Table 4.

Summary of events per 100 patient-years from Week 0 through Week 252; all patients and randomized patients entering the LTE

All patients entering the LTE
	Placeboa	Ustekinumab 90 mg q12wb	Ustekinumab 90 mg q8wc	Combined ustekinumab
N	151	213	354	567
Average duration of follow-up (weeks)	105.2	209.0	207.3	208.0
Total patient-years of follow-up	305.5	856.1	1411.4	2267.6
Deaths	0	2	4	6
Number of events per 100 patient -years of follow-up (95% CI)e
Adverse events	440.3 (417.1,464.5)	303.2 (291.7,315.1)	342.3 (332.8,352.1)	327.6 (320.2,335.1)
Serious adverse events	19.3 (14.7,24.9)	18.2 (15.5,21.3)	17.0 (14.9,19.3)	17.5 (15.8,19.3)
Infectionsd	99.8 (88.9,111.7)	91.7 (85.4,98.3)	95.2 (90.1,100.4)	93.8 (89.9,97.9)
Serious infectionsd	3.9 (2.0,6.9)	4.7 (3.3,6.4)	2.7 (1.9,3.7)	3.4 (2.7,4.3)
Malignancies	1.70	1.19	0.99	1.06
Randomized patients entering the LTE
		Ustekinumab
			90 mg SC q8w
				On 90 mg SC q8w due to dose adjustment prior to Week 44
	Placebo SCf.g	Ustekinumab 90 mg q12wf.g	Ustekinumab 90 mg q8wf.g	90 mg SC q8w → 90 mg SC q8wh	placebo SC → 90 mg SC q8wh	90 mg SC q12w → 90 mg SC q8wh	All 90 mg SC q8w	All ustekinumab
N	96	103	99	17	35	19	153	237
Average duration of follow-up (weeks)	71.7	175.3	181.7	170.1	183.0	195.4	202.6	206.9
Total patient-years of follow-up	132.4	347.3	345.9	55.6	123.2	71.4	596.0	943.2
Deaths	0	1	0	0	2	0	2	3
Number of events per 100 patient -years of follow-up
Adverse events	474.44	279.34	301.57	352.44	353.88	423.04	331.71	312.44
Serious adverse events	24.18	12.38	11.85	23.38	12.99	16.81	13.76	13.25
Infectionsd	108.79	84.95	77.20	98.90	92.53	96.66	84.73	84.82
Serious infectionsd	7.55	4.03	3.18	3.60	1.62	1.40	2.68	3.18
Malignancies	1.48	1.11	0	0	1.88	4.90	1.03	1.06

CI, Confidence interval; IV, intravenous; LTE, long-term extension; q12w, every 12 weeks; q8w, every 8 weeks; SC, subcutaneous

^aIncludes: 1) Patients who were in clinical response to ustekinumab IV induction dosing, were randomized and received placebo SC on entry into this maintenance study, and did not meet loss of response criteria from Week 8 through Week 32; 2) Patients who were in clinical response to placebo IV induction dosing and received placebo SC on entry into this maintenance study.

^bIncludes: 1) Patients who were in clinical response to ustekinumab IV induction dosing, were randomized and received ustekinumab 90 mg SC q12w, and did not meet loss of response criteria from Week 8 through Week 32; 2)Patients who were not in clinical response to placebo IV induction dosing, received ustekinumab 130 mg IV at Week 0, achieved clinical response at Week 8, and initiated ustekinumab 90 mg SC q12w.

^cIncludes: 1)Patients who were in clinical response to ustekinumab IV induction dosing, were randomized on entry into this maintenance study, received ustekinumab 90 mg SC q8w, or met loss of response criteria from Week 8 through Week 32 and received ustekinumab 90 mg SC q8w thereafter; 2)Patients who were not in clinical response to ustekinumab IV induction dosing, received ustekinumab 90 mg SC at Week 0, achieved clinical response at Week 8, and initiated ustekinumab 90 mg SC q8w.

^dInfections as assessed by the investigator.

^eConfidence intervals based on an exact method, assuming that the observed number of events follows a Poisson distribution.

^fIncludes: Patient who were in clinical response to ustekinumab IV induction dosing and were randomized to receive study drug on entry to the maintenance study.

^gIncludes data up to the time of meeting loss of response criteria for dose adjustment (occurred from Week 8 through Week 32).

^hIncludes data from the time of meeting loss of response criteria for dose adjustment (occurred from Week 8 through Week 32) onward.