Table 2

Summary of patient-reported and composite outcome measures through Week52 of the DISCOVER-1 tTrial

Guselkumab 100 mg Q4WGuselkumab 100 mg Q8WPlacebo (Week0-20)→ Guselkumab 100 mg Q4W (Week24-48)
Week24*Week52Week24*Week52Week24*Week52
HAQ-DI, N128127126†
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, N110112110§
≥0.35 improvement, %57.367.350.951.829.145.5
 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, N128127126†
PCS, LSmean change‡6.98.66.16.62.05.5
 95% CI5.6 to 8.17.2 to 10.04.8 to 7.45.2 to 8. 00.7 to 3.24.1 to 6.9
MCS, LSmean change‡3.64.33.24.42.44.1
 95% CI2.2 to 5.03.0 to 5.61.8 to 4.63.1 to 5.70.9 to 3.82.8 to 5.4
Composite indices¶, N128127126†
MDA, %30.539.122.829.911.125.4
 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, %9.416.43.911.01.611.9
  • 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.