Table 3.
Clinical outcomes at 16 weeks in the intention-to-treat B-cell rich population
|
Histological classification |
RNA sequencing classification |
|||||||
|---|---|---|---|---|---|---|---|---|
| Rituximab (n=33) | Tocilizumab (n=31) | Treatment effect | Unadjusted p value | Rituximab (n=30) | Tocilizumab (n=29) | Treatment effect | Unadjusted p value | |
| Primary endpoint* | ||||||||
| CDAI ≥50% improvement at week 16 | 13 (39%) | 16 (52%) | 12% (−12 to 37) | 0·33 | 15 (50%) | 14 (48%) | −2% (−27 to 24) | 0·89 |
| Supplementary endpoint* | ||||||||
| CDAI ≥50% improvement and CDAI ≤10·1 at week 16 | 5 (15%) | 11 (36%) | 20% (−1 to 41) | 0·085 | 7 (23%) | 9 (31%) | 8% (−15 to 30) | 0·51 |
| Binary secondary endpoints* | ||||||||
| CDAI ≤10·1 at week 16 | 7 (21%) | 12 (39%) | 18% (−5 to 40) | 0·13 | 10 (33%) | 10 (35%) | 1% (−23 to 25) | 0·93 |
| DAS28-ESR ≤3·2 at week 16 | 8 (24%) | 13 (42%) | 18% (−5 to 40) | 0·13 | 9 (30%) | 10 (35%) | 5% (−19 to 28) | 0·71 |
| DAS28-CRP ≤3·2 at week 16 | 12 (36%) | 13 (42%) | 6% (−18 to 30) | 0·65 | 14 (47%) | 11 (38%) | −9% (−34 to 16) | 0·50 |
| DAS28-ESR ≤2·6 at week 16 | 2 (6%) | 11 (36%) | 29% (11 to 48) | 0·0047 | 3 (10%) | 10 (35%) | 25% (4 to 45) | 0·03 |
| DAS28-CRP ≤2·6 at week 16 | 4 (12%) | 9 (29%) | 17% (−3 to 36) | 0·12 | 4 (13%) | 8 (28%) | 14% (−6 to 35) | 0·21 |
| Moderate or good EULAR DAS28-ESR response at week 16 | 25 (76%) | 27 (87%) | 11% (−8 to 30) | 0·34 | 24 (80%) | 24 (83%) | 3% (−17 to 23) | 1·00 |
| Moderate or good EULAR DAS28-CRP response at week 16 | 23 (70%) | 25 (81%) | 11% (−10 to 32) | 0·31 | 23 (77%) | 23 (79%) | 3% (−19 to 24) | 0·81 |
| Continuous secondary endpoints† | ||||||||
| CDAI, least squares mean change at week 16 | −13·2 (2·1) | −14·2 (2·1) | 1·0 (−4·9 to 6·8) | 0·73 | −15 (2·1) | −14·1 (2·2) | −0·5 (−6·5 to 5·6) | 0·88 |
| DAS28-ESR, least squares mean change at week 16 | −1·5 (0·2) | −2·6 (0·2) | 1·1 (0·5 to 1·8) | 0·0009 | −1·7 (0·2) | −2·4 (0·2) | 0·7 (0·1 to 1·4) | 0·026 |
| DAS28-CRP, least squares mean change at week 16 | −1·5 (0·2) | −2·0 (0·2) | 0·6 (−0·0 to 1·1) | 0·059 | −1·7 (0·2) | −1·9 (0·2) | 0·3 (−0·3 to 0·9) | 0·34 |
| HAQ, least squares mean change at week 16 | −0·3 (0·1) | −0·4 (0·1) | 0·1 (−0·2 to 0·4) | 0·41 | −0·3 (0·1) | −0·5 (0·1) | 0·2 (−0·0 to 0·5) | 0·085 |
| FACIT, least squares mean change at week 16 | 8·5 (1·9) | 7·8 (2·0) | 0·7 (−4·8 to 6·3) | 0·79 | 6·9 (1·8) | 8·34 (1·9) | −1·5 (−6·7 to 3·8) | 0·58 |
| SF36-PCS, least squares mean change at week 16 | 7·0 (2·0) | 8·5 (2·1) | −1·5 (−7·2 to 4·2) | 0·59 | 6·9 (1·9) | 10·9 (2·1) | −4·0 (−9·6 to 1·6) | 0·16 |
| SF36-MCS, least squares mean change at week 16 | 5·4 (2·2) | 3·3 (2·4) | 2·1 (−4·5 to 8·5) | 0·53 | 4·4 (2·3) | 3·01 (2·5) | 1·4 (−5·4 to 8·2) | 0·68 |
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).