Table 2.
Key primary and secondary outcomes at week 4 and 12
| Continue methotrexate (n=127) | Suspend methotrexate (n=127) | Mixed-effects model | ||
|---|---|---|---|---|
| Anti-S1-RBD titres, U/mL | ||||
| Absolute titres (mean [SD]) | ||||
| Baseline | 3448 (11649; n=125) | 4011 (18 325; n=124) | .. | |
| 4 weeks | 17 682 (20 872; n=126) | 34 556 (38 323; n=124) | .. | |
| 12 weeks | 14 060 (14 698; n=124) | 27 407 (35 665; n=117) | .. | |
| Log10 values, U/mL (geometric mean titre [95% CI]) | ||||
| Baseline | 546 (394 to 757; n=125) | 530 (385 to 729; n=124) | .. | |
| 4 weeks | 10 798 (8970 to 12 997; n=126) | 22 750 (19 314 to 26 796; n=124) | GMR 2·19 (95% CI 1·57 to 3·04; p<0·0001)* | |
| 12 weeks | 8094 (6587 to 9946; n=124) | 16 520 (13 787 to 19 794; n=117) | GMR 2·11 (95% CI 1·51 to 2·94; p<0·0001)* | |
| EQ-5D-5L utility (mean [SD]) | ||||
| Baseline | 0·81 (0·17; n=127) | 0·77 (0·20; n=126) | .. | |
| 4 weeks | 0·79 (0·17; n=124) | 0·75 (0·20; n=122) | Mean difference −0·006 (95% CI −0·039 to 028) | |
| 12 weeks | 0·78 (0·19; n=125) | 0·75 (0·21; n=120) | Mean difference −0·005 (95% CI −0·038 to 0·029) | |
| EQ-VAS (mean [SD]) | ||||
| Baseline | 79·3 (16·5; n=127) | 77·4 (16·1; n=127) | .. | |
| 4 weeks | 79·0 (14·1; n=124) | 73·8 (19·3; n=122) | Mean difference −4·26 (95% CI −8·10 to −0·42) | |
| 12 weeks | 75·6 (18·5; n=125) | 71·2 (20·5; n=119) | Mean difference −4·08 (95% CI −7·93 to −0·24) | |
| Disease impact (general health; mean [SD]) | ||||
| Baseline | 8·00 (1·91; n=127) | 7·38 (2·01; n=127) | .. | |
| 2 weeks | 7·37 (1·78; n=123) | 6·97 (2·00; n=124) | Mean difference 0·06 (95% CI −0·40 to 0·52) | |
| 4 weeks | 7·61 (1·90; n=120) | 6·97 (2·11; n=118) | Mean difference −0·17 (95% CI −0·63 to 0·29) | |
| 12 weeks | 7·33 (2·02; n=124) | 6·93 (2·10; n=120) | Mean difference 0·09 (95% CI −0·36 to 0·55) | |
| Experienced ≥1 flare-up | ||||
| 0–4 weeks | 38/124 (31%) | 69/123 (56%) | OR 3·10 (95% CI 1·78 to 5·40)† | |
| 0–12 weeks | 56/125 (45%) | 85/120 (71%) | OR 2·83 (95% CI 1·64 to 4·88)† | |
Logistic regression models at 4 and 12 weeks were adjusted by baseline value, randomisation factors (ie, age, inflammatory condition, vaccine platform), previous infection, and booster platform. Mixed-effects model were adjusted by baseline value, randomisation factors (ie, age, inflammatory condition, vaccine platform), previous infection, and booster platform (main analysis), and include a treatment-by-time interaction. Missing information on booster vaccine received by three participants means total numbers in the model are lower at 4 weeks. GMR=geometric mean ratio. OR=odds ratio. S1-RBD=S1 subunit of spike protein in receptor-binding domain.
Main analysis.
Calculated using a logistic regression model; a flare-up was counted if it was reported at either 4 or 12 weeks for the 0–12 weeks outcome.