Secondary efficacy assessments at week 28
| Ustekinumab+MTX | Guselkumab+MTX | ||||||
|---|---|---|---|---|---|---|---|
| Placebo+MTX (N=55) | 90 mg every 8 weeks (N=55) | 90 mg every 12 weeks (N=55) | Combined | 50 mg every 8 weeks (N=55) | 200 mg every 8 weeks (N=54) | Combined | |
| Patients, n | 55 | 54 | 55 | 109 | 55 | 54 | 109 |
| ACR20, n (%) | 22 (40.0) | 29 (53.7) | 30 (54.5) | 59 (54.1) | 21 (38.2) | 24 (44.4) | 45 (41.3) |
| ACR50, n (%) | 8 (14.5) | 12 (22.2) | 8 (14.5) | 20 (18.3) | 12 (21.8) | 12 (22.2) | 24 (22.0) |
| ACR70, n (%) | 3 (5.5) | 8 (14.8) | 3 (5.5) | 11 (10.1) | 3 (5.5) | 4 (7.4) | 7 (6.4) |
| Per cent change in ACR core components, median (IQR) | |||||||
| SJC | −26.7 (−75.0, 7.1) | −65.2 (−91.2, −28.6) | −71.9 (−86.7, −40.0) | −69.7 (−87.5, −34.8) | −50.0 (−86.7, −25.0) | −58.6 (−86.7, −40.0) | −57.1 (−86.7, −27.3) |
| TJC | −23.7 (−68.0, 13.6) | −43.7 (−79.2, −16.7) | −50.0 (−72.2, −25.0) | −45.8 (−75.0, −21.4) | −50.0 (−77.8, −15.8) | −45.0 (−71.4, −20.8) | −50.0 (−73.3, −20.5) |
| Pain, VAS | −25.8 (−56.5, 11.1) | −31.9 (−48.5, −8.8) | −20.8 (−47.7, 2.2) | −23.5 (−48.3, −5.7) | −15.6 (−45.3, 2.5) | −19.9 (−38.5, 1.2) | −19.7 (−40.0, 2.0) |
| Patient's global assessment of disease activity | −22.8 (−50.0, 4.6) | −31.0 (−58.3, −12.2) | −25.0 (−46.8, −4.2) | −30.1 (−49.3, −6.3) | −17.0 (−58.6, 3.7) | −16.7 (−38.9, 1.2) | −16.9 (−41.3, 2.4) |
| Physician's global assessment of disease activity | −26.4 (−59.4, −5.7) | −41.4 (−82.0, −16.7) | −49.4 (−64.7, −25.7) | −45.5 (−73.9, −23.3) | −52.0 (−71.9, −24.6) | −44.8 (−68.1, −20.4) | −49.2 (−71.0, −20.4) |
| HAQ-DI | −14.3 (−36.8, 6.3) | −21.1 (−57.1, −4.5) | −20.0 (−40.0, −7.1) | −20.0 (−45.5, −5.9) | −26.3 (−45.0. 0.0) | −18.8 (−45.0, 5.6) | −23.8 (−45.0, 0.0) |
| CRP | −28.4 (−60.6, 37.8) | −24.8 (−76.6, 26.1) | −29.1 (−69.1, 50.5) | −24.8 (−72.8, 40.8) | 0.0 (−40.2, 141.2) | −36.0 (−69.3, 51.4) | −7.2 (−55.3, 88.4) |
| DAS28-CRP change from baseline, least squares mean (95% CI) | −0.9 (−1.3, −0.6) | −1.5* (−1.9, −1.2) | −1.5* (−1.9, −1.1) | −1.5** (−1.8, −1.3) | −1.4 (−1.8, −1.1) | −1.2 (−1.5, −0.9) | −1.3 (−1.6, −1.1) |
| DAS28-CRP response, n (%) | 24 (43.6) | 36 (66.7) | 33 (60.0) | 69 (63.3) | 31 (56.4) | 32 (59.3) | 63 (57.8) |
| CDAI change from baseline, mean±SD | −11.3±16.4 | −17.2±16.8 | −19.9±10.9** | −18.6±14.2** | −16.7±12.8 | −18.6±14.9* | −17.6±13.8* |
| SDAI change from baseline, mean±SD | −11.4±17.0 | −17.9±17.5 | −20.4±11.6** | −19.2±14.8** | −16.5±13.1 | −19.1±15.5* | −17.8±14.3* |
| Patients in remission, n (%) | 0 | 3 (5.6) | 1 (1.8) | 4 (3.7) | 0 | 1 (1.9) | 1 (0.9) |
| HAQ-DI change from baseline, least squares mean (95% CI) | −0.3 (−0.4, −0.1) | −0.4 (−0.6, −0.3) | −0.5 (−0.6, −0.3) | −0.5 (−0.6, −0.4) | −0.4 (−0.5, −0.2) | −0.4 (−0.6, −0.3) | −0.4 (−0.5, −0.3) |
*p<0.05; **p<0.01.
ACR20/50/70, ≥20%/50%/70% improvement in the American College of Rheumatology criteria; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28-CRP; 28-joint count Disease Activity Score with CRP; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.