Table 3:
Tuberculosis in Vedolizumab Clinical Trials
| Study in Which Event Reported (Days From First VDZ Dose to TB) | Sex, Age, Indication | Events | Serious? | Intensity | Other Medical History | Induction treatment in GEMINI 1/2/3 (first 6 wk) | Maintenance Treatment in GEMINI 1/2/3 (≤52 wk) | Relationship to VDZ (Investigator’s Assessment) | Concomitant Medication | Prior Medication | Was VDZ discontinued? | Country (total VDZ exposure in country) | Incidence of TB in country of origin (per 100,000 people) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GEMINI LTS (938) | Male, 19 y, Crohn’s disease | Latent TB*† Pharyngitis | No‡ | Moderate | Tonsillectomy | Placebo (GEMINI 3) | NA§ | No | Azathioprine, loperamide, mesalazine, omeprazole | Azithromycin | Yes | Slovakia (56.2 PY) | 6.5 |
| GEMINI 2 (46) | Male, 38 y, Crohn’s disease | Latent TB* | Yes | Mild | NR | Vedolizumab | Vedolizumab Q4W | Yes | Mesalazine | Azathioprine, mesalazine, prednisone | Yes | Czech Republic (314.9 PY) | 5.2 |
| GEMINI LTS (105) | Female, 30 y, ulcerative colitis | Pulmonary TB | Yes | Moderate | NR | Vedolizumab (GEMINI 1) | Placebo (GEMINI 1) | No | Not reported | Azathioprine, Bacillus subtilis/ Streptococcus faecalis (Medilac-S), infliximab, mesalazine, prednisone | Yes, but prior to onset of TB because of lack of efficacy | Republic of Korea (110.4 PY) | 80 |
| GEMINI LTS (72 and 82) | Male, 31 y, Crohn’s disease | Pulmonary TB (2 events) | Event 1: Yes Event 2: No‡ |
Event 1: Moderate Event 2: Mild |
Gastrointestinal TB Anemia Peritonitis |
Placebo (GEMINI 2) | Placebo (GEMINI 2) | Yes | Budesonide | Unspecified anti-TB drugs, mesalazine, methylprednisolone | Yes | India (145.0 PY) | 217 |
| GEMINI LTS (141) | Female, 23 y, Crohn’s disease | Pulmonary TB | Yes | Moderate | Hiatal hernia Craniocerebral injury Craniotomy Anemia Thrombocytosis Hypoalbuminemia Arthritis Chronic gastritis Recurrent peptic ulcer Gastroesophageal reflux disease Rhinopharyngitis |
Vedolizumab (GEMINI 2) | Vedolizumab Q8W (GEMINI 2) | Yes | Azathioprine, desogestrel-ethinyl estradiol, mesalazine, prednisone | Ciprofloxacin, ferrous sulfate, folic acid, infliximab, iron preparations, mesalazine, omeprazole, proton pump inhibitors | Yes | Russian Federation (170.1 PY) | 80 |
*Not reported as part of the patient’s concomitant or previous medical history (diagnosed after the start of treatment with VDZ).
†On the date of event onset, the patient had a non-productive cough and physical examination results were normal. The diagnosis of latent TB infection was confirmed by Mycobacterium tuberculosis complex tests.
‡Two events of TB were assessed by the investigator as nonserious.
§GEMINI 3 was only 10 weeks in duration (no maintenance phase).
LTS indicates long-term safety; NA, not applicable; NR, not reported; PY, patient-years; Q4W, once every 4 weeks; Q8W, once every 8 weeks; TB, tuberculosis; VDZ, vedolizumab.