Study A (patients naive to tofacitinib) primary endpoint: proportion of patients achieving satisfactory* humoral response to pneumococcal and influenza vaccines at 35 days after vaccination, by treatment group and stratified by background MTX use
| Tofacitinib 10 mg twice daily (N=102) | Placebo (N=98) | Percentage difference between treatment groups (95% CI) | |
|---|---|---|---|
| PPSV-23 vaccine | |||
| Overall, n (%) | 46 (45.1) | 67 (68.4) | −23.3 (−36.6 to −9.6) |
| Stratified by MTX use at baseline, n/N (%) | |||
| Yes | 18/57 (31.6) | 34/55 (61.8) | −30.2 (−47.3 to −11.4) |
| No | 28/45 (62.2) | 33/43 (76.7) | −14.5 (−34.8 to 6.2) |
| Influenza vaccine | |||
| Overall, n (%) | 58 (56.9) | 61 (62.2) | −5.4 (−19.3 to 8.5) |
| Stratified by MTX use at baseline, n/N (%) | |||
| Yes | 29/57 (50.9) | 32/55 (58.2) | −7.3 (−25.9 to 11.4) |
| No | 29/45 (64.4) | 29/43 (67.4) | −3.0 (−24.0 to 17.4) |
*Satisfactory response to pneumococcal vaccine defined as a twofold or more titre increase against six or more of 12 pneumococcal serotypes; satisfactory response to influenza vaccine defined as a fourfold or more titre increase against two or more of three influenza antigens.
MTX, methotrexate; PPSV-23, 23-valent pneumococcal polysaccharide vaccine.