Study B (patients using tofacitinib) primary endpoint: proportion of patients achieving satisfactory* humoral responses at 35 days after vaccination, by treatment subgroup (‘continuous’ and ‘withdrawn’) and stratified by background MTX use
| Tofacitinib 10 mg twice daily | Percentage difference between treatment groups (95% CI) | ||
|---|---|---|---|
| Continuous (N=92) | Withdrawn (N=91) | ||
| PPSV-23 vaccine | |||
| Overall, n (%) | 69 (75.0) | 77 (84.6) | −9.6 (−24.0 to 4.7) |
| Stratified by MTX use at baseline, n/N (%) | |||
| Yes | 36/55 (65.5) | 44/55 (80.0) | −14.5 (−33.3 to 5.0) |
| No | 33/37 (89.2) | 33/36 (91.7) | −2.5 (−25.2 to 20.0) |
| Influenza vaccine | |||
| Overall, n (%) | 61 (66.3) | 58 (63.7) | 2.6 (−12.2 to 16.6) |
| Stratified by MTX use at baseline, n/N (%) | |||
| Yes | 38/55 (69.1) | 34/55 (61.8) | 7.3 (−12.2 to 26.4) |
| No | 23/37 (62.2) | 24/36 (66.7) | −4.5 (−27.8 to 17.7) |
*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.