nonrandomized populations were summarized through Wk252. For continuous endpoints, patients who had a treatment failure between Wk44 and Wk252 had their induction baseline value carried forward and patients who had insufficient data had their last value carried forward. Binary endpoints were analyzed using a nonresponder imputation approach (patients who had a treatment failure between Wk44 and Wk252 or who had insufficient data were considered not to have achieved clinically meaningful improvement).
Results: Mean IBDQ scores (Table 1) and SF-36 scores (Table 2) at maintenance baseline were comparable for both UST regimens. At Wk252, for both UST regimens, the improvements in IBDQ and SF-36 scores that were achieved by maintenance baseline were maintained; further improvement was observed in IBDQ bowel and emotional symptoms scores. From baseline to Wk252, 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. Clinically meaningful improvement was also observed for both UST regimens in SF-36 PCS (90 mg q12w, 37.5%; 90 mg q8w, 37.7%) and MCS scores (90 mg q12w, 33.9%; 90 mg q8w, 31.0%) during the same period.
Conclusion: 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.

Number: Sa576
LONG-TERM (5-YEAR) MAINTENANCE OF CLINICALLY MEANINGFUL IMPROVEMENT IN HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE TREATED WITH USTEKINUMAB IN THE IM-UNITI LONG-TERM EXTENSION STUDY

Society: AGA
Track: Inflammatory Bowel Diseases
Category: Immunology‚ Microbiology & Inflammatory Bowel Diseases

Author(s): William J. Sandborn1, Subrata Ghosh2, Chenglong Han3, Christopher Gasink4, Bin Zou5, Brian G. Feagan61 University of California San Diego, La Jolla, California, United States; 2 University of Birmingham, Birmingham, Birmingham, United Kingdom; 3 Janssen Global Services, Malvern, Pennsylvania, United States; 4 Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, United States; 5 Janssen Research and Development LLC, Spring House, Pennsylvania, United States; 6 Robarts Clinical Trials, London, Ontario, Canada

Background: In the IM-UNITI study, subcutaneous (SC) ustekinumab (UST) was safe and efficacious for maintenance therapy in patients with moderately to severely active Crohn's disease (CD) who responded to UST induction therapy. In the long-term extension (LTE) of IM-UNITI, UST therapy maintained clinically meaningful improvement in health-related quality of life (HRQoL) through Week (Wk) 140. Here, we present the final HRQoL results for patients who received UST in the LTE study through 5 years (Wk252).
Methods: Patients who completed the Wk44 IM-UNITI study safety and efficacy evaluations were eligible to continue their regimen in the LTE study (UST 90 mg every 12 weeks [q12w] or UST 90 mg every 8 weeks [q8w]; placebo group not evaluated in this analysis). HRQoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a 32-item questionnaire with 4 dimensions (bowel symptoms, systemic symptoms, emotional function, and social function [total score 32 to 224]) and the Medical Outcomes Study 36-Item Short Form (SF-36; mental and physical component summary [MCS and PCS] scores, each scored 0 to 100); higher scores indicate better quality of life. Clinically meaningful improvement was defined as an IBDQ change ≥16 points or change in SF-36 MCS or PCS score ≥5 points. Data for all treated patients from randomized and nonrandomized populations were summarized through Wk252. For continuous endpoints, patients who had a treatment failure between Wk44 and Wk252 had their induction baseline value carried forward and patients who had insufficient data had their last value carried forward. Binary endpoints were analyzed using a nonresponder imputation approach (patients who had a treatment failure between Wk44 and Wk252 or who had insufficient data were considered not to have achieved clinically meaningful improvement).
Results: Mean IBDQ scores (Table 1) and SF-36 scores (Table 2) at maintenance baseline were comparable for both UST regimens. At Wk252, for both UST regimens, the improvements in IBDQ and SF-36 scores that were achieved by maintenance baseline were maintained; further improvement was observed in IBDQ bowel and emotional symptoms scores. From baseline to Wk252, 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. Clinically meaningful improvement was also observed for both UST regimens in SF-36 PCS (90 mg q12w, 37.5%; 90 mg q8w, 37.7%) and MCS scores (90 mg q12w, 33.9%; 90 mg q8w, 31.0%) during the same period.
Conclusion: 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.

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