SUMMARY OF THE IM-UNITI EXTENSION STUDY

Tables

Table 38Patient Disposition in the Long-Term Extension Study

	PLA SC^a	UST
	PLA SC^a	90 mg SC q.12.w.^a	90 mg SC q.8.w.^a	Prior dosage adjustment^b
Randomized patients in clinical response at week 44^c
N	▬	▬	▬	▬
Treatment discontinuation from week 44 to week 96, n (%)	▬	▬	▬	▬
Reasons for discontinuations, n (%)
AEs	▬	▬	▬	▬
Lack of efficacy	▬	▬	▬	▬
Protocol violation	▬	▬	▬	▬
Study termination by sponsor	▬	▬	▬	▬
Physician decision^d	▬	▬	▬	▬
Lost to follow-up^d	▬	▬	▬	▬
Withdrawn consent^d	▬	▬	▬	▬
Death, n (%)	▬	▬	▬	▬
Placebo patients who discontinued study treatment due to unblinding (after week 44 analysis completed), n (%)	▬	▬	▬	▬
	PLA SC^e	90 mg SC q.12.w.^f	90 mg SC q.8.w.^g	-
Non-randomized patients in clinical response at week 44^c
N	▬	▬	▬	-
Treatment discontinuation from week 44 to week 96, n (%)	▬	▬	▬	-
Reasons for discontinuations, n (%)
AEs	▬	▬	▬	-
Lack of efficacy	▬	▬	▬	-
Protocol violation	▬	▬	▬	-
Study termination by sponsor	▬	▬	▬	-
Physician decision^d	▬	▬	▬	-
Lost to follow-up^d	▬	▬	▬	-
Withdrawn consent^d	▬	▬	▬	-
Death, n (%)	▬	▬	▬	-
Placebo patients who discontinued study treatment due to unblinding (after week 44 analysis completed), n (%)	▬	▬	▬	-

: AE = adverse event; PLA = placebo; q.8.w. = every eight weeks; q.12.w. = every 12 weeks; SC = subcutaneous; UST = ustekinumab.
a: ▬⁶⁸
b: ▬⁶⁸
c: ▬⁶⁸
d: ▬
e: ▬⁶⁸
f: ▬⁶⁸
g: ▬⁶⁸
: Source: Clinical Study Report.⁶⁸

Table 39Clinical Outcomes for the Long-Term Extension Study

	PLA SC^a	UST
	PLA SC^a	90 mg SC q.12.w.^a	90 mg SC q.8.w.^a	90 mg SC q.8.w. prior dosage adjustment^b
Randomized patients in clinical response at week 44^c
N	▬	▬	▬	▬
Clinical remission, n (%)
Week 44	▬	▬	▬	▬
Week 92^c,^d	▬	▬	▬	▬
Steroid-free clinical remission, n (%)
Week 92^c,^d,^e	▬	▬	▬	▬
	PLA SC^f	90 mg SC q.12.w.^g	90 mg SC q.8.w.^h
Non-randomized patients in clinical response at week 44^c
N	▬	▬	▬	-
Clinical remission, n (%)
Week 44	▬	▬	▬	-
Week 92	▬	▬	▬	-
Steroid-free clinical remission, n (%)
Week 92^c,^d,^e	▬	▬	▬	-

: PLA = placebo; q.8.w. = every eight weeks; q.12.w. = every 12 weeks; SC = subcutaneous; UST = ustekinumab.
a: ▬⁶⁸
b: ▬⁶⁸
c: ▬⁶⁸
d: ▬⁶⁸
e: ▬⁶⁸
f: ▬⁶⁸
g: ▬⁶⁸
h: ▬⁶⁸
: Source: Clinical Study Report.⁶⁸

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Contents

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APPENDIX 6SUMMARY OF THE IM-UNITI EXTENSION STUDY

Objective

Findings

Study Design

Results

Clinical Remission

Steroid-Free Clinical Remission

Disease–Related Surgery Through Week 92

Limitations

Summary

Tables

Table 38Patient Disposition in the Long-Term Extension Study

Table 39Clinical Outcomes for the Long-Term Extension Study