Table III.

GEMINI 1 and GEMINI 2 Patient Vedolizumab ADA Status Using the ELISA

	Maintenance study ITTa			Non-ITT		Combined
	Placebob (from week 6)	Vedolizumab Q8W	Vedolizumab Q4W	Placeboc (from week 0)	Vedolizumab Q4W (week 6 nonresponders)	Continuous vedolizumabd
ADA status up to week 52, n (%)	N = 279	N = 276	N = 279	N = 296	N = 879	N = 1434
ADA negative	234 (84)	268 (97)	276 (99)	288 (97)	834 (95)	1378 (96)
ADA positive	45 (16)	8 (3)	3 (1)	8 (3)	45 (5)	56 (4)
Transiently positive	14	6	3	3	38	47
Persistently positive	31	2	0	5	7	9
Any neutralizing ADA positivee	24	4	3	4	26	33
ADA status at week 66,f n (%)	N = 24	N = 26	N = 35	N = 47	N = 259	N = 320
ADA positive	2 (8)	4 (15)	1 (3)	0	27 (10)	32 (10)

Not all patients had evaluable samples. N = total number of patients with samples tested in each treatment group. Proportions are based on nonmissing values

ADA vedolizumab anti-drug antibody, ELISA enzyme-linked immunosorbent assay, ITT intent to treat, Q4W every 4 weeks, Q8W every 8 weeks

^aPatients who were responders to vedolizumab induction at week 6 and were randomized into the maintenance-phase ITT population

^bPatients who received vedolizumab during induction and were randomized to placebo at the maintenance phase

^cPatients who were randomized to placebo at both the induction and maintenance phases

^dAll patients who received induction and maintenance vedolizumab, including week 6 responders who were randomized to vedolizumab in the maintenance phase plus patients who did not respond at week 6 and received maintenance vedolizumab Q4W

^eSamples positive for neutralizing ADAs with no reportable titer were considered missing (i.e., no detectable positive neutralizing ADA was present in the sample)

^fWeek 66 was the final safety visit and approximately 4.5 to 5 half-lives after the last dose of vedolizumab; 320 samples were available for this analysis