Table 2.
Additional secondary efficacy assessments at week 24 and week 48 analysed using non-responder imputation*
| Week 24 | Week 48 | |||
| Guselkumab 100 mg Q8W |
Placebo | Guselkumab 100 mg Q8W |
Placebo→guselkumab 100 mg Q8W |
|
| Treated participants according to randomised group, N | 189 | 96 | 189 | 51 |
| ACR70 response | 15 (7.9%) | 1 (1.0%) | 45 (23.8%) | 9 (17.6%) |
| % difference (95% CI)† | 6.8 (2.6 to 11.1) | |||
| Unadjusted p value vs placebo‡ | 0.018 | |||
| Enthesitis resolution (LEI score=0)§ | 50/126 (39.7%) | 12/64 (18.8%) | 70/126 (55.6%) | 14/35 (40.0%) |
| % difference (95% CI)† | 21.6 (8.8 to 34.4) | |||
| Unadjusted p value vs placebo‡ | 0.003 | |||
| Dactylitis resolution (DSS=0)¶ | 30/67 (44.8%) | 9/36 (25.0%) | 45/67 (67.2%) | 11/13 (84.6%) |
| % difference (95% CI)† | 19.9 (2.7 to 37.1) | |||
| Unadjusted p value vs placebo‡ | 0.040 | |||
| IGA response (IGA 0/1 and ≥2-grade improvement from baseline)** | 64/133 (48.1%) | 5/53 (9.4%) | 87/133 (65.4%) | 14/23 (60.9%) |
| % difference (95% CI)† | 38.8 (27.3 to 50.4) | |||
| Unadjusted p value vs placebo‡ | <0.001 | |||
| PASI75 response** | 79/133 (59.4%) | 5/53 (9.4%) | 99/133 (74.4%) | 19/23 (82.6%) |
| % difference (95% CI)† | 49.6 (38.3 to 60.9) | |||
| Unadjusted p value vs placebo‡ | <0.001 | |||
| PASI90 response** | 68/133 (51.1%) | 4/53 (7.5%) | 89/133 (66.9%) | 14/23 (60.9%) |
| % difference (95% CI)† | 43.7 (32.7 to 54.7) | |||
| Unadjusted p value vs placebo‡ | <0.001 | |||
| HAQ-DI response (≥0.35 improvement from baseline)†† | 66/176 (37.5%) | 14/87 (16.1%) | 94 (53.4%) | 17 (37.0%) |
| % difference (95% CI)† | 21.5 (11.1 to 31.9) | |||
| Unadjusted p value vs placebo‡ | <0.001 | |||
| SF-36 MCS score | ||||
| LSmean change from baseline‡‡ | 2.10 (0.54 to 3.65) | 0.36 (−1.52 to 2.25) | – | – |
| LSmean difference (95% CI)† | 1.73 (−0.14 to 3.61) | – | – | |
| Unadjusted p value vs placebo‡‡ | 0.070 | |||
| Mean change from baseline (SD)§§ | – | – | 3.05 (9.95) | 3.82 (8.91) |
| FACIT-F response (≥4-point improvement from baseline) | 81 (42.9%) | 20 (20.8%) | 105 (55.6%) | 26 (51.0%) |
| % difference (95% CI)† | 21.9 (11.2 to 32.7) | |||
| Unadjusted p value vs placebo‡ | <0.001 | |||
| DAPSA score | ||||
| LSmean change from baseline‡‡ | −14.5 | −5.7 | – | – |
| LSmean difference (95% CI)† | −8.8 (12.5 to –5.0) | – | – | |
| Unadjusted p value vs placebo‡‡ | <0.001 | |||
| Mean change from baseline (SD)§§ | – | – | −23.4 (19.8) | −20.3 (15.9) |
| DAPSA LDA (≤14) | 56 (29.6%) | 13 (13.5%) | 84 (44.4%) | 21 (41.2%) |
| % difference (95% CI)† | 16.0 (6.7 to 25.4) | |||
| Unadjusted p value vs placebo‡ | 0.003 | |||
| DAPSA remission (≤4) | 10 (5.3%) | 2 (2.1%) | 30 (15.9%) | 6 (11.8%) |
| % difference (95% CI)† | 3.2 (−1.1 to 7.5) | |||
| Unadjusted p value vs placebo‡ | 0.202 | |||
| MDA | 28 (14.8%) | 3 (3.1%) | 51 (27.0%) | 14 (27.5%) |
| % difference (95% CI)† | 11.7 (5.6 to 17.7) | |||
| Unadjusted p value vs placebo‡ | 0.003 | |||
| VLDA | 7 (3.7%) | 0 | 21 (11.1%) | 2 (3.9%) |
| % difference (95% CI)† | 3.7 (1.0 to 6.4) | |||
| Unadjusted p value vs placebo‡ | 0.057 | |||
Data shown are n (%) or n/N (%) unless stated otherwise.
*Through week 24, patients who discontinued study agent/study participation for any reason, initiated or increased the dose of allowed csDMARDs/oral corticosteroids over baseline for PsA, initiated protocol-prohibited medications/therapies for PsA or met EE criteria (including those incorrectly assigned to EE) were considered to be non-responders or to have no improvement from baseline at subsequent timepoints. After week 24, patients who met the EE criteria (excluding those who were incorrectly assigned to EE) and patients who discontinued study agent/study participation for any reason were considered to be non-responders or to have no improvement from baseline at subsequent timepoints; missing data were imputed as non-response or multiple imputation (assumed to be missing-at-random). Among patients randomised to placebo, only those who crossed over to guselkumab at week 24 were included in the week 48 analyses.
†CIs based on Wald statistic.
‡Unadjusted (nominal) p values based on the Cochran–Mantel–Haenszel test, stratified by baseline use of csDMARD (yes/no) and prior exposure to TNFi (1 vs 2).
§In patients with LEI score ≥1 at baseline.
¶In patients with DSS ≥1 at baseline.
**In patients with ≥3% BSA psoriasis involvement and IGA ≥2 at baseline.
††In patients with HAQ-DI score ≥0.35 at baseline.
‡‡LSmeans and unadjusted (nominal) p values based on a mixed model for repeated measures under the missing-at-random assumption for missing data. LSmeans were determined only through week 24.
§§Post-week 24, mean changes from baseline were determined using change of 0 for patients who discontinued or met the EE criteria prior to week 24 (excluding patients incorrectly assigned to EE) and multiple imputation (assumed to be missing-at-random) for missing data.
ACR, American College of Rheumatology; BSA, body surface area; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAPSA, Disease Activity in Psoriatic Arthritis; DSS, Dactylitis Severity Score; EE, early escape; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; IGA, Investigator’s Global Assessment of psoriasis; LDA, low disease activity; LEI, Leeds Enthesitis Index; LS, least squares; MDA, Minimal Disease Activity; PASI75/90, ≥75%/90% improvement in Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q8W, every 8 weeks; SF-36 MCS, 36-item Short-Form Health Survey Mental Component Summary; TNFi, tumour necrosis factor inhibitor; VLDA, very low disease activity.