Guselkumab 100 mg Q4W | Guselkumab 100 mg Q8W | |||||||||
Week | 8 | 16 | 24 | 52 | 100 | 8 | 16 | 24 | 52 | 100 |
DAPSA | ||||||||||
LDA (≤14) | 43 (18) | 61 (25) | 88 (36) | 125 (51) | 151 (62) | 43 (17) | 79 (32) | 97 (39) | 130 (52) | 147 (59) |
Remission (≤4) | 5 (2) | 12 (5) | 21 (9) | 39 (16) | 52 (21) | 3 (1) | 15 (6) | 23 (9) | 46 (19) | 60 (24) |
cDAPSA | ||||||||||
LDA (≤13)* | 41 (17) | 58 (24) | 89 (36) | 125 (51) | 150 (61) | 44 (18) | 75 (30) | 95 (38) | 131 (53) | 147 (60) |
Remission (≤4) | 5 (2) | 13 (5) | 29 (12) | 44 (18) | 59 (24) | 4 (2) | 19 (8) | 25 (10) | 53 (21) | 65 (26) |
Enthesitis resolution† | 45 (27) | 66 (40) | 71 (43) | 93 (56) | 102 (61) | 50 (32) | 75 (48) | 87 (55) | 97 (62) | 110 (70) |
Dactylitis resolution† | 39 (32) | 64 (53) | 80 (66) | 90 (74) | 87 (72) | 34 (31) | 51 (46) | 66 (59) | 86 (77) | 92 (83) |
Skin response | ||||||||||
PASI 90‡§ | – | 100 (54) | 114 (62) | 142 (77) | 136 (74) | – | 97 (55) | 121 (69) | 131 (74) | 123 (70) |
PASI 100‡§ | – | 62 (34) | 83 (45) | 106 (58) | 109 (59) | – | 48 (27) | 80 (45) | 93 (53) | 94 (53) |
IGA 0/1 response‡§¶ | – | 122 (66) | 127 (69) | 147 (80) | 140 (76) | – | 110 (62) | 124 (70) | 131 (74) | 126 (72) |
Skin VAS ≤15 mm§** | 26 (14) | 58 (32) | 68 (37) | 93 (51) | 96 (53) | 38 (22) | 61 (36) | 71 (42) | 88 (52) | 95 (56) |
PASDAS | ||||||||||
LDA (≤3.2) | 25 (10) | 44 (18) | 58 (24) | 105 (43) | 126 (51) | 28 (11) | 56 (23) | 76 (31) | 106 (43) | 122 (49) |
Remission (≤1.9) | 4 (2) | 11 (4) | 22 (9) | 36 (15) | 51 (21) | 2 (1) | 16 (6) | 23 (9) | 52 (21) | 58 (23) |
MDA* | 8 (3) | 33 (14) | 47 (19) | 83 (34) | 93 (38) | 9 (4) | 42 (17) | 63 (25) | 77 (31) | 100 (40) |
Absolute change in response rate from previous visit | ||||||||||
±1 to <5 | +5 to <10 | +10 to <15 | +15 to <20 | ≥20 |
Number (%) of guselkumab-randomised patients (N=493) achieving therapeutic endpoints over time (NRI) are shown.
*Excludes patients who achieved endpoint at baseline.
†Among patients with domain at baseline.
‡PASI and IGA not assessed at Week 8.
§Among patients with baseline BSA ≥3% and IGA ≥2 .
¶IGA skin response=score of 0 or 1 and ≥2 grade improvement from baseline.
**Patients with Skin VAS >15mm at baseline.
BSA, body surface area; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; DAPSA, Disease Activity Index for Psoriatic Arthritis; IGA, Investigator’s Global Assessment of psoriasis; LDA, low disease activity; MDA, minimal disease activity; NRI, non-responder imputation; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI 90/100, ≥90% improvement/100% improvement in Psoriasis Area and Severity Index; Q4W, every 4 weeks; Q8W, every 8 weeks; VAS, Visual Analogue Scale.