Table 1.
Extraarticular and HRQoL assessments, composite indices, and radiographic progression through week 100 in the DISCOVER‐2 study*
| Guselkumab Q4W | Guselkumab Q8W | Placebo–guselkumab crossover Q4W | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Week 24 | Week 52 | Week 100 | Week 24 | Week 52 | Week 100 | Week 24 | Week 52 | Week 100 | |
| No. patients with enthesitis at week 0 | 170 | 170 | 170 | 158 | 158 | 158 | 178 | 178 | 178 |
| Enthesitis resolution, % | 44 | 57 | 62 | 54 | 61 | 70 | 30 | 64 | 65 |
| LSM change (95% CI) | −1.5 (−1.8, −1.3) | −1.8 (−2.0, −1.6) | −1.9 (−2.1, −1.7) | −1.6 (−1.8, −1.4) | −1.9 (−2.1, −1.7) | −2.1 (−2.3, −1.8) | −1.0 (−1.3, −0.8) | −2.0 (−2.2, −1.8) | −2.1 (−2.3, −1.9) |
|
No. patients with dactylitis at week 0 |
121 | 121 | 121 | 111 | 111 | 111 | 99 | 99 | 99 |
| Dactylitis resolution, % | 64 | 74 | 72 | 57 | 78 | 83 | 38 | 74 | 73 |
| LSM change (95% CI) | −5.9 (−6.7, −5.0) | −6.5 (−7.2, −5.8) | −6.5 (−7.1, −5.8) | −6.0 (−6.8, −5.1) | −7.2 (−7.9, −6.5) | −7.5 (−8.1, −6.8) | −4.0 (−5.0, −3.1) | −6.9 (−7.6, −6.2) | −6.9 (−7.6, −6.2) |
| HAQ DI | |||||||||
| No. patients assessed | 245 | 245 | 245 | 248 | 248 | 248 | 246 | 246 | 246 |
| LSM change (95% CI) | −0.40 (−0.46, −0.34) | −0.49 (−0.56, −0.42) | −0.55 (−0.62, −0.48) | −0.37 (−0.43, 0.31) | −0.45 (−0.52, −0.38) | −0.53 (−0.59, −0.46) | −0.13 (−0.19, −0.07) | −0.35 (−0.42, −0.29) | −0.46 (−0.53, −0.40) |
|
No. patients with HAQ DI ≥0.35 at week 0 |
228 | 228 | 228 | 228 | 228 | 228 | 236 | 236 | 236 |
| Improvement ≥0.35, % | 56 | 59 | 63 | 50 | 58 | 64 | 31 | 48 | 56 |
|
No. patients with HAQ DI >0.5 at week 0 |
214 | 214 | 214 | 211 | 211 | 211 | 218 | 218 | 218 |
| HAQ DI score ≤0.5, % | 29 | 36 | 40 | 23 | 28 | 35 | 14 | 31 | 33 |
| SF‐36 | |||||||||
| No. patients assessed | 245 | 245 | 245 | 248 | 248 | 248 | 246 | 246 | 246 |
|
LSM change in PCS (95% CI) |
7.0 (6.1, 7.9) | 8.6 (7.6, 9.6) | 10.0 (8.9, 11.1) | 7.4 (6.5, 8.3) | 9.0 (7.9, 10.0) | 10.4 (9.3, 11.5) | 3.4 (2.5, 4.3) | 7.5 (6.5, 8.6) | 9.3 (8.2, 10.4) |
| Improvement ≥5, % | 56 | 61 | 62 | 60 | 63 | 63 | 40 | 59 | 63 |
|
LSM change in MCS (95% CI) |
4.2 (3.1, 5.3) | 4.5 (3.4, 5.5) | 4.9 (3.9, 6.0) | 4.2 (3.1, 5.2) | 4.3 (3.3, 5.4) | 4.2 (3.2, 5.3) | 2.1 (1.1, 3.2) | 4.0 (3.0, 5.1) | 3.9 (2.8, 4.9) |
| Improvement ≥5, % | 34 | 36 | 39 | 38 | 42 | 42 | 31 | 39 | 37 |
| Composite indices | |||||||||
| MDA, % | 19 | 34 | 38 | 25 | 31 | 40 | 6 | 30 | 37 |
| VLDA, % | 5 | 11 | 14 | 4 | 16 | 17 | 1 | 7 | 13 |
| Radiographic results† | |||||||||
| No. patients assessed | 221 | 221 | 211 | 228 | 228 | 216 | 215 | 213 | 202 |
|
Changes in Sharp/van der Heijde modified score for PsA, mean ± SD |
0.48 ± 2.70 | 0.57 ± 2.67 | 0.75 ± 4.02 | 0.68 ± 2.36 | 0.31 ± 1.57 | 0.46 ± 2.42 | 1.12 ± 3.80 | 0.34 ± 2.79 | 0.13 ± 3.74 |
Data are summarized by treatment group with application of missing data handling rules, with the exception of radiographic results (see Patients and Methods). Clinical efficacy and health‐related quality of life (HRQoL) results at week 24 (ref. 16) and week 52 (ref. 17) were previously published and are included here for reference. Q4W = every 4 weeks; Q8W = every 8 weeks; LSM = least squares mean; 95% CI = 95% confidence interval; HAQ DI = Health Assessment Questionnaire disability index; SF‐36 = Short Form 36; PCS = physical component summary; MCS = mental component summary; PsA = psoriatic arthritis; MDA = minimal disease activity; VLDA = very low disease activity.
Corresponding study periods for radiographic results are weeks 0–24, weeks 24–52, and weeks 52–100.