Table 2.
Summary of patient-reported and composite outcome measures through Week52 of the DISCOVER-1 tTrial
| Guselkumab 100 mg Q4W | Guselkumab 100 mg Q8W | Placebo (Week0-20)→ Guselkumab 100 mg Q4W (Week24-48) | ||||
| Week24* | Week52 | Week24* | Week52 | Week24* | Week52 | |
| HAQ-DI, N | 128 | 127 | 126† | |||
| LSmean change‡ | −0.4 | −0.5 | −0.3 | −0.4 | −0.1 | −0.3 |
| 95% CI | −0.5 to –0.3 | −0.6 to –0.4 | −0.4 to –0.2 | −0.5 to –0.3 | −0.2 to 0.0 | −0.4 to –0.2 |
| HAQ-DI ≥0.35 at Week0, N | 110 | 112 | 110§ | |||
| ≥0.35 improvement, % | 57.3 | 67.3 | 50.9 | 51.8 | 29.1 | 45.5 |
| TNFi-naïve, n/N (%) | 43/77 (55.8) | 53/77 (68.8) | 37/73 (50.7) | 37/73 (50.7) | 22/74 (29.7) | 33/74 (44.6) |
| TNFi-experienced, n/N (%) | 20/33 (60.6) | 21/33 (63.6) | 20/39 (51.3) | 21/39 (53.8) | 10/36 (27.8) | 17/36 (47.2) |
| SF-36 core, N | 128 | 127 | 126† | |||
| PCS, LSmean change‡ | 6.9 | 8.6 | 6.1 | 6.6 | 2.0 | 5.5 |
| 95% CI | 5.6 to 8.1 | 7.2 to 10.0 | 4.8 to 7.4 | 5.2 to 8. 0 | 0.7 to 3.2 | 4.1 to 6.9 |
| MCS, LSmean change‡ | 3.6 | 4.3 | 3.2 | 4.4 | 2.4 | 4.1 |
| 95% CI | 2.2 to 5.0 | 3.0 to 5.6 | 1.8 to 4.6 | 3.1 to 5.7 | 0.9 to 3.8 | 2.8 to 5.4 |
| Composite indices¶, N | 128 | 127 | 126† | |||
| MDA, % | 30.5 | 39.1 | 22.8 | 29.9 | 11.1 | 25.4 |
| TNFi-naïve, n/N (%) | 29/90 (32.2) | 39/90 (43.3) | 22/86 (25.6) | 29/86 (33.7) | 13/87 (14.9) | 27/87 (31.0) |
| TNFi-experienced, n/N (%) | 10/38 (26.3) | 11/38 (28.9) | 7/41 (17.1) | 9/41 (22.0) | 1/39 (2.6) | 5/39 (12.8) |
| VLDA, % | 9.4 | 16.4 | 3.9 | 11.0 | 1.6 | 11.9 |
Data shown for randomised and treated patients, with imputation of missing data.
*Previously reported Week24 data14 are shown for reference.
†114 patients crossed over to guselkumab 100 mg Q4W (after Week24 response assessments); 12 patients who received only placebo before discontinuing study agent were included as non-responders at Week52.
‡The LSmean was adjusted for baseline DMARD use (yes/no), prior TNFi use (yes/no) and baseline value.
§100 patients crossed over to guselkumab 100mg Q4W (after Week24 response assessments); 10 patients who received only placebo before discontinuing study agent were included as non-responders at Week52.
¶MDA required meeting ≥5/7 and VLDA required meeting all 7 of the following criteria: tender joint count ≤1, swollen joint count ≤1, Psoriasis Area and Severity Index score ≤1, patient pain VAS score ≤15, patient global disease activity VAS score ≤20, HAQ-DI score ≤0.5 and tender entheseal points ≤1.
DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; LS, least squares; MCS, mental component summary; MDA, minimal disease activity; PCS, physical component summary; Q4/8W, every 4/8 weeks; SF-36, 36-item Short-Form Health Survey; TNFi, tumor necrosis factor inhibitor; VAS, Visual Analog Scale; VLDA, very low disease activity.