Table 2.
Clinical outcomes at 16 weeks in the intention-to-treat B-cell poor population
|
Histological classification |
RNA sequencing classification |
|||||||
|---|---|---|---|---|---|---|---|---|
| Rituximab (n=38) | Tocilizumab (n=41) | Treatmenteffect | Unadjusted p value | Rituximab (n=33) | Tocilizumab (n=32) | Treatmenteffect | Unadjusted p value | |
| Primary endpoint* | ||||||||
| CDAI ≥50% improvement at week 16 | 17 (45%) | 23 (56%) | 11% (−11 to 33) | 0·31 | 12 (36%) | 20 (63%) | 26% (3 to 50) | 0·035 |
| Supplementary endpoint* | ||||||||
| CDAI ≥50% improvement and CDAI ≤10·1 at week 16 | 9 (24%) | 19 (46%) | 23% (2 to 43) | 0·035 | 4 (12%) | 16 (50%) | 38% (17 to 59) | 0·0012 |
| Binary secondary endpoints* | ||||||||
| CDAI ≤10·1 at week 16 | 11 (29%) | 19 (46%) | 17% (−3 to 38) | 0·11 | 5 (15%) | 16 (50%) | 35% (14 to 56) | 0·0036 |
| DAS28-ESR ≤3·2 at week 16 | 10 (26%) | 18 (44%) | 18% (−4 to 38) | 0·10 | 6 (18%) | 17 (53%) | 35% (13 to 57) | 0·0032 |
| DAS28-CRP ≤3·2 at week 16 | 12 (32%) | 19 (46%) | 15% (−7 to 36) | 0·18 | 7 (21%) | 16 (50%) | 29% (7 to 51) | 0·015 |
| DAS28-ESR ≤2·6 at week 16 | 6 (16%) | 15 (37%) | 21% (2 to 40) | 0·037 | 3 (9%) | 13 (41%) | 32% (12 to 51) | 0·004 |
| DAS28-CRP ≤2·6 at week 16 | 7 (18%) | 13 (32%) | 13% (−6 to 32) | 0·17 | 4 (12%) | 10 (31%) | 19% (0 to 39) | 0·076 |
| Moderate or good EULAR DAS28-ESR response at week 16 | 25 (66%) | 36 (88%) | 22% (4 to 40) | 0·031 | 21 (64%) | 30 (94%) | 30% (12 to 49) | 0·0053 |
| Moderate or good EULAR DAS28-CRP response at week 16 | 22 (58%) | 32 (78%) | 20% (0 to 40) | 0·054 | 18 (55%) | 27 (84%) | 30% (9 to 51) | 0·015 |
| Continuous secondary endpoints† | ||||||||
| CDAI, least squares mean change at week 16 | −12·1 (1·9) | −15·7 (1·9) | 3·6 (−1·7 to 8·9) | 0·18 | −10·9 (2·0) | −17·2 (2·0) | 6·3 (0·7 to 12·0) | 0·029 |
| DAS28-ESR, least squares mean change at week 16 | −1·5 (0·2) | −2·6 (0·2) | 1·1 (0·5 to 1·7) | 0·0006 | −1·3 (0·2) | −2·8 (0·2) | 1·5 (0·9 to 2·2) | <0·0001 |
| DAS28-CRP, least squares mean change at week 16 | −1·3 (0·2) | −2·0 (0·2) | 0·7 (0·1 to 1·3) | 0·032 | −1·1 (0·2) | −2·1 (0·2) | 1·0 (0·4 to 1·6) | 0·0021 |
| HAQ, least squares mean change at week 16 | −0·3 (0·1) | −0·4 (0·1) | 0·1 (−0·1 to 0·3) | 0·40 | −0·2 (0·1) | −0·2 (0·1) | <0·1 (−0·2 to 0·2) | 0·91 |
| FACIT, least squares mean change at week 16 | 1·6 (1·1) | 5·6 (1·1) | −4·0 (−7·2 to −0·8) | 0·015 | 2·1 (1·4) | 4·9 (1·4) | −2·8 (−6·9 to 1·2) | 0·16 |
| SF36-PCS, least squares mean change at week 16 | 4·1 (1·5) | 7·3 (1·5) | −3·2 (−7·4 to 0·9) | 0·12 | 3·5 (1·5) | 4·3 (1·5) | −0·8 (−5·0 to 3·5) | 0·72 |
| SF36-MCS, least squares mean change at week 16 | −0·7 (1·6) | 2·1 (1·6) | −2·8 (−7·3 to 1·8) | 0·22 | 0·9 (1·8) | 4·5 (1·9) | −3·7 (−8·8 to 1·5) | 0·16 |
Data are n (%) or least squares mean (SD), unless otherwise specified. Patients classified histologically are compared with those categorised with RNA sequencing. CDAI=Clinical Disease Activity Index. CRP=C-reactive protein. DAS28=28 joint count Disease Activity Score. EULAR=European League against Rheumatism. ESR=erythrocyte sedimentation rate. FACIT=Functional Assessment of Chronic Illness Therapy. HAQ=Health Assessment Questionnaire. SF36-MCS=Mental Components Summary of the SF-36 questionnaire. SF36-PCS=Physical Components Summary of the SF-36 questionnaire. SF36=36-Item Short Form Health Survey.
Treatment effect measured with percentage difference (95% CI).
Treatment effect measured with least squares mean (95% CI).