Table 1.
Patient characteristics for women who received tofacitinib and became pregnant in the RA and psoriasis clinical trials
| Characteristic | RA | Psoriasis |
|---|---|---|
| Patients with reports of pregnancy (n/N of female patients aged 18–44a) | 31/1309 (2.4 %) | 16/512 (3.1 %) |
| Median age (range), yearsb | 31 (22–40) | 27 (19–40) |
| Study medication (n; % of identified cases) | Tofacitinib monotherapy (18; 58.1 %) Tofacitinib + MTX (13; 41.9 %) |
Tofacitinib monotherapy (16; 100 %) |
| Pregnancy outcomes, n (% of identified cases) | ||
| Fetal death | 0 (0.0 %) | 0 (0.0 %) |
| Congenital malformation | 1 (3.2 %) | 0 (0.0 %) |
| Spontaneous abortion | 6 (19.4 %) | 1 (6.3 %) |
| Healthy newborn | 16 (51.6 %) | 9 (56.3 %) |
| Medical termination | 4 (12.9 %) | 4 (25.0 %) |
| Lost/pending to follow-up | 4 (12.9 %) | 2 (12.5 %) |
| Range of total time on study medication at time of pregnancy identification, range, daysc | 28–1344 | 21–349 |
| Duration of in utero study medication exposure, daysd | ||
| Range | 7–244 | 14–43 |
| ≤90 days | 29 cases | 16 cases |
| >90 and ≤180 days | 1 case | 0 case |
| >180 days | 1 case | 0 case |
MTX methotrexate, RA rheumatoid arthritis
aEnrolled in RA or psoriasis clinical trials
bBased on 30 and 15 patients with data, respectively
cData available for n = 26 and n = 10 patients in the RA and psoriasis clinical trials, respectively
dBased on when pregnancy occurred and when the subject was discontinued from the study drug