Table V.
Infusion-Related Reactions and Immunogenicity Status of Patients During Vedolizumab Maintenance in GEMINI 1 and GEMINI 2 Using the ECL Assay
| Maintenance study ITTa | Non-ITT | Combined | ||||
|---|---|---|---|---|---|---|
| AEs defined by the investigator as infusion-related reactions (yes/no), n (%) | Placebob (from week 6) | Vedolizumab Q8W | Vedolizumab Q4W | Placeboc (from week 0) | Vedolizumab Q4W (week 6 nonresponders) | Continuous vedolizumabd |
| N = 278 | N = 276 | N = 279 | N = 295 | N = 872 | N = 1427 | |
| Yes | 8 | 12 | 18 | 9 | 31 | 61 |
| ADA negative | 5 (63) | 9 (75) | 18 (100) | 9 (100) | 28 (90) | 55 (90) |
| ADA positive | 3 (38) | 3 (25) | 0 | 0 | 3 (10) | 6 (10) |
| Transiently positive | 1 | 2 | 0 | 0 | 2 | 4 |
| Persistently positive | 2 | 1 | 0 | 0 | 1 | 2 |
| Any neutralizing ADA positivee | 2 | 3 | 0 | 0 | 2 | 5 |
| No | 270 | 264 | 261 | 286 | 841 | 1366 |
| ADA negative | 213 (79) | 250 (95) | 251 (96) | 278 (97) | 785 (93) | 1286 (94) |
| ADA positive | 57 (21) | 14 (5) | 10 (4) | 8 (3) | 56 (7) | 80 (6) |
| Transiently positive | 11 | 10 | 8 | 1 | 44 | 62 |
| Persistently positive | 46 | 4 | 2 | 7 | 12 | 18 |
| Any neutralizing ADA positivee | 44 | 7 | 4 | 3 | 40 | 51 |
Not all patients had evaluable samples. N = total number of patients with samples tested in each treatment group. Proportions are based on nonmissing values.
AE adverse event, ADA vedolizumab anti-drug antibody, ECL electrochemiluminescence, 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)